U.S. Food and Drug Administration (FDA)
Is Semax legal in United States?
Not approvedNo FDA approval; an advisory panel voted in July 2026 to recommend considering it for the 503A list, but FDA has not acted
Not approved as a medicine here.
Semax is not approved as a drug in the US. FDA's Category 2 page lists it among withdrawn nominations and notes little or no safety information for the proposed routes. The Pharmacy Compounding Advisory Committee reviewed it for cerebral ischemia, migraine and trigeminal neuralgia on 24 July 2026 and, per a law-firm report, voted 8 to 5 with one abstention to recommend it. The committee's advice is non-binding and listing would need FDA action; US customs also reported seizing semax among unapproved peptide shipments.
Last verified 2026-09-29 · how we verify
Semax elsewhere
Sources (4)
- 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
- 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration · 2026-08-06 · accessed 2026-09-29
- 03Bulk list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte · 2026-07-27 · accessed 2026-09-29
- 04Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.U.S. Customs and Border Protection · 2026-03-31 · accessed 2026-09-29