Peptides & growth hormone

Epitalon

Updated · 23 sources · Editorial policy

Epitalon (also spelled epithalon or epithalone, and written by its sequence as AEDG) is a synthetic peptide made of four amino acids: alanine, glutamic acid, aspartic acid and glycine. It was developed by Vladimir Khavinson’s group in St. Petersburg, Russia, as a synthetic stand-in for epithalamin, a peptide extract of cattle pineal glands. Online it is promoted as an “anti-aging” or “longevity” peptide, mainly because of cell-culture reports that it switches on telomerase.

The single most important fact: epitalon is not an approved drug, and FDA found no clinical studies that assess its safety in humans. Most of the research is in cell cultures, fruit flies, rodents and monkeys, and most of it comes from one research group. In 2026 FDA staff advised against allowing pharmacies to compound it, but an FDA advisory committee voted in favor, for insomnia. FDA has not made a final decision.

This page summarizes what FDA’s 2026 review, the laboratory studies and the few human reports actually show. It is for education only and is not medical advice.

Property Detail
Class Synthetic tetrapeptide (Ala-Glu-Asp-Gly); investigational
Other names Epithalon, epithalone, AEDG. Not the same substance as epithalamin, the pineal extract
Formula and weight C₁₄H₂₂N₄O₉, 390.35 g/mol (free base); acetate salt 450.40 g/mol
Approval Not approved by FDA or EMA; an FDA orphan designation for retinitis pigmentosa (2010) was revoked in 2016
Routes studied in humans Injection next to the eye (parabulbar) and a sublingual spray, in small Russian studies; no human data for injection under the skin
Half-life Unknown. FDA found no pharmacokinetic data in humans and no formal pharmacokinetic studies in animals
Proposed mechanism Telomerase activation in cell culture; raised evening melatonin in old monkeys. No defined molecular target
US compounding status Not on the 503A bulks list. FDA staff recommended against it; an advisory committee voted in favor (insomnia) in July 2026; no final FDA action
WADA Not named on the 2026 list; class S0 covers substances with no government approval for human use

What it is

Epitalon’s structure is H-Ala-Glu-Asp-Gly-OH. It is sold as the free base and as an acetate salt. FDA treats these as two different bulk substances (PubChem; FDA briefing document, 2026):

Form CAS number Formula Molecular weight
Epitalon (free base) 307297-39-8 C₁₄H₂₂N₄O₉ 390.35 g/mol
Epitalon acetate 307297-40-1 C₁₄H₂₂N₄O₉·C₂H₄O₂ 450.40 g/mol

The peptide was designed from the amino acid makeup of epithalamin, a mixture of peptides extracted from the pineal gland of cattle (Araj et al., Int J Mol Sci 2025). In 2017 the same group reported detecting AEDG among the tetrapeptides of a pineal polypeptide complex using mass spectrometry (Khavinson et al., Bull Exp Biol Med 2017).

Sellers sometimes list “epithalamin” as another name for epitalon. FDA rejects this. It considers epithalamin a separate substance: a natural extract, not a single synthetic peptide (FDA briefing document, 2026). This matters because the best-known human “longevity” data are for epithalamin, not epitalon (see below).

FDA judged both forms “not well-characterized.” Its reasons were inconsistent naming (epitalon has no official USAN or INN name), certificates of analysis that did not test for peptide aggregates, specific impurities, microbial load or bacterial endotoxins, and limited solubility data. FDA noted that the two withdrawn nominations named one form but supplied certificates of analysis for the other (FDA briefing document, 2026).

How it works in the body

Nobody has shown how epitalon acts in people. The main proposed mechanisms come from laboratory work:

Pharmacokinetics

FDA found no pharmacokinetic data for epitalon in humans. The only animal distribution data come from pregnant rabbits given a fluorescent-labeled dose. Fluorescence appeared in maternal and fetal organs one hour later, but FDA cautioned that the study did not show the signal came from the labeled peptide (FDA briefing document, 2026). FDA found no study reporting a half-life, bioavailability or a comparison of routes, so half-life figures quoted online are not based on published measurements.

Regulatory status

  • Not an approved drug. Epitalon is not a component of any FDA-approved drug and has no USP or NF monograph. FDA found no approved epitalon product in Canada, Australia, the UK, or the European countries it checked, and none authorized by the European Medicines Agency. It is not in the European or Japanese pharmacopeias (FDA briefing document, 2026).
  • Orphan designation revoked. Epitalon received an FDA orphan drug designation for retinitis pigmentosa on September 2, 2010. The designation was revoked on January 6, 2016 (FDA briefing document, 2026).
  • FDA safety-risk listing. FDA’s page on bulk substances that may present significant safety risks lists epitalon among substances whose compounding nominations were withdrawn. FDA says compounded epitalon “may pose risk for immunogenicity” and that the agency lacks enough information “to know whether the drug would cause harm” in humans (FDA, updated April 22, 2026).
  • 2026 advisory committee. FDA evaluated both forms for insomnia on its own initiative. It presented them to its Pharmacy Compounding Advisory Committee on July 24, 2026 (Federal Register, 91 FR 20465). FDA staff concluded that the evidence weighed against adding either form to the list, citing poor characterization, no evidence of effectiveness for insomnia, and no human safety data (FDA briefing document, 2026). The committee voted to recommend listing epitalon for insomnia, overriding the staff position. The vote is advisory, and FDA makes the final decision (RAPS, 2026).
  • Illegal products. Belgium’s Scientific Institute of Public Health identified epitalon in two illegal pharmaceutical preparations (Vanhee et al., Drug Test Anal 2015). FDA found epitalon sold online as vials, capsules and sprays, several labeled “for research use only” (FDA briefing document, 2026).
  • Sport. Epitalon is not named on the 2026 WADA Prohibited List. Class S0 bans, at all times, any pharmacological substance “with no current approval by any governmental regulatory health authority for human therapeutic use” (WADA 2026 Prohibited List).

What the research shows

FDA noted that “most pharmacological studies of epitalon have been conducted and published by Dr. Khavinson’s research group in Russia” (FDA briefing document, 2026).

Human studies

FDA’s 2026 search found only three studies in which people received epitalon, and none tested it for insomnia or by injection under the skin (FDA briefing document, 2026):

Study Design and n Dose and route Reported result
Retinitis pigmentosa (Khavinson et al. 2002) 162 patients aged 18–72 examined; control group given conventional treatment; randomization and blinding not described 5.0 µg per eye, parabulbar injection, 10 days “Positive clinical effect in 90% of the cases”; visual acuity up 0.15–0.20 on average; no side effects reported (details per Araj et al. 2025)
Night-shift workers (Ivko et al., as summarized by FDA) Women aged 40–50 (n = 75); 40 with low melatonin output randomized to epitalon or placebo spray; blinding not stated 0.5 mg/day, sublingual spray, 20 days Urinary 6-sulfatoxymelatonin (a melatonin breakdown product) rose 1.7-fold vs no change with placebo; sleep not measured; no safety data reported
Clock genes in night-shift workers (Khavinson et al., as cited by FDA) Sublingual epitalon in night-shift workers Sublingual Changes in circadian gene expression in blood cells

A Russian-language abstract also states that epitalon and epithalamin increased night-time melatonin in older people with reduced pineal function and had “no side effects.” FDA noted that the abstract gives no route, dose, duration or number of participants (Korkushko et al., Adv Gerontol 2007).

In cell culture, epitalon loosened condensed chromatin in lymphocytes taken from people aged 76–80 (Khavinson et al., Neuro Endocrinol Lett 2003). This was a laboratory experiment on cells, not a treatment study.

Epitalon vs epithalamin. Claims that pineal peptides “prolong human life” usually trace to a study of epithalamin (the extract) and thymalin (a thymus extract) in 266 older adults followed for 6–8 years. It reported 1.6–1.8-fold lower mortality with epithalamin (Khavinson and Morozov, Neuro Endocrinol Lett 2003). That study did not use epitalon. FDA treats the two as different substances.

Telomeres in cell culture

Study Cells Finding
Khavinson et al. 2003 Human fetal fibroblasts (telomerase-negative) Telomerase expression and activity switched on; telomeres lengthened
Khavinson et al. 2004 Aging human fetal lung fibroblasts Cells made 10 extra divisions (44 vs 34 passages) and kept dividing
Al-Dulaimi et al. 2025 (independent UK group) Normal fibroblasts and breast epithelial cells; two breast cancer cell lines Normal cells: telomeres lengthened after 3 weeks via hTERT and telomerase. Cancer cells: telomeres lengthened within 4 days through ALT (alternative lengthening of telomeres), with ALT activity up about 10-fold in one line and 3-fold in the other

The 2025 study is notable because it came from outside the Russian group, and because epitalon lengthened telomeres in cancer cells as well as normal ones (Al-Dulaimi et al., Biogerontology 2025). All of these results come from cell culture.

Lifespan and tumors in animals

Most animal studies gave about 1 µg per mouse or rat by injection, usually on 5 consecutive days each month:

Model Main result
Fruit flies (Khavinson et al., Mech Ageing Dev 2000) Lifespan up 11–16% when added to the culture medium during development
Female SHR mice, 54 per group (Anisimov et al., Biogerontology 2003) No change in mean lifespan; lifespan of the last 10% of survivors up 13.3%; chromosome aberrations 17.1% lower; total tumor incidence unchanged; leukemia 6.0-fold less common
HER-2/neu transgenic mice (Anisimov et al., Int J Cancer 2002) Fewer and smaller breast tumors; HER-2/neu mRNA 3.7-fold lower in tumors
Rats given a colon carcinogen (Anisimov et al., Cancer Lett 2002) 2.7 vs 4.1 colon tumors per rat with epitalon throughout vs saline
Female C3H/He mice (Kossoy et al., In Vivo 2006) Fewer mice with malignant tumors; no metastases vs 3 of 9 tumor-bearing controls

FDA cautioned that the mouse tumor studies used a single fixed dose, only female mice, and short total exposure. For the 2003 study, FDA estimated that mice were exposed for at most about 22 weeks in total, far less than a standard 2-year carcinogenicity study (FDA briefing document, 2026).

Melatonin and stress hormones in monkeys

In female rhesus monkeys given 2 µg/kg by intramuscular injection daily for 10 days, epitalon raised evening melatonin more than 4-fold in old animals and lowered evening cortisol by about 30%. It had no effect on melatonin in young animals. FDA noted that no study measured sleep itself, by behavior or by brain-wave (EEG) recording (Khavinson et al., Neuro Endocrinol Lett 2001; FDA briefing document, 2026).

Side effects and risks

No human safety data

FDA concluded that “there are no clinical data to support the safety” of either form of epitalon in humans. No study has assessed safety, and none has used injection under the skin. A FAERS (FDA Adverse Event Reporting System) search through December 2025 and a search of FDA’s food and supplement complaint system found no reports. FDA notes that this does not show safety, because reporting is voluntary and compounders generally do not report (FDA briefing document, 2026).

FDA found no acute toxicity, repeat-dose toxicity, or reproductive and developmental toxicity studies. Two small mouse studies found no increase in chromosome damage at a single fixed dose. FDA judged them too limited to rule out genotoxicity (damage to DNA) (FDA briefing document, 2026).

Theoretical cancer risk

The property that makes epitalon attractive, activating telomerase, is also FDA’s main mechanistic concern. FDA noted that long telomeres have been associated with a higher risk of malignant tumors, and wrote that continuous exposure “could enable cells to evade senescence and become cancerous,” and that the short, intermittent animal studies cannot settle the question (FDA briefing document, 2026). The 2025 finding that epitalon lengthened telomeres in breast cancer cell lines adds to this uncertainty (Al-Dulaimi et al., Biogerontology 2025). The Russian animal studies reported fewer tumors, not more, but they were not designed as carcinogenicity tests.

Immunogenicity and product quality

FDA is concerned that injected epitalon could trigger an immune response. This risk comes from peptide clumping (aggregation) and from synthesis impurities that the available certificates of analysis did not measure. Such responses range from silent antibodies to severe reactions (FDA briefing document, 2026). Because the products sold online are not regulated drugs, their identity, purity and sterility are not verified.

Unknowns

FDA identified no studies of epitalon’s dose-response in humans, no reproductive or developmental toxicity studies, and no drug interaction data. Its effects in pregnancy, breastfeeding, children and people with existing disease are unknown.

Key takeaways

  • A synthetic four-amino-acid peptide. Epitalon (Ala-Glu-Asp-Gly) was designed from a cattle pineal extract, epithalamin, but FDA treats the two as different substances.
  • Not an approved drug anywhere FDA checked. Its US orphan designation for retinitis pigmentosa was revoked in 2016.
  • Human evidence is minimal. Three Russian studies measured eye function, melatonin markers and gene expression. None measured sleep, aging outcomes or safety in a rigorous way.
  • Telomere and lifespan claims come from cells and animals. Telomerase activation was shown in cell culture, and modest lifespan effects in flies and mice. An independent 2025 study also found telomere lengthening in cancer cell lines.
  • No pharmacokinetic or toxicology package exists. FDA found no human pharmacokinetic data, no standard toxicity studies and no human safety studies, and it flagged cancer and immunogenicity concerns.
  • US compounding status is unresolved. FDA staff opposed listing it. An advisory committee voted in favor for insomnia in July 2026, and the final decision rests with FDA.

Sources

  1. Food and Drug Administration. FDA evaluation of epitalon-related bulk drug substances (epitalon (free base) and epitalon acetate). FDA Briefing Document, Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026. FDA.
  2. 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.
  3. Food and Drug Administration. Pharmacy Compounding Advisory Committee; notice of meeting; establishment of a public docket; request for comments—bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. Federal Register. April 16, 2026;91:20465 (FR Doc 2026-07361). Federal Register.
  4. Eglovitch JS. FDA advisory committee backs two more peptides, rejects one for compounding list. Regulatory Focus (RAPS). July 24, 2026. RAPS.
  5. World Anti-Doping Agency. The 2026 Prohibited List. In effect January 1, 2026. WADA.
  6. National Center for Biotechnology Information. PubChem compound summary for CID 219042, Epitalon. PubChem.
  7. Araj SK, Brzezik J, Mądra-Gackowska K, et al. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025;26(6):2691. PubMed.
  8. Khavinson VK, Kopylov AT, Vaskovsky BV, et al. Identification of Peptide AEDG in the Polypeptide Complex of the Pineal Gland. Bull Exp Biol Med. 2017;164(1):41–43. PubMed.
  9. 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):590–592. PubMed.
  10. Khavinson VKh, Bondarev IE, Butyugov AA, et al. Peptide promotes overcoming of the division limit in human somatic cell. Bull Exp Biol Med. 2004;137(5):503–506. PubMed.
  11. Al-Dulaimi S, Thomas R, Matta S, et al. Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology. 2025;26(5):178. PubMed.
  12. Khavinson V, Razumovsky M, Trofimova S, et al. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett. 2002;23(4):365–368. PubMed.
  13. 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. In Russian. Adv Gerontol. 2007;20(1):74–85. PubMed.
  14. Khavinson VKh, Lezhava TA, Monaselidze JR, et al. Peptide Epitalon activates chromatin at the old age. Neuro Endocrinol Lett. 2003;24(5):329–333. PubMed.
  15. Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3-4):233–240. PubMed.
  16. Khavinson V, Goncharova N, Lapin B. Synthetic tetrapeptide epitalon restores disturbed neuroendocrine regulation in senescent monkeys. Neuro Endocrinol Lett. 2001;22(4):251–254. PubMed.
  17. Djeridane Y, Khavinson VKh, Anisimov VN, et al. Effect of a synthetic pineal tetrapeptide (Ala-Glu-Asp-GLy) on melatonin secretion by the pineal gland of young and old rats. J Endocrinol Invest. 2003;26(3):211–215. PubMed.
  18. Khavinson VK, Izmaylov DM, Obukhova LK, et al. Effect of epitalon on the lifespan increase in Drosophila melanogaster. Mech Ageing Dev. 2000;120(1-3):141–149. PubMed.
  19. 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. PubMed.
  20. Anisimov VN, Khavinson VK, Provinciali M, et al. Inhibitory effect of the peptide epitalon on the development of spontaneous mammary tumors in HER-2/neu transgenic mice. Int J Cancer. 2002;101(1):7–10. PubMed.
  21. Anisimov VN, Khavinson VKh, Popovich IG, et al. Inhibitory effect of peptide Epitalon on colon carcinogenesis induced by 1,2-dimethylhydrazine in rats. Cancer Lett. 2002;183(1):1–8. PubMed.
  22. Kossoy G, Anisimov VN, Ben-Hur H, et al. Effect of the synthetic pineal peptide epitalon on spontaneous carcinogenesis in female C3H/He mice. In Vivo. 2006;20(2):253–257. PubMed.
  23. Vanhee C, Moens G, Van Hoeck E, et al. 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. PubMed.