CognitiveNot approvedHHS draft policy (proposed, not final)Evidence tier: Human Observational

Semax

Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 29, 2026.

FDA status

Not approved

Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.

FDA primary source on file

Evidence tier

Human Observational. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 3/5. 165 PubMed citations indexed.

Semax in the literature

Synthetic ACTH4-7 analog that increases BDNF expression, activates dopaminergic signaling, and provides neuroprotective effects via serotonin 5-HT receptor modulation.

What the literature studies

Neuroprotection & Cognitive Function

Evidence tier

Human Observational

Compounding record

HHS proposed 503A enforcement discretion (not final)

Confidence
3/5

Regulatory record

HHS proposed 503A enforcement discretion (not final). FDA substance context: Semax. Named in the proposed HHS 503A enforcement-discretion notice (Federal Register 2026-22192, October 2026). The policy is proposed, not final, and is not FDA approval. FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source checked October 29, 2026. This compounding label is separate from the approval line above.

FDA primary source 1 FDA primary source 2

limited controlled trial data available in English.

Questions

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Semax is a synthetic ACTH(4-10) analog with a Pro-Gly-Pro extension, studied mainly in small Russian stroke and neurology cohorts; it is not FDA-approved, FDA's own PCAC briefing weighed against 503A listing, and a July 2026 advisory vote reportedly favored listing anyway - advisory only, not approval.

What it is

Heptapeptide Met-Glu-His-Phe-Pro-Gly-Pro (ACTH4-7 fragment plus PGP), developed in Russia as a peptide drug for neurologic indications [FDA-SEMAX].

Legal / FDA status (as of Oct 27 2026)

Not FDA-approved. FDA lists semax (heptapeptide) under nominated-but-withdrawn with immunogenicity/impurity concerns and "no, or limited" safety information for proposed routes [FDA-RISK]. FDA evaluated semax free base and acetate for the Jul 23-24 2026 PCAC; the agency briefing concluded a balancing of criteria weighs against placing semax on the 503A list, citing physicochemical characterization problems and references that "demonstrated lack of effectiveness" for the uses FDA could assess [FDA-SEMAX]. Secondary reports (AJMC / law-firm accounts) say the committee still voted to recommend listing (commonly cited as ~8-5 with abstention); FDA has not posted official minutes with tallies, and a recommendation is not a final rule [AJMC].

Human evidence

  • Small Russian trial-type publications report use in acute ischemic stroke, optic nerve disease, and motor neuron disease; sample sizes are small and literature is largely Russian-language [R1][FDA-SEMAX].
  • FDA's briefing states it could not find a human pharmacokinetic study by any route and that assessed clinical references did not support effectiveness for the nominated uses [FDA-SEMAX].
  • No large English-language multicenter placebo-controlled RCT establishing cognitive "nootropic" benefit in healthy adults was identified.

Animal / lab evidence

Extensive rodent neurobiology literature (neurotrophic/BDNF-related pathways in secondary reviews). Animal results are not evidence of clinical benefit in people.

Risks and unknowns

FDA immunogenicity and characterization concerns; limited US-grade safety package [FDA-RISK][FDA-SEMAX]. Gray-market nasal products unverified.

What's coming

Any 503A bulks-list addition still requires notice-and-comment rulemaking after advisory input [FDA-PCAC]. Interim peptide compounding policy (RIN 0910-ZD94) under White House review; covered list not public [OIRA].

Sources

  1. [R1] Gusev EI et al. Effectiveness of semax in acute period of hemispheric ischemic stroke (clinical and electrophysiological study). Zh Nevrol Psikhiatr Im S S Korsakova 1997. PMID 11517472 (Russian; n=30 Semax vs 80 conventional therapy)
  2. [FDA-SEMAX] FDA. PCAC Jul 23-24 2026 briefing materials for Semax-related bulk drug substances. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 (briefing docs linked from meeting page)
  3. [FDA-RISK] FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  4. [AJMC] AJMC. FDA Panel Backs 6 Peptides for Compounding. Jul 31 2026. https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
  5. [FDA-PCAC] FDA. July 23-24, 2026 PCAC meeting page. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  6. [OIRA] OIRA. Pending EO 12866 Review, RIN 0910-ZD94. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964

Last checked 2026-10-27

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