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

By Peptide America · Publisher · Reviewed August 2026

Regulatory record

3 dated actions on record; no FDA final action yet.
April 2026
Removed from Category 2 without Category 1 listing.
July 2026
PCAC votes 7–4 (one abstention) to recommend 503A listing; advisory only. FDA has published no minutes, transcript or vote summary for this meeting; the tally is as reported by McDermott Will & Schulte and LumaLex Law.
FDA final action
None as of August 2026.

Every entry above is dated; the record is current as of the review date.

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 randomized trial of the tetrapeptide has been published for any endpoint. The one record PubMed tags as a controlled clinical trial of Epitalon is a 2002 report in retinitis pigmentosa whose abstract states a response rate without a denominator [9]; the remaining trial-type records study epithalamin, the extract, and their mortality findings are findings about the extract [5]. 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 to recommend adding it to the section 503A list. The margin is reported as 7–4 with one abstention by McDermott Will & Schulte, whose vote table gives it as "7 – 4 (1 abstention)", and by LumaLex Law, which prints it as 7–4–1; the two accounts agree substance by substance [3, 4]. The FDA has published no minutes, transcript or vote summary for the meeting, so the figure is secondary and this page says so wherever it appears. 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.

The substance also appears in a criminal case. In October 2020 Tailor Made Compounding, a Kentucky pharmacy, pleaded guilty in federal court to distributing unapproved new drugs between October 2018 and April 2020; the Justice Department's account of the plea agreement names Epitalon among them, and the company agreed to forfeit $1,788,906.82, its 2019 sales of those products [13].

Supply

No lawful US supply route exists for this molecule today. Lawfully available alternatives are recorded in the molecule index; the regulatory record on this page tracks the rulemaking that could change this.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

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, Brzezik J, Mądra-Gackowska K, Szeleszczuk Ł. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025 Mar 17;26(6). PMID 40141333
  3. McDermott Will & Schulte. Bulk-list bound? PCAC backs majority of peptides in two-day public meeting. July 27, 2026. Read August 2026. A secondary account, cited because the FDA has published no minutes, transcript or vote summary for the July 23–24, 2026 meeting; the agency's meeting page, content current as of August 6, 2026 and re-read in August 2026, carries the briefing documents, the final agenda, the final meeting roster and the FDA presentations, and no record of any vote. Its vote table gives Epitalon (free base / acetate), on Friday, July 24, as "7 – 4 (1 abstention)", recommended for inclusion. Source
  4. LumaLex Law. The July 2026 PCAC Peptide Meeting. July 25, 2026. Read August 2026. A second, independent secondary account, checked against the first: it prints all seven July 23–24, 2026 votes as a table — BPC-157, KPV and TB-500 at 8–6–1, MOTS-c at 7–5–2, Semax at 8–5–1, Epitalon at 7–4–1, and emideltide (DSIP) at 6–7–1 — and the two accounts agree substance by substance. Source
  5. PubMed, National Library of Medicine. Census run September 2026 across four name variants — "Epitalon" OR "Epithalon" OR "epithalamin" OR "Ala-Glu-Asp-Gly" — returning 215 indexed records, 79 carrying the Humans MeSH term, 9 under "clinical trial"[Publication Type] and 6 under "randomized controlled trial"[Publication Type]; 106 of the 215 are Russian-language records and 6 of the 9 trial-type records are Russian-language. The two tetrapeptide names alone — "Epitalon" OR "Epithalon" — return 114 records, 35 tagged Humans, 1 under the clinical-trial type and 0 under the randomized type; the tetrapeptide names combined with telomer* return 10 records, 6 tagged Humans, none of either trial type. All nine trial-type records were opened and read: one names the tetrapeptide (a 2002 retinitis pigmentosa report); the other eight study epithalamin or an unnamed pineal-gland peptide preparation, in cervical cancer (1979, 1999), craniocerebral trauma (2004), melatonin rhythm (2004), arterial pressure (2008) and the geroprotective series of 2003, 2006 and 2011. Every one appears in a Russian journal or its translated edition, or carries the designing institute's authors. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term, and a deliberately invalid record identifier errored at the start and the end of the run. The counts reproduce the August 2026 run behind the trial-record table exactly. Source
  6. Korkushko OV, Khavinson VKh, Shatilo VB, Antonyk-Sheglova IA. Peptide geroprotector from the pituitary gland inhibits rapid aging of elderly people: results of 15-year follow-up. Bull Exp Biol Med. 2011;151(3):366–369. PMID 22451889
  7. Korkushko OV, Khavinson VKh, Shatilo VB, Antonyuk-Shcheglova IA. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging. Bull Exp Biol Med. 2006;142(3):356–359. PMID 17426848
  8. Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3-4):233–240. PMID 14523363
  9. Khavinson V, Razumovsky M, Trofimova S, Grigorian R, Razumovskaya A. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett. 2002;23(4):365–368. PMID 12195242
  10. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, table of bulk drug substances nominated but withdrawn, entry for Epitalon. Read September 2026. The entry states that compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities, that FDA has not identified safety-related information regarding epitalon for the proposed route of administration, and that the agency therefore lacks sufficient information to know whether the drug would cause harm if administered to humans. Source
  11. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full September 2026: neither "Epitalon" nor "Epithalon" occurs anywhere in the document, so the substance appears in none of Category 1, Category 2, or Category 3. Control in the same read: the same document names GHK-Cu six times. Source
  12. US Food and Drug Administration, Drugs@FDA through the openFDA drugsfda endpoint. Queried September 2026 on the generic name, the substance name and the brand name for "epitalon" and "epithalon": no matching application. Control in the same run: the identical query for "bremelanotide" returned NDA 210557. Source
  13. US Attorney's Office, Eastern District of Kentucky, US Department of Justice. Nicholasville compounding pharmacy and its owner plead guilty to unlawful distribution of prescription drugs. Press release, October 29, 2020. Read September 2026. Tailor Made Compounding LLC pleaded guilty to one count of distributing unapproved new drugs from October 25, 2018 through April 1, 2020; "According to the plea agreement, TMC also unlawfully distributed other unapproved new drugs, including BPC 157, Cerebrolysin, CJC 1295, DSIP, Epitalon, GW 501516, Ipamorelin, LGD-4033, LL-37, Melanotan II, MK 677, PEG-MGF, Selank, and Semax"; the company agreed to forfeit $1,788,906.82, "representing its 2019 sales for these products." The office's release of February 24, 2021 reports the sentence: three years of probation for the company and the forfeiture. Source