What is Semax?
The short answer
Semax is a lab-made peptide based on part of a hormone, made as a nose spray.
What it is
Lab-made peptide based on a short piece of the hormone ACTH, studied in nerve-cell research.
What people look into
Brain
- 7 sources
- Status as of
- How we source
- Ellum doesn't sell peptides.
Get updates on Semax
What it is
- Type
- ACTH(4-7) analog heptapeptide
- Also known as
- semax peptide, semax heptapeptide
- How it works
- Lab-made peptide based on a short piece of the hormone ACTH, studied in nerve-cell research.
Regulatory status
Not FDA-approved · advisory vote July 2026 · no FDA decision How we label status
As of October 4, 2026, Semax is not FDA-approved. On July 24, 2026, FDA's compounding advisory committee voted to recommend adding it to the 503A bulks list; FDA staff had recommended against it. FDA has not proposed that change.
- Federal (FDA)
- Not FDA-approved
- 503A compounding
- No category since 2026-04-22 (nomination withdrawn); PCAC recommended 2026-07-23/24; no proposed rule as of 2026-10-04 (as of October 4, 2026)
- PCAC history
- 2026-07-24: recommended 8-5-1 (free base and acetate; uses reviewed: cerebral ischemia, migraine, trigeminal neuralgia; count as read into FDA's meeting recording; written minutes not posted as of 2026-10-04); FDA staff: against
Timeline
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Timeline table
| Date | What happened | Source |
|---|---|---|
| FDA warning letter to a compounding pharmacy states that Semax was not nominated for inclusion on the 503A bulks list. | FDA, event of November 10, 2021, on fda.gov | |
| Federal Register notice of an FDA Pharmacy Compounding Advisory Committee meeting lists Semax among bulk drug substances under consideration for the 503A bulks list. | Federal Register, event of April 16, 2026, on federalregister.gov | |
| FDA presentations for the Pharmacy Compounding Advisory Committee meeting cover Semax as a bulk drug substance under consideration for the 503A bulks list. | FDA, event of July 24, 2026, on fda.gov |
References
Sources as of October 4, 2026
- FDA: www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- FDA: www.fda.gov/media/193348/download
- FDA: www.fda.gov/media/193342/download
- Federal Register: www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request
- FDA: www.fda.gov/media/94155/download
- FDA: www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- YouTube: youtube.com/live/xXM5ecHxlMU