Thymogen (oglufanide)

updated

Thymogen is the synthetic dipeptide L-glutamyl-L-tryptophan (Glu-Trp, oglufanide), first found in the calf thymus extract Thymalin. A commercial Russian drug reference lists three Thymogen products, and small Russian randomized trials report effects on surrogate endpoints in sick patients. A US phase III of the disodium salt IM862 in Kaposi's sarcoma was negative, no trial gave it to healthy people, and no FDA approval or label was found.

Synthetic dipeptide immunomodulator

  • PubChem lists Oglufanide as CID 100094, C16H19N3O5, molecular weight 333.34, CAS 38101-59-6, with Thymogen among its synonyms. The disodium salt, IM862, is a separate record, CID 158780.
  • A 2000 paper states that L-Glu-L-Trp was isolated from the calf thymic peptide complex Thymalin and that a pharmaceutical designed on the synthesized dipeptide later received the brand name Thymogen. It is a synthetic dipeptide, not an extract.
  • A commercial Russian drug reference lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection, a nasal spray and a cream. The readings were not confirmed against the state register.
  • A US phase III in 202 HIV-positive patients with Kaposi's sarcoma found response in 23% on IM862 versus 21% on placebo (P = .46), and a shorter median time to progression on IM862 (16 versus 35 weeks, P = .012).
  • A 2023 randomized placebo-controlled study in 116 patients with H. pylori-associated chronic atrophic gastritis found gland number up 26.1% from baseline on alpha-glutamyl-tryptophan (p = 0.028). The abstract gives no dose, route, duration or trade name.
  • A PubMed search on 10 October 2026 found no trial in healthy people for immune function, no human pharmacokinetics and no independent replication of the Russian trials.

What is Thymogen, and where is it approved?

Thymogen is the synthetic dipeptide L-glutamyl-L-tryptophan (Glu-Trp, oglufanide), first found in the calf thymus extract Thymalin. A commercial Russian drug reference lists three Thymogen products, and no FDA approval or label was found on 10 October 2026.

PubChem lists Oglufanide as CID 100094, C16H19N3O5, molecular weight 333.34, CAS 38101-59-6 (122933-59-9 is also listed), with synonyms that include Thymogen, Glutamyltryptophan, alpha-Glu-Trp and L-alpha-Glu-L-Trp. The disodium salt is a separate record, Oglufanide disodium, CID 158780, C16H17N3Na2O5, molecular weight 377.30, CAS 237068-57-4, with synonyms IM862 and Oglufanide disodium [USAN]. The ClinicalTrials.gov record NCT00003773 lists its intervention as oglufanide disodium under the study title IM-862, which ties the registry name IM862 to the same salt. The active form is the alpha-linked L-glutamyl-L-tryptophan dipeptide.

A 2000 paper states that L-Glu-L-Trp was isolated from the calf thymic peptide complex Thymalin by reverse-phase high performance liquid chromatography, and that a pharmaceutical designed on the synthesized dipeptide later received the brand name Thymogen. Thymogen is therefore a synthetic dipeptide first found in Thymalin, not an extract. Thymalin, the extract-based drug, has its own page on this site and is not the same product.

Vidal.ru, a commercial drug reference, lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, for intramuscular use), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC code L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries. These are secondary-source readings and were not confirmed against the Russian state register, so no certificate numbers or dates are quoted here.

On 10 October 2026, an openFDA Drugs@FDA query for oglufanide returned no match, and DailyMed searches for oglufanide and for thymogen returned no label. Oglufanide has USAN and WHO drug dictionary names in PubChem, but no FDA approval or label was found. ClinicalTrials.gov holds four IM862 or oglufanide records, none with posted results, which are described in the cancer trials section below.

PubChem: oglufanide (Thymogen) and IM862 disodium salt identity

Chemical identity record

National Library of Medicine. PubChem compound records CID 100094 (Oglufanide) and CID 158780 (Oglufanide disodium). ClinicalTrials.gov record NCT00003773 for the IM862 naming.

PubChem lists Oglufanide as CID 100094, C16H19N3O5, molecular weight 333.34, CAS 38101-59-6 (122933-59-9 is also listed), with synonyms that include Thymogen, Glutamyltryptophan, alpha-Glu-Trp and L-alpha-Glu-L-Trp. The disodium salt is a separate record, Oglufanide disodium, CID 158780, C16H17N3Na2O5, molecular weight 377.30, CAS 237068-57-4, with synonyms IM862 and Oglufanide disodium [USAN]. The ClinicalTrials.gov record NCT00003773 lists its intervention as oglufanide disodium under the study title IM-862, which ties the registry name IM862 to the same salt. The active form is the alpha-linked L-glutamyl-L-tryptophan dipeptide.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined dipeptide (free acid and disodium salt)
Follow-up
Not applicable
Study design
NLM chemical record and registry record
Funding
not stated in the source

Oglufanide has USAN and WHO drug dictionary names in PubChem, but no FDA approval or label was found.

Read the original source
2000 rat paper: origin of Thymogen, 12-month subcutaneous study in 76 female rats

Animal study

Anisimov VN et al. Biogerontology. 2000;1(1):55-9. PMID 11707921.

A 2000 paper states that L-Glu-L-Trp was isolated from the calf thymic peptide complex Thymalin by reverse-phase high performance liquid chromatography, and that a pharmaceutical designed on the synthesized dipeptide later received the brand name Thymogen. In 76 five-month-old outbred female rats given 5 micrograms per rat of the dipeptide (44 rats) or saline (32 rats) subcutaneously 5 times a week for 12 months, mean life span was similar, but the longest-lived 10% of treated rats lived 1048 days versus 949 days in controls (P less than 0.001). Total tumor incidence was 1.5 times lower, malignant tumor incidence 1.7 times lower, and leukemias and lymphomas 3.4 times lower in treated rats.

Participants / model
Outbred female rats
Treatment
Subcutaneous L-Glu-L-Trp, 5 micrograms per rat, 5 times a week for 12 months
Follow-up
12 months
Study design
Original preclinical study
Funding
not stated in the source

A rat study from the originating group, with Khavinson as a co-author. Thymogen is a synthetic dipeptide first found in Thymalin, not an extract.

Read the original source
Vidal.ru (commercial reference): three Thymogen products, Russia

Regulatory record

Vidal.ru drug reference, Thymogen product pages (holder MBNPK Cytomed, Russia). A commercial reference, not the Russian state register. A 2009 review (PMID 19355963) lists Thymogen among interferon inducers.

Vidal.ru lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, solution for intramuscular injection), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication in prose is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries (PMID 19355963).

Participants / model
Patients with infections and immune deficiency, per the indication text
Treatment
Intramuscular injection, nasal spray and cream in Russia
Follow-up
Not applicable
Study design
Commercial drug reference, not the state register
Funding
not stated in the source

These are secondary-source readings and were not confirmed against the Russian state register (grls.rosminzdrav.ru), so no certificate numbers or dates are quoted on the page.

Read the original source
FDA, DailyMed and ClinicalTrials.gov: no US approval; four IM862 records, none with results

Trial registry record

ClinicalTrials.gov record NCT00002445 (phase 3, Kaposi's sarcoma, sponsor Cytran), with NCT00003773, NCT00006037 and NCT00017303. openFDA Drugs@FDA and DailyMed queries run 10 October 2026.

On 2026-10-10 an openFDA Drugs@FDA query for oglufanide returned no match, and DailyMed searches for oglufanide and for thymogen returned no label. ClinicalTrials.gov holds four IM862 or oglufanide records, none with posted results: a phase 3 randomized double-blind placebo-controlled study in AIDS-related Kaposi's sarcoma sponsored by Cytran (NCT00002445, completed, enrollment 200, last update 2005-06-24), a completed phase 1 in 43 patients with recurrent ovarian cancer (NCT00003773), a terminated phase 2 with chemotherapy in 18 patients with metastatic colorectal cancer (NCT00006037), and a phase 2 in ovarian or primary peritoneal cancer with unknown status (NCT00017303). No results are posted.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10; NCT00002445 last updated 2005-06-24
Study design
Official FDA and NLM records and trial registry
Funding
Sponsor of NCT00002445: Cytran

No FDA approval or label was found. Registry records with no posted results support no efficacy conclusion.

Read the original source

Which compounds are easy to confuse with Thymogen?

Gamma-L-glutamyl-L-tryptophan is a different compound from the alpha dipeptide. Thymodepressin, written D-Glu(D-Trp), is called an immunosuppressor, the opposite of Thymogen's stated effect. Thymalin is the parent extract, not the same product. One abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Gamma-L-glutamyl-L-tryptophan is a different compound from the alpha dipeptide. In a randomized, placebo-controlled crossover study in nine healthy men, a 1 hour intravenous infusion of the gamma isomer did not change urinary 5-HT or sodium excretion compared with placebo (PMID 8877028), so it should not be cited as Thymogen evidence.

The 2024 review that calls Thymogen an immunostimulant (L-Glu-L-Trp) pairs it with Thymodepressin, written D-Glu(D-Trp) and called an immunosuppressor (PMID 38732260). A mirror-image form, and possibly a different linkage that the abstract does not state, therefore exists with the opposite stated effect.

The 2005 phase III abstract describes IM862 as L-glutamine L-tryptophan, which does not match the L-Glu-L-Trp of the 2004 renal cancer abstract (PMID 15354209) or the PubChem record, so this page takes the identity from those. The substance also has other trade names. A 2023 paper names Regasthym Gastro as alpha-glutamyl-tryptophan (PMID 38158980), and a Russian drug reference page for the substance lists Regastim Gastro, Thymogen, Thymogen sodium and Thymogen sodium trituration, with no registration data on that page.

The Khavinson group names this dipeptide (EW) and a Lys-Glu dipeptide (KE) as the active substances of Thymalin, the extract-based drug that has its own page on this site (PMID 37686182). Thymalin is the parent extract and not the same product.

Gamma isomer crossover in 9 healthy men: a different compound, not Thymogen evidence

Chemical identity record

Li Kam Wa TC et al. Br J Clin Pharmacol. 1996;42(3):365-70. PMID 8877028.

Gamma-L-glutamyl-L-tryptophan is a different compound from the alpha dipeptide. In a randomized, placebo-controlled crossover study in nine healthy men, a 1 hour intravenous infusion of the gamma isomer did not change urinary 5-HT or sodium excretion compared with placebo. The 2024 review that calls Thymogen an immunostimulant (L-Glu-L-Trp) pairs it with Thymodepressin, written D-Glu(D-Trp) and called an immunosuppressor (PMID 38732260). The 2005 phase III abstract (PMID 15598977) describes IM862 as L-glutamine L-tryptophan, which does not match the L-Glu-L-Trp of the 2004 renal cancer abstract (PMID 15354209) or the PubChem record. A 2023 paper names Regasthym Gastro as alpha-glutamyl-tryptophan (PMID 38158980), and a Russian drug reference page for the substance lists Regastim Gastro, Thymogen, Thymogen sodium and Thymogen sodium trituration, with no registration data on that page. The Khavinson group names this dipeptide (EW) and a Lys-Glu dipeptide (KE) as the active substances of Thymalin (PMID 37686182).

Participants / model
Chemical identity, not a clinical population; the cited crossover study was in nine healthy men
Treatment
Dipeptide isomers and brand names
Follow-up
Not applicable; the crossover study used a 1 hour intravenous infusion
Study design
Original reports and reviews on identity; the linked crossover study tested the gamma isomer, not Thymogen
Funding
not stated in the source

This row is cited only for identity. The gamma isomer result must not be cited as Thymogen evidence, and Thymodepressin is a different substance with the opposite stated effect. The other papers are described from the same source record and are not separate page sources.

Read the original source
PubChem: oglufanide (Thymogen) and IM862 disodium salt identity

Chemical identity record

National Library of Medicine. PubChem compound records CID 100094 (Oglufanide) and CID 158780 (Oglufanide disodium). ClinicalTrials.gov record NCT00003773 for the IM862 naming.

PubChem lists Oglufanide as CID 100094, C16H19N3O5, molecular weight 333.34, CAS 38101-59-6 (122933-59-9 is also listed), with synonyms that include Thymogen, Glutamyltryptophan, alpha-Glu-Trp and L-alpha-Glu-L-Trp. The disodium salt is a separate record, Oglufanide disodium, CID 158780, C16H17N3Na2O5, molecular weight 377.30, CAS 237068-57-4, with synonyms IM862 and Oglufanide disodium [USAN]. The ClinicalTrials.gov record NCT00003773 lists its intervention as oglufanide disodium under the study title IM-862, which ties the registry name IM862 to the same salt. The active form is the alpha-linked L-glutamyl-L-tryptophan dipeptide.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined dipeptide (free acid and disodium salt)
Follow-up
Not applicable
Study design
NLM chemical record and registry record
Funding
not stated in the source

Oglufanide has USAN and WHO drug dictionary names in PubChem, but no FDA approval or label was found.

Read the original source
Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source

What did the human trials find?

Small Russian randomized trials report effects on surrogate endpoints in sick patients: restored cellular immunity and fewer complications in elderly surgical patients, and more gastric glands in 116 patients with H. pylori gastritis. The US intranasal IM862 cancer trials found no benefit, and no trial gave it to healthy people.

A double-blind, randomized, placebo-controlled Russian study in elderly patients having surgery for solid tumors in the abdominal cavity and retroperitoneal space gave Thymogen by intranasal instillation for 7 days before surgery, against saline. The authors report that it restored parameters of cellular immunity and that complications and the length of the postoperative period fell significantly. The abstract gives no patient numbers, values or statistics, and the dose unit it prints does not match the microgram-scale strengths on the Russian product labels, so no dose is reproduced here. The full text is needed.

A 1996 Russian report in type 1 diabetes with secondary immunodeficiency says a clinical effect was registered in 94.4% and a laboratory effect in 83.3% of patients, with no control group described (PMID 9026934).

In a 2023 multicenter, double-blind, randomized, placebo-controlled Russian study, biopsies from 116 patients with Helicobacter pylori-associated chronic atrophic gastritis were studied. In patients taking alpha-glutamyl-tryptophan, gland number per mm2 of gastric mucosa rose 26.1% from baseline (p = 0.028) and was higher than on placebo (p = 0.026), with a tendency toward fewer signs of intestinal metaplasia, and CDX-2 expression rose from baseline (p = 0.015). CXCL-12 expression rose in the placebo group and did not change in the treated group. The authors call the drug a repair stimulator. The abstract gives no dose, route, duration or trade name, and the endpoints are biopsy measures rather than symptoms.

A second 2023 analysis of a double-blind placebo-controlled study (PMID 38158980) reviewed endoscopy and morphometry retrospectively in 80 patients with the same disease, 43 on Regasthym Gastro (named in the abstract as alpha-glutamyl-tryptophan) and 37 on placebo, and found a significant fall in mucosal edema (p = 0.008) and in a combined inflammation score (p = 0.006). Neither gastritis abstract names Thymogen, so this page says alpha-glutamyl-tryptophan when citing them.

A PubMed search on 10 October 2026 for thymogen, oglufanide, IM862 or alpha-glutamyl-tryptophan with randomized, placebo or double-blind terms returned 10 records. Six are human randomized or placebo-controlled studies. The other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. In the records reviewed there is no trial in healthy people for immune function and no head-to-head or independent replication of the Russian trials.

Russian surgical trial: cellular immunity and complications, no numbers in the abstract

Randomized controlled trial

Smirnov VS et al. Adv Gerontol. 2011;24(2):278-84. PMID 21957588.

A double-blind, randomized, placebo-controlled study in elderly patients having surgery for solid tumors in the abdominal cavity and retroperitoneal space gave Thymogen by intranasal instillation for 7 days before surgery, against saline. The authors report that it restored parameters of cellular immunity and that complications and the length of the postoperative period fell significantly. A 1996 Russian report in type 1 diabetes with secondary immunodeficiency says a clinical effect was registered in 94.4% and a laboratory effect in 83.3% of patients, with no control group described (PMID 9026934).

Participants / model
Elderly surgical patients with abdominal tumors; patients with type 1 diabetes (1996 report)
Treatment
Intranasal Thymogen before surgery; scheme for diabetes not stated
Follow-up
7 days before surgery
Study design
Randomized, double-blind, placebo-controlled study (Russian language)
Funding
not stated in the source

The abstract gives no patient numbers, no values and no statistics. It prints the dose in mg, which does not match the microgram-scale strengths on the Russian labels, so the full text is needed and no dose is reproduced. The 1996 report is described from the same source record and is not a separate page source.

Read the original source
2023 gastritis trial: 116 patients, gland count up 26.1%, biopsy endpoints

Randomized controlled trial

Baryshnikova NV et al. Arkh Patol. 2023;85(3):54-63. PMID 37272441.

In a multicenter, double-blind, randomized, placebo-controlled study, biopsies from 116 patients with Helicobacter pylori-associated chronic atrophic gastritis were studied. In patients taking alpha-glutamyl-tryptophan, gland number per mm2 of gastric mucosa rose 26.1% from baseline (p = 0.028) and was higher than on placebo (p = 0.026), with a tendency toward fewer signs of intestinal metaplasia, and CDX-2 expression rose from baseline (p = 0.015). CXCL-12 expression rose in the placebo group and did not change in the treated group. A second 2023 analysis of a double-blind placebo-controlled study (PMID 38158980) reviewed endoscopy and morphometry retrospectively in 80 patients with the same disease, 43 on Regasthym Gastro (named in the abstract as alpha-glutamyl-tryptophan) and 37 on placebo, and found a significant fall in mucosal edema (p = 0.008) and in a combined inflammation score (p = 0.006).

Participants / model
116 patients with H. pylori-associated chronic atrophic gastritis; 80 patients in the second analysis
Treatment
alpha-glutamyl-tryptophan; dose and route not stated in the abstract
Follow-up
not stated in the source
Study design
Randomized, double-blind, placebo-controlled study (Russian language); second analysis retrospective
Funding
not stated in the source

The authors call the drug a repair stimulator. The abstract gives no dose, route, duration or trade name, and the endpoints are biopsy measures rather than symptoms. The abstract does not name Thymogen, so the page says alpha-glutamyl-tryptophan. The second analysis is described from the same source record and is not a separate page source.

Read the original source
2008 absorption paper and searches, 10 October 2026: no human PK, no healthy-volunteer trial

PubMed search record

Bergeon JA et al. Biopolymers. 2008;90(5):633-43. PMID 18428206.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability, and made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. A PubMed search for (thymogen OR oglufanide OR IM862 OR alpha-glutamyl-tryptophan) AND (randomized OR randomised OR placebo OR double-blind) returned 10 records. Six are human randomized or placebo-controlled studies; the other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper, and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. A search for (thymogen OR oglufanide OR Glu-Trp OR IM862) AND (pharmacokinetic OR pharmacokinetics OR bioavailability OR half-life) returned 6 records, none reporting human pharmacokinetics by title. In the records reviewed there is no trial in healthy people for immune function, no human pharmacokinetics, and no head-to-head or independent replication of the Russian trials.

Participants / model
Records returned, not a population; rats and Caco-2 cells for the absorption paper
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10
Study design
Literature search plus a preclinical absorption paper
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists. The abstracts of the 2000 rat paper and the 2008 absorption paper describe rat and cell work.

Read the original source

What happened in the IM862 cancer trials?

An early Kaposi's sarcoma report found major responses in 36% of 44 patients with no placebo arm. The 202-patient phase III then found 23% versus 21% on placebo and a shorter median time to progression on IM862 (16 versus 35 weeks). Renal cell carcinoma and prostate cancer trials found no significant objective responses or no superiority over placebo.

In 44 patients with AIDS-related Kaposi's sarcoma (42 men and 2 women, median age 38), IM862 5 mg as intranasal drops was randomized between two schedules (5 days on and 5 off, n = 18, or every other day, n = 26). Major responses were documented in 36% (5 complete and 11 partial remissions), and adverse effects were mild and transient headache, fatigue, tingling and nausea. There was no placebo arm, and all but five patients were on concurrent protease inhibitors. This is an oncology use in people with HIV, not an immune-support use, and a later trial did not confirm it.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates.

A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities. The authors say IM862 failed to show superiority over placebo (PMID 17879948).

ClinicalTrials.gov holds four IM862 or oglufanide records, none with posted results: a phase 3 randomized double-blind placebo-controlled study in AIDS-related Kaposi's sarcoma sponsored by Cytran (NCT00002445, completed, enrollment 200, last update 24 June 2005), a completed phase 1 in 43 patients with recurrent ovarian cancer (NCT00003773), a terminated phase 2 with chemotherapy in 18 patients with metastatic colorectal cancer (NCT00006037), and a phase 2 in ovarian or primary peritoneal cancer with unknown status (NCT00017303).

Early Kaposi's sarcoma report: 44 patients, 36% major responses, no placebo arm

Clinical trial

Tulpule A et al. J Clin Oncol. 2000;18(4):716-23. PMID 10673512.

In 44 patients with AIDS-related Kaposi's sarcoma (42 men and 2 women, median age 38), IM862 5 mg as intranasal drops was randomized between two schedules (5 days on and 5 off, n = 18, or every other day, n = 26). Major responses were documented in 36% (5 complete and 11 partial remissions), and adverse effects were mild and transient headache, fatigue, tingling and nausea.

Participants / model
Patients with AIDS-related Kaposi's sarcoma
Treatment
Intranasal IM862 5 mg drops, two schedules
Follow-up
not stated in the source
Study design
Randomized dose-schedule study, no placebo arm
Funding
not stated in the source

There was no placebo arm, and all but five patients were on concurrent protease inhibitors. This is an oncology use in people with HIV, not an immune-support use, and a later trial did not confirm it.

Read the original source
Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source
FDA, DailyMed and ClinicalTrials.gov: no US approval; four IM862 records, none with results

Trial registry record

ClinicalTrials.gov record NCT00002445 (phase 3, Kaposi's sarcoma, sponsor Cytran), with NCT00003773, NCT00006037 and NCT00017303. openFDA Drugs@FDA and DailyMed queries run 10 October 2026.

On 2026-10-10 an openFDA Drugs@FDA query for oglufanide returned no match, and DailyMed searches for oglufanide and for thymogen returned no label. ClinicalTrials.gov holds four IM862 or oglufanide records, none with posted results: a phase 3 randomized double-blind placebo-controlled study in AIDS-related Kaposi's sarcoma sponsored by Cytran (NCT00002445, completed, enrollment 200, last update 2005-06-24), a completed phase 1 in 43 patients with recurrent ovarian cancer (NCT00003773), a terminated phase 2 with chemotherapy in 18 patients with metastatic colorectal cancer (NCT00006037), and a phase 2 in ovarian or primary peritoneal cancer with unknown status (NCT00017303). No results are posted.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10; NCT00002445 last updated 2005-06-24
Study design
Official FDA and NLM records and trial registry
Funding
Sponsor of NCT00002445: Cytran

No FDA approval or label was found. Registry records with no posted results support no efficacy conclusion.

Read the original source

What do the rat and absorption studies show?

In 76 female rats given 5 micrograms per rat subcutaneously 5 times a week for 12 months, mean life span was similar but the longest-lived 10% lived 1048 versus 949 days and tumor incidence was lower. A chemistry paper describes the dipeptide as highly hydrophilic with low membrane permeability.

In 76 five-month-old outbred female rats given 5 micrograms per rat of the dipeptide (44 rats) or saline (32 rats) subcutaneously 5 times a week for 12 months, mean life span was similar, but the longest-lived 10% of treated rats lived 1048 days versus 949 days in controls (P less than 0.001). Total tumor incidence was 1.5 times lower, malignant tumor incidence 1.7 times lower, and leukemias and lymphomas 3.4 times lower in treated rats. This is a rat study from the originating group, with Khavinson as a co-author.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability. The authors made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. This paper and the 2000 rat paper describe rat and cell work, and no human pharmacokinetics were found.

2000 rat paper: origin of Thymogen, 12-month subcutaneous study in 76 female rats

Animal study

Anisimov VN et al. Biogerontology. 2000;1(1):55-9. PMID 11707921.

A 2000 paper states that L-Glu-L-Trp was isolated from the calf thymic peptide complex Thymalin by reverse-phase high performance liquid chromatography, and that a pharmaceutical designed on the synthesized dipeptide later received the brand name Thymogen. In 76 five-month-old outbred female rats given 5 micrograms per rat of the dipeptide (44 rats) or saline (32 rats) subcutaneously 5 times a week for 12 months, mean life span was similar, but the longest-lived 10% of treated rats lived 1048 days versus 949 days in controls (P less than 0.001). Total tumor incidence was 1.5 times lower, malignant tumor incidence 1.7 times lower, and leukemias and lymphomas 3.4 times lower in treated rats.

Participants / model
Outbred female rats
Treatment
Subcutaneous L-Glu-L-Trp, 5 micrograms per rat, 5 times a week for 12 months
Follow-up
12 months
Study design
Original preclinical study
Funding
not stated in the source

A rat study from the originating group, with Khavinson as a co-author. Thymogen is a synthetic dipeptide first found in Thymalin, not an extract.

Read the original source
2008 absorption paper and searches, 10 October 2026: no human PK, no healthy-volunteer trial

PubMed search record

Bergeon JA et al. Biopolymers. 2008;90(5):633-43. PMID 18428206.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability, and made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. A PubMed search for (thymogen OR oglufanide OR IM862 OR alpha-glutamyl-tryptophan) AND (randomized OR randomised OR placebo OR double-blind) returned 10 records. Six are human randomized or placebo-controlled studies; the other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper, and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. A search for (thymogen OR oglufanide OR Glu-Trp OR IM862) AND (pharmacokinetic OR pharmacokinetics OR bioavailability OR half-life) returned 6 records, none reporting human pharmacokinetics by title. In the records reviewed there is no trial in healthy people for immune function, no human pharmacokinetics, and no head-to-head or independent replication of the Russian trials.

Participants / model
Records returned, not a population; rats and Caco-2 cells for the absorption paper
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10
Study design
Literature search plus a preclinical absorption paper
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists. The abstracts of the 2000 rat paper and the 2008 absorption paper describe rat and cell work.

Read the original source

Is Thymogen a Russian immunomodulator that supports immune function?

As a description of a regionally registered drug, yes. As immune support, it rests on small Russian trials in sick patients with surrogate endpoints and not at all on healthy people, and the one large Western trial, in Kaposi's sarcoma, was an oncology use that failed.

Sellers call Thymogen, the Glu-Trp dipeptide also called oglufanide, a Russian immunomodulator that supports immune function. Russian immunomodulator is accurate as a description of a regionally registered drug, based on a commercial drug reference that lists three products. Supports immune function is backed only by small Russian trials in sick patients (surgical oncology, gastritis, type 1 diabetes) with surrogate endpoints, and not at all in healthy people. No independent group has replicated the Russian trials in the records reviewed.

The one large Western trial, in Kaposi's sarcoma, was an oncology use that failed, and its median time to progression was shorter on IM862 than on placebo.

Vidal.ru (commercial reference): three Thymogen products, Russia

Regulatory record

Vidal.ru drug reference, Thymogen product pages (holder MBNPK Cytomed, Russia). A commercial reference, not the Russian state register. A 2009 review (PMID 19355963) lists Thymogen among interferon inducers.

Vidal.ru lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, solution for intramuscular injection), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication in prose is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries (PMID 19355963).

Participants / model
Patients with infections and immune deficiency, per the indication text
Treatment
Intramuscular injection, nasal spray and cream in Russia
Follow-up
Not applicable
Study design
Commercial drug reference, not the state register
Funding
not stated in the source

These are secondary-source readings and were not confirmed against the Russian state register (grls.rosminzdrav.ru), so no certificate numbers or dates are quoted on the page.

Read the original source
Russian surgical trial: cellular immunity and complications, no numbers in the abstract

Randomized controlled trial

Smirnov VS et al. Adv Gerontol. 2011;24(2):278-84. PMID 21957588.

A double-blind, randomized, placebo-controlled study in elderly patients having surgery for solid tumors in the abdominal cavity and retroperitoneal space gave Thymogen by intranasal instillation for 7 days before surgery, against saline. The authors report that it restored parameters of cellular immunity and that complications and the length of the postoperative period fell significantly. A 1996 Russian report in type 1 diabetes with secondary immunodeficiency says a clinical effect was registered in 94.4% and a laboratory effect in 83.3% of patients, with no control group described (PMID 9026934).

Participants / model
Elderly surgical patients with abdominal tumors; patients with type 1 diabetes (1996 report)
Treatment
Intranasal Thymogen before surgery; scheme for diabetes not stated
Follow-up
7 days before surgery
Study design
Randomized, double-blind, placebo-controlled study (Russian language)
Funding
not stated in the source

The abstract gives no patient numbers, no values and no statistics. It prints the dose in mg, which does not match the microgram-scale strengths on the Russian labels, so the full text is needed and no dose is reproduced. The 1996 report is described from the same source record and is not a separate page source.

Read the original source
2023 gastritis trial: 116 patients, gland count up 26.1%, biopsy endpoints

Randomized controlled trial

Baryshnikova NV et al. Arkh Patol. 2023;85(3):54-63. PMID 37272441.

In a multicenter, double-blind, randomized, placebo-controlled study, biopsies from 116 patients with Helicobacter pylori-associated chronic atrophic gastritis were studied. In patients taking alpha-glutamyl-tryptophan, gland number per mm2 of gastric mucosa rose 26.1% from baseline (p = 0.028) and was higher than on placebo (p = 0.026), with a tendency toward fewer signs of intestinal metaplasia, and CDX-2 expression rose from baseline (p = 0.015). CXCL-12 expression rose in the placebo group and did not change in the treated group. A second 2023 analysis of a double-blind placebo-controlled study (PMID 38158980) reviewed endoscopy and morphometry retrospectively in 80 patients with the same disease, 43 on Regasthym Gastro (named in the abstract as alpha-glutamyl-tryptophan) and 37 on placebo, and found a significant fall in mucosal edema (p = 0.008) and in a combined inflammation score (p = 0.006).

Participants / model
116 patients with H. pylori-associated chronic atrophic gastritis; 80 patients in the second analysis
Treatment
alpha-glutamyl-tryptophan; dose and route not stated in the abstract
Follow-up
not stated in the source
Study design
Randomized, double-blind, placebo-controlled study (Russian language); second analysis retrospective
Funding
not stated in the source

The authors call the drug a repair stimulator. The abstract gives no dose, route, duration or trade name, and the endpoints are biopsy measures rather than symptoms. The abstract does not name Thymogen, so the page says alpha-glutamyl-tryptophan. The second analysis is described from the same source record and is not a separate page source.

Read the original source
Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source
2008 absorption paper and searches, 10 October 2026: no human PK, no healthy-volunteer trial

PubMed search record

Bergeon JA et al. Biopolymers. 2008;90(5):633-43. PMID 18428206.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability, and made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. A PubMed search for (thymogen OR oglufanide OR IM862 OR alpha-glutamyl-tryptophan) AND (randomized OR randomised OR placebo OR double-blind) returned 10 records. Six are human randomized or placebo-controlled studies; the other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper, and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. A search for (thymogen OR oglufanide OR Glu-Trp OR IM862) AND (pharmacokinetic OR pharmacokinetics OR bioavailability OR half-life) returned 6 records, none reporting human pharmacokinetics by title. In the records reviewed there is no trial in healthy people for immune function, no human pharmacokinetics, and no head-to-head or independent replication of the Russian trials.

Participants / model
Records returned, not a population; rats and Caco-2 cells for the absorption paper
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10
Study design
Literature search plus a preclinical absorption paper
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists. The abstracts of the 2000 rat paper and the 2008 absorption paper describe rat and cell work.

Read the original source

How is Thymogen thought to work?

No mechanism is established in the sources reviewed. Its developers describe it as a thymic immunomodulator, a 2009 review lists it among interferon inducers, and the 2023 gastritis authors call it a repair stimulator. In a renal cell carcinoma trial of IM862, plasma VEGF fell.

The 2008 chemistry paper calls L-Glu-L-Trp a naturally occurring thymic immunomodulator, and a 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries. The authors of the 2023 gastritis trial call alpha-glutamyl-tryptophan a repair stimulator, and in that trial CXCL-12 expression rose in the placebo group but did not change in the treated group. In the renal cell carcinoma phase II trial of IM862, plasma VEGF fell.

By its own chemistry paper the dipeptide has high hydrophilic character and low membrane permeability, which is why the authors made lipid and sugar conjugates to improve intestinal permeability. No human pharmacokinetics were found.

2008 absorption paper and searches, 10 October 2026: no human PK, no healthy-volunteer trial

PubMed search record

Bergeon JA et al. Biopolymers. 2008;90(5):633-43. PMID 18428206.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability, and made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. A PubMed search for (thymogen OR oglufanide OR IM862 OR alpha-glutamyl-tryptophan) AND (randomized OR randomised OR placebo OR double-blind) returned 10 records. Six are human randomized or placebo-controlled studies; the other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper, and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. A search for (thymogen OR oglufanide OR Glu-Trp OR IM862) AND (pharmacokinetic OR pharmacokinetics OR bioavailability OR half-life) returned 6 records, none reporting human pharmacokinetics by title. In the records reviewed there is no trial in healthy people for immune function, no human pharmacokinetics, and no head-to-head or independent replication of the Russian trials.

Participants / model
Records returned, not a population; rats and Caco-2 cells for the absorption paper
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10
Study design
Literature search plus a preclinical absorption paper
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists. The abstracts of the 2000 rat paper and the 2008 absorption paper describe rat and cell work.

Read the original source
Vidal.ru (commercial reference): three Thymogen products, Russia

Regulatory record

Vidal.ru drug reference, Thymogen product pages (holder MBNPK Cytomed, Russia). A commercial reference, not the Russian state register. A 2009 review (PMID 19355963) lists Thymogen among interferon inducers.

Vidal.ru lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, solution for intramuscular injection), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication in prose is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries (PMID 19355963).

Participants / model
Patients with infections and immune deficiency, per the indication text
Treatment
Intramuscular injection, nasal spray and cream in Russia
Follow-up
Not applicable
Study design
Commercial drug reference, not the state register
Funding
not stated in the source

These are secondary-source readings and were not confirmed against the Russian state register (grls.rosminzdrav.ru), so no certificate numbers or dates are quoted on the page.

Read the original source
2023 gastritis trial: 116 patients, gland count up 26.1%, biopsy endpoints

Randomized controlled trial

Baryshnikova NV et al. Arkh Patol. 2023;85(3):54-63. PMID 37272441.

In a multicenter, double-blind, randomized, placebo-controlled study, biopsies from 116 patients with Helicobacter pylori-associated chronic atrophic gastritis were studied. In patients taking alpha-glutamyl-tryptophan, gland number per mm2 of gastric mucosa rose 26.1% from baseline (p = 0.028) and was higher than on placebo (p = 0.026), with a tendency toward fewer signs of intestinal metaplasia, and CDX-2 expression rose from baseline (p = 0.015). CXCL-12 expression rose in the placebo group and did not change in the treated group. A second 2023 analysis of a double-blind placebo-controlled study (PMID 38158980) reviewed endoscopy and morphometry retrospectively in 80 patients with the same disease, 43 on Regasthym Gastro (named in the abstract as alpha-glutamyl-tryptophan) and 37 on placebo, and found a significant fall in mucosal edema (p = 0.008) and in a combined inflammation score (p = 0.006).

Participants / model
116 patients with H. pylori-associated chronic atrophic gastritis; 80 patients in the second analysis
Treatment
alpha-glutamyl-tryptophan; dose and route not stated in the abstract
Follow-up
not stated in the source
Study design
Randomized, double-blind, placebo-controlled study (Russian language); second analysis retrospective
Funding
not stated in the source

The authors call the drug a repair stimulator. The abstract gives no dose, route, duration or trade name, and the endpoints are biopsy measures rather than symptoms. The abstract does not name Thymogen, so the page says alpha-glutamyl-tryptophan. The second analysis is described from the same source record and is not a separate page source.

Read the original source
Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source

What is known about the safety of Thymogen?

Safety data come mainly from cancer trials. In the US phase III in Kaposi's sarcoma, median time to progression was shorter on IM862 than on placebo (16 versus 35 weeks), and the authors say it may accelerate progression. Other trials reported mild or no significant toxicity, but no human pharmacokinetics or healthy-volunteer data were found.

The phase III authors conclude IM862 was not superior to placebo and may accelerate time to progression in Kaposi's sarcoma. The early Kaposi's sarcoma report listed mild and transient headache, fatigue, tingling and nausea. The renal cell carcinoma phase II found no grade 2 or 3 toxicities attributed to the drug, and the prostate cancer trial found no significant toxicities. The Russian trial abstracts described here report no adverse event figures.

No human pharmacokinetics were found, no trial gave it to healthy people, and no independent group has replicated the Russian trials. The IM862 trials used milligram-scale intranasal doses that do not match the microgram-scale strengths of the Russian products, so neither set of results can be assumed to apply to the other.

Results for gamma-glutamyl-tryptophan and for Thymodepressin, written D-Glu(D-Trp), do not apply to Thymogen, and Thymalin is the parent extract, not the same product.

Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source
Early Kaposi's sarcoma report: 44 patients, 36% major responses, no placebo arm

Clinical trial

Tulpule A et al. J Clin Oncol. 2000;18(4):716-23. PMID 10673512.

In 44 patients with AIDS-related Kaposi's sarcoma (42 men and 2 women, median age 38), IM862 5 mg as intranasal drops was randomized between two schedules (5 days on and 5 off, n = 18, or every other day, n = 26). Major responses were documented in 36% (5 complete and 11 partial remissions), and adverse effects were mild and transient headache, fatigue, tingling and nausea.

Participants / model
Patients with AIDS-related Kaposi's sarcoma
Treatment
Intranasal IM862 5 mg drops, two schedules
Follow-up
not stated in the source
Study design
Randomized dose-schedule study, no placebo arm
Funding
not stated in the source

There was no placebo arm, and all but five patients were on concurrent protease inhibitors. This is an oncology use in people with HIV, not an immune-support use, and a later trial did not confirm it.

Read the original source
2008 absorption paper and searches, 10 October 2026: no human PK, no healthy-volunteer trial

PubMed search record

Bergeon JA et al. Biopolymers. 2008;90(5):633-43. PMID 18428206.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability, and made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. A PubMed search for (thymogen OR oglufanide OR IM862 OR alpha-glutamyl-tryptophan) AND (randomized OR randomised OR placebo OR double-blind) returned 10 records. Six are human randomized or placebo-controlled studies; the other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper, and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. A search for (thymogen OR oglufanide OR Glu-Trp OR IM862) AND (pharmacokinetic OR pharmacokinetics OR bioavailability OR half-life) returned 6 records, none reporting human pharmacokinetics by title. In the records reviewed there is no trial in healthy people for immune function, no human pharmacokinetics, and no head-to-head or independent replication of the Russian trials.

Participants / model
Records returned, not a population; rats and Caco-2 cells for the absorption paper
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10
Study design
Literature search plus a preclinical absorption paper
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists. The abstracts of the 2000 rat paper and the 2008 absorption paper describe rat and cell work.

Read the original source
Vidal.ru (commercial reference): three Thymogen products, Russia

Regulatory record

Vidal.ru drug reference, Thymogen product pages (holder MBNPK Cytomed, Russia). A commercial reference, not the Russian state register. A 2009 review (PMID 19355963) lists Thymogen among interferon inducers.

Vidal.ru lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, solution for intramuscular injection), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication in prose is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries (PMID 19355963).

Participants / model
Patients with infections and immune deficiency, per the indication text
Treatment
Intramuscular injection, nasal spray and cream in Russia
Follow-up
Not applicable
Study design
Commercial drug reference, not the state register
Funding
not stated in the source

These are secondary-source readings and were not confirmed against the Russian state register (grls.rosminzdrav.ru), so no certificate numbers or dates are quoted on the page.

Read the original source
Gamma isomer crossover in 9 healthy men: a different compound, not Thymogen evidence

Chemical identity record

Li Kam Wa TC et al. Br J Clin Pharmacol. 1996;42(3):365-70. PMID 8877028.

Gamma-L-glutamyl-L-tryptophan is a different compound from the alpha dipeptide. In a randomized, placebo-controlled crossover study in nine healthy men, a 1 hour intravenous infusion of the gamma isomer did not change urinary 5-HT or sodium excretion compared with placebo. The 2024 review that calls Thymogen an immunostimulant (L-Glu-L-Trp) pairs it with Thymodepressin, written D-Glu(D-Trp) and called an immunosuppressor (PMID 38732260). The 2005 phase III abstract (PMID 15598977) describes IM862 as L-glutamine L-tryptophan, which does not match the L-Glu-L-Trp of the 2004 renal cancer abstract (PMID 15354209) or the PubChem record. A 2023 paper names Regasthym Gastro as alpha-glutamyl-tryptophan (PMID 38158980), and a Russian drug reference page for the substance lists Regastim Gastro, Thymogen, Thymogen sodium and Thymogen sodium trituration, with no registration data on that page. The Khavinson group names this dipeptide (EW) and a Lys-Glu dipeptide (KE) as the active substances of Thymalin (PMID 37686182).

Participants / model
Chemical identity, not a clinical population; the cited crossover study was in nine healthy men
Treatment
Dipeptide isomers and brand names
Follow-up
Not applicable; the crossover study used a 1 hour intravenous infusion
Study design
Original reports and reviews on identity; the linked crossover study tested the gamma isomer, not Thymogen
Funding
not stated in the source

This row is cited only for identity. The gamma isomer result must not be cited as Thymogen evidence, and Thymodepressin is a different substance with the opposite stated effect. The other papers are described from the same source record and are not separate page sources.

Read the original source

Why does Thymogen sit in C tier?

Thymogen is one defined dipeptide with a regional registration and randomized human data. The immune trials are small Russian studies on surrogate endpoints with no independent replication, and the US phase III was negative with a shorter time to progression on IM862.

The 2023 gastritis trial and the surgical trial are randomized and placebo-controlled, but they report biopsy and immune surrogate endpoints, with few numbers in the abstracts. The dipeptide has low membrane permeability by its own chemistry paper, no trial gave it to healthy people, and the Russian registration rests on a commercial reference that was not confirmed against the state register.

Vidal.ru (commercial reference): three Thymogen products, Russia

Regulatory record

Vidal.ru drug reference, Thymogen product pages (holder MBNPK Cytomed, Russia). A commercial reference, not the Russian state register. A 2009 review (PMID 19355963) lists Thymogen among interferon inducers.

Vidal.ru lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, solution for intramuscular injection), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication in prose is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries (PMID 19355963).

Participants / model
Patients with infections and immune deficiency, per the indication text
Treatment
Intramuscular injection, nasal spray and cream in Russia
Follow-up
Not applicable
Study design
Commercial drug reference, not the state register
Funding
not stated in the source

These are secondary-source readings and were not confirmed against the Russian state register (grls.rosminzdrav.ru), so no certificate numbers or dates are quoted on the page.

Read the original source
Russian surgical trial: cellular immunity and complications, no numbers in the abstract

Randomized controlled trial

Smirnov VS et al. Adv Gerontol. 2011;24(2):278-84. PMID 21957588.

A double-blind, randomized, placebo-controlled study in elderly patients having surgery for solid tumors in the abdominal cavity and retroperitoneal space gave Thymogen by intranasal instillation for 7 days before surgery, against saline. The authors report that it restored parameters of cellular immunity and that complications and the length of the postoperative period fell significantly. A 1996 Russian report in type 1 diabetes with secondary immunodeficiency says a clinical effect was registered in 94.4% and a laboratory effect in 83.3% of patients, with no control group described (PMID 9026934).

Participants / model
Elderly surgical patients with abdominal tumors; patients with type 1 diabetes (1996 report)
Treatment
Intranasal Thymogen before surgery; scheme for diabetes not stated
Follow-up
7 days before surgery
Study design
Randomized, double-blind, placebo-controlled study (Russian language)
Funding
not stated in the source

The abstract gives no patient numbers, no values and no statistics. It prints the dose in mg, which does not match the microgram-scale strengths on the Russian labels, so the full text is needed and no dose is reproduced. The 1996 report is described from the same source record and is not a separate page source.

Read the original source
2023 gastritis trial: 116 patients, gland count up 26.1%, biopsy endpoints

Randomized controlled trial

Baryshnikova NV et al. Arkh Patol. 2023;85(3):54-63. PMID 37272441.

In a multicenter, double-blind, randomized, placebo-controlled study, biopsies from 116 patients with Helicobacter pylori-associated chronic atrophic gastritis were studied. In patients taking alpha-glutamyl-tryptophan, gland number per mm2 of gastric mucosa rose 26.1% from baseline (p = 0.028) and was higher than on placebo (p = 0.026), with a tendency toward fewer signs of intestinal metaplasia, and CDX-2 expression rose from baseline (p = 0.015). CXCL-12 expression rose in the placebo group and did not change in the treated group. A second 2023 analysis of a double-blind placebo-controlled study (PMID 38158980) reviewed endoscopy and morphometry retrospectively in 80 patients with the same disease, 43 on Regasthym Gastro (named in the abstract as alpha-glutamyl-tryptophan) and 37 on placebo, and found a significant fall in mucosal edema (p = 0.008) and in a combined inflammation score (p = 0.006).

Participants / model
116 patients with H. pylori-associated chronic atrophic gastritis; 80 patients in the second analysis
Treatment
alpha-glutamyl-tryptophan; dose and route not stated in the abstract
Follow-up
not stated in the source
Study design
Randomized, double-blind, placebo-controlled study (Russian language); second analysis retrospective
Funding
not stated in the source

The authors call the drug a repair stimulator. The abstract gives no dose, route, duration or trade name, and the endpoints are biopsy measures rather than symptoms. The abstract does not name Thymogen, so the page says alpha-glutamyl-tryptophan. The second analysis is described from the same source record and is not a separate page source.

Read the original source
Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source
2008 absorption paper and searches, 10 October 2026: no human PK, no healthy-volunteer trial

PubMed search record

Bergeon JA et al. Biopolymers. 2008;90(5):633-43. PMID 18428206.

A 2008 paper describes L-Glu-L-Trp as a naturally occurring thymic immunomodulator with high hydrophilic character and low membrane permeability, and made lipid and sugar conjugates to improve its intestinal permeability, with an initial rat absorption experiment. A PubMed search for (thymogen OR oglufanide OR IM862 OR alpha-glutamyl-tryptophan) AND (randomized OR randomised OR placebo OR double-blind) returned 10 records. Six are human randomized or placebo-controlled studies; the other four are a Kaposi's sarcoma treatment review, a 1992 rat carcinogenesis paper, a 1998 animal behavior paper, and a 2018 paper on tryptophan-containing peptides and angiotensin-converting enzyme. A search for (thymogen OR oglufanide OR Glu-Trp OR IM862) AND (pharmacokinetic OR pharmacokinetics OR bioavailability OR half-life) returned 6 records, none reporting human pharmacokinetics by title. In the records reviewed there is no trial in healthy people for immune function, no human pharmacokinetics, and no head-to-head or independent replication of the Russian trials.

Participants / model
Records returned, not a population; rats and Caco-2 cells for the absorption paper
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10
Study design
Literature search plus a preclinical absorption paper
Funding
not stated in the source

A search result shows what the databases returned on that date. It is not proof that no unindexed study exists. The abstracts of the 2000 rat paper and the 2008 absorption paper describe rat and cell work.

Read the original source

Studies and sources

PubChem: oglufanide (Thymogen) and IM862 disodium salt identity

Chemical identity record

National Library of Medicine. PubChem compound records CID 100094 (Oglufanide) and CID 158780 (Oglufanide disodium). ClinicalTrials.gov record NCT00003773 for the IM862 naming.

PubChem lists Oglufanide as CID 100094, C16H19N3O5, molecular weight 333.34, CAS 38101-59-6 (122933-59-9 is also listed), with synonyms that include Thymogen, Glutamyltryptophan, alpha-Glu-Trp and L-alpha-Glu-L-Trp. The disodium salt is a separate record, Oglufanide disodium, CID 158780, C16H17N3Na2O5, molecular weight 377.30, CAS 237068-57-4, with synonyms IM862 and Oglufanide disodium [USAN]. The ClinicalTrials.gov record NCT00003773 lists its intervention as oglufanide disodium under the study title IM-862, which ties the registry name IM862 to the same salt. The active form is the alpha-linked L-glutamyl-L-tryptophan dipeptide.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined dipeptide (free acid and disodium salt)
Follow-up
Not applicable
Study design
NLM chemical record and registry record
Funding
not stated in the source

Oglufanide has USAN and WHO drug dictionary names in PubChem, but no FDA approval or label was found.

Read the original source
2000 rat paper: origin of Thymogen, 12-month subcutaneous study in 76 female rats

Animal study

Anisimov VN et al. Biogerontology. 2000;1(1):55-9. PMID 11707921.

A 2000 paper states that L-Glu-L-Trp was isolated from the calf thymic peptide complex Thymalin by reverse-phase high performance liquid chromatography, and that a pharmaceutical designed on the synthesized dipeptide later received the brand name Thymogen. In 76 five-month-old outbred female rats given 5 micrograms per rat of the dipeptide (44 rats) or saline (32 rats) subcutaneously 5 times a week for 12 months, mean life span was similar, but the longest-lived 10% of treated rats lived 1048 days versus 949 days in controls (P less than 0.001). Total tumor incidence was 1.5 times lower, malignant tumor incidence 1.7 times lower, and leukemias and lymphomas 3.4 times lower in treated rats.

Participants / model
Outbred female rats
Treatment
Subcutaneous L-Glu-L-Trp, 5 micrograms per rat, 5 times a week for 12 months
Follow-up
12 months
Study design
Original preclinical study
Funding
not stated in the source

A rat study from the originating group, with Khavinson as a co-author. Thymogen is a synthetic dipeptide first found in Thymalin, not an extract.

Read the original source
Gamma isomer crossover in 9 healthy men: a different compound, not Thymogen evidence

Chemical identity record

Li Kam Wa TC et al. Br J Clin Pharmacol. 1996;42(3):365-70. PMID 8877028.

Gamma-L-glutamyl-L-tryptophan is a different compound from the alpha dipeptide. In a randomized, placebo-controlled crossover study in nine healthy men, a 1 hour intravenous infusion of the gamma isomer did not change urinary 5-HT or sodium excretion compared with placebo. The 2024 review that calls Thymogen an immunostimulant (L-Glu-L-Trp) pairs it with Thymodepressin, written D-Glu(D-Trp) and called an immunosuppressor (PMID 38732260). The 2005 phase III abstract (PMID 15598977) describes IM862 as L-glutamine L-tryptophan, which does not match the L-Glu-L-Trp of the 2004 renal cancer abstract (PMID 15354209) or the PubChem record. A 2023 paper names Regasthym Gastro as alpha-glutamyl-tryptophan (PMID 38158980), and a Russian drug reference page for the substance lists Regastim Gastro, Thymogen, Thymogen sodium and Thymogen sodium trituration, with no registration data on that page. The Khavinson group names this dipeptide (EW) and a Lys-Glu dipeptide (KE) as the active substances of Thymalin (PMID 37686182).

Participants / model
Chemical identity, not a clinical population; the cited crossover study was in nine healthy men
Treatment
Dipeptide isomers and brand names
Follow-up
Not applicable; the crossover study used a 1 hour intravenous infusion
Study design
Original reports and reviews on identity; the linked crossover study tested the gamma isomer, not Thymogen
Funding
not stated in the source

This row is cited only for identity. The gamma isomer result must not be cited as Thymogen evidence, and Thymodepressin is a different substance with the opposite stated effect. The other papers are described from the same source record and are not separate page sources.

Read the original source
Vidal.ru (commercial reference): three Thymogen products, Russia

Regulatory record

Vidal.ru drug reference, Thymogen product pages (holder MBNPK Cytomed, Russia). A commercial reference, not the Russian state register. A 2009 review (PMID 19355963) lists Thymogen among interferon inducers.

Vidal.ru lists three Thymogen products from the holder MBNPK Cytomed (Russia): an injection (alpha-glutamyl-tryptophan sodium, solution for intramuscular injection), a nasal spray and a cream, each with a Russian registration certificate. The pages give ATC L03AX for the injection and the spray and D11AX for the cream, and the first-listed indication in prose is complex therapy of acute and chronic viral and bacterial diseases. A 2009 review lists Thymogen among interferon inducers developed and used mostly in former socialist countries (PMID 19355963).

Participants / model
Patients with infections and immune deficiency, per the indication text
Treatment
Intramuscular injection, nasal spray and cream in Russia
Follow-up
Not applicable
Study design
Commercial drug reference, not the state register
Funding
not stated in the source

These are secondary-source readings and were not confirmed against the Russian state register (grls.rosminzdrav.ru), so no certificate numbers or dates are quoted on the page.

Read the original source
FDA, DailyMed and ClinicalTrials.gov: no US approval; four IM862 records, none with results

Trial registry record

ClinicalTrials.gov record NCT00002445 (phase 3, Kaposi's sarcoma, sponsor Cytran), with NCT00003773, NCT00006037 and NCT00017303. openFDA Drugs@FDA and DailyMed queries run 10 October 2026.

On 2026-10-10 an openFDA Drugs@FDA query for oglufanide returned no match, and DailyMed searches for oglufanide and for thymogen returned no label. ClinicalTrials.gov holds four IM862 or oglufanide records, none with posted results: a phase 3 randomized double-blind placebo-controlled study in AIDS-related Kaposi's sarcoma sponsored by Cytran (NCT00002445, completed, enrollment 200, last update 2005-06-24), a completed phase 1 in 43 patients with recurrent ovarian cancer (NCT00003773), a terminated phase 2 with chemotherapy in 18 patients with metastatic colorectal cancer (NCT00006037), and a phase 2 in ovarian or primary peritoneal cancer with unknown status (NCT00017303). No results are posted.

Participants / model
Not a clinical population
Treatment
Not applicable
Follow-up
Searches run on 2026-10-10; NCT00002445 last updated 2005-06-24
Study design
Official FDA and NLM records and trial registry
Funding
Sponsor of NCT00002445: Cytran

No FDA approval or label was found. Registry records with no posted results support no efficacy conclusion.

Read the original source
Early Kaposi's sarcoma report: 44 patients, 36% major responses, no placebo arm

Clinical trial

Tulpule A et al. J Clin Oncol. 2000;18(4):716-23. PMID 10673512.

In 44 patients with AIDS-related Kaposi's sarcoma (42 men and 2 women, median age 38), IM862 5 mg as intranasal drops was randomized between two schedules (5 days on and 5 off, n = 18, or every other day, n = 26). Major responses were documented in 36% (5 complete and 11 partial remissions), and adverse effects were mild and transient headache, fatigue, tingling and nausea.

Participants / model
Patients with AIDS-related Kaposi's sarcoma
Treatment
Intranasal IM862 5 mg drops, two schedules
Follow-up
not stated in the source
Study design
Randomized dose-schedule study, no placebo arm
Funding
not stated in the source

There was no placebo arm, and all but five patients were on concurrent protease inhibitors. This is an oncology use in people with HIV, not an immune-support use, and a later trial did not confirm it.

Read the original source
Phase III in 202 patients: no benefit, shorter time to progression; renal and prostate trials

Randomized controlled trial

Noy A et al. J Clin Oncol. 2005;23(5):990-8. PMID 15598977.

A 24-week randomized, double-blinded, placebo-controlled phase III trial enrolled 202 HIV-positive patients with Kaposi's sarcoma, 104 on IM862 5 mg intranasally every other day and 98 on placebo. Response rates did not differ (23% on IM862, 21% on placebo, P = .46), and median time to progression was shorter on IM862 (16 weeks versus 35 weeks, P = .012). The authors conclude it was not superior to placebo and may accelerate time to progression, and that antiretroviral therapy alone had a substantial sustained tumor response and may have contributed to the earlier response estimates. A phase II trial in 25 patients with metastatic renal cell carcinoma (20 mg intranasally three times daily) found no grade 2 or 3 toxicities attributed to the drug, 8 patients with stable disease and 17 with progression, no significant objective responses, and a fall in plasma VEGF (PMID 15354209). A randomized, double-blind trial that added intranasal IM862 or placebo to androgen ablation in men with rising PSA after prostate cancer treatment evaluated 71 patients and found disease progression at 6 months in 14 of 34 (41%) on IM862 and 18 of 37 (49%) on placebo (P = 0.39), with no significant toxicities (PMID 17879948).

Participants / model
Patients with AIDS-related Kaposi's sarcoma (202); patients with metastatic renal cell carcinoma (25); men with prostate cancer on androgen ablation (71 evaluable)
Treatment
Intranasal IM862
Follow-up
24 weeks for the phase III trial
Study design
Randomized phase III trial, phase II trial and randomized prostate cancer trial
Funding
not stated in the source

Oncology uses of IM862, not immune support. The renal and prostate trials are described from the same source record and are not separate page sources. The abstract describes IM862 as L-glutamine L-tryptophan, which does not match the PubChem record.

Read the original source
Russian surgical trial: cellular immunity and complications, no numbers in the abstract

Randomized controlled trial

Smirnov VS et al. Adv Gerontol. 2011;24(2):278-84. PMID 21957588.

A double-blind, randomized, placebo-controlled study in elderly patients having surgery for solid tumors in the abdominal cavity and retroperitoneal space gave Thymogen by intranasal instillation for 7 days before surgery, against saline. The authors report that it restored parameters of cellular immunity and that complications and the length of the postoperative period fell significantly. A 1996 Russian report in type 1 diabetes with secondary immunodeficiency says a clinical effect was registered in 94.4% and a laboratory effect in 83.3% of patients, with no control group described (PMID 9026934).

Participants / model
Elderly surgical patients with abdominal tumors; patients with type 1 diabetes (1996 report)
Treatment
Intranasal Thymogen before surgery; scheme for diabetes not stated
Follow-up
7 days before surgery
Study design
Randomized, double-blind, placebo-controlled study (Russian language)
Funding
not stated in the source

The abstract gives no patient numbers, no values and no statistics. It prints the dose in mg, which does not match the microgram-scale strengths on the Russian labels, so the full text is needed and no dose is reproduced. The 1996 report is described from the same source record and is not a separate page source.

Read the original source
2023 gastritis trial: 116 patients, gland count up 26.1%, biopsy endpoints

Randomized controlled trial

Baryshnikova NV et al. Arkh Patol. 2023;85(3):54-63. PMID 37272441.

In a multicenter, double-blind, randomized, placebo-controlled study, biopsies from 116 patients with Helicobacter pylori-associated chronic atrophic gastritis were studied. In patients taking alpha-glutamyl-tryptophan, gland number per mm2 of gastric mucosa rose 26.1% from baseline (p = 0.028) and was higher than on placebo (p = 0.026), with a tendency toward fewer signs of intestinal metaplasia, and CDX-2 expression rose from baseline (p = 0.015). CXCL-12 expression rose in the placebo group and did not change in the treated group. A second 2023 analysis of a double-blind placebo-controlled study (PMID 38158980) reviewed endoscopy and morphometry retrospectively in 80 patients with the same disease, 43 on Regasthym Gastro (named in the abstract as alpha-glutamyl-tryptophan) and 37 on placebo, and found a significant fall in mucosal edema (p = 0.008) and in a combined inflammation score (p = 0.006).

Participants / model
116 patients with H. pylori-associated chronic atrophic gastritis; 80 patients in the second analysis
Treatment
alpha-glutamyl-tryptophan; dose and route not stated in the abstract
Follow-up
not stated in the source
Study design
Randomized, double-blind, placebo-controlled study (Russian language); second analysis retrospective
Funding
not stated in the source

The authors call the drug a repair stimulator. The abstract gives no dose, route, duration or trade name, and the endpoints are biopsy measures rather than symptoms. The abstract does not name Thymogen, so the page says alpha-glutamyl-tryptophan. The second analysis is described from the same source record and is not a separate page source.

Read the original source

Why is Thymogen (oglufanide) in C tier?

C fits a defined dipeptide with a regional registration and small Russian randomized trials on surrogate endpoints, set against a negative US phase III with a shorter time to progression on IM862 and no independent replication of the immune trials. No trial gave it to healthy people, and its own chemistry paper describes low membrane permeability.