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Epitalon, also spelled Epithalon, is a synthetic peptide made of four amino acids: alanine, glutamic acid, aspartic acid and glycine (Ala-Glu-Asp-Gly). It is not FDA-approved, and it is not the active ingredient in any approved medicine in the United States.
It was developed by Vladimir Khavinson and colleagues in Russia and modeled on epithalamin, an extract of the pineal gland, a small gland in the brain that makes melatonin.
Much of the interest in Epitalon comes from a 2003 laboratory study in the Bulletin of Experimental Biology and Medicine. Researchers reported that adding Epitalon to cultured human fetal cells switched on telomerase, an enzyme that rebuilds telomeres, and lengthened those telomeres. Telomeres are protective caps on the ends of chromosomes that shorten as cells divide. A result in cells grown in a dish does not show that the same thing happens in people, or that it would be safe.
Most published research on Epitalon and epithalamin comes from the same Russian research network and was done in cells and animals. Clinical reports from that group mostly concern the older extract, epithalamin, and include small studies such as one that followed 39 older adults with coronary disease who received it and 40 who did not over three years. These studies have not been confirmed by large, independent, controlled trials.
In its 2026 review for an advisory committee, the FDA said it did not identify clinical safety data in humans, particularly for Epitalon given under the skin.
Current status: Not FDA-approved.
The FDA previously placed Epitalon in Category 2 of its compounding lists, the group of bulk substances that raise significant safety risks. In April 2026 it was removed from Category 2 because the nomination was withdrawn. That removal does not make it eligible for compounding under section 503A.
At its July 23 and 24, 2026 meeting, the FDA's Pharmacy Compounding Advisory Committee voted 7 to 4, with 1 abstention, to recommend adding Epitalon to the 503A Bulks List, the list of bulk substances pharmacies may use for compounding. Law firms reporting on the meeting said the use under review was insomnia. FDA staff had recommended against adding it. The committee's vote is advisory only. The FDA must still make its own decision and complete formal rulemaking, and as of late September 2026 it had not added the substance to the list. Being on that list would allow compounding with a prescription; it would not make a substance an FDA-approved drug.
Products sold online as "research chemicals" or labeled "for research purposes only" are not approved medicines, and the FDA has not reviewed their identity, purity or quality.
In its safety summary, the FDA said compounded Epitalon may pose a risk of immunogenicity (an unwanted immune response) for certain routes of administration because of the potential for the peptide to clump together and for peptide-related impurities. The agency said it lacked enough information to know whether the drug would cause harm if given to people by the proposed routes.
Peptide Labs does not sell this compound. This page is general information, not medical advice. We do not supply, prepare or distribute Epitalon in any form, and nothing on this page should be read as an offer.
If you have questions about Epitalon, aging or sleep, talk to a licensed healthcare provider who knows your medical history.
See the full list of compound profiles in the Peptide Guide. Related compounds include Pinealon, from the same research program, and MOTS-c, which the same advisory committee also reviewed. For the legal background, read whether peptides are legal in the U.S.
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