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

Semax

A synthetic ACTH fragment analogue with no FDA-approved drug product in the United States. It is used as a registered product in some other jurisdictions. FDA reviewed Semax-related bulk substances at the 24 July 2026 PCAC meeting.

Also listed as: MEHFPGP, ACTH(4-10) analogue

Chemical identity

Compound class
Synthetic heptapeptide analogue of ACTH(4-10) with a C-terminal Pro-Gly-Pro extension
Sequence
MEHFPGP
Molecular formula
C37H51N9O10S
Molecular weight
813.93 g/mol
CAS number
80714-61-0
PubChem CID
122178
Research categories
Peptide fragments, Preclinical research compounds

United States regulatory status

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  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn, as Semax (heptapeptide).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 Nominations had been withdrawn; FDA elected to proceed.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, and it says nothing about the quality of any particular material.

Evidence overview

3 records in this file

  • ANIMAL1
  • REGULATORY2

Research areas. Neurotrophin models; United States compounding.

Publication span. 2006–2026.

Open the evidence file

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 FDA's withdrawn-nominations table lists Semax (heptapeptide).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).

Sources

  1. PubChem CID 122178
  2. Drugs@FDA — approved drug products
  3. FDA — Pharmacy Compounding Advisory Committee, 23–24 July 2026
  4. FDA — Certain bulk drug substances for use in compounding may present significant safety risks

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