Peptide Intelligence · peptide
Semax
A synthetic peptide derived from ACTH, used as a nasal spray in Russia for cognitive and neurological indications. Marketed for focus and cognition.
Approval status
Not FDA-approved
Not FDA-approved. Approved in Russia.
Compounding status
PCAC-recommended (Jul 2026) · rulemaking pending
PCAC voted Jul 23–24 2026 to recommend adding to the 503A list; non-binding, rulemaking pending.
Evidence grade
B · Small or uncontrolled human studies
Small human studies, largely Russian-language and not replicated in US trials.
If you already have a vial
Products sold as research-use-only are unapproved drugs. Nothing required the seller to verify identity, purity, sterility or concentration. That is the practical risk, more than the compound itself. Worth discussing with your clinician before you continue, and worth logging so your labs can be read against it.
Known risks and label warnings
- Limited safety data outside Russia
- Product quality varies
Interactions people ask about
- Unknown
What people often measure
Framed as things to discuss with your clinician, not a protocol.
- Symptoms; blood pressure
Questions for your clinician
- Is there any US-quality evidence for my goal?
Get the full report by email
- The Semax status card, monitoring list and clinician questions, printable
- The pre-therapy baseline checklist: what people commonly measure before starting any injectable
- A note the next time FDA or HHS acts on this compound
Wellness guidance only, not medical advice. We never sell or dispense medication.
Regulatory timeline for Semax
2026-07-24
PCAC votes to recommend six peptides for the 503A bulks list
The Pharmacy Compounding Advisory Committee voted in favor of BPC-157, TB-500, KPV, MOTS-c, Semax and epitalon. The votes are advisory only. Until FDA completes rulemaking, none of the six is legally compoundable and research-use-only products remain unapproved drugs.
FDA PCAC meeting page2026-04-15
Federal Register notice updates the peptide 'do not compound' list
FDA published an update to the Category 2 list and opened the process for nominated peptides to be evaluated for the 503A bulks list.
Frier Levitt analysis of the Apr 15 2026 notice2026-02-27
HHS announces a review of peptide compounding policy
HHS signaled it would revisit the compounding status of several peptides, setting up the April Federal Register notice and the July advisory-committee meeting.
Frier Levitt analysis
Sources and review
Status as of 2026-09-02. Reviewed 2026-09-02 by Curtis Holder (product); clinical review pending; next review due 2026-11-01. Regulatory status changes; we update this page after each FDA or HHS action. Wellness guidance only, not medical advice. Med.xyz does not sell, prescribe or recommend any compound.