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Peptide (bioregulator)Mostly animalNot FDA approved

Epitalon

Epitalon (Ala-Glu-Asp-Gly tetrapeptide)

Last reviewed October 27, 2026 · 23 sources · Written for general readers · Compare with another compound →

The bottom line

Epitalon is a lab made peptide of four amino acids, studied mostly by one research group in Russia in cells and mice. FDA found no human safety data and no trials for insomnia, and raised a possible cancer concern because it switches on telomerase.[1] An FDA panel voted 7 to 4 in July 2026 to allow compounding, and in October 2026 HHS said it would not act against pharmacies compounding it under conditions, but epitalon is still not FDA approved.[2][3]

Where the evidence stands

What it is

Epitalon is a synthetic tetrapeptide, meaning a chain of four amino acids (alanine, glutamic acid, aspartic acid and glycine). It was first made in the late 1980s by a team led by Vladimir Khavinson in Russia, based on an extract from cattle pineal glands called epithalamin. FDA treats epitalon and epithalamin as different substances.[1]

It is sold online for aging, longevity, telomeres, skin and sleep, as injections, sprays and capsules, some labeled for research use only. It is often grouped with Khavinson's other short bioregulator peptides.[1]

A 2025 review noted that even basic chemical and structural research on epitalon is still limited.[4] European drug testing labs have found it in illegal medicines sold online.[15]

Name
Epitalon (Epitalon (Ala-Glu-Asp-Gly tetrapeptide))
Other names
epithalon, epitalone, AEDG peptide
Type
Peptide (bioregulator)
Sequence
AEDG
CAS number
307297-39-8
Formula
C14H22N4O9
Molecular weight
About 390.4 g/mol

What it does in the body

Epitalon does not occur naturally as a medicine. It is a lab made chain of four amino acids (alanine, glutamic acid, aspartic acid and glycine), designed in Russia from the idea of epithalamin, an extract of cattle pineal glands.[1] Its proposed actions are switching on telomerase, the enzyme that rebuilds the protective caps on chromosomes, and nudging the pineal gland's melatonin rhythm, but no clear receptor or target has been proven.[1][4]

This is the biology, area by area. A change measured in the body, like a higher blood level, does not always mean a person feels a benefit. The claims check below covers that.

Energy and cells

Lab finding

In human fetal lung cells in a dish, epitalon switched on telomerase and lengthened telomeres, the caps that shorten as cells age.[5] A 2025 study by a different research team found longer telomeres in normal human cells through telomerase, but in two breast cancer cell lines telomeres grew through a different backup route called ALT.[6] In white blood cells taken from 11 men and treated in a dish, telomere length changed in 7, rising in five and falling in two.[7]

Sleep

Measured in people

In one Russian trial of 40 women aged 40 to 50 with low melatonin output, a melatonin breakdown product in urine rose about 1.7 fold after 20 days of the peptide under the tongue, with no change on placebo. Sleep itself was not measured.[1] In older monkeys, epitalon raised evening melatonin more than fourfold and lowered evening cortisol, a stress hormone, by about 30%.[1] The developers also report restored night melatonin in elderly people, without numbers.[8]

Cancer and tumors

Seen in animals

In female mice treated for life, fewer developed leukemia.[9] In a 6.5 month study in older female mice, fewer treated mice developed cancerous tumors, and none had spread tumors, versus 3 of 9 tumor bearing untreated mice.[10] FDA warns the same telomerase effect could, in theory, help cells turn cancerous, and no standard cancer safety study exists.[1]

Lifespan

Seen in animals

In female mice treated from young adulthood, average lifespan did not change but maximum lifespan rose about 12%.[9] In female rats kept under natural light, maximum lifespan rose by 95 days, and by 24 days under constant light.[11] Nearly all of this work comes from the developer's group.[1]

Brain and mood

Lab finding

In human stem cells from gum tissue that were being turned into nerve cells, epitalon raised several nerve cell markers about 1.6 to 1.8 fold. The authors propose it binds histone proteins that package DNA.[12] No human brain or mood study exists.

Eyes

Lab finding

In human retina support cells stressed with high sugar to mimic diabetic eye disease, epitalon restored their ability to close a scratch and calmed scarring signals.[13] An older study injected it near the eye in people with retinitis pigmentosa, but FDA's review gives no results.[1]

How it works

The main claims are that epitalon lengthens telomeres and resets melatonin rhythms.

  • In human fetal cells grown in a dish, epitalon switched on telomerase, the enzyme that rebuilds telomeres (the protective caps on chromosomes), and lengthened telomeres.[5]
  • A 2025 study by a different research team found the same in normal cells, but cancer cells used a separate route called ALT to lengthen their telomeres.[6]
  • In older monkeys, it raised evening melatonin, the sleep hormone, more than fourfold and lowered evening cortisol, a stress hormone, by about 30%. Sleep was not measured.[1]
  • In rat pineal glands kept alive in a dish, it did not increase melatonin release, which cuts against a direct effect on the gland.[1]
  • Lab studies also report antioxidant and anti inflammatory activity in cells, and the developers propose it binds DNA packaging proteins to switch genes on.[1][12]

These effects come from small lab and animal studies, mostly from one group, and no clear mechanism has been proven in people.

What the research shows

We keep animal and human evidence apart. A result in animals is a reason to study something in people, not proof that it works in people.

Animal and lab studies

Some lifespan signals in mice and rats, from one group

  • In female mice injected regularly for life, epitalon did not change average lifespan but raised maximum lifespan by about 12% and lowered leukemia rates.[9]
  • Three lifespan studies from the same group reported longer life and fewer spontaneous tumors in female mice. FDA said they used one dose, only females and limited exposure, so they cannot rule out cancer harm.[1]
  • In female rats kept under natural light, maximum lifespan rose by 95 days and tumors were suppressed, but the tumor effect was not seen under constant light.[11]
  • In older female mice treated for 6.5 months, no toxic effects were seen, fewer had cancerous tumors, and none had spread tumors versus 3 of 9 tumor bearing controls.[10]
  • In some mouse strains, treated animals had fewer chromosome defects in bone marrow, but FDA said the controls used were not validated. In pregnant rabbits, a tracer signal appeared in both mother and fetal tissues.[1]
  • FDA found no standard acute toxicity, repeat dose toxicity, reproductive toxicity, absorption or two year cancer studies.[1]

Limit: Almost all studies come from the developer's group and have not been widely repeated by others.[1]

Human studies

A few small studies, none on sleep or injections

  • FDA found three human studies of epitalon. The largest enrolled 75 healthy women aged 40 to 50, mostly night shift workers. The 40 with low melatonin output used the peptide under the tongue or a placebo for 20 days, and a melatonin breakdown product in urine rose about 1.7 fold with the peptide. Sleep was not measured and blinding was not described.[1]
  • In that trial, the authors reported positive changes in emotional and physical condition in 83% of the peptide group versus 25% on placebo, without saying how this was judged. Safety results were not reported.[1]
  • A second small study gave the peptide under the tongue to night shift workers and measured body clock genes in blood. FDA gave no health outcomes for it.[1]
  • An older study injected epitalon near the eye in people with retinitis pigmentosa, an inherited eye disease. FDA's review gives no numbers or results for it.[1]
  • A 2007 report from the developers said pineal peptides, including epitalon, restored night melatonin release in elderly people with weak pineal function, with no numbers in the summary and no side effects noted.[8]
  • A 2012 review by the developers said pineal peptide preparations roughly doubled melatonin in elderly people with a shrunken pineal gland but had no clear effect in younger people or elderly people with normal glands.[1]
  • The often quoted Russian survival study used epithalamin, the pineal extract, not epitalon. In 266 people over 60 followed for 6 to 8 years, death rates were reported as 1.6 to 1.8 times lower than controls, but randomization, placebo and group sizes were not described.[14]
  • A 2007 Russian abstract claimed no side effects in elderly people, but gave no route, length, numbers or monitoring methods. FDA's adverse event databases held no reports for epitalon through December 2025, which cannot prove safety.[1]
  • No trial tested epitalon for insomnia or as a shot under the skin, the use proposed to FDA.[1]

Limit: FDA found no clinical data supporting human safety, and no trial measures a real health outcome.

Claims check

The most common claims about this compound, and what studies actually found. Verdicts rate the evidence, not whether you should use it.

Lengthens telomeres

Only in animals

In human cells grown in a dish, epitalon switched on telomerase, the enzyme that rebuilds the protective caps on chromosomes, and lengthened those caps.[5][6] In white blood cells from 11 men treated in a dish, results went both ways.[7] None of the human studies FDA reviewed measured telomeres in people.[1]

Extends lifespan

Only in animals

In female mice given injections from young adulthood for the rest of their lives, epitalon did not change average lifespan but raised maximum lifespan by about 12%.[9] Female rats under natural light gained 95 days of maximum lifespan.[11] FDA noted these studies came from one group, used a single dose and only females, and cannot inform cancer risk well.[1] No human study has measured lifespan with epitalon itself. A Russian study of the related pineal extract epithalamin in 266 older people reported lower death rates, but it was not epitalon and its methods were poorly described.[14]

Improves sleep

Not tested

None of the studies FDA reviewed measured sleep. In older monkeys, epitalon raised evening melatonin, but sleep itself was not assessed, and FDA found no trial in people with insomnia.[1]

Restores melatonin levels

Mixed results

In one Russian trial, 40 healthy women aged 40 to 50 with low melatonin output were split between the peptide given under the tongue and a placebo for 20 days. A melatonin breakdown product in urine rose about 1.7 fold with the peptide and did not change with placebo. Blinding was not described, and FDA called the study small and short.[1] In rat pineal glands in a dish, epitalon did not raise melatonin release.[1]

Prevents cancer

Only in animals

In female mice treated for life or for 6.5 months, treated mice developed leukemia or spreading tumors less often.[9][10] FDA takes the opposite worry seriously: switching on telomerase over time could help cells dodge normal aging and turn cancerous, and no proper cancer study has been done.[1] A 2025 lab study found epitalon also lengthened telomeres in breast cancer cells.[6]

Boosts energy and wellbeing

Mixed results

In the 20 day trial in women, the authors reported positive changes in emotional and physical condition in 83% of the peptide group and 25% of the placebo group. They did not explain how this was measured, and safety data were not reported.[1]

Protects eyesight

Only in animals

In stressed human retina cells in a dish, epitalon helped repair and reduced scarring signals.[13] It once had orphan drug status for retinitis pigmentosa, but FDA's review gives no results from the human eye study, and the status was withdrawn.[1]

Improves skin and slows visible aging

Not tested

FDA notes epitalon is promoted online for skin. None of the studies FDA reviewed tested skin outcomes in people.[1]

Known risks and side effects

  • Possible cancer concern. Long telomeres have been linked with cancer, and FDA is concerned that switching on telomerase over time could let cells escape normal aging and become cancerous.[1] In a 2025 lab study, epitalon also lengthened telomeres in breast cancer cells.[6]
  • Immune reactions. FDA flagged a risk that clumped peptide and impurities could trigger immune reactions, especially when injected under the skin.[1]
  • No human safety data. No human study reported proper safety results, and FDA found no standard repeat dose, reproductive or absorption studies.[1]
  • Unregulated products. Epitalon is sold online as sprays, capsules and injections, some labeled research use only, and European labs have found it in illegal medicines.[1][15] FDA found no tests for bacterial toxins or contamination in the paperwork it saw, and noted the plain form dissolves poorly in water.[1]

Regulatory status

Today: Epitalon is not FDA approved. Its earlier category 2 nomination was withdrawn, and FDA now lists it among withdrawn nominations.[16] It is not on FDA's current nomination list in any category.[17] On July 24, 2026 FDA's compounding advisers voted 7 to 4 with 1 abstaining to recommend allowing compounding, against FDA staff advice.[2][18] On October 28, 2026 HHS filed an interim policy saying it does not plan to act against state licensed pharmacies and doctors compounding epitalon for individual patients with a prescription.[3][19] For epitalon the policy covers only injections under the skin or into muscle, given in courses with breaks, from a single ingredient made by an FDA registered maker with a quality test certificate, and serious side effects must be reported.[20] This is not approval and lasts until FDA rulemaking.[3] Epitalon is not named on the 2026 or 2027 World Anti Doping Agency lists, although their S0 class bans substances with no current approval for human use.[21][22]

  1. Epitalon receives orphan drug status for retinitis pigmentosa, an inherited eye disease.[1]
  2. That orphan designation is withdrawn.[1]
  3. FDA lists epitalon among category 2 nominations that were withdrawn.[16]
  4. FDA's briefing finds no human safety data and recommends against adding epitalon to the compounding list.[1]
  5. FDA's Pharmacy Compounding Advisory Committee meets on epitalon and six other peptides.[23]
  6. The panel votes 7 to 4, with 1 abstaining, to recommend allowing compounding. The vote is not binding.[2]
  7. HHS files an interim policy not to act against compounding of injectable epitalon under set conditions. Comments are due about two weeks after its October 30 publication.[3][20]

Sources

  1. U.S. Food and Drug Administration. FDA evaluation of epitalon (free base) and epitalon acetate for the 503A Bulk Drug Substances List. Briefing document for the Pharmacy Compounding Advisory Committee, July 23-24, 2026 (dated May 12, 2026). FDA briefing document
  2. FDA Law Blog (Hyman, Phelps & McNamara). The PEPTIDE-L Wave Rolls On! PCAC Adds Two More Bulk Drug Substances for the 503A List. July 28, 2026. Regulatory news
  3. U.S. Department of Health and Human Services, Office of the Secretary. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496. Filed for public inspection October 28, 2026; Federal Register document 2026-22192, publication October 30, 2026. FR Doc. 2026-22192
  4. Araj SK, Brzezik J, Madra-Gackowska K, Szeleszczuk L. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025;26(6):2691. PMID 40141333
  5. Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003;135(6):590-2. PMID 12937682
  6. Al-Dulaimi S, Thomas R, Matta S, Roberts T. Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology. 2025;26(5):178. PMID 40908429
  7. Khavinson VKh, Pendina AA, Efimova OA, et al. Effect of Peptide AEDG on Telomere Length and Mitotic Index of PHA-Stimulated Human Blood Lymphocytes. Bull Exp Biol Med. 2019;168(1):141-144. PMID 31761987
  8. Korkushko OV, Lapin BA, Goncharova ND, et al. Normalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people. Adv Gerontol. 2007;20(1):74-85. PMID 17969590
  9. Anisimov VN, Khavinson VKh, Popovich IG, et al. Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice. Biogerontology. 2003;4(4):193-202. PMID 14501183
  10. Kossoy G, Anisimov VN, Ben-Hur H, Kossoy N, Zusman I. Effect of the synthetic pineal peptide epitalon on spontaneous carcinogenesis in female C3H/He mice. In Vivo. 2006;20(2):253-257. PMID 16634527
  11. Vinogradova IA, Bukalev AV, Zabezhinski MA, et al. Effect of Ala-Glu-Asp-Gly peptide on life span and development of spontaneous tumors in female rats exposed to different illumination regimes. Bull Exp Biol Med. 2007;144(6):825-830. PMID 18856211
  12. Khavinson V, Diomede F, Mironova E, et al. AEDG Peptide (Epitalon) Stimulates Gene Expression and Protein Synthesis during Neurogenesis: Possible Epigenetic Mechanism. Molecules. 2020;25(3):609. PMID 32019204
  13. Gatta M, Dovizio M, Milillo C, et al. The Antioxidant Tetrapeptide Epitalon Enhances Delayed Wound Healing in an in Vitro Model of Diabetic Retinopathy. Stem Cell Rev Rep. 2025;21(6):1822-1834. PMID 40493162
  14. Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3-4):233-240. PMID 14523363
  15. Vanhee C, Moens G, Van Hoeck E, Deconinck E, De Beer JO. Identification of the small research tetra peptide Epitalon, assumed to be a potential treatment for cancer, old age and Retinitis Pigmentosa in two illegal pharmaceutical preparations. Drug Test Anal. 2015;7(3):259-264. PMID 25535022
  16. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of April 22, 2026. FDA category 2 page
  17. U.S. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Updated May 14, 2026. FDA 503A bulks list
  18. Steinzor P. FDA Panel Backs 6 Peptides for Compounding. The American Journal of Managed Care. July 31, 2026. PCAC vote coverage
  19. Steinzor P. 5 Things to Know About HHS's Interim Peptide Compounding Policy. The American Journal of Managed Care. October 29, 2026. Policy coverage
  20. U.S. Department of Health and Human Services. 503A Peptide Enforcement Discretion Policy, Appendix B: peptide identity and route limits. October 2026. HHS policy appendix
  21. World Anti-Doping Agency. The 2026 Prohibited List. Effective 1 January 2026. WADA 2026 List
  22. World Anti-Doping Agency. The 2027 Prohibited List. Comes into effect 1 January 2027. WADA 2027 List
  23. U.S. Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting agenda, July 23-24, 2026. FDA meeting agenda
Medical disclaimer

This page is educational information only. It is not medical advice and does not replace care from a licensed medical provider. Do not use this page to decide whether to take any substance. Talk to a licensed medical provider first.

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