Epitalon

Also called epithalon, epithalone, AEDG and Ala-Glu-Asp-Gly¹

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Epitalon is a synthetic chain of 4 amino acids, Ala-Glu-Asp-Gly. FDA says most studies of it come from one research group in Russia, led by Vladimir Khavinson.¹ Its telomere claims rest on cells in a dish, and the famous lifespan study used a different substance, a pineal gland extract.^{9, 11} FDA found three small human studies and no evidence it helps insomnia.¹ Since October 28, 2026, HHS has said it won't act against licensed pharmacies that compound it as an injection with a prescription. It is still not FDA-approved.^{2, 4}

Reviewed by FDA's advisers on the same day as DSIP, which was rejected. See the peptide regulatory tracker

At a glance

Where to get it

MoveWell sells no peptides. All options and prices

Molecular structure

A straight chain of 4 amino acids with no ring or metal. The middle two, glutamic acid and aspartic acid, both carry an acid side chain.

Glutamic acid and aspartic acid, the two acidic amino acids

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AAlaEGluDAspGGly

Sequence

AEDG

Length

4 amino acids

Formula

C14H22N4O9

Weight

390.35 g/mol

Acetate

C14H22N4O9 · C2H4O2, 450.40 g/mol

CAS

307297-39-8 (free base) · 307297-40-1 (acetate)

FDA UNII

O65P17785G (free base). None for the acetate

Drawn from the sequence FDA and HHS list. Formula, weights and identifiers are from FDA's briefing document.^{1, 2}

What it is

Epitalon is a lab-made peptide of four amino acids. It was developed by Vladimir Khavinson's group in Russia, which first worked with epithalamin, a pineal gland extract.^{1, 11} FDA is clear that "epitalon and epithalamin" are "different substances."¹ That matters, because some of the best-known human results were with the extract, not epitalon.

Khavinson's group is based at the St. Petersburg Institute of Bioregulation and Gerontology. FDA notes that "most pharmacological studies of epitalon have been conducted and published by Dr. Khavinson's research group."^{1, 12} Some of the cited work is published only in Russian, and FDA couldn't locate all of it.¹

How it works

No one knows for sure. These are the main ideas, all from lab and animal work:

• Telomeres. In human fetal lung cells, epitalon lengthened telomeres, the caps on chromosomes that shorten with age, and the cells kept dividing past their usual limit.⁹ An independent 2025 study in London saw the same in normal cell lines, and also in two breast cancer cell lines.¹⁰
• Melatonin. Old rhesus monkeys given injections for 10 days had more evening melatonin and less evening cortisol. In rat pineal glands in a dish, it didn't raise melatonin.¹
• Gene activity. Khavinson's group reports it changes the activity of body-clock genes in blood cells. This hasn't been confirmed independently.¹²

No human study has measured telomeres after epitalon, and no study has tracked its pharmacokinetics, how the body absorbs and clears it.¹

Evidence map

Each claimed use is graded separately, because the evidence differs by use.

Scale: 5 FDA-approved, 4 strong human, 3 limited human, 2 animal or lab only, 1 anecdotal

Key studies

FDA reviewed the 23 articles the nominators sent and found that none described a compounded epitalon product. Seven were about epithalamin.¹ The 2025 London study is the only independent lab work we found.¹⁰

By goal and route

Pick your goal to see what the evidence supports.

Sources: HHS Appendix B,² FDA briefing,¹ Superpower.¹⁴

How it's used

No study has set a dose for any use, and no pharmacokinetic study exists for either form.¹ The HHS policy says compounded epitalon must be dispensed in "intermittent courses," but sets no course length. HHS notes that the documented regimens are "intermittent rather than continuous."² We don't give a dose.

Side effects and who should avoid it

• No human safety data. FDA says "there are no clinical data to support the safety" of either form in humans.¹
• Immune reactions. FDA: "Injectable routes of administration may present a particular risk for immunogenicity."^{1, 7}
• Cancer, in theory. FDA writes that "from the mechanistic standpoint, epitalon has the potential to be carcinogenic," because it lengthens telomeres. No long-term cancer study exists.¹ In the 2025 London study, it also lengthened telomeres in breast cancer cells.¹⁰ People with cancer or a history of it have the most reason for caution.
• Impurities. The certificate FDA saw listed 99.5% purity, with impurities allowed up to 2%. None were named, and no bioburden or endotoxin test was listed. FDA calls both forms "not well-characterized."¹
• Reported side effects. FDA found no reports in its adverse event database through Dec 2025. With few users tracked, that doesn't mean it's safe.¹
• Pregnancy and breastfeeding. No human data.

Compared with

Sources: FDA briefing,¹ FDA Law Blog,⁵ RAPS,¹⁹ HHS Appendix B.² We don't have a DSIP guide yet. For another covered peptide, see BPC-157

Stacks

No epitalon combination has been tested, and all blends fall outside the HHS policy.²

Myths vs evidence

All options and prices

MoveWell sells no peptides. Options inside the HHS policy first. Checked November 1, 2026

Licensed compounding, with a prescription

We found no other provider offering epitalon injection on prescription. Superpower's page says "Injection" but doesn't say whether it uses the acetate, which the policy requires. Compounded drugs are generally not covered by insurance.

Outside the policy

Nasal and under-the-tongue sprays, capsules, blends and "supplement" versions aren't covered.² The 2021 human study describes its spray as a dietary supplement from a French company.¹²

Research use only vials

The HHS policy excludes research chemicals, so we don't list sellers.⁴ In August 2026 FDA warned five peptide sellers that a "research use only" label doesn't excuse products clearly meant for people.¹⁷

Legal status history

Newest first.

1. Current statusNov 1, 2026HHS says it won't take action against licensed 503A pharmacies, federal facilities and licensed physicians that compound single-ingredient epitalon acetate, by injection, in intermittent courses, with a prescription. The policy is interim, and state rules still apply. Not FDA-approved.^{2, 4}
2. Next · no dateA formal rule to add epitalon to the 503A bulks list. It had not started as of Oct 16. Comments on the HHS policy are due 2 weeks after it is published in the Federal Register; publication was scheduled for Oct 30, 2026.^{3, 16}
3. Oct 28, 2026HHS enforcement discretion policy for epitalon and five other peptides. Docket HHS-OASH-2026-0496.^{3, 4, 6}
4. Jul 24, 2026FDA's compounding advisory committee votes to add epitalon to the compounding list, for insomnia. The vote is reported as 7–4–1 or 7–5–1; FDA minutes not yet posted. Opponents raised cancer risk from telomere effects. FDA staff had recommended against. The vote is advisory.^{1, 5, 8, 19}
5. Apr 22, 2026Removed from Category 2 with 11 other peptides after the nomination was withdrawn. This did not make it legal to compound.^{7, 15}
6. Sep 2023Placed in Category 2, citing immune reaction risk for some routes.⁷

What the HHS policy covers

Sources: HHS Appendix B,² BakerHostetler,⁴ Federal Register.³

FAQ

Related guides

References