A synthetic heptapeptide based on a fragment of ACTH, used in Russia as a nasal spray. It is not approved in the U.S.
Key takeaway
Semax combines a short ACTH fragment with a stabilizing tail. It is registered as a medicine in Russia, where it has been studied for stroke and cognition.
At a glance
| FDA status | Not FDA-approved |
|---|---|
| 503A compounding | No 503A pathway: nomination withdrawn after FDA safety review |
| Body areas | Brain, mood & sleep |
| Through ScriptMates | Information only |
| Open questions | None noted |
What is semax?
Semax combines a short ACTH fragment with a stabilizing tail. It is registered as a medicine in Russia, where it has been studied for stroke and cognition.
FDA says it has no, or limited, safety information for the proposed routes.
Dosage forms
No FDA-approved dosage form. A standardized dosage form for human use was not confirmed from the sources below.
Is semax FDA-approved?
Not FDA-approved. Semax was nominated for the 503A bulks list and placed in Category 2 over safety concerns; the nomination was later withdrawn. FDA notes it has no, or only limited, safety information for the proposed uses.
Can it be prescribed through ScriptMates?
No 503A pathway: nomination withdrawn after FDA safety review. A partner pharmacy lists it, but it has no lawful 503A pathway today (nomination withdrawn after FDA safety review).
Sources
- FDA: Bulk substances that may present significant safety risks (Category 2 and withdrawn nominations)
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.