What is Epitalon?

The short answer

Epitalon is a small lab-made peptide based on an extract of the pineal gland.

  • What it is

    Lab-made four-amino-acid peptide based on a pineal gland extract.

  • What people look into

    Aging, sleep

Get updates on Epitalon

What it is

Type
Synthetic tetrapeptide
Also known as
epithalon, epithalone, ala-glu-asp-gly, aedg
How it works
Lab-made four-amino-acid peptide based on a pineal gland extract.

Regulatory status

Not FDA-approved · advisory vote July 2026 · no FDA decision How we label status

As of October 4, 2026, Epitalon is not FDA-approved. On July 24, 2026, FDA's compounding advisory committee voted to recommend adding it to the 503A bulks list; FDA staff had recommended against it. FDA has not proposed that change.

See Epitalon in the Index →

Federal (FDA)
Not FDA-approved
503A compounding
No category since 2026-04-22 (nomination withdrawn); PCAC recommended 2026-07-23/24; no proposed rule as of 2026-10-04 (as of October 4, 2026)
PCAC history
2026-07-24: recommended 7-4-1 (free base and acetate; use reviewed: insomnia; count as read into FDA's meeting recording; written minutes not posted as of 2026-10-04); FDA staff: against

Timeline

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Timeline table
DateWhat happenedSource
Federal Register notice of an FDA Pharmacy Compounding Advisory Committee meeting lists epitalon among bulk drug substances under consideration for the 503A bulks list.Federal Register, event of April 16, 2026, on federalregister.gov
FDA presentations for the Pharmacy Compounding Advisory Committee meeting cover epitalon as a bulk drug substance under consideration for the 503A bulks list.FDA, event of July 24, 2026, on fda.gov

References

Sources as of October 4, 2026

  1. FDA: www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  2. FDA: www.fda.gov/media/193345/download
  3. FDA: www.fda.gov/media/193342/download
  4. Federal Register: www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request
  5. FDA: www.fda.gov/media/94155/download
  6. FDA: www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  7. YouTube: youtube.com/live/xXM5ecHxlMU