U.S. regulatory status

Semax

Also known as Semax acetate

Under reviewNo approved product; before the FDA committee Jul 24, 2026

Is Semax legal right now?

Semax is a synthetic heptapeptide with no FDA-approved drug product and no USP monograph in the United States, so the 503A Bulk Drug Substances List is the only potential compounding pathway. It was placed in Category 2 (significant safety risks) in 2023 and its Category 2 nomination was later withdrawn - but it was never in Category 1, so it is not currently compoundable. It is scheduled for FDA advisory committee (PCAC) evaluation on July 24, 2026 (Docket FDA-2025-N-6895); the committee's recommendation is advisory and any listing would require formal rulemaking.

Under review: Actively before the FDA advisory committee; a decision is pending and the status can move.

Verified Jul 7, 2026 (ET) · status held since Apr 16, 2026

Primary source: Federal Register All 2 sources

Where it sits in the process

Nominated(completed)
Under review(current stage)
Rulemaking(upcoming)
Compounding-legal(upcoming)

Next milestoneFDA advisory committee (PCAC) evaluates Semax for the 503A list - Jul 24, 2026 (in 16 days)

What changed last

Apr 16, 2026
Placed on the July 24, 2026 FDA advisory committee agenda for possible inclusion on the 503A list.
Review scheduledView on federalregister.gov

Status elsewhere

Semax: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Under review	Never in Category 1; Category 2 nomination withdrawn; before PCAC July 24, 2026.
Australia (TGA)	Unscheduled	Not individually named in the Poisons Standard; sits in a grey area.
Sport / anti-doping (WADA)	Unscheduled	Not specifically named; a non-approved experimental peptide could fall under the S0 catch-all.

Sources & transparency

Sources for this entry

Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primarySemax (free base and acetate) on the July 24, 2026 agenda.
FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisSemax moved to Category 2 in 2023; under PCAC review; recommendation non-binding.

Last verified by a human: Jul 7, 2026 (ET) · how we verify
Who runs this: Peptlas Research Team - independent. About us.
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Confidence: medium - some facts here rest on secondary reporting. Always confirm against the primary source before you rely on it.

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