For clinicians
Semax for prescribers: status, evidence and what FDA has said
A neutral reference. It reports Semax's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | ACTH(4-7)PGP |
| Substances FDA reviewed | Semax (free base) and semax acetate |
| FDA approval | Not FDA-approved; approved in Russia |
| Compounding (503A) | Not compoundable; PCAC recommended it 8–5 (Jul 2026), FDA has not acted |
| Outsourcing (503B) | No 503B status recorded |
| FDA advisory committee | Reviewed July 23–24, 2026 (docket FDA-2025-N-6895): recommended, 8–5, 1 abstention |
| WADA 2026 List | Unsettled (S0 may apply) |
| WADA 2027 List | Unsettled (S0 may apply) |
| Evidence grade | Medium |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA staff's position, in its briefing for the July 23–24, 2026 committee meeting: FDA proposes not adding either semax substance to the 503A Bulks List. Two things distinguish this evaluation: FDA says some of the available references demonstrated a lack of effectiveness rather than merely failing to demonstrate it, and it raises two specific pharmacological safety signals.
The use FDA evaluated. FDA evaluated all three nominated uses: cerebral ischemia, migraine, and trigeminal neuralgia.
FDA's objections
FDA says neither form is well characterised, citing missing endotoxin data for the injectable routes and no information showing how an appropriate container and pump for an intranasal spray product would be selected and qualified.
FDA describes the available references as limited by small sample size and missing clinical endpoints — and says some demonstrated a lack of effectiveness. It concluded the evidence is insufficient to support semax for cerebral ischemia, migraine or trigeminal neuralgia, all of which it notes are serious conditions with approved therapies available.
FDA says there is a lack of information on the safety profile and that compounding use may raise safety concerns, and that it did not identify information addressing immunogenicity risk.
Specific to Semax
FDA cites direct evidence from studies in non-ischemic rats that semax has anticoagulant and antithrombotic properties — increased plasma anticoagulant and fibrinolytic activity, smaller thrombi, and roughly 35% reduced platelet aggregation. Because the study did not establish a dose-response relationship, FDA says it is unclear whether doses could be titrated to reverse a hypercoagulating state without creating conditions favouring a bleeding event. This is a pharmacological effect on clotting in a substance marketed for cognition.
In mice, semax potentiated amphetamine-induced dopamine release in the striatum and amphetamine-induced locomotor activity. FDA calls this concerning, noting that increased striatal dopaminergic tone is a response typically induced by drugs of abuse such as cocaine. It adds that it found no nonclinical study assessing abuse potential by the proposed subcutaneous route.
Semax is an approved medicine in Russia. It is not FDA-approved, and FDA's briefing states it is not a component of any FDA-approved drug. Approval in another jurisdiction is not a US regulatory status and carries no weight in a 503A Bulks List decision.
FDA lists Semax (heptapeptide) among substances it has identified as potentially presenting significant safety risks outside Category 2 (page current as of 2026-04-22). In FDA's words:
Compounded drugs containing semax (heptapeptide) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.
Monitoring: what the literature does and does not say
- No label. Semax has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
- Immunogenicity. FDA's July 2026 review found no adequate information to assess the risk that semax provokes an immune response.
- What is in the vial. FDA judged the substance not well characterised physically and chemically — the property FDA relies on to know what a compounded product actually contains.
- Findings specific to semax. FDA's review also describes points particular to this compound, some of them safety signals; they are set out above in FDA's own terms.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for Semax: Not compoundable; PCAC recommended it 8–5 (Jul 2026), FDA has not acted. An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
Grey Peptides grades semax's evidence base as medium — the highest of the seven, and still short of the bar. That grade reflects a real Russian clinical literature. FDA's reading of that same literature is that it is small, methodologically limited, and in places negative.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID and FDA's full briefing is summarised on our page for the July 2026 review.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026: briefing documents, docket FDA-2025-N-6895. FDA
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for Semax, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
Others in this group: BPC-157 · Emideltide (DSIP) · Epitalon · KPV · MOTS-c · TB-500