Semax

Clinical maturity: Registered in one national market; limited Western-quality controlled evidence

The Russian registration is for a nasal-drop formulation. Intranasal and injectable products sold in the US research market are unapproved; a route being marketed is not evidence it works or is safe.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

A seven-amino-acid peptide derived from a fragment of ACTH, developed in Russia and promoted internationally for cognition, focus and recovery from neurological injury.

• Improves memory, focus and mental performance
• Speeds recovery after stroke
• Helps anxiety and migraine

The published human literature is concentrated in one research ecosystem and does not meet the standard of adequately powered, independently replicated controlled trials. Semax is not established as effective for cognition, stroke recovery, migraine or anxiety in general populations, however confidently it is marketed.

• Russian clinical literature exists but is largely inaccessible to independent Western appraisal and lacks the trial quality required here.
• No adequately powered, independently replicated randomised controlled trials in major indexed journals support the nootropic claims.

• Rodent studies reporting effects on neurotrophin expression and stress responses.

Animal and cell findings are Level 1–2 evidence.

• Proposed effects on BDNF and other neurotrophic signalling.
• Structural relationship to ACTH(4-7) fragments, which have melanocortin-system activity in animal models.

• The FDA's 503A Category 2 listing identifies significant safety risks for compounding; a formal safety review was scheduled at the July 2026 PCAC meeting.
• No systematic, regulator-reviewed human safety dataset exists for the products actually sold outside Russia.
• Unapproved supply chains carry documented purity, sterility and mislabelling risks.

Not approved by the FDA or other major Western regulators. FDA material notes Semax is registered in Russia as nasal drops, while intranasal and injectable products marketed in the US are not FDA-approved. It appears on the FDA 503A Category 2 list of bulk substances identified as presenting significant safety risks for compounding — a compounding safety classification, not an 'FDA ban' — and was scheduled for Pharmacy Compounding Advisory Committee review in July 2026.

• Adequately powered, independently conducted randomised controlled trials with pre-registered endpoints.
• A published regulator-grade human safety dataset.

• Regulatory / labelFDA — Certain bulk drug substances for use in compounding that may present significant safety risks
• Regulatory / labelFDA — July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee
• Regulatory / labelFDA — Semax acetate briefing material (PCAC 2026)

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

1. 2026-08-23

   Editorial update: profiles created or revised using FDA 2026 Pharmacy Compounding Advisory Committee material.

   L1MechanisticBaseline entry
   This reflects curation of existing regulatory documents, not new clinical findings. FDA 2026 PCAC review material established, for example, that no clinical studies or human exposure data were identified for KPV via any route — a fact that sets the ceiling for every marketed claim about it.