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Is Semax Legal? FDA, Compounding and WADA Status

Semax's FDA status, compounding rules and anti-doping status, with a dated timeline of every change we track.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureACTH(4-10) analogUpdated
FDA status
Not approved
Off Category 2, 15 Apr 2026
PCAC vote
8–5 for 503A
Jul 2026, not final
WADA
Unclear
Not named on the 2026 list
Not legal adviceStatus reflects public FDA and WADA records on the date shown. Rules differ by country and state.

Current status

PCAC voted 8–5 for 503A (Jul 2026)

No. Semax is not FDA approved for any use. The FDA removed it from Category 2 on 15 Apr 2026. Its advisory committee voted 8–5 in July 2026 to add it to the 503A compounding list. That vote is not final.

Semax: regulatory status by country
CountryStatusSource
United StatesNo approved product foundNo FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "semax" returned no matches on 2 Oct 2026.api.fda.govchecked 2 Oct 2026

Timeline

  1. Advisory committee backs 6 of 7 peptides for the 503A listPCAC vote
  2. FDA gives notice that 12 peptides will be removed from Category 2 (nominations withdrawn)FDA
Every peptide on the FDA tracker

Compounding and research-use sellers

  • Category 2 is the FDA's list of bulk substances it flagged as raising significant safety concerns. Compounding pharmacies are not expected to compound from them while they are on it.
  • The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA on which substances belong on the 503A bulks list that pharmacies may compound from. Its votes are advice; the FDA decides.
  • "Research use only" products are sold outside these rules and are not checked by the FDA for identity, purity or dose.
  • Semax was removed from Category 2 on 15 Apr 2026. Removal is not approval.

FDA compounding record: Semax was removed from FDA's 503A category 2 after the nominators withdrew; FDA announced a PCAC consultation on 24 July 2026. · fda.gov, checked 2 Oct 2026

Sport and drug testing

WADA status unclear

Semax: This is not named on the 2026 list. The catch-all class S0 prohibits any drug with no approval anywhere for human use, so it would be banned if no health authority has approved it, but we have not verified that for this substance.

Outside the US

Rules differ by country. What each regulator's own records show, with the date we checked:

Semax: regulatory status by country
CountryStatusSource
United KingdomNo approved product foundNo approved product found in an emc (UK SmPC compendium) search for "semax" on 2 Oct 2026.medicines.org.ukchecked 2 Oct 2026
CanadaNo approved product foundNo product found in a Health Canada Drug Product Database search for ingredient "semax" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
European UnionNo centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026ema.europa.euchecked 2 Oct 2026

Common questions

Is Semax FDA approved?

No. Semax is not FDA approved for any use. The FDA removed it from Category 2 on 15 Apr 2026. Its advisory committee voted 8–5 in July 2026 to add it to the 503A compounding list. That vote is not final.

Is Semax legal to buy?

It is not an approved drug. Online sellers label it "for research use only, not for human use"; the FDA sent warning letters to five such sellers on 24 Aug 2026. Whether a pharmacy may compound it depends on its FDA bulk-substance status. Rules differ by country.

Is Semax banned by WADA?

It is unclear. Semax: This is not named on the 2026 list. The catch-all class S0 prohibits any drug with no approval anywhere for human use, so it would be banned if no health authority has approved it, but we have not verified that for this substance.

More on Semax

DosageDoses used in published studies, with the source for each.CalculatorVial, water and dose to syringe units.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.Half-lifeWhat is measured, by route, and what is not.StoragePowder and mixed vials: temperature and shelf life.

Sources

  1. 1Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2; 'nominated but withdrawn' table, content current as of 22 Apr 2026)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  2. 2Pharmacy Compounding Advisory Committee meeting, 23–24 Jul 2026 (agenda and materials)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  3. 3World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  4. 4United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "semax" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  5. 5US compounding: Semax was removed from FDA's 503A category 2 after the nominators withdrew; FDA announced a PCAC consultation on 24 July 2026.U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  6. 6United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "semax" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
  7. 7Canada: No product found in a Health Canada Drug Product Database search for ingredient "semax" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  8. 8EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
  9. 9Advisory committee backs 6 of 7 peptides for the 503A listNCPA · 2026ncpa.org
  10. 10FDA gives notice that 12 peptides will be removed from Category 2 (nominations withdrawn)FDA · 2026fda.govAccessed 2 Oct 2026

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