Peptide Graded

Semax

Is Semax legal in the US?

No approved product. Since October 2026 a licensed pharmacy may compound the nasal spray under an HHS policy, but it is still unapproved. It is a prescription drug in Russia.

BSome human evidenceNot approvedas of 2026-10-29

Semax is not approved by the FDA for any use and is sold in the United States as a research chemical. It is registered as a prescription drug in Russia. In July 2026 the FDA's Pharmacy Compounding Advisory Committee voted to recommend adding semax to the list of substances pharmacies may compound, against the advice of FDA staff. On 28 October 2026 HHS issued an enforcement discretion policy covering semax as a nasal product only, compounded by licensed pharmacies and physicians for named patients under sourcing, testing, labeling and reporting conditions. That is not an approval. 25131415

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Citations

  1. Neuropeptides 2020: review of semax pharmacology and clinical studies doi.org
  2. STAT, July 2026: FDA peptide compounding panel outcomes statnews.com
  3. Drug Test Anal 2019: analytical and pharmacological review of semax and selank doi.org
  4. Cell Mol Neurobiol 2009: semax and BDNF and NGF expression in rat hippocampus doi.org
  5. FDA: Pharmacy Compounding Advisory Committee materials on semax, 2026 fda.gov
  6. Zh Nevrol Psikhiatr 2018: semax and rehabilitation timing after ischemic stroke pubmed.ncbi.nlm.nih.gov
  7. Zh Nevrol Psikhiatr 2005: semax in chronic cerebrovascular insufficiency pubmed.ncbi.nlm.nih.gov
  8. Vestn Oftalmol 2000: semax in optic nerve disease pubmed.ncbi.nlm.nih.gov
  9. Neurochem Res 2005: semax effects on serotonin and dopamine in rat striatum doi.org
  10. Lebedeva 2018, Bull Exp Biol Med: effects of semax on the default mode network pubmed.ncbi.nlm.nih.gov
  11. Gusev 1997, Zh Nevrol Psikhiatr: semax in acute hemispheric ischemic stroke pubmed.ncbi.nlm.nih.gov
  12. FDA: interim 503A bulk drug substances category list fda.gov
  13. Healio, July 2026: FDA committee recommends looser restrictions for several peptides healio.com
  14. HHS 2026: Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances, with appendices A and B hhs.gov
  15. Federal Register 2026: notice of availability of the HHS peptide enforcement discretion policy, document 2026-22192, docket HHS-OASH-2026-0496 federalregister.gov
  16. Associated Press via CNN, 28 October 2026: FDA scientists opposed the move to ease peptide access edition.cnn.com

Reference information only, not medical advice. Drawn from the Semax article, fact-checked against the cited sources. No dosing anywhere on this site.