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Is SS-31 Legal? FDA, Compounding and WADA Status

SS-31'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 · · DisclosureMitochondria-targeting peptideUpdated
FDA status
accelerated approval for Barth syndrome (Sep 2025)
PCAC vote
Not reviewed
not on the Jul 2026 PCAC agenda
WADA
Not listed
2026 Prohibited List
Not legal adviceStatus reflects public FDA and WADA records on the date shown. Rules differ by country and state.

Current status

FDA accelerated approval for Barth syndrome (Sep 2025)

SS-31 is FDA accelerated approval for Barth syndrome (Sep 2025). Products sold as research chemicals are not the approved drug and are not checked by the FDA.

SS-31: regulatory status by country
CountryStatusSource
United StatesApprovedApproved by FDA as Forzinity (elamipretide), Stealth BioTherapeutics, original approval 19 Sept 2025, under accelerated approval to improve muscle strength in Barth syndrome (label quote).api.fda.govchecked 2 Oct 2026

Timeline

  1. FDA warning letters to five research-peptide sellersEnforcement
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.

Sport and drug testing

Not on the WADA Prohibited List

SS-31 (elamipretide) is not named on the list. It received FDA accelerated approval in 2025, so the S0 catch-all does not apply to it.

Outside the US

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

SS-31: regulatory status by country
CountryStatusSource
United KingdomNo approved product foundNo approved product found in an emc (UK SmPC compendium) search for "elamipretide (SS-31)" 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 "elamipretide (SS-31)" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
AustraliaNo approved product foundNo approved product found in an ARTG search for "elamipretide (SS-31)" on 2 Oct 2026.tga.gov.auchecked 2 Oct 2026
European UnionNo centrally authorised EU medicine foundEMA medicines list, searched 2 Oct 2026ema.europa.euchecked 2 Oct 2026

Common questions

Is SS-31 FDA approved?

SS-31 is FDA accelerated approval for Barth syndrome (Sep 2025). Products sold as research chemicals are not the approved drug and are not checked by the FDA.

Is SS-31 legal to buy?

As an approved drug it requires a prescription in the US. Products sold online as research chemicals "not for human use" are not the approved drug.

Is SS-31 banned by WADA?

No. SS-31 (elamipretide) is not named on the list. It received FDA accelerated approval in 2025, so the S0 catch-all does not apply to it.

More on SS-31

DosageDoses used in published studies, with the source for each.CalculatorVial, water and dose to syringe units.Side effectsWhat labels and studies report, and what is unknown.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.50 mg vialConcentration and unit tables for the 50 mg size.

Sources

  1. 1World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  2. 2United States: Approved by FDA as Forzinity (elamipretide), Stealth BioTherapeutics, original approval 19 Sept 2025, under accelerated approval to improve muscle strength in Barth syndrome (label quote).U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  3. 3United Kingdom: No approved product found in an emc (UK SmPC compendium) search for "elamipretide (SS-31)" on 2 Oct 2026.Electronic Medicines Compendium (UK) · 2026medicines.org.ukAccessed 2 Oct 2026
  4. 4Canada: No product found in a Health Canada Drug Product Database search for ingredient "elamipretide (SS-31)" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  5. 5Australia: No approved product found in an ARTG search for "elamipretide (SS-31)" on 2 Oct 2026.Therapeutic Goods Administration (Australia) · 2026tga.gov.auAccessed 2 Oct 2026
  6. 6EMA medicines export (centrally authorised medicines) (searched 2 Oct 2026)European Medicines Agency · 2026ema.europa.euAccessed 2 Oct 2026
  7. 7FDA warning letters to five research-peptide sellersFDA warning letter (NuScience Peptides; 1 of 5) · 2026fda.govAccessed 2 Oct 2026

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