Epitalon
A synthetic tetrapeptide promoted for telomerase/longevity effects on mostly Russian, largely preclinical evidence; not FDA-approved, in FDA Category 2, and slated for July 2026 PCAC review.
What it is
Epitalon (also spelled epithalon) is a synthetic tetrapeptide derived from research on pineal-gland peptides, studied in a longevity/aging context.S3
Marketed as
Epitalon carries some of the category's most ambitious anti-aging claims — it is promoted for activating telomerase, lengthening telomeres, and slowing aging. These are marketing claims, and among the least substantiated in the field — not established effects.S1S3
Regulatory status (US)
Epitalon is not FDA-approved and holds no approval from major regulators.S1S3 It appears among the peptides in FDA's Category 2 compounding review and is on the agenda for the July 2026 Pharmacy Compounding Advisory Committee.S1S2 In the US it is otherwise treated as a research-use-only compound.S3
Around the world
Epitalon is not an approved medicine in major Western markets; it circulates as a research compound rather than a licensed drug.S3
Evidence
The telomerase and longevity claims rest largely on Russian research and animal data, with limited independently replicated human evidence (see caveat).S3 These claims should be framed as unproven, not established.S3
Epitalon's telomerase/longevity claims rest largely on Russian research and animal data, with limited independently replicated human evidence; they should be treated as unproven, not established. S3
Anti-doping
Epitalon is not a GH secretagogue; its specific anti-doping status should be checked against the current WADA List rather than assumed.S1
Safety
As an unapproved research peptide, Epitalon has little independent long-term human safety data, and use falls outside FDA finished-drug oversight; FDA's general Category 2 concerns (characterization, purity, limited safety information) apply.S1S3
What's changing
The near-term item is the July 2026 PCAC review and any subsequent FDA decision on Epitalon's compounding status.S1S2
Sources
Every reference below is a primary source cited in this entry, drawn from the approved corpus.
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01
FDA — Certain Bulk Drug Substances for Use in Compounding (Category 2)fda.gov · Federal regulatory listing
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02
FDA — July 23–24, 2026: Meeting of the Pharmacy Compounding Advisory Committeefda.gov · Federal advisory-committee notice
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03
Epitalon (Wikipedia — synthetic pineal-derived tetrapeptide, origin, claimed mechanism)en.wikipedia.org · Tertiary reference
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