What it is
Epithalon is also spelled epitalon. It is a lab-made chain of just four amino acids: alanine, glutamic acid, aspartic acid and glycine. A short chain of amino acids like this is called a peptide. Its makers designed it as a simple lab-made copy of epithalamin. Epithalamin is an extract taken from the pineal glands of cattle. The pineal gland is a small gland in the brain. It makes melatonin, the sleep hormone.
Epithalon is best known for lab tests on human cells grown in dishes. In those tests, it was reported to switch on telomerase. Telomerase is an enzyme. It rebuilds the protective caps on the ends of chromosomes. This finding, plus mouse studies on lifespan, gave it a name as an “anti-ageing” peptide. These results have not been shown in people. It is not an approved medicine in the United States.
Epitalon is H-Ala-Glu-Asp-Gly-OH (C14H22N4O9, 390.35 g/mol, CAS 307297-39-8). Its developers describe it as derived from the amino-acid composition of epithalamin, a low-molecular-weight polypeptide extract of bovine pineal gland; FDA treats the two as distinct substances and does not list epithalamin as a synonym.
No receptor has been identified. The developer group proposes that short peptides such as Ala-Glu-Asp-Gly enter the nucleus and bind DNA or histones to regulate gene expression, an epigenetic hypothesis supported mainly by modelling and in-vitro work. Reported in-vitro effects include induction of the telomerase catalytic subunit and telomere elongation in fibroblasts, and antioxidant and anti-inflammatory activity in cell models. In old female rhesus monkeys, the same group reported changes in the daily pattern of melatonin and cortisol; in isolated rat pineal glands, epitalon did not increase melatonin release (Djeridane et al. 2003, as summarised by FDA).
Pharmacokinetics are essentially unknown. The only distribution data are from a study giving fluorescently labelled epitalon intravenously to pregnant rabbits, which FDA said should be interpreted with caution because the signal was not shown to come from epitalon itself. FDA found no pharmacokinetic, acute toxicity, repeat-dose toxicity or reproductive toxicity studies, and no human pharmacokinetic data.
Who made it and when
Epithalon came from the work of Vladimir Khavinson. He is a Russian scientist who studies ageing. With Vladimir Morozov, he made peptide extracts from animal organs, such as the thymus and the pineal gland. The FDA’s review says epithalon was first made in the late 1980s. This was under Khavinson’s direction. His group later became the St Petersburg Institute of Bioregulation and Gerontology. That institute has published most of the research on it. No drug company has taken it through modern testing in people. In 2010 it got a US orphan-drug status. This is a special status for drugs meant for rare diseases. That status ended in 2016.
FDA’s 2026 briefing document states that epitalon was first synthesised in the late 1980s by researchers under Professor Vladimir Khavinson in St Petersburg, as the putative active component of epithalamin. Epithalamin, the bovine pineal extract, and thymalin, a calf-thymus extract, are the two polypeptide preparations studied by Khavinson and Morozov in their 2003 elderly-cohort report.
Nearly all subsequent pharmacology, including the telomerase and mouse-lifespan work with V.N. Anisimov at the N.N. Petrov Institute of Oncology, comes from Khavinson’s institute and its collaborators; FDA noted that most pharmacological studies of epitalon “have been conducted and published by Dr. Khavinson’s research group in Russia”. Some key references cited by nominators are available only in Russian.
According to FDA, epitalon received a US orphan-drug designation for retinitis pigmentosa on 2010-09-02, which was withdrawn or revoked on 2016-01-06. An orphan designation is a development incentive, not an approval. No developer patent was verified for this article, so none is listed.
What the data say
Most of the evidence comes from cells and animals. The developers grew human fetal lung cells in the lab. They reported that epithalon switched on telomerase. They also said it made telomeres (the chromosome caps) longer. In 2025, an independent British team reported the same kind of telomere lengthening. They saw it in several cell types, including cancer cells. In mice, monthly injections did not make average lifespan longer. But the longest-lived mice lived somewhat longer.
Studies in people are small. Almost all come from the same Russian group. The best-known reports of “longer life” in older people used epithalamin, the cattle-gland extract. They did not use epithalon. One small study from the 2020s included 40 night-shift workers. It measured a melatonin breakdown product in urine. It did not measure sleep. No trial is registered on ClinicalTrials.gov.
In vitro: Khavinson et al. (2003) reported that epitalon (50 ng/mL, 4 days) induced hTERT expression, telomerase activity and telomere elongation in telomerase-negative human fetal fibroblasts. Al-Dulaimi et al. (2025, Brunel University London) reported dose-dependent telomere extension via hTERT upregulation in normal epithelial cells and fibroblasts, and via the telomerase-independent ALT pathway in breast-cancer lines. FDA cautioned that sustained telomerase activation could in principle favour malignant transformation.
Animals: in female SHR mice (54 per group) given 1 µg subcutaneously for 5 days monthly from 3 months of age, Anisimov et al. (2003) found no change in mean lifespan, a 12.3% longer maximum lifespan and less leukaemia, with no change in total tumour incidence. The studies used single fixed doses and females only.
Humans: Khavinson and Morozov (2003) reported 1.6–1.8-fold lower mortality over 6–8 years in elderly people given epithalamin, not epitalon, in a 266-person cohort without described randomisation or blinding. For epitalon itself, Ivko et al. randomised 40 women aged 40–50 on night shifts with low urinary 6-sulfatoxymelatonin to placebo or sublingual spray (0.5 mg/day, 20 days) and reported a 1.7-fold rise in the metabolite; blinding was not specified and sleep was not measured.
Regulatory picture
Approval: the FDA has not approved any medicine that contains epithalon. It once had orphan-drug status for an inherited eye disease. That status ended in 2016.
Compounding (when a pharmacy mixes its own version): in September 2023, the FDA put epithalon in “Category 2”. This is the group of substances pharmacies should not use to make medicines. The FDA gave two reasons. It might cause immune reactions. And there was not enough safety information. By April 2026, the FDA listed it as withdrawn from that group. The people who had put it forward had withdrawn it.
FDA staff looked at it as a treatment for trouble sleeping (insomnia). They advised against allowing it. But in July 2026, an FDA advisory panel voted by a narrow margin to allow it. The vote was to add it to the list of allowed compounding ingredients. The vote is not binding. The FDA had not made a final decision when this was written.
In October 2026, the US health department (HHS) announced a draft policy. It said it does not intend to take enforcement action against licensed pharmacies or doctors who make single-ingredient epithalon products, as long as they follow set conditions, while the FDA writes its final rule. The policy is not binding, and it is not FDA approval. Epithalon is still not on the official list of allowed ingredients. Comments on the draft are due in mid-November 2026. This page will be updated when a final policy is published.
Enforcement: in 2020, the FDA sent a warning letter to a compounding pharmacy. The letter named epitalon as one of the ingredients it should not have used.
Approval: none. No US IND-stage programme could be verified; the 2010 orphan designation (retinitis pigmentosa) was withdrawn or revoked on 2016-01-06, according to FDA.
Compounding: “Epitalon” entered Category 2 of the interim 503A policy on 2023-09-29. FDA’s safety-risk page (updated 2026-04-22) lists it among substances withdrawn by the nominators, and it is not on the 503A bulks list (21 CFR 216.23), so this article records compounding status as restricted (see the HHS policy below).
FDA’s 2026 briefing document evaluated epitalon free base and acetate for insomnia only; it did not evaluate the other nominated uses (anti-ageing, telomere lengthening and others) because the nominations lacked sufficient supporting information. It concluded that the criteria weigh against inclusion: characterisation data (impurities, aggregates, endotoxin) were missing, immunogenicity could not be ruled out for subcutaneous products, no clinical safety or pharmacokinetic data existed, no study measured sleep outcomes, and FDA-approved and OTC insomnia treatments exist. On 2026-07-24 the Pharmacy Compounding Advisory Committee voted in favour of inclusion; published accounts agree on 7 votes in favour but differ on the number against (4 or 5), and official minutes had not been posted when this was written. Rulemaking is required before any change takes effect.
On 2026-10-30 HHS published a notice of availability of a draft interim Enforcement Discretion Policy (docket HHS-OASH-2026-0496) covering 503A compounding of epitalon and five other peptides. HHS states it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding single-active-ingredient products from bulk substance sourced from an FDA-registered manufacturer with a certificate of analysis, dispensed on patient-specific prescriptions with MedWatch adverse-event reporting, pending rulemaking (the list of peptides and these conditions are taken from the Alliance for Pharmacy Compounding’s summary, because the HHS appendices could not be retrieved for this article). The notice says it is not binding and does not add epitalon to 21 CFR 216.23; 503B outsourcing facilities and products sold for “research use” are outside it. FDA staff had recommended against listing. Comments are due about 2026-11-13; no final policy had been published when this was written.
