The Longevity Registry

§ — Substance profile

D

Epitalon

Epithalon · Epithalone · AEDG peptide · Synthetic tetrapeptide derived from pineal extract

01 — Regulatory status

Regulatory status · United States · as of September 2026

Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List.

Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026

A
Approved drug with randomized controlled trials for the approved indication
B
Human clinical data exists, but no approval for the researched use
C
Animal or in-vitro data only, no controlled human trials
D
No published clinical data; use rests on anecdote

Reviewed September 2026 · Sources: FDA, EMA

02 — Researched for

What is being studied.

Telomerase activation, melatonin regulation, lifespan extension.

03 — What the evidence shows

The published record.

Almost all data comes from one Russian research group, largely in animals and cell lines, with limited peer review outside Russia. No independent controlled human trial exists.

04 — What is claimed but not shown

Claimed, not demonstrated.

Telomere lengthening and life extension in humans; improved sleep; reversal of aging markers.

05 — Known risks

Documented risks.

Theoretical concern that telomerase activation could favor tumor cells; no human safety data.

06 — Researched for these goals

Where Epitalon appears.

07 — Questions for your physician

Six questions worth printing.

  1. 01What is your primary board certification, and in what year did you obtain it?
  2. 02Is this peptide approved for what you are prescribing it for — and if not, what is the legal basis on which you are supplying it?
  3. 03Which human trials support this use, and what were their size and duration?
  4. 04Where does the product come from, and can you show me a certificate of analysis for this batch?
  5. 05What outcome will we measure, when, and what happens if it does not improve?
  6. 06What is the total cost for the first three months, in writing?

Reviewed September 2026 · Sources: FDA, EMA

This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.