For clinicians
Epitalon for prescribers: status, evidence and what FDA has said
A neutral reference. It reports Epitalon's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | Epithalon, AEDG, Ala-Glu-Asp-Gly |
| Substances FDA reviewed | Epitalon (free base) and epitalon acetate |
| FDA approval | Not FDA-approved |
| Compounding (503A) | Not compoundable; PCAC recommended it 7–4 or 7–5 (Jul 2026), FDA has not acted |
| Outsourcing (503B) | No 503B status recorded |
| FDA advisory committee | Reviewed July 23–24, 2026 (docket FDA-2025-N-6895): recommended, 7–4 or 7–5, 1 abstention |
| WADA 2026 List | Prohibited (S0 catch-all) |
| WADA 2027 List | Prohibited (S0 catch-all) |
| Evidence grade | Low |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA staff's position, in its briefing for the July 23–24, 2026 committee meeting: FDA proposes not adding either epitalon substance to the 503A Bulks List, citing inadequate characterisation, limited historical use, no evidence of effectiveness for insomnia, and an absence of safety data — including on whether it would cause harm in humans.
The use FDA evaluated. FDA evaluated epitalon for insomnia — not for the anti-ageing uses it is mostly marketed for.
FDA's objections
FDA says neither form is well characterised, citing naming that does not follow established chemical nomenclature standards among other gaps.
FDA describes the information on historical use as limited — weaker than for most of the other six.
FDA concluded there is a lack of evidence to support effectiveness for insomnia, a condition it notes is associated with multiple serious adverse health outcomes and for which approved drugs with well-characterised safety profiles exist.
FDA says it lacks data to support the safety of these substances in humans, including whether they would cause harm when given subcutaneously, and did not identify information addressing immunogenicity risk.
Specific to Epitalon
FDA's briefing describes epitalon being marketed online by wellness clinics and concierge practices as an anti-ageing agent — with websites calling it a fountain of youth, claiming it raises telomerase and thereby reverses ageing, extends lifespan and prevents cancer, heart disease and dementia. FDA reports these as claims made by those websites. They are not findings, and FDA did not evaluate epitalon for any of them.
FDA describes three studies of epitalon's effect on spontaneous malignant tumour incidence and lifespan in mice — similar designs, all from the same research group. It identified no additional studies assessing genotoxic potential, and no developmental or reproductive toxicity studies. For a compound promoted for indefinite anti-ageing use, the long-term data is three related mouse studies from one lab.
FDA notes an orphan drug designation for retinitis pigmentosa granted in September 2010 was withdrawn or revoked in January 2016. A designation is not an approval, and this one no longer stands.
FDA lists Epitalon among substances it has identified as potentially presenting significant safety risks outside Category 2 (page current as of 2026-04-22). In FDA's words:
Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has not identified safety-related information regarding epitalon for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.
Monitoring: what the literature does and does not say
- No label. Epitalon has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
- Immunogenicity. FDA's July 2026 review found no adequate information to assess the risk that epitalon provokes an immune response.
- What is in the vial. FDA judged the substance not well characterised physically and chemically — the property FDA relies on to know what a compounded product actually contains.
- Findings specific to epitalon. FDA's review also describes points particular to this compound, some of them safety signals; they are set out above in FDA's own terms.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for Epitalon: Not compoundable; PCAC recommended it 7–4 or 7–5 (Jul 2026), FDA has not acted. An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
Grey Peptides grades epitalon's evidence base as low. The literature is largely Russian-language work centred on one research group, and the marketed anti-ageing claims are not supported by the kind of evidence a regulator weighs. Note that FDA spells it “epitalon”; this site's encyclopedia entry uses “Epithalon,” and both refer to the same tetrapeptide.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID and FDA's full briefing is summarised on our page for the July 2026 review.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026: briefing documents, docket FDA-2025-N-6895. FDA
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for Epitalon, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
Others in this group: BPC-157 · Emideltide (DSIP) · KPV · MOTS-c · Semax · TB-500