Retinalamin

updated

Retinalamin is a Russian-registered injectable mixture of water-soluble polypeptide fractions from cattle retina, labeled in Russia for glaucoma, diabetic retinopathy and retinal dystrophies. Its trials are unmasked Russian studies: one 12-month glaucoma comparison favored it, a 24-month comparison found no between-group difference at the end, and the one controlled animal study found no protection. It has no published sequence or molecular weight and no registration outside Russia.

Retinal polypeptide extract (tissue repair stimulator, ATC S01XA)

  • Retinalamin is a mixture of polypeptide fractions from cattle retina; no sequence, molecular weight or CAS number is published in the sources reviewed.
  • The Russian State Register lists Retinalamin under holder Gerofarm LLC, with a state registration date of 21 January 2022.
  • openFDA, DailyMed and ClinicalTrials.gov returned no record for it on 11 October 2026.
  • In a 24-month randomized glaucoma comparison in 147 patients, visual field and nerve-layer measures did not differ between groups at the end.
  • In 36 rabbits with light-induced retinal injury, Retinalamin did not differ from saline on any measure.
  • A PubMed search found 24 records on the drug, all in Russian journals, and none describing a placebo or masking.

What is Retinalamin, and where is it registered?

Retinalamin is a mixture of water-soluble polypeptide fractions from cattle retina, given by intramuscular or parabulbar injection. It is registered in Russia under Gerofarm LLC, and no US application, label or registered trial was found.

The Russian State Register gives the group name polypeptides of cattle retina. A pharmacy reference compiled from the Russian label gives the contents of each vial as 5 mg of retinalamin, described as a complex of water-soluble polypeptide fractions, with 17 mg of glycine as stabilizer. A 2021 pharmacology study also describes it as water-soluble polypeptide fractions produced from animal retina (PMID 34726863). A PubChem name lookup returned no compound on 11 October 2026, and no source reviewed gives a peptide sequence, molecular weight, CAS number or batch composition.

A search of the Russian State Register of Medicines on 11 October 2026 returned one record: Retinalamin, holder Gerofarm LLC (Russia), registration number LP-No(000519)-(RG-RU) with Cyrillic letters transliterated, state registration date 21 January 2022, re-issue date 16 November 2023, decision date 21 April 2025, and no expiry date shown. The pharmacy reference shows an earlier certificate, LS-000684, registered 7 July 2010 and listed as expired, with an expiry date of 19 July 2025. Its price list also shows a second retinalamin product from another Russian manufacturer, Longvi-Farm, which was not matched to the Gerofarm product.

The Russian label, as reproduced by the pharmacy reference (manufacturer instruction approved 10 February 2022), covers adults with diabetic retinopathy, central retinal dystrophy of inflammatory or traumatic origin, or central and peripheral tapetoretinal abiotrophy, compensated primary open-angle glaucoma, recovery after retinal detachment surgery and myopic disease, and children aged 1 to 18 with retinal dystrophy or abiotrophy. On 11 October 2026 openFDA Drugs@FDA returned no application, DailyMed no label and ClinicalTrials.gov no study.

Identity: polypeptides of cattle retina, 5 mg per vial with glycine

Chemical identity record

State Register of Medicines, Ministry of Health of the Russian Federation, entry for Retinalamin (group name polypeptides of cattle retina), searched 11 October 2026; composition per vial from a pharmacy reference compiled from the Russian label; PubChem name lookup for retinalamin, 11 October 2026.

The register gives the group name polypeptides of cattle retina. Each vial contains 5 mg of retinalamin, a complex of water-soluble polypeptide fractions, with 17 mg of glycine as stabilizer. A 2021 pharmacology study (PMID 34726863) describes water-soluble polypeptide fractions produced from animal retina. PubChem returned no compound. No sequence, molecular weight, CAS number or batch composition is given.

Participants / model
Chemical identity, not a clinical population
Treatment
Lyophilized powder for intramuscular and parabulbar solution, 5 mg per vial (Gerofarm)
Follow-up
Not applicable
Study design
Official Russian register entry, secondary label compilation and dated PubChem lookup
Funding
not stated in the source

A second retinalamin product (powder for intramuscular solution, Longvi-Farm, Russia) appears in a price list and was not matched to the Gerofarm product.

Read the original source
Russian register, 11 October 2026: one record, holder Gerofarm LLC

Regulatory record

State Register of Medicines, Ministry of Health of the Russian Federation. Retinalamin, holder Gerofarm LLC (Russia), registration number LP-No(000519)-(RG-RU) (Cyrillic letters transliterated), state registration date 21 January 2022, re-issue date 16 November 2023, decision date 21 April 2025. Searched 11 October 2026. With openFDA Drugs@FDA, DailyMed and ClinicalTrials.gov searches the same day.

One record: Retinalamin, holder Gerofarm LLC, registration number LP-No(000519)-(RG-RU), registered 21 January 2022, re-issued 16 November 2023, decision dated 21 April 2025, no expiry date shown. A pharmacy reference shows an earlier certificate, LS-000684, registered 7 July 2010, listed as expired with an expiry date of 19 July 2025 and amendments dated 29 November 2021. openFDA returned no application, DailyMed no label and ClinicalTrials.gov no study.

Participants / model
Regulatory records, not a clinical population
Treatment
Not applicable
Follow-up
Searches run on 11 October 2026
Study design
Official Russian register search, with US regulator and trial registry searches
Funding
not stated in the source

A Russian registration is not a US review, and no registration outside Russia was found.

Read the original source
Russian label (rlsnet.ru): indications, class tissue repair stimulator

Official label

Retinalamin (lyophilisate for intramuscular and parabulbar solution), Russian manufacturer instruction approved 10 February 2022, as reproduced on rlsnet.ru, a commercial pharmacy reference. ATC S01XA.

Given by intramuscular or parabulbar injection. Covers adults with diabetic retinopathy, central retinal dystrophy of inflammatory or traumatic origin, or central and peripheral tapetoretinal abiotrophy; compensated primary open-angle glaucoma; recovery after retinal detachment surgery; myopic disease; and children aged 1 to 18 with retinal dystrophy or abiotrophy. Class: tissue repair stimulator.

Participants / model
Adults and children as listed on the Russian label
Treatment
Intramuscular or parabulbar injection of 5 mg vials
Follow-up
Manufacturer instruction approved 10 February 2022
Study design
Russian label reproduced by a pharmacy reference; a secondary compilation, not the manufacturer's instruction itself
Funding
not stated in the source

Label doses are not reproduced on this page. Registration and label facts should be compared with the official register entry and the manufacturer's instruction.

Read the original source

What did the glaucoma studies find?

A 12-month randomized comparison in 180 patients reported better visual fields with Retinalamin than controls, but the groups started at different values. A 24-month randomized comparison in 147 patients found no between-group difference at the end, and neither trial describes a placebo or masking.

In 180 patients (355 eyes) with open-angle glaucoma and normalized eye pressure, 90 were randomized to intramuscular Retinalamin, with the course repeated at 6 months, and 90 to a control group. Over 12 months, perimetry mean deviation rose from -5.52 +/- 2.76 to -4.82 +/- 2.73 dB in the treated group and fell from -3.51 +/- 1.84 to -4.60 +/- 2.61 dB in controls. Eye pressure and nerve fiber layer thickness were stable in both groups. The groups started at different mean deviation values, and the abstract does not describe a placebo or masking.

In 147 patients (249 eyes) with stage I to II glaucoma, 69 were randomized to a Retinalamin course every 6 months and 78 to controls. At 24 months the groups did not differ in mean deviation (p=0.59), pattern deviation (p=0.53), nerve fiber layer (p=0.524), neuroretinal rim (p=0.909) or ganglion cell layer (p=0.51). Within groups, nerve fiber layer thickness fell from 83.5 +/- 22.47 to 76.7 +/- 20.7 um in controls (p=0.001) but not significantly in the treated group (p=0.078), and rim measurements rose with treatment (p=0.012) and fell in controls (p=0.0006). The authors concluded that regular treatment arrests glaucomatous optic neuropathy, which the between-group results do not by themselves show.

In a non-randomized cohort of 56 patients (98 eyes) with advanced glaucoma and stable eye pressure, the treated group received 10 intramuscular injections of 5 mg every three months for two years and the control group no neuroprotective therapy. Mean deviation fell 0.98 dB a year with treatment and 1.65 dB a year in controls, and nerve fiber layer thinning was 1.5 versus 3.0 um a year. The abstract gives no between-group test.

Glaucoma comparison: 180 patients, 12 months, no stated placebo

Randomized controlled trial

Egorov EA et al. Vestn Oftalmol. 2019;135(3):20-30. PMID 31393444.

Over 12 months, mean deviation rose from -5.52 +/- 2.76 to -4.82 +/- 2.73 dB in the treated group and fell from -3.51 +/- 1.84 to -4.60 +/- 2.61 dB in controls. Eye pressure and nerve fiber layer thickness were stable in both groups.

Participants / model
180 patients (355 eyes) with primary open-angle glaucoma and compensated eye pressure; 90 per group
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), course repeated at 6 months, or control
Follow-up
12 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The groups started at different mean deviation values.

Read the original source
Glaucoma comparison: 147 patients, 24 months, no between-group difference

Randomized controlled trial

Strakhov VV et al. Vestn Oftalmol. 2020;136(5):58-66. PMID 33056965.

At 24 months the groups did not differ in mean deviation (p=0.59), pattern deviation (p=0.53), nerve fiber layer (p=0.524), neuroretinal rim (p=0.909) or ganglion cell layer (p=0.51). Nerve fiber layer thickness fell from 83.5 +/- 22.47 to 76.7 +/- 20.7 um in controls (p=0.001) but not significantly with treatment (p=0.078); rim measurements rose with treatment (p=0.012) and fell in controls (p=0.0006).

Participants / model
147 patients (249 eyes) with stage I to II primary open-angle glaucoma and compensated eye pressure; 69 treated, 78 controls
Treatment
Retinalamin course every 6 months (route and dose not stated in the abstract), or control
Follow-up
24 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The authors concluded that regular treatment arrests glaucomatous optic neuropathy; the between-group results do not by themselves show that.

Read the original source
Advanced glaucoma cohort: 56 patients, not randomized

Human study

Dorofeev DA et al. Vestn Oftalmol. 2025;141(6):75-80. PMID 41432508.

Mean deviation fell 0.98 dB a year in the treated group and 1.65 dB a year in controls; nerve fiber layer thinning was 1.5 versus 3.0 um a year (pairing as the abstract reads). No between-group test is given.

Participants / model
56 patients (98 eyes) with advanced primary open-angle glaucoma and stable eye pressure
Treatment
10 intramuscular injections of Retinalamin 5 mg every three months, or no neuroprotective therapy
Follow-up
Two years
Study design
Prospective non-randomized cohort study (Russian journal)
Funding
not stated in the source

Group assignment was not randomized.

Read the original source

What do the diabetic retinopathy and childhood studies show?

The diabetic retinopathy study reports positive change but gives no values, so the size of any effect is unknown. The childhood retinal abiotrophy report describes improvement in 33 children but has no control group.

Fifty-six patients (112 eyes) with type 1 or type 2 diabetes and retinopathy without macular edema were studied: 28 received intramuscular Retinalamin and 28 controls did not. Ganglion cell complex thickness by OCT and pattern and full-field electroretinography were measured. The abstract states there was convincing objective evidence of positive change in the treated group but reports no values, and the allocation method is not stated.

In a 2005 report on 33 children aged 4 to 7 with 5 types of retinal abiotrophy, the disease was described as stabilized over 18 months in all cases of developed disease. Visual acuity improved in 82% after treatment, visual fields enlarged and central scotomas shrank in 54%, and electroretinography improved in 37%. The abstract describes no control group, dose or route.

Diabetic retinopathy study: 56 patients, no values reported

Human study

Malakhova AI et al. Vestn Oftalmol. 2024;140(5):97-104. PMID 39569781.

The abstract states there was convincing objective evidence of positive change in the treated group on OCT ganglion cell complex thickness and pattern and full-field electroretinography, but reports no values.

Participants / model
56 patients (112 eyes) with type 1 or type 2 diabetes and retinopathy without macular edema; 28 treated, 28 controls
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), or no treatment
Follow-up
not stated in the source
Study design
Clinical study with a control group; allocation method not stated (Russian journal)
Funding
not stated in the source

The abstract gives no values, so the size of any effect is unknown.

Read the original source
Childhood report (2005): 33 children, no control group

Human study

Khvatova AV et al. Vestn Oftalmol. 2005;121(2):19-21. PMID 15881150.

Disease was stabilized over 18 months in all cases of developed disease; visual acuity improved in 82% after treatment, visual fields enlarged and central scotomas reduced in 54%, and electroretinography improved in 37%.

Participants / model
33 children aged 4 to 7 with 5 types of retinal abiotrophy
Treatment
Retinalamin; dose and route not stated in the abstract
Follow-up
18 months
Study design
Uncontrolled clinical report (Russian journal, 2005)
Funding
not stated in the source

No control group is described.

Read the original source

Does Retinalamin protect or restore retinal function?

The protection claim rests only on unmasked Russian trials with mixed internal results and is contradicted by one rabbit study. The claim of restoring function has no controlled evidence in the records reviewed.

Sellers describe Retinalamin as a Russian retinal polypeptide extract that protects and restores retinal function in glaucoma, diabetic retinopathy and retinal dystrophies. The 12-month glaucoma comparison favored treatment from unequal starting points, the 24-month comparison found no between-group difference at the end, the diabetic retinopathy abstract gives no numbers, and the childhood report has no control group.

A PubMed search on 11 October 2026 for retinalamin or retinalamine returned 25 records. One, from 1966, is unrelated retinal-amine chemistry; the other 24 are about the drug: 17 in Vestnik Oftalmologii, 3 in Advances in Gerontology, 2 in Bulletin of Experimental Biology and Medicine, 1 in Problems of Tuberculosis and 1 in Experimental and Clinical Pharmacology. Adding placebo, double-blind, masked or randomized controlled trial returned 3 records, and none of their abstracts describes a placebo or masking. No record came from a journal outside Russia, and no independent replication was found.

Glaucoma comparison: 180 patients, 12 months, no stated placebo

Randomized controlled trial

Egorov EA et al. Vestn Oftalmol. 2019;135(3):20-30. PMID 31393444.

Over 12 months, mean deviation rose from -5.52 +/- 2.76 to -4.82 +/- 2.73 dB in the treated group and fell from -3.51 +/- 1.84 to -4.60 +/- 2.61 dB in controls. Eye pressure and nerve fiber layer thickness were stable in both groups.

Participants / model
180 patients (355 eyes) with primary open-angle glaucoma and compensated eye pressure; 90 per group
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), course repeated at 6 months, or control
Follow-up
12 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The groups started at different mean deviation values.

Read the original source
Glaucoma comparison: 147 patients, 24 months, no between-group difference

Randomized controlled trial

Strakhov VV et al. Vestn Oftalmol. 2020;136(5):58-66. PMID 33056965.

At 24 months the groups did not differ in mean deviation (p=0.59), pattern deviation (p=0.53), nerve fiber layer (p=0.524), neuroretinal rim (p=0.909) or ganglion cell layer (p=0.51). Nerve fiber layer thickness fell from 83.5 +/- 22.47 to 76.7 +/- 20.7 um in controls (p=0.001) but not significantly with treatment (p=0.078); rim measurements rose with treatment (p=0.012) and fell in controls (p=0.0006).

Participants / model
147 patients (249 eyes) with stage I to II primary open-angle glaucoma and compensated eye pressure; 69 treated, 78 controls
Treatment
Retinalamin course every 6 months (route and dose not stated in the abstract), or control
Follow-up
24 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The authors concluded that regular treatment arrests glaucomatous optic neuropathy; the between-group results do not by themselves show that.

Read the original source
Diabetic retinopathy study: 56 patients, no values reported

Human study

Malakhova AI et al. Vestn Oftalmol. 2024;140(5):97-104. PMID 39569781.

The abstract states there was convincing objective evidence of positive change in the treated group on OCT ganglion cell complex thickness and pattern and full-field electroretinography, but reports no values.

Participants / model
56 patients (112 eyes) with type 1 or type 2 diabetes and retinopathy without macular edema; 28 treated, 28 controls
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), or no treatment
Follow-up
not stated in the source
Study design
Clinical study with a control group; allocation method not stated (Russian journal)
Funding
not stated in the source

The abstract gives no values, so the size of any effect is unknown.

Read the original source
Childhood report (2005): 33 children, no control group

Human study

Khvatova AV et al. Vestn Oftalmol. 2005;121(2):19-21. PMID 15881150.

Disease was stabilized over 18 months in all cases of developed disease; visual acuity improved in 82% after treatment, visual fields enlarged and central scotomas reduced in 54%, and electroretinography improved in 37%.

Participants / model
33 children aged 4 to 7 with 5 types of retinal abiotrophy
Treatment
Retinalamin; dose and route not stated in the abstract
Follow-up
18 months
Study design
Uncontrolled clinical report (Russian journal, 2005)
Funding
not stated in the source

No control group is described.

Read the original source
Rabbit study: 36 rabbits, no difference from saline

Animal study

Suetov AA et al. Vestn Oftalmol. 2021;137(5):57-67. PMID 34726859.

No significant differences between the Retinalamin and control groups in any electroretinography or histology measure (p above 0.05); the authors found no significant evidence of a neuroprotective effect in this model.

Participants / model
36 rabbits (72 eyes) with light-induced retinal damage, randomized to four groups
Treatment
Parabulbar Retinalamin 0.25 mg/kg for 10 days, started on day 1 or day 10, or saline injections
Follow-up
20-day 405 nm light exposure
Study design
Randomized preclinical study (Russian journal)
Funding
not stated in the source

The one controlled animal study found, and it showed no protection.

Read the original source
PubMed search, 11 October 2026: 24 drug records, all in Russian journals

PubMed search record

PubMed search run on 11 October 2026: retinalamin[tiab] OR retinalamine[tiab]. 25 records returned. A second query adding placebo, double-blind, masked or randomized controlled trial returned 3 records.

Of 25 records, 1 (1966) is unrelated retinal-amine chemistry and 24 are about the drug: 17 in Vestnik Oftalmologii, 3 in Advances in Gerontology, 2 in Bulletin of Experimental Biology and Medicine, 1 in Problems of Tuberculosis and 1 in Experimental and Clinical Pharmacology. The added-term query returned PMIDs 30721201, 31393444 and 33056965, and none of their abstracts describes a placebo or masking. ClinicalTrials.gov returned no study. No record comes from a journal outside Russia.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 11 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. No independent replication and no independent safety source were found in these records.

Read the original source

What did the rabbit study find?

In 36 rabbits with light-induced retinal injury, parabulbar Retinalamin did not differ from saline on any electroretinography or histology measure, and the authors found no significant evidence of a neuroprotective effect.

Thirty-six rabbits (72 eyes) were randomized to four groups. Parabulbar Retinalamin at 0.25 mg/kg for 10 days, started on day 1 or day 10 of a 20-day exposure to 405 nm light, was compared with saline injections. There were no significant differences between the Retinalamin and control groups in multifocal or flicker electroretinography, retinal cell counts or apoptosis (p above 0.05).

Rabbit study: 36 rabbits, no difference from saline

Animal study

Suetov AA et al. Vestn Oftalmol. 2021;137(5):57-67. PMID 34726859.

No significant differences between the Retinalamin and control groups in any electroretinography or histology measure (p above 0.05); the authors found no significant evidence of a neuroprotective effect in this model.

Participants / model
36 rabbits (72 eyes) with light-induced retinal damage, randomized to four groups
Treatment
Parabulbar Retinalamin 0.25 mg/kg for 10 days, started on day 1 or day 10, or saline injections
Follow-up
20-day 405 nm light exposure
Study design
Randomized preclinical study (Russian journal)
Funding
not stated in the source

The one controlled animal study found, and it showed no protection.

Read the original source

How is Retinalamin supposed to work?

The Russian label classes it as a tissue repair stimulator, and sources describe it as polypeptide fractions from animal retina. No source reviewed identifies a molecular target, and the one controlled animal test found no protective effect.

The Russian label, as reproduced by a pharmacy reference, lists ATC code S01XA and the class tissue repair stimulator. That is a regulatory category, not a measured mechanism. Because the product is a mixture with no published sequence or molecular weight, no single active component has been identified in the sources reviewed, and no pharmacokinetic data were found.

Russian label (rlsnet.ru): indications, class tissue repair stimulator

Official label

Retinalamin (lyophilisate for intramuscular and parabulbar solution), Russian manufacturer instruction approved 10 February 2022, as reproduced on rlsnet.ru, a commercial pharmacy reference. ATC S01XA.

Given by intramuscular or parabulbar injection. Covers adults with diabetic retinopathy, central retinal dystrophy of inflammatory or traumatic origin, or central and peripheral tapetoretinal abiotrophy; compensated primary open-angle glaucoma; recovery after retinal detachment surgery; myopic disease; and children aged 1 to 18 with retinal dystrophy or abiotrophy. Class: tissue repair stimulator.

Participants / model
Adults and children as listed on the Russian label
Treatment
Intramuscular or parabulbar injection of 5 mg vials
Follow-up
Manufacturer instruction approved 10 February 2022
Study design
Russian label reproduced by a pharmacy reference; a secondary compilation, not the manufacturer's instruction itself
Funding
not stated in the source

Label doses are not reproduced on this page. Registration and label facts should be compared with the official register entry and the manufacturer's instruction.

Read the original source
Identity: polypeptides of cattle retina, 5 mg per vial with glycine

Chemical identity record

State Register of Medicines, Ministry of Health of the Russian Federation, entry for Retinalamin (group name polypeptides of cattle retina), searched 11 October 2026; composition per vial from a pharmacy reference compiled from the Russian label; PubChem name lookup for retinalamin, 11 October 2026.

The register gives the group name polypeptides of cattle retina. Each vial contains 5 mg of retinalamin, a complex of water-soluble polypeptide fractions, with 17 mg of glycine as stabilizer. A 2021 pharmacology study (PMID 34726863) describes water-soluble polypeptide fractions produced from animal retina. PubChem returned no compound. No sequence, molecular weight, CAS number or batch composition is given.

Participants / model
Chemical identity, not a clinical population
Treatment
Lyophilized powder for intramuscular and parabulbar solution, 5 mg per vial (Gerofarm)
Follow-up
Not applicable
Study design
Official Russian register entry, secondary label compilation and dated PubChem lookup
Funding
not stated in the source

A second retinalamin product (powder for intramuscular solution, Longvi-Farm, Russia) appears in a price list and was not matched to the Gerofarm product.

Read the original source
Rabbit study: 36 rabbits, no difference from saline

Animal study

Suetov AA et al. Vestn Oftalmol. 2021;137(5):57-67. PMID 34726859.

No significant differences between the Retinalamin and control groups in any electroretinography or histology measure (p above 0.05); the authors found no significant evidence of a neuroprotective effect in this model.

Participants / model
36 rabbits (72 eyes) with light-induced retinal damage, randomized to four groups
Treatment
Parabulbar Retinalamin 0.25 mg/kg for 10 days, started on day 1 or day 10, or saline injections
Follow-up
20-day 405 nm light exposure
Study design
Randomized preclinical study (Russian journal)
Funding
not stated in the source

The one controlled animal study found, and it showed no protection.

Read the original source

What is known about Retinalamin's safety?

Little: no independent safety source was found in the records reviewed, so adverse effects are not characterized. The product is an uncharacterized mixture from cattle retina with no published sequence or batch composition, and a second product from another manufacturer was not matched to the registered one.

No independent safety source was found in the records reviewed, so the type and frequency of adverse effects are not established. The trials are unmasked or have no stated placebo, which limits what they can show about harms as well as benefits.

Identity is a second concern. Retinalamin is a mixture of polypeptide fractions from cattle retina, and no source gives a sequence, molecular weight or batch composition. A pharmacy price list shows a second retinalamin powder from another Russian manufacturer, and whether it matches the Gerofarm product was not established.

Identity: polypeptides of cattle retina, 5 mg per vial with glycine

Chemical identity record

State Register of Medicines, Ministry of Health of the Russian Federation, entry for Retinalamin (group name polypeptides of cattle retina), searched 11 October 2026; composition per vial from a pharmacy reference compiled from the Russian label; PubChem name lookup for retinalamin, 11 October 2026.

The register gives the group name polypeptides of cattle retina. Each vial contains 5 mg of retinalamin, a complex of water-soluble polypeptide fractions, with 17 mg of glycine as stabilizer. A 2021 pharmacology study (PMID 34726863) describes water-soluble polypeptide fractions produced from animal retina. PubChem returned no compound. No sequence, molecular weight, CAS number or batch composition is given.

Participants / model
Chemical identity, not a clinical population
Treatment
Lyophilized powder for intramuscular and parabulbar solution, 5 mg per vial (Gerofarm)
Follow-up
Not applicable
Study design
Official Russian register entry, secondary label compilation and dated PubChem lookup
Funding
not stated in the source

A second retinalamin product (powder for intramuscular solution, Longvi-Farm, Russia) appears in a price list and was not matched to the Gerofarm product.

Read the original source
PubMed search, 11 October 2026: 24 drug records, all in Russian journals

PubMed search record

PubMed search run on 11 October 2026: retinalamin[tiab] OR retinalamine[tiab]. 25 records returned. A second query adding placebo, double-blind, masked or randomized controlled trial returned 3 records.

Of 25 records, 1 (1966) is unrelated retinal-amine chemistry and 24 are about the drug: 17 in Vestnik Oftalmologii, 3 in Advances in Gerontology, 2 in Bulletin of Experimental Biology and Medicine, 1 in Problems of Tuberculosis and 1 in Experimental and Clinical Pharmacology. The added-term query returned PMIDs 30721201, 31393444 and 33056965, and none of their abstracts describes a placebo or masking. ClinicalTrials.gov returned no study. No record comes from a journal outside Russia.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 11 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. No independent replication and no independent safety source were found in these records.

Read the original source

Why does Retinalamin sit in C tier?

A current Russian registration, randomized glaucoma comparisons in 147 and 180 patients and a documented bovine retinal source put it at the top of the range for Russian bioregulator extracts. Unmasked trials, a null 24-month between-group result, a null rabbit study and no evidence outside Russia keep it at C.

Comparable Russian bioregulator products on this site sit at C or D. Retinalamin has more trial volume and a current registration than most, but no masked or placebo-controlled trial, no published sequence or molecular weight, and no independent replication.

Russian register, 11 October 2026: one record, holder Gerofarm LLC

Regulatory record

State Register of Medicines, Ministry of Health of the Russian Federation. Retinalamin, holder Gerofarm LLC (Russia), registration number LP-No(000519)-(RG-RU) (Cyrillic letters transliterated), state registration date 21 January 2022, re-issue date 16 November 2023, decision date 21 April 2025. Searched 11 October 2026. With openFDA Drugs@FDA, DailyMed and ClinicalTrials.gov searches the same day.

One record: Retinalamin, holder Gerofarm LLC, registration number LP-No(000519)-(RG-RU), registered 21 January 2022, re-issued 16 November 2023, decision dated 21 April 2025, no expiry date shown. A pharmacy reference shows an earlier certificate, LS-000684, registered 7 July 2010, listed as expired with an expiry date of 19 July 2025 and amendments dated 29 November 2021. openFDA returned no application, DailyMed no label and ClinicalTrials.gov no study.

Participants / model
Regulatory records, not a clinical population
Treatment
Not applicable
Follow-up
Searches run on 11 October 2026
Study design
Official Russian register search, with US regulator and trial registry searches
Funding
not stated in the source

A Russian registration is not a US review, and no registration outside Russia was found.

Read the original source
Glaucoma comparison: 180 patients, 12 months, no stated placebo

Randomized controlled trial

Egorov EA et al. Vestn Oftalmol. 2019;135(3):20-30. PMID 31393444.

Over 12 months, mean deviation rose from -5.52 +/- 2.76 to -4.82 +/- 2.73 dB in the treated group and fell from -3.51 +/- 1.84 to -4.60 +/- 2.61 dB in controls. Eye pressure and nerve fiber layer thickness were stable in both groups.

Participants / model
180 patients (355 eyes) with primary open-angle glaucoma and compensated eye pressure; 90 per group
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), course repeated at 6 months, or control
Follow-up
12 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The groups started at different mean deviation values.

Read the original source
Glaucoma comparison: 147 patients, 24 months, no between-group difference

Randomized controlled trial

Strakhov VV et al. Vestn Oftalmol. 2020;136(5):58-66. PMID 33056965.

At 24 months the groups did not differ in mean deviation (p=0.59), pattern deviation (p=0.53), nerve fiber layer (p=0.524), neuroretinal rim (p=0.909) or ganglion cell layer (p=0.51). Nerve fiber layer thickness fell from 83.5 +/- 22.47 to 76.7 +/- 20.7 um in controls (p=0.001) but not significantly with treatment (p=0.078); rim measurements rose with treatment (p=0.012) and fell in controls (p=0.0006).

Participants / model
147 patients (249 eyes) with stage I to II primary open-angle glaucoma and compensated eye pressure; 69 treated, 78 controls
Treatment
Retinalamin course every 6 months (route and dose not stated in the abstract), or control
Follow-up
24 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The authors concluded that regular treatment arrests glaucomatous optic neuropathy; the between-group results do not by themselves show that.

Read the original source
Rabbit study: 36 rabbits, no difference from saline

Animal study

Suetov AA et al. Vestn Oftalmol. 2021;137(5):57-67. PMID 34726859.

No significant differences between the Retinalamin and control groups in any electroretinography or histology measure (p above 0.05); the authors found no significant evidence of a neuroprotective effect in this model.

Participants / model
36 rabbits (72 eyes) with light-induced retinal damage, randomized to four groups
Treatment
Parabulbar Retinalamin 0.25 mg/kg for 10 days, started on day 1 or day 10, or saline injections
Follow-up
20-day 405 nm light exposure
Study design
Randomized preclinical study (Russian journal)
Funding
not stated in the source

The one controlled animal study found, and it showed no protection.

Read the original source
PubMed search, 11 October 2026: 24 drug records, all in Russian journals

PubMed search record

PubMed search run on 11 October 2026: retinalamin[tiab] OR retinalamine[tiab]. 25 records returned. A second query adding placebo, double-blind, masked or randomized controlled trial returned 3 records.

Of 25 records, 1 (1966) is unrelated retinal-amine chemistry and 24 are about the drug: 17 in Vestnik Oftalmologii, 3 in Advances in Gerontology, 2 in Bulletin of Experimental Biology and Medicine, 1 in Problems of Tuberculosis and 1 in Experimental and Clinical Pharmacology. The added-term query returned PMIDs 30721201, 31393444 and 33056965, and none of their abstracts describes a placebo or masking. ClinicalTrials.gov returned no study. No record comes from a journal outside Russia.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 11 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. No independent replication and no independent safety source were found in these records.

Read the original source

Studies and sources

Identity: polypeptides of cattle retina, 5 mg per vial with glycine

Chemical identity record

State Register of Medicines, Ministry of Health of the Russian Federation, entry for Retinalamin (group name polypeptides of cattle retina), searched 11 October 2026; composition per vial from a pharmacy reference compiled from the Russian label; PubChem name lookup for retinalamin, 11 October 2026.

The register gives the group name polypeptides of cattle retina. Each vial contains 5 mg of retinalamin, a complex of water-soluble polypeptide fractions, with 17 mg of glycine as stabilizer. A 2021 pharmacology study (PMID 34726863) describes water-soluble polypeptide fractions produced from animal retina. PubChem returned no compound. No sequence, molecular weight, CAS number or batch composition is given.

Participants / model
Chemical identity, not a clinical population
Treatment
Lyophilized powder for intramuscular and parabulbar solution, 5 mg per vial (Gerofarm)
Follow-up
Not applicable
Study design
Official Russian register entry, secondary label compilation and dated PubChem lookup
Funding
not stated in the source

A second retinalamin product (powder for intramuscular solution, Longvi-Farm, Russia) appears in a price list and was not matched to the Gerofarm product.

Read the original source
Russian register, 11 October 2026: one record, holder Gerofarm LLC

Regulatory record

State Register of Medicines, Ministry of Health of the Russian Federation. Retinalamin, holder Gerofarm LLC (Russia), registration number LP-No(000519)-(RG-RU) (Cyrillic letters transliterated), state registration date 21 January 2022, re-issue date 16 November 2023, decision date 21 April 2025. Searched 11 October 2026. With openFDA Drugs@FDA, DailyMed and ClinicalTrials.gov searches the same day.

One record: Retinalamin, holder Gerofarm LLC, registration number LP-No(000519)-(RG-RU), registered 21 January 2022, re-issued 16 November 2023, decision dated 21 April 2025, no expiry date shown. A pharmacy reference shows an earlier certificate, LS-000684, registered 7 July 2010, listed as expired with an expiry date of 19 July 2025 and amendments dated 29 November 2021. openFDA returned no application, DailyMed no label and ClinicalTrials.gov no study.

Participants / model
Regulatory records, not a clinical population
Treatment
Not applicable
Follow-up
Searches run on 11 October 2026
Study design
Official Russian register search, with US regulator and trial registry searches
Funding
not stated in the source

A Russian registration is not a US review, and no registration outside Russia was found.

Read the original source
Russian label (rlsnet.ru): indications, class tissue repair stimulator

Official label

Retinalamin (lyophilisate for intramuscular and parabulbar solution), Russian manufacturer instruction approved 10 February 2022, as reproduced on rlsnet.ru, a commercial pharmacy reference. ATC S01XA.

Given by intramuscular or parabulbar injection. Covers adults with diabetic retinopathy, central retinal dystrophy of inflammatory or traumatic origin, or central and peripheral tapetoretinal abiotrophy; compensated primary open-angle glaucoma; recovery after retinal detachment surgery; myopic disease; and children aged 1 to 18 with retinal dystrophy or abiotrophy. Class: tissue repair stimulator.

Participants / model
Adults and children as listed on the Russian label
Treatment
Intramuscular or parabulbar injection of 5 mg vials
Follow-up
Manufacturer instruction approved 10 February 2022
Study design
Russian label reproduced by a pharmacy reference; a secondary compilation, not the manufacturer's instruction itself
Funding
not stated in the source

Label doses are not reproduced on this page. Registration and label facts should be compared with the official register entry and the manufacturer's instruction.

Read the original source
Glaucoma comparison: 180 patients, 12 months, no stated placebo

Randomized controlled trial

Egorov EA et al. Vestn Oftalmol. 2019;135(3):20-30. PMID 31393444.

Over 12 months, mean deviation rose from -5.52 +/- 2.76 to -4.82 +/- 2.73 dB in the treated group and fell from -3.51 +/- 1.84 to -4.60 +/- 2.61 dB in controls. Eye pressure and nerve fiber layer thickness were stable in both groups.

Participants / model
180 patients (355 eyes) with primary open-angle glaucoma and compensated eye pressure; 90 per group
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), course repeated at 6 months, or control
Follow-up
12 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The groups started at different mean deviation values.

Read the original source
Glaucoma comparison: 147 patients, 24 months, no between-group difference

Randomized controlled trial

Strakhov VV et al. Vestn Oftalmol. 2020;136(5):58-66. PMID 33056965.

At 24 months the groups did not differ in mean deviation (p=0.59), pattern deviation (p=0.53), nerve fiber layer (p=0.524), neuroretinal rim (p=0.909) or ganglion cell layer (p=0.51). Nerve fiber layer thickness fell from 83.5 +/- 22.47 to 76.7 +/- 20.7 um in controls (p=0.001) but not significantly with treatment (p=0.078); rim measurements rose with treatment (p=0.012) and fell in controls (p=0.0006).

Participants / model
147 patients (249 eyes) with stage I to II primary open-angle glaucoma and compensated eye pressure; 69 treated, 78 controls
Treatment
Retinalamin course every 6 months (route and dose not stated in the abstract), or control
Follow-up
24 months
Study design
Randomized comparison with a control group; no placebo or masking described (Russian journal)
Funding
not stated in the source

The authors concluded that regular treatment arrests glaucomatous optic neuropathy; the between-group results do not by themselves show that.

Read the original source
Advanced glaucoma cohort: 56 patients, not randomized

Human study

Dorofeev DA et al. Vestn Oftalmol. 2025;141(6):75-80. PMID 41432508.

Mean deviation fell 0.98 dB a year in the treated group and 1.65 dB a year in controls; nerve fiber layer thinning was 1.5 versus 3.0 um a year (pairing as the abstract reads). No between-group test is given.

Participants / model
56 patients (98 eyes) with advanced primary open-angle glaucoma and stable eye pressure
Treatment
10 intramuscular injections of Retinalamin 5 mg every three months, or no neuroprotective therapy
Follow-up
Two years
Study design
Prospective non-randomized cohort study (Russian journal)
Funding
not stated in the source

Group assignment was not randomized.

Read the original source
Diabetic retinopathy study: 56 patients, no values reported

Human study

Malakhova AI et al. Vestn Oftalmol. 2024;140(5):97-104. PMID 39569781.

The abstract states there was convincing objective evidence of positive change in the treated group on OCT ganglion cell complex thickness and pattern and full-field electroretinography, but reports no values.

Participants / model
56 patients (112 eyes) with type 1 or type 2 diabetes and retinopathy without macular edema; 28 treated, 28 controls
Treatment
Intramuscular Retinalamin (dose not stated in the abstract), or no treatment
Follow-up
not stated in the source
Study design
Clinical study with a control group; allocation method not stated (Russian journal)
Funding
not stated in the source

The abstract gives no values, so the size of any effect is unknown.

Read the original source
Childhood report (2005): 33 children, no control group

Human study

Khvatova AV et al. Vestn Oftalmol. 2005;121(2):19-21. PMID 15881150.

Disease was stabilized over 18 months in all cases of developed disease; visual acuity improved in 82% after treatment, visual fields enlarged and central scotomas reduced in 54%, and electroretinography improved in 37%.

Participants / model
33 children aged 4 to 7 with 5 types of retinal abiotrophy
Treatment
Retinalamin; dose and route not stated in the abstract
Follow-up
18 months
Study design
Uncontrolled clinical report (Russian journal, 2005)
Funding
not stated in the source

No control group is described.

Read the original source
Rabbit study: 36 rabbits, no difference from saline

Animal study

Suetov AA et al. Vestn Oftalmol. 2021;137(5):57-67. PMID 34726859.

No significant differences between the Retinalamin and control groups in any electroretinography or histology measure (p above 0.05); the authors found no significant evidence of a neuroprotective effect in this model.

Participants / model
36 rabbits (72 eyes) with light-induced retinal damage, randomized to four groups
Treatment
Parabulbar Retinalamin 0.25 mg/kg for 10 days, started on day 1 or day 10, or saline injections
Follow-up
20-day 405 nm light exposure
Study design
Randomized preclinical study (Russian journal)
Funding
not stated in the source

The one controlled animal study found, and it showed no protection.

Read the original source
PubMed search, 11 October 2026: 24 drug records, all in Russian journals

PubMed search record

PubMed search run on 11 October 2026: retinalamin[tiab] OR retinalamine[tiab]. 25 records returned. A second query adding placebo, double-blind, masked or randomized controlled trial returned 3 records.

Of 25 records, 1 (1966) is unrelated retinal-amine chemistry and 24 are about the drug: 17 in Vestnik Oftalmologii, 3 in Advances in Gerontology, 2 in Bulletin of Experimental Biology and Medicine, 1 in Problems of Tuberculosis and 1 in Experimental and Clinical Pharmacology. The added-term query returned PMIDs 30721201, 31393444 and 33056965, and none of their abstracts describes a placebo or masking. ClinicalTrials.gov returned no study. No record comes from a journal outside Russia.

Participants / model
Records returned, not a population
Treatment
Not applicable
Follow-up
Search run on 11 October 2026
Study design
Literature search
Funding
not stated in the source

A search result shows what PubMed returned on that date. No independent replication and no independent safety source were found in these records.

Read the original source

Why is Retinalamin in C tier?

C fits a Russian-registered extract with randomized comparisons in 147 and 180 glaucoma patients and a documented bovine retinal source, which puts it at the top of the range for Russian bioregulator extracts. Every trial found is unmasked or has no stated placebo, the 24-month trial showed no between-group difference at the end, the one controlled animal study found no protection, and nothing was found outside Russian journals or Russian registration.