vilon

Q: What is Vilon?

Vilon is a lab-made peptide only two amino acids long, lysine joined to glutamic acid, and it is sold on an anti-ageing claim. The Russian literature writes it as KE or Lys-Glu, research-chemical sellers list it under the name Vilon, and the patents covering it never use the name Vilon at all, calling it only the L-Lys-L-Glu dipeptide. Formally it is a synthetic dipeptide, L-lysyl-L-glutamic acid, developed in Vladimir Khavinson's short-peptide program at the St Petersburg Institute of Bioregulation and Gerontology. 275.30 Da, CAS 45234-02-4. It has no FDA or EMA approval and is sold as a research chemical.

Q: How is Vilon studied in the published literature?

Almost entirely in cells and rodents. With no registered trial, there is no protocol to report. The only human dose figures in the whole literature appear inside patent examples written by the applicants: 1 microgram intramuscular daily for 5 or 10 days in the repair-processes patent, and 10 micrograms parabulbar daily for 10 days in the ophthalmology patent. Animal work runs at 0.1 to 1 microgram per animal on monthly five-day courses. The two patents claim different active ranges, 0.01 to 100 micrograms per kilogram in one and 0.1 to 100 in the other.

Q: What are the side effects of Vilon?

Almost nothing has been characterised. No registered trial has ever been run, and the three human papers carry no adverse-event data at all. The one quantified harm signal in the literature is an animal result. In HER-2/neu transgenic mice the originating group reported increased mammary cancer incidence, a shorter mean latent period and a larger cumulative tumour count, each at p below 0.05. Three other rodent tumour models run the opposite way, so the tumour picture is genuinely in conflict. One interaction has been documented. In mice bearing transplanted Lewis lung carcinoma, giving Vilon at the same time as cyclophosphamide decreased survival, and the authors of that paper conclude the two should not be administered together. Rodent toxicology in the patent examples was run at milligram-per-kilogram doses, roughly a thousand to a hundred thousand times the microgram-per-kilogram range the same documents claim as active, so it describes exposure at a dose nobody claims is active.

Q: Is Vilon FDA approved?

No. Vilon has no FDA approval and no EMA marketing authorisation for any indication. A harmonised drug registry of more than 22,000 molecules that does index thymalfasin, alanyl-glutamine and thymic humoral factor gamma-2 returns nothing at all for Vilon. It is sold as a research chemical. No Russian registration certificate was located either, while the two preparations it is most often confused with, Thymalin and Thymogen, both carry Soviet-era registration numbers.

Q: How much does Vilon cost?

There is no clinical retail price, because there is no approved product anywhere. On the research-chemical market it is inexpensive, which is what two amino acids cost to make.

two amino acids from a russian lab, lysine joined to glutamic acid, sold on an anti-ageing claim. nobody has registered a trial of it in any registry checked, the three human papers state no sample size, and the strongest animal study reports more tumours.

tier D · focus · 0 registered trials · ClinicalTrials.gov + WHO ICTRP

verdict

two amino acids sold to slow ageing and to hold tumours back, and both claims come back weaker than the label. the one lifespan experiment that compared them head to head gave the survival gain to the sibling pineal peptide and reported no survival figure for this one. on tumours, three animal models favour it and the best-refereed study reports more mammary cancer. the human immune claim has never been tested at all.

on whether vilon has been tested in people: no, not in a registered trial anywhere checked. a direct ClinicalTrials.gov intervention query returns totalCount 0, and a sweep of ClinicalTrials.gov plus the WHO ICTRP mirror returns nothing under the name either. the entire human literature is three russian-language papers carrying pubmed clinical publication tags, and every result in all three is a direction word, something went up or something came down. patient counts, doses and p values are absent from all three abstracts. the colorectal authors call their own work preliminary. roughly 194 human subjects do appear with counts, and every one of them sits inside a patent example the inventors wrote themselves.

on the oncostatic claim: the animal studies disagree with each other, and the strongest one says the cancer got worse. three models favour the compound: induced bladder tumours in rats at 56 percent against 75.5 percent in controls, dimethylhydrazine tumours in mice at 14.3 percent against 60 percent, and transplanted lewis lung carcinoma where 1 mg/kg significantly increased survival. the most rigorous paper, published in int j cancer by the originating group with italian co-authors, reports the reverse in her-2/neu transgenic mice: more mammary cancer, appearing sooner, and more tumours per animal, each at p below 0.05. the lung paper carries a warning of its own. given at the same time as cyclophosphamide, survival went down, and its authors say the two should not be combined. thin evidence that argues with itself is what the D tier is for.

on the cell-culture numbers in the marketing: the numbers are real, they come from real journals, and every one of them was measured on cells in a dish. sirt1 gene expression up 6-fold and sirt1 protein up 8.2-fold in young human mesenchymal stem cells, with no peptide concentration, donor age or passage number stated in the retrievable abstract. collagen type I up 83 percent in aged skin fibroblasts. the anti-inflammatory paper reports a 1.4 to 6.0-fold cytokine reduction across three preparations in blood cells from four donors. one thp-1 macrophage paper found this was the single peptide of five that did not raise phosphorylated erk1/2.

based on published evidence and the public registry record. not medical advice.

why D-tier

D-tier because the evidence is thin and it argues with itself. Start with the human data. Three Russian-language papers carry PubMed clinical publication tags, and every reported outcome in them is a direction word, with the sample size, allocation method, blinding procedure and effect sizes all left out. The largest human dataset with actual counts, roughly 194 subjects, sits inside patent specifications the inventors wrote themselves. A direct registry check returns nothing at all. That rules out C, which fits a compound whose preclinical work points one way and simply has not reached people yet. Vilon's preclinical work points two ways. It inhibited chemically induced bladder tumours in rats and dimethylhydrazine tumours in mice and raised survival in transplanted Lewis lung carcinoma, while the most rigorous study of the set, run by the originating group with Italian co-authors in Int J Cancer, found significantly increased mammary tumour incidence, a shorter mean latent period and a larger tumour burden in HER-2/neu transgenic mice. The other selling claim answers more sharply, and it answers against the compound. The one head-to-head lifespan experiment, Mech Ageing Dev 2001, reports mean survival up 5.3 percent and maximum lifespan up 10 months for the sibling pineal tetrapeptide, and no survival figure at all for Lys-Glu. F would be too harsh, because there is real quantified signal here and the harm result is one dose in one transgenic strain, contradicted in direction by two other rodent models. D is where the combination lands: thirty-two years since the founding patent was filed, no trial registration in any registry checked, human results with no numbers in them, and one author on 49 of the 80 PubMed records, including the modern Western-journal papers that read as independent replication.

the core tension

Vilon is sold as a compound that slows ageing and holds tumours back. The single most rigorous animal study in its literature, run by the men who invented it and published in Int J Cancer, reports that the treated HER-2/neu transgenic mice got more mammary cancer, got it sooner, and carried more tumours each, at p below 0.05. Three other rodent tumour models say the opposite, which is what keeps this a conflict. The lifespan claim, meanwhile, was actually tested in a head-to-head the marketing never cites. Mech Ageing Dev 2001 reports mean survival up 5.3 percent and maximum lifespan up 10 months for the sibling pineal tetrapeptide, and reports no survival figure at all for Lys-Glu. The numbers that do exist for Vilon appear later, in a review the developers wrote about their own work and in a patent specification they filed themselves, and neither reports a p value.

what it is

Vilon is two amino acids joined together, lysine and glutamic acid, made in a lab. The formal name is L-lysyl-L-glutamic acid, and it comes out of Vladimir Khavinson's short-peptide program at the St Petersburg Institute of Bioregulation and Gerontology. Two residues, 275.30 Da, CAS 45234-02-4. Eight independent commercial and reference registries agree on the formula and the mass. The founding patent was filed in July 1994, with a July 1993 priority, and published in February 1995. Its first claim covers an L-Lys-L-Glu or an L-Glu-L-Trp preparation, which puts Vilon and its sibling Thymogen inside a single founding document. All three patents call it the L-Lys-L-Glu dipeptide. The word Vilon appears in none of them.

what it does

It is sold to slow ageing, to hold cancer back and to rebuild the immune system. What has been measured is cell-culture work, rodent tumour experiments that disagree with each other, and three human papers that give no sample size. The cell numbers are where the marketing comes from: SIRT1 gene expression up 6-fold and SIRT1 protein up 8.2-fold in young human mesenchymal stem cells, collagen type I up 83 percent in aged skin fibroblasts, and a 1.4 to 6.0-fold reduction in IL-1 beta, IL-6 and TNF-alpha across Thymalin and its two constituent dipeptides in blood cells from four donors. Each figure is exact, and each one was measured in a dish.

origin

One group made the compound, filed the patents, ran the animal work and wrote the human reports. That group is Khavinson's, in St Petersburg. The program grew out of calf-thymus peptide extracts that Morozov and Khavinson had been publishing on since the 1970s, and the developers describe their method in their own words. Analyse the amino acid composition of a tissue extract, then synthesise the two-to-four-residue peptide it points to. Thymalin is the extract. Vilon is one of the dipeptides the extract was reduced to. Khavinson is an author on 49 of the 80 PubMed records that mention Vilon. He is also a co-author on the recent Western-journal papers that read at first glance like independent replication.

why researchers are interested

It is two amino acids, it is cheap to make, and the anti-ageing pitch has been running for three decades. The cell-culture figures quoted in vendor copy are genuine figures from genuine journals, which is more than several compounds in this category can say. The sibling preparations carry real institutional history, Thymalin registered in the USSR in 1982 and Thymogen in 1990, and Vilon gets carried along with them.

does it work

Mixed. The two things it is sold for fail in two different ways. The lifespan claim was tested head to head, and the survival gain went to a different molecule. That study, Mech Ageing Dev 2001;122(1):41-68, reports mean survival up 5.3 percent (P<0.05) and maximum lifespan up 10 months for the pineal tetrapeptide, and no survival figure at all for Lys-Glu. Everything Vilon-specific comes from the developers' own 2013 review, claiming maximum lifespan up by nearly two months, with no p value. On tumours, three rodent models favour it and one goes against it, and the one against it is the best study of the set. In its favour: induced bladder tumours in rats at 56 against 75.5 percent, dimethylhydrazine tumours in mice at 14.3 against 60 percent, and transplanted Lewis lung carcinoma where 1 mg/kg significantly increased survival. Against them, Int J Cancer reports significantly increased mammary cancer incidence, a shorter mean latent period and a larger cumulative tumour count in HER-2/neu transgenic mice, and that study came from the originating group itself. The human immune claim has never been tested. No trial registration exists under this name in ClinicalTrials.gov or the WHO ICTRP registries. The three clinically tagged PubMed records report directions with no numbers attached. The roughly 194 human subjects that do appear with counts exist inside patent examples written by the applicants, and a patent office examines novelty and inventive step, then stops.

key facts

molecular formula: C11H21N3O5
molecular weight: 275.30 Da
amino acids: 2
half-life: not characterised; no published human pharmacokinetic study was located
type: synthetic dipeptide (L-Lys-L-Glu, written KE in the Russian literature)
CAS: 45234-02-4
0 trial registrations found, ClinicalTrials.gov and WHO ICTRP
3 human papers on PubMed, none stating a sample size
194 human subjects, all inside applicant-written patent examples
49/80 PubMed records with Khavinson as an author

frequently asked questions

What is Vilon?

Vilon is a lab-made peptide only two amino acids long, lysine joined to glutamic acid, and it is sold on an anti-ageing claim. The Russian literature writes it as KE or Lys-Glu, research-chemical sellers list it under the name Vilon, and the patents covering it never use the name Vilon at all, calling it only the L-Lys-L-Glu dipeptide. Formally it is a synthetic dipeptide, L-lysyl-L-glutamic acid, developed in Vladimir Khavinson's short-peptide program at the St Petersburg Institute of Bioregulation and Gerontology. 275.30 Da, CAS 45234-02-4. It has no FDA or EMA approval and is sold as a research chemical.

What does Vilon do?

It is sold to slow ageing, to hold cancer back and to rebuild the immune system. All three claims rest on cell and animal work, and none of them has been demonstrated in a person. In cell culture the published effects are quantified: SIRT1 gene expression up 6-fold and SIRT1 protein up 8.2-fold in young human mesenchymal stem cells, collagen type I up 83 percent in aged skin fibroblasts, and a 1.4 to 6.0-fold reduction in IL-1 beta, IL-6 and TNF-alpha across Thymalin and its two constituent dipeptides in blood cells from four donors. In animals the record is split. Three tumour models favour the compound, and one transgenic mammary model from the same group reports significantly worse outcomes: more breast tumours, appearing sooner, and a higher tumour count overall. On lifespan, the one head-to-head experiment gives the survival gain to the sibling pineal peptide and reports no survival figure for this one. In people, three Russian-language papers carry PubMed clinical publication tags, and all three describe their results as directions, with no sample size and no effect size anywhere in them.

How is Vilon studied in the published literature?

Almost entirely in cells and rodents. With no registered trial, there is no protocol to report. The only human dose figures in the whole literature appear inside patent examples written by the applicants: 1 microgram intramuscular daily for 5 or 10 days in the repair-processes patent, and 10 micrograms parabulbar daily for 10 days in the ophthalmology patent. Animal work runs at 0.1 to 1 microgram per animal on monthly five-day courses. The two patents claim different active ranges, 0.01 to 100 micrograms per kilogram in one and 0.1 to 100 in the other.

What are the side effects of Vilon?

Almost nothing has been characterised. No registered trial has ever been run, and the three human papers carry no adverse-event data at all. The one quantified harm signal in the literature is an animal result. In HER-2/neu transgenic mice the originating group reported increased mammary cancer incidence, a shorter mean latent period and a larger cumulative tumour count, each at p below 0.05. Three other rodent tumour models run the opposite way, so the tumour picture is genuinely in conflict. One interaction has been documented. In mice bearing transplanted Lewis lung carcinoma, giving Vilon at the same time as cyclophosphamide decreased survival, and the authors of that paper conclude the two should not be administered together. Rodent toxicology in the patent examples was run at milligram-per-kilogram doses, roughly a thousand to a hundred thousand times the microgram-per-kilogram range the same documents claim as active, so it describes exposure at a dose nobody claims is active.

Is Vilon FDA approved?

No. Vilon has no FDA approval and no EMA marketing authorisation for any indication. A harmonised drug registry of more than 22,000 molecules that does index thymalfasin, alanyl-glutamine and thymic humoral factor gamma-2 returns nothing at all for Vilon. It is sold as a research chemical. No Russian registration certificate was located either, while the two preparations it is most often confused with, Thymalin and Thymogen, both carry Soviet-era registration numbers.

How much does Vilon cost?

There is no clinical retail price, because there is no approved product anywhere. On the research-chemical market it is inexpensive, which is what two amino acids cost to make.

related peptides

epithalon: sister Khavinson peptide, same single-lab problem, graded a tier higher
pinealon: another Khavinson short peptide with a small clinical base
thymosin α-1: thymic peptide that does carry registered trials, the fair comparison

reptides grades the research record and cites the literature behind every call. research reference only; not medical advice.