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Research PeptidesCOGNITIVE & NEURO
Evidence grade C

Semax

Graded C: approved and used clinically only in Russia, and trial evidence is small, mostly Russian-language, and judged insufficient by FDA.

Strengths
10, 30 mg
Also known as
Семакс, MEHFPGP, (Pro8,Gly9,Pro10)ACTH(4–10), ACTH(4–7) analog
Molecule
7-amino-acid ACTH-fragment analog (no hormonal activity)
Formula
C37H51N9O10S
Mol. weight
813.93 g/mol
CAS
80714-61-0 (free base)
Sequence
Met-Glu-His-Phe-Pro-Gly-Pro

Origin

Built from a fragment of the stress hormone ACTH with a Pro-Gly-Pro tail added for stability. Russia registered it as prescription nasal drops for stroke, cognitive problems and optic nerve disease, and lists it as an essential medicine.

How it works

FDA calls the mechanism poorly understood. Proposed pathways, almost all from rodents, include a rapid rise in hippocampal BDNF and its receptor, activation of serotonin and dopamine systems, action at melanocortin MC4/MC5 receptors, and inhibition of enkephalin-degrading enzymes. In rat stroke models it suppressed inflammatory genes and pushed ischemia-disrupted gene expression back toward normal.

What the research shows

FDA's 2026 review found no adequate controlled trials it could assess for stroke, migraine or facial pain, and excluded Russian-language studies without translation. Available human reports are small and largely uncontrolled; across all studies, a few hundred adults and children have received it, with adverse events rarely reported. In rat stroke models it reduced infarct size. Human pharmacokinetics, toxicology and abuse potential are unstudied.

Key studies

  • FDA Briefing Document, PCAC July 2026 No adequate controlled trials for cerebral ischemia, migraine or trigeminal neuralgia; key safety data missing.
  • Koroleva et al., 1996 Open-label migraine and facial-pain study: no analgesic effect of its own, by the authors' conclusion.
  • Filippenkov et al., Biomedicines 2024 Rat stroke model: reversed most ischemia-driven gene changes.
  • Dolotov et al., Brain Research 2006 Raised BDNF and TrkB expression in rat hippocampus.

Safety findings

The Russian label lists only mild nasal irritation with prolonged use, and trials rarely reported adverse events. FDA flagged possible immunogenicity, bleeding risk based on animal antithrombotic effects, a possible abuse signal, and one hospitalization for eye pain after drops bought online.

Regulatory status

Not FDA-approved and not a component of any approved drug. In July 2026 FDA's Pharmacy Compounding Advisory Committee voted 8–5–1 to recommend adding it to the 503A bulks list; the vote is advisory, FDA had issued no final rule as of October 2026, and it concerns pharmacy compounding for patients, not research-grade material. Approved in Russia as nasal drops. Not named on the 2026 WADA list; whether the corticotropin category applies is unclear.

Catalog notes

Available in 10 and 30 mg; the 10 mg strength has a certificate (lot SEMX10-0803, 99.82% purity, COA7586, August 17, 2026), and none is published for 30 mg. Follow the storage stated on the label and certificate. NA-Semax Amidate, offered as a spray, is a different molecule.

In kits: Neuro Bundle