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Synthetic heptapeptide analogue of ACTH(4-10) with a C-terminal Pro-Gly-Pro extension

Semax — 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

  • ANIMAL1
  • REGULATORY2

Research areas. Neurotrophin models; United States compounding.

Publication span. 2006–2026.

What we know

  • A rodent BDNF literature exists, including Dolotov et al. 2006 in Journal of Neurochemistry.
  • No United States approved product. FDA's withdrawn-nominations table lists Semax (heptapeptide).
  • PCAC discussed Semax-related bulk substances on 24 July 2026. FDA briefing materials proposed against inclusion. That is not a listing decision.

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

What remains uncertain

  • How non-US labelled use, if any, should be read against US compounding policy — they are different systems.
  • Independent Western interventional trials on the endpoints FDA evaluated (cerebral ischemia, migraine, trigeminal neuralgia).

Regulatory notes

No FDA-approved product

  • No record of United States approval in Drugs@FDA.
  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn, as Semax (heptapeptide). Published concerns include immunogenicity risk and limited safety information for the proposed routes.
  • On 24 July 2026 PCAC discussed Semax (free base) and Semax acetate (uses evaluated: cerebral ischemia, migraine and trigeminal neuralgia). 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 Nominations had been withdrawn; FDA elected to proceed.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.

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    FDA — bulk substances nominated for compounding and withdrawn: Semax (heptapeptide)

    U.S. Food and Drug AdministrationFDA compounding communications

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

    Semax (heptapeptide) appears on FDA's withdrawn-nominations table. Published concerns include immunogenicity risk from aggregation and peptide-related impurities, and limited safety information for the proposed routes.

    Limitations. Withdrawn nomination; not a review of non-US labelled use.

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

  2. REGULATORY2026FDA advisory-committee briefing

    FDA PCAC briefing — Semax-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 Semax.
    Endpoint investigated
    Proposed compounding-list classification

    PCAC discussed Semax (free base) and Semax acetate on 24 July 2026 (uses evaluated: cerebral ischemia, migraine and trigeminal neuralgia). 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 Semax-related bulk drug substancesReviewed 12 September 2026

  3. ANIMAL2006In vivo (rat) with supporting binding work

    Semax, an analogue of adrenocorticotropin (4-10), binds specifically and increases levels of brain-derived neurotrophic factor protein in rat basal forebrain

    Dolotov OV, et al.Journal of Neurochemistry

    Population
    Rat basal forebrain after intranasal application
    Objective
    To test whether Semax binds in rat basal forebrain and alters BDNF protein after intranasal application.
    Endpoint investigated
    BDNF protein in rat basal forebrain versus cerebellum

    Reports specific binding sites for Semax in rat basal forebrain and a rapid increase in BDNF protein there, but not in cerebellum, after intranasal application at 50 and 250 µg/kg. The paper is mechanistic rodent work, not a United States clinical programme.

    Limitations. Rodent BDNF biochemistry. Intranasal application in rats is not a labelled human indication, and the United States has no approved Semax product.

    DOI 10.1111/j.1471-4159.2006.03658.xDolotov et al., J Neurochem (2006)Reviewed 12 September 2026

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