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Synthetic tetrapeptide

Epitalon — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

4 records in this file

  • HUMAN DATA1
  • IN VITRO1
  • REGULATORY2

Research areas. Extract programme (not synthetic AEDG); Telomere biology (in vitro); United States compounding.

Publication span. 2003–2026.

What we know

  • The 2003 Khavinson in-vitro paper reports telomerase activity and telomere elongation in cultured human somatic cells.
  • Popular “human lifespan” citations often point at extract programmes (epithalamin), which are not the synthetic AEDG tetrapeptide.
  • No US approved product. Withdrawn compounding nomination. Distinct from Epithalamin (different CAS association in PubChem).

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Independent in-vivo human interventional data on synthetic AEDG.
  • Whether in-vitro telomerase findings have a defined relationship to organism-level ageing endpoints.
  • FDA's eventual decision on the July 2026 PCAC recommendation — a committee vote is not a listing.

Regulatory notes

No FDA-approved product

  • No approved drug product exists in Drugs@FDA.
  • Listed on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator, citing aggregation and impurity immunogenicity risk and absence of safety information.
  • On 24 July 2026 PCAC discussed Epitalon (free base) and Epitalon acetate (use evaluated: insomnia). FDA briefing materials proposed that they NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. Committee recommendations are non-binding; FDA has not published a listing decision as of this review.
  • Not named on the WADA 2026 Prohibited List.

Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

Studies and documents

  1. REGULATORY2026FDA advisory-committee briefing

    FDA PCAC briefing — Epitalon-related bulk drug substances (24 July 2026)

    U.S. Food and Drug AdministrationFDA PCAC briefing

    Objective
    To record FDA staff's published proposal on 503A Bulks List inclusion for Epitalon.
    Endpoint investigated
    Proposed compounding-list classification

    PCAC discussed Epitalon (free base) and Epitalon acetate on 24 July 2026 (use evaluated: insomnia). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed.

    Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.

    FDA — PCAC briefing for Epitalon-related bulk drug substancesReviewed 12 September 2026

  2. REGULATORY2026Regulatory listing

    FDA table of bulk drug substances nominated for compounding and subsequently withdrawn

    U.S. Food and Drug AdministrationFDA compounding communications

    Objective
    To record FDA's published compounding position.
    Endpoint investigated
    Compounding classification

    Listed on the withdrawn-nominations table, citing aggregation and impurity immunogenicity risk and absence of safety information. Considered at FDA's Pharmacy Compounding Advisory Committee meeting of 24 July 2026. Committee recommendations reported in the trade press are not an FDA decision and are not recorded here as one.

    Limitations. Identity record remains a withdrawn nomination until FDA publishes minutes and any rulemaking. Secondary vote tallies disagree in places (STAT vs Regulatory Focus on epitalon).

    FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026

  3. IN VITRO2003In vitro (cultured human somatic cells)

    Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells

    Khavinson VKh, Bondarev IE, Butyugov AABulletin of Experimental Biology and Medicine

    Population
    Cultured human somatic cells (originating laboratory)
    Objective
    To test whether the AEDG tetrapeptide induced telomerase activity and telomere elongation in culture.
    Endpoint investigated
    Telomerase activity and telomere length in cultured cells

    Foundational in-vitro paper from Khavinson's group reporting that epithalon induced telomerase activity and telomere elongation in cultured human somatic cells. This is the paper popular claims about “telomerase activation” point at.

    Limitations. Cell culture, not a living human. Does not show systemic delivery, tissue distribution, or a lifespan endpoint. Single-laboratory origin. A later independent in-vitro replication (Al-Dulaimi et al., 2025) is still cell-culture data.

    DOI 10.1023/A:1025493705728Khavinson et al., Bull Exp Biol Med (2003)Reviewed 12 September 2026

  4. HUMAN DATA2003Report of long-term observations — pineal/thymic extracts

    Peptides of pineal gland and thymus prolong human life

    Khavinson V, Morozov VNeuro Endocrinology Letters

    Population
    Elderly patients in a Russian clinical programme
    Objective
    To report long-term observations after pineal and thymic peptide preparations.
    Endpoint investigated
    Mortality and related observations in that programme

    Often cited in popular epitalon writing. The preparations in this paper are pineal and thymic peptide preparations (epithalamin / thymalin extracts) used in a long-term observational programme — not a Western RCT of synthetic AEDG (epitalon).

    Limitations. Extract preparations are not the synthetic tetrapeptide. Observational, originating group, not independently replicated as a synthetic-epitalon RCT. Do not treat this as Phase 3 evidence for AEDG.

    Khavinson and Morozov, Neuro Endocrinol Lett (2003) — Epithalamin/thymalin extracts, not synthetic epitalon.Reviewed 12 September 2026

Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built