Epitalon
Grey marketNot approved for human use in the US, and sold anyway.
One small randomized trial found that 20 days of epitalon raised a urine marker of melatonin 1.7-fold in middle-aged women with low levels. No human research on sleep, aging or lifespan was sourced. Epitalon is not FDA-approved. FDA found no human safety data and raised a cancer concern that its limited mouse studies could not resolve.
Add to Bio HackChecked 2026-11-09
- Status
- Not FDA-approved for any use in the US. FDA removed epitalon from compounding category 2 on April 22, 2026, after its nominations were withdrawn, and did not place it in category 1. Under a draft, interim HHS policy announced October 30, 2026, HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding with epitalon while the 503A bulks list is developed through rulemaking.
- Also called
- epithalon, epithalone, epitalone, AEDG peptide, Ala-Glu-Asp-Gly, epitalon acetate
- Taken for
- anti-aging, longevity, telomeres, sleep, melatonin, skin aging
Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on
Shown to help1
Reported risks3
- LimitedFDA states it has not identified safety-related information for the proposed route. It removed epitalon from category 2 in April 2026 after nominations were withdrawn.How often is not known
- LimitedFDA states there are no clinical data to support epitalon's safety in humans, and that injected forms may present a particular risk of immune reactions.How often is not known
- LimitedHHS states it does not intend to take enforcement action against licensed compounders using epitalon during rulemaking, and that compounded drugs are not FDA-approved.How often is not known
What people take it for, and what was found
Shown to help1
Melatonin production
One small trial found sublingual epitalon raised a urine melatonin marker 1.7-fold in women aged 40 to 50 with low levels. No health outcome was measured.
The numbers and sources
- Effect
- In women with low urinary excretion of 6-sulfatoxymelatonin, a breakdown product of melatonin, sublingual epitalon raised that excretion 1.7-fold [1]. FDA's review of the trial reports that levels did not change on placebo, and that after treatment the epitalon group reached the level the authors described as normal for age [2].
- Population
- 75 women aged 40 to 50, mostly working night shifts. The 40 with low melatonin marker levels were split between epitalon and placebo sprays for 20 days, and 35 with normal levels served as a reference group [2].
- Sources
- [1], [2]
- Caveats
- One small, short trial. FDA notes that the publication did not specify blinding, did not measure sleep and used a sublingual spray, not injection [2]. A urine marker is a laboratory measure, not a health outcome. A 2026 review found that human evidence for epitalon is limited to small physiological or biomarker studies and that no adequately powered randomized trial has established a therapeutic effect [3].
Not yet researched2
Sleep and insomnia
We haven't sourced research on this yet.
Aging, longevity and telomeres
We haven't sourced research on this yet.
Risks
Reported risks3
FDA compounding category 2 listing
FDA states it has not identified safety-related information for the proposed route. It removed epitalon from category 2 in April 2026 after nominations were withdrawn.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- FDA states that it has not identified safety-related information regarding epitalon for the proposed route of administration. Epitalon appears on FDA's list of substances previously in category 2 whose nominations were withdrawn by the nominators [4]. FDA removed epitalon from category 2 on April 22, 2026, because the nominations were withdrawn, and epitalon does not appear in category 1 of that update [5].
- Population
- Compounded drug products in the US [4][5].
- Sources
- [4], [5]
- Caveats
- A regulatory assessment of compounded products, not a study of harm.
FDA's 2026 safety review
FDA states there are no clinical data to support epitalon's safety in humans, and that injected forms may present a particular risk of immune reactions.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- FDA's briefing document for its Pharmacy Compounding Advisory Committee concluded that there are no clinical data to support the safety of epitalon in humans. FDA found no human pharmacokinetic data and no clinical studies assessing its safety. It described epitalon as not well characterized, with data on peptide impurities, aggregates and microbial quality lacking or inadequate, and stated that injected forms may present a particular risk of immune reactions. FDA concluded that the balance of criteria weighs against placing epitalon on the list of substances allowed for pharmacy compounding [2].
- Population
- FDA review of published literature, adverse event databases and the nominations [2].
- Sources
- [2]
- Caveats
- The advisory committee considered epitalon on July 24, 2026 [5], and its votes are advice to FDA, which makes the final determination [2]. HHS states that the committee voted in favor of inclusion [6]. Trade press reported a vote of 7 to 4, with 1 abstention [7]. No FDA-published tally was located for this page.
HHS interim compounding policy
HHS states it does not intend to take enforcement action against licensed compounders using epitalon during rulemaking, and that compounded drugs are not FDA-approved.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In a notice of a draft, interim policy, HHS states that it does not intend to take enforcement action against a State-licensed pharmacy, Federal facility or licensed physician compounding with a peptide listed in the policy's Appendix A while the 503A bulks list is developed through rulemaking [8]. Epitalon is on that list [6]. The notice states: "Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed." HHS may revisit the policy "if, among other things, a safety signal or product quality issue arises" with a compounded product it covers, and the policy is "not binding on HHS or the public" [8].
- Population
- Compounded drug products in the US [6][8].
- Sources
- [6], [8]
- Caveats
- A statement of enforcement intent, not an FDA approval and not a study of harm. FDA's future rulemaking may or may not add epitalon to the 503A bulks list [8].
Checked, no increase found1
Reported adverse events
FDA's databases held no adverse event reports for epitalon through December 2025. Reporting is voluntary, and compounding pharmacies generally do not report.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- FDA's adverse event database held no reports for epitalon through December 8, 2025, and FDA's food and supplement complaint system held no cases through December 5, 2025 [2].
- Population
- Voluntary reports to FDA [2].
- Sources
- [2]
- Caveats
- Reporting is voluntary and incomplete, and FDA notes that pharmacies compounding under section 503A generally do not report adverse events to it [2]. No reports does not mean no harm.
Possible, not studied in people1
Cancer concern
FDA states epitalon has the potential to cause cancer from a mechanistic standpoint, and that the mouse studies were too limited to judge it.
No study in people. This rests on animal studies, how it acts in the body.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- FDA stated that, from a mechanistic standpoint, epitalon has the potential to cause cancer. It found the available mouse studies too limited to inform epitalon's genotoxic or cancer-causing potential, because they used one fixed dose, female mice only and short exposures [2].
- Population
- Animal studies (mice) and mechanistic reasoning reviewed by FDA [2].
- Sources
- [2]
- Caveats
- A theoretical concern with no human cancer data either way. No carcinogenicity study adequate to settle it was located by FDA [2].
Sources
- Ivko OM, Linkova NS, Ilina AR, Sharova AA, Ryzhak GA. Peptide regulates human circadian rhythms genes expression during pineal gland accelerated aging. Uspekhi Gerontologii (Advances in Gerontology). 2020. https://doi.org/10.34922/ae.2020.33.3.002
- U.S. Food and Drug Administration. FDA Briefing Document: Epitalon-Related Bulk Drug Substances (Epitalon (free base) and Epitalon acetate). Pharmacy Compounding Advisory Committee, July 23-24, 2026. 2026. https://www.fda.gov/media/193345/download
- Jain A, Gallacher DM, Issa MA, et al. Epitalon and Epithalamin: A Narrative Review of Mechanistic, Preclinical, and Clinical Evidence. International Journal of Molecular Sciences. 2026. https://doi.org/10.3390/ijms27198922
- U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- 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 April 22, 2026. 2026. https://web.archive.org/web/20260422215502/https://www.fda.gov/media/94155/download
- U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B. 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
- Bascom E. FDA committee recommends looser restrictions for several peptides. Healio. 2026. https://www.healio.com/news/primary-care/20260724/fda-committee-recommends-looser-restrictions-for-several-peptides
- U.S. Department of Health and Human Services. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Federal Register 91:68526. 2026. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances