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#43Neurological, Sexual & Related

Semax

synthetic ACTH-fragment-derived peptide

Evidence: other human studyReviewed 2026-08-09
July 2026 PCAC recommendation

Recommended for possible 503A list inclusion

Semax-related bulk drug substances for cerebral ischemia, migraine, and trigeminal neuralgia

Nonbinding advisory recommendation; not FDA drug approval and not a final addition to the 503A Bulks List as of 2026-08-09.

Investigated uses

  • Ischemic neurologic conditions, migraine and trigeminal neuralgia in small regional studies.

Mechanism and hypotheses

  • Semax is an ACTH-fragment-derived peptide; FDA judged human efficacy evidence for reviewed neurologic uses insufficient.
  • Hypothesized: Neurotrophic, ischemia-modulating and cognitive effects remain inadequately confirmed.

Human evidence

  • Small and often uncontrolled studies have investigated ischemia, migraine and trigeminal neuralgia; FDA judged efficacy and safety evidence insufficient. Limitations: Regional publications, small samples, route heterogeneity and incomplete adverse-event reporting.

Safety highlights

  • Adverse-event reporting in the available small studies is incomplete.
  • FDA identified insufficient safety evidence and a possible bleeding concern in relevant neurologic contexts.

Regulatory context

No FDA-approved Semax drug was identified. In July 2026, PCAC recommended Semax-related bulk drug substances for possible inclusion on the 503A Bulks List for cerebral ischemia, migraine, and trigeminal neuralgia. The recommendation is nonbinding and was not a final FDA listing as of August 9, 2026.

Sources used for this entry