Peptide dossier, updated Oct 31, 2026
Epitalon
A four-amino-acid synthetic peptide (Ala-Glu-Asp-Gly), also written epithalon. A 2026 review describes it as developed from the amino-acid composition of epithalamin, a separate pineal-gland preparation. FDA found no clinical safety data in humans. Since Oct 30, HHS has said it will pause enforcement against some pharmacies that compound it. This page lays out what each source actually says.
See all 10 verified records for Epitalon on the Records page
Human studies
ClinicalTrials.gov returns one record for epitalon, epithalon or Ala-Glu-Asp-Gly as of Oct 31, 2026. Epitalon is one of five peptides in it.
| Registry | Study | Sponsor | Status | What the record says |
|---|---|---|---|---|
| NCT07888595 | Early Phase 1, single group, unmasked: a topical anti-aging peptide serum assessed with biological-age measurements | Frontiers in Bioscience Research Institute and Aging (as listed) | Enrolling by invitation | Planned 48 participants at one site in Irvine, California. Estimated start Oct 21, 2026. First posted Oct 22, 2026. The record lists one intervention, a topical serum, and its summary says the study tests whether certain medicines and a skin treatment can slow or partly reverse aging. No results posted. |
Flag. Epitalon is not the study’s sole intervention. The record’s intervention is a serum containing five peptides, and the study is a topical, single-group early-phase study, so it says little about epitalon by injection, the route FDA reviewed.
Registry entries are written by the sponsors and are not reviewed for scientific merit. A registered study is not a result.
FDA review
Two FDA documents address epitalon: the safety-risk page (content current Apr 22, 2026) and a briefing document for the July advisory committee, in a memo dated May 12, 2026.
What the briefing document found
- FDA evaluated epitalon (free base) and epitalon acetate for the 503A bulks list. The nominations were withdrawn, so FDA reviewed both on its own initiative.
- The use evaluated was insomnia. The nominated products were subcutaneous injections at 10 mg/mL and 3,000 µg/mL.
- FDA lists CAS numbers 307297-39-8 (free base) and 307297-40-1 (acetate). It notes that “epitalon” is a common name, not a United States Adopted Name, and that no USP or National Formulary monograph exists and neither form is part of an FDA-approved drug.
- No clinical studies of safety in humans. The clinical information FDA found concerns effects on melatonin or a melatonin metabolite, not studies in people with insomnia.
- FDA says information suggests epitalon has been used in compounding since at least 2018, but it found no pharmacies that compound it and says the data are too limited to understand its historical use.
- FDA noted that epitalon has been shown to activate telomerase and lengthen telomeres, and that longer telomeres are generally associated with increased cancer risk. It said the mouse studies it found used a fixed dose in female mice and do not adequately inform carcinogenic potential.
- A search of FDA’s adverse event database (FAERS) through Dec 8, 2025 retrieved no reports.
What FDA concluded
- It proposed not adding either form to the list.
- FDA called both forms not well characterized: names that do not follow standard nomenclature, and no impurity, aggregate or endotoxin results in the literature or the nominations.
- It found a lack of evidence of effectiveness for insomnia. It said a change in melatonin levels does not show a therapeutic effect without a clinical outcome.
- It said it found no animal studies of epitalon’s effects on sleep behavior or brain-wave measures.
- It said several FDA-approved drugs with established effectiveness exist for insomnia, and that it concluded there are no clinical data supporting safety in humans.
Published research
PubMed returns 147 results for epitalon, epithalon, epithalone or AEDG in the title or abstract. Many of the human papers are laboratory studies on blood cells taken from people. Russian-language papers in this set carry English abstracts.
Human and human-cell studies
- Retinitis pigmentosa, 2002. The abstract reports a rat study and says epitalon therapy in patients with degenerative retinal lesions gave a positive clinical effect in 90% of cases. The abstract gives no group sizes or controls. Neuro Endocrinol Lett PubMed
- Circadian genes, 2020. The abstract says the peptide raised excretion of a melatonin metabolite 1.7 times in middle-aged people with reduced pineal function and changed expression of some circadian genes in blood cells. Adv Gerontol PubMed
- Blood-cell study, 2019. The paper tested the peptide on stimulated human blood lymphocytes in culture and measured telomere length and mitotic index. Other papers in this set use blood cells in a similar way. Bull Exp Biol Med PubMed
Lab studies and read with care
- Cell and animal work. A 2025 study of telomere length in human cell lines, including breast-cancer lines, and a 2025 study of bovine egg maturation. Biogerontology PubMed Life Sci PubMed
- Review, Oct 2026. A narrative review says human evidence is limited to small physiological or biomarker studies and an older controlled study, that no adequately powered randomized trial has established efficacy, and that pharmacokinetic, dose-ranging and long-term safety data remain inadequate. Int J Mol Sci PubMed
- Author concentration. In our tally of the 159 PubMed records we screened, the name Khavinson appears in about 103 author lists, in several spellings. The tally comes from PubMed author fields and counts name variants. It describes who published, not whether the findings are right.
- We read abstracts only. Reported effects have not been tested in an adequately powered randomized trial.
FDA warning letters
We found one FDA warning letter that names epitalon. It is addressed to a compounding pharmacy, not about epitalon’s safety. This rests on web searches, not a full pull of FDA’s database.
| Recipient | Date | Letter | What it says |
|---|---|---|---|
| Tailor Made Compounding LLC, a compounding pharmacy | Apr 1, 2020 | Warning letter 594743 | FDA says an inspection found the firm compounding with a list of 22 bulk substances that includes epitalon, and that drugs made from them were not eligible for the section 503A exemptions. The letter says none of them is covered by a USP or NF monograph or is a component of an FDA-approved drug, and that epitalon had not been nominated for the bulks list. We read the letter text. |
A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find.
SEC filings
We found one SEC filing that names epitalon. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.
| Filer | Filing | What it says |
|---|---|---|
| Carnyx Therapeutics, Ltd | Form C (crowdfunding offering statement) Dated December 2025 | The company says its sleep program is an orally available peptide analog derived from epitalon. It also says epitalon is off-patent and that no approved epitalon product exists. |
What a company says in a filing is its own claim about its business. It is not a finding about epitalon. We read the passages naming epitalon, not the whole document.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six compounded peptides, epitalon among them
State-licensed pharmacies, federal facilities and licensed physicians would not face enforcement for compounding it, under conditions including a patient-specific prescription and quality testing. Not FDA approval. HHS says it may revisit the policy if a safety or quality problem arises.
- Oct 22, 2026TrialsA study that includes epitalon in a topical serum is first posted
Single group, early phase, with five peptides in one serum. See the flag above.
- Oct 8, 2026LiteratureNarrative review of epitalon and epithalamin
Published in Int J Mol Sci. It finds human evidence limited to small studies and no adequately powered randomized trial.
- July 23–24, 2026RegulatoryFDA advisory committee recommends epitalon for the compounding list
The committee recommended six of the seven peptides it reviewed; emideltide was the exception. The vote is nonbinding: compounding stays unlawful until FDA finishes rulemaking or Congress changes the law. Vote counts differ between trade-press reports, and no official tally was in the FDA documents we could read.
- May 12, 2026RegulatoryFDA staff brief the committee: it proposes not adding epitalon
The briefing memo concludes that the balance of criteria weighs against listing. Details above.
- Apr 22, 2026RegulatoryFDA’s safety-risk page lists epitalon
The page showed content current as of Apr 22, 2026. Its wording on this peptide is quoted above.
- Dec 2025FilingA company describes an epitalon-derived sleep program in a crowdfunding filing
Carnyx Therapeutics’ Form C. A company statement about its own plans.
- Jan 1, 2022Anti-dopingWADA’s 2022 Prohibited List does not name epitalon
We checked the 2022 and 2026 lists. Neither names epitalon. Section S0 covers substances with no current approval from any government health authority; we found no WADA statement on epitalon.
- Apr 1, 2020EnforcementFDA warning letter to a compounding pharmacy names epitalon among 22 substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
- Aug 2002LiteratureRetinitis pigmentosa study
Published in Neuro Endocrinol Lett. A 2026 review calls it an older controlled study; the abstract gives no group sizes. Details above.
Still not covered
Left off rather than guessed:
- Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. “Epitalon acetate: subcutaneous or intramuscular injectable dosage forms, dispensed in intermittent courses” comes from a law-firm summary of that list, not from the document itself.
- Russian-language sources: we read English abstracts only. Full texts and non-English publications were not read, and translations could add to this page.
- Panel vote counts: not in the FDA documents we could read, and trade-press tallies differ.
- Epithalamin: the pineal-gland preparation is a different substance. Studies of it are not counted here.
- Patents: not researched for this dossier.
- Seller claims and independent lab reports: how it is marketed versus what testing finds. We have not collected testing data.
- Unread items: full text of every paper, the rest of the Carnyx filing, and WADA lists for years other than 2022 and 2026.
- Warning letter and SEC completeness: web searches only.