PeptideAmerica

Longevity peptides

Epitalon

Epithalon; AEDG tetrapeptide

US status
PCAC-recommended · pending
Class
Longevity peptides
Approved product
None
Route
None lawful; sold as research-use-only material

Regulatory record

April 2026
Removed from Category 2 without Category 1 listing.
July 2026
PCAC votes 7–5 (one abstention) to recommend 503A listing; advisory only.
FDA final action
None as of August 2026.

Status verified for this index · August 2026

Definition

Epitalon is the synthetic tetrapeptide alanine-glutamate-aspartate-glycine, designed in St. Petersburg as a defined analogue of epithalamin, a crude pineal-gland extract studied in Soviet and Russian gerontology since the 1980s.

It is marketed almost entirely on longevity claims — telomere extension chief among them — which makes the distance between its laboratory record and its sales copy the monograph's central subject.

Evidence

The foundational claim is a 2003 report that Epitalon induced telomerase activity and telomere elongation in cultured human fetal fibroblasts [1] — a cell-culture observation from the same institute that designed the peptide. The surrounding longevity literature concerns epithalamin, the parent extract, in rodents and fruit flies, not the tetrapeptide in people; a 2025 review collects what has and has not been replicated since [2].

No controlled human trial of Epitalon has been published for any endpoint. A buyer weighing a telomere claim against this record is weighing a marketing document against a fibroblast dish.

Lawful access

Epitalon was removed from Category 2 of the interim 503A bulks list in April 2026 without Category 1 listing. In July 2026 the Pharmacy Compounding Advisory Committee voted 7–5, with one abstention, to recommend adding it to the section 503A list — the narrowest recommendation of the meeting, alongside MOTS-c. The vote is advisory; no FDA final rule has issued, and no licensed pharmacy may lawfully compound Epitalon as of August 2026.

Vials sold online today are research-use-only supply, outside pharmacy oversight; the pending page explains the rulemaking still to come.

References

  1. Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003;135(6):590–592. PMID 12937682
  2. Araj SK, et al. Overview of Epitalon — highly bioactive pineal tetrapeptide with promising properties. Int J Mol Sci. 2025;26(6). PMID 40141333