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

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.

See Semax in the Index →

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No category since 2026-04-22 (nomination withdrawn); PCAC recommended 2026-07-23/24; no proposed rule as of 2026-10-04 (as of October 4, 2026)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
DateWhat happenedSource
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

  1. FDA: www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
  2. FDA: www.fda.gov/media/193348/download
  3. FDA: www.fda.gov/media/193342/download
  4. Federal Register: www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request
  5. FDA: www.fda.gov/media/94155/download
  6. FDA: www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  7. YouTube: youtube.com/live/xXM5ecHxlMU