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- Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn, as Semax (heptapeptide).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 Nominations had been withdrawn; FDA elected to proceed.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 fileWhat 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 FDA's withdrawn-nominations table lists Semax (heptapeptide).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
Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built
