U.S. regulatory status

Epitalon

Also known as Epithalon · Epithalone · AEDG · Epitalon acetate

Under reviewRemoved from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 24, 2026

Is Epitalon legal right now?

Epitalon (also spelled epithalon, and related to the pineal peptide epithalamin) is a synthetic tetrapeptide, Ala-Glu-Asp-Gly, studied in aging and sleep research and widely marketed around telomerase-activation and longevity claims that remain scientifically unsettled. In the United States it is not FDA-approved, there is no approved product, and it is not on the FDA's Section 503A list of bulk substances eligible for pharmacy compounding. It was removed from the interim Category 2 list in April 2026, but that removal reflects a withdrawn nomination and does not authorize compounding, and Epitalon was never on the permitted Category 1 list. FDA advisory reviewers have also raised a theoretical concern that telomerase activation could relate to cancer risk. It is scheduled for FDA advisory committee (PCAC) evaluation on July 24, 2026 (Docket FDA-2025-N-6895); that vote is advisory only, and any listing would require formal rulemaking.

Under review: Actively before the FDA advisory committee; a decision is pending and the status can move.

Verified Jul 16, 2026 (ET) · status held since Apr 16, 2026

Primary source: Federal Register All 4 sources

Where it sits in the process

Nominated(completed)
Under review(current stage)
Rulemaking(upcoming)
Compounding-legal(upcoming)

Next milestoneFDA advisory committee (PCAC) evaluates Epitalon for the 503A list - Jul 24, 2026 (in 8 days)

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

Epitalon: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Under review	Not on the 503A list; removed from Category 2 in April 2026 (never in Category 1); under active PCAC review, meeting July 23-24, 2026 (Docket FDA-2025-N-6895).
Australia (TGA)	Unscheduled	Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides.
Sport / anti-doping (WADA)	Restricted	Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances.

Sources & transparency

Sources for this entry

Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primaryEpitalon (free base and acetate) on the July 24, 2026 agenda.
FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryEpitalon is not on the 503A (Category 1) list; the FDA 503A categories govern compounding eligibility.
Frier Levitt - FDA to remove peptides from the Category 2 list (2026) analysisEpitalon among the peptides removed from Category 2 in April 2026; removal does not authorize compounding.
FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisConfirms Epitalon on the July 2026 PCAC agenda; the vote is advisory and any listing requires rulemaking.

Last verified by a human: Jul 16, 2026 (ET) · how we verify
Who runs this: Peptlas Research Team - independent. About us.
What we sell: Nothing. No products, no affiliates, no sponsored placements.

This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.