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Synthetic hexadecapeptide corresponding to the C-terminal fragment of human growth hormone with an N-terminal tyrosine

AOD-9604 — 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

3 records in this file

  • CLINICAL TRIAL1
  • REGULATORY2

Research areas. Anti-doping; Human tolerability; United States compounding.

Publication span. 2013–2026.

What we know

  • A 2013 paper summarises six sponsor-run randomised tolerability trials and reports a placebo-like safety narrative in those studies. That is not an approved obesity indication.
  • No FDA-approved drug product exists. The substance is on FDA's withdrawn compounding-nominations table.
  • WADA names AOD-9604 at S2.2.3 as a growth-hormone fragment. That is an anti-doping classification.

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

What remains uncertain

  • Independent, contemporary human interventional data outside the originating sponsor programme.
  • How closely commercial research-use material matches the material used in the 2013 summary.

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  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn. Published concerns include immunogenicity risk, peptide-related impurities, API characterisation complexity, limited safety information, and serious adverse events whose causality FDA states is not clear.
  • Not treated here as interchangeable with native growth hormone.

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

Studies and documents

  1. REGULATORY2026FDA compounding classification

    FDA — bulk substances nominated for compounding and withdrawn: AOD-9604

    U.S. Food and Drug AdministrationFDA compounding communications

    Objective
    To record FDA's published compounding position on AOD-9604.
    Endpoint investigated
    Compounding classification, not efficacy

    AOD-9604 appears on FDA's table of bulk substances nominated for compounding and withdrawn by the nominator. Published concerns include immunogenicity risk, peptide-related impurities, API characterisation complexity, limited safety information, and serious adverse events whose causality FDA states is not clear.

    Limitations. A withdrawn nomination is not a safety assessment of any particular material, and it is not a clinical evidence review.

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

  2. REGULATORY2026Anti-doping listing

    WADA Prohibited List — S2.2.3 growth hormone fragments, e.g. AOD-9604

    World Anti-Doping AgencyWADA Prohibited List

    Objective
    To record the 2026 Prohibited List entry.
    Endpoint investigated
    Sporting prohibition status

    Named at S2.2.3 as an example of a growth-hormone fragment, alongside hGH 176-191. Prohibited at all times; non-Specified. This is an anti-doping classification, not a finding about laboratory research use.

    Limitations. WADA listing is not a determination of chemical identity or of any research endpoint.

    WADA 2026 Prohibited ListReviewed 12 September 2026

  3. CLINICAL TRIAL2013Summary of six randomised, double-blind, placebo-controlled trials

    Safety and tolerability of the hexadecapeptide AOD9604 in humans

    Stier H, Vos E, Kenley DJournal of Endocrinology and Metabolism

    Population
    Human volunteers in six sponsor-run randomised trials
    Objective
    To summarise safety and tolerability observations for AOD-9604 across six randomised trials, with attention to IGF-1, glucose handling and antibodies.
    Endpoint investigated
    IGF-1, oral glucose tolerance, anti-AOD9604 antibodies, withdrawals and serious adverse events as reported by the authors

    The authors summarise six randomised, double-blind, placebo-controlled trials of AOD-9604. They report no effect on serum IGF-1, no negative effect on carbohydrate metabolism in oral glucose-tolerance testing, no anti-AOD9604 antibodies in assayed subjects, and no withdrawal or serious adverse event they judged related to the peptide. The paper is a pooled safety narrative, not an FDA-reviewed efficacy programme.

    Limitations. Sponsor-linked authors (Metabolic Pharmaceuticals / Calzada). Trial-level n, protocols and full adverse-event tables are not independently reproduced here. A tolerability summary is not an approved indication.

    DOI 10.4021/jem157wStier, Vos and Kenley, J Endocrinol Metab (2013)Reviewed 12 September 2026

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