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Is PT-141 Legal? FDA, Compounding and WADA Status

PT-141'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 · · DisclosureMelanocortin agonistUpdated
FDA status
Approved for HSDD (Vyleesi)
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 approved for HSDD (Vyleesi)

PT-141 is FDA approved for HSDD (Vyleesi). Products sold as research chemicals are not the approved drug and are not checked by the FDA.

PT-141: regulatory status by country
CountryStatusSource
United StatesApprovedApproved by FDA as Vyleesi (bremelanotide), Cosette, original approval 21 June 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder (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

PT-141 (bremelanotide) is not named on the list and is FDA-approved (Vyleesi), so S0 does not apply. It does not fit the named S2 subclasses.

Outside the US

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

PT-141: regulatory status by country
CountryStatusSource
United KingdomNo approved product foundNo approved product found in an emc (UK SmPC compendium) search for "bremelanotide (PT-141)" 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 "bremelanotide (PT-141)" on 2 Oct 2026.health-products.canada.cachecked 2 Oct 2026
AustraliaNo approved product foundNo approved product found in an ARTG search for "bremelanotide (PT-141)" 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 PT-141 FDA approved?

PT-141 is FDA approved for HSDD (Vyleesi). Products sold as research chemicals are not the approved drug and are not checked by the FDA.

Is PT-141 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 PT-141 banned by WADA?

No. PT-141 (bremelanotide) is not named on the list and is FDA-approved (Vyleesi), so S0 does not apply. It does not fit the named S2 subclasses.

More on PT-141

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.How to injectSites, syringe types and hygiene, step by step.

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 Vyleesi (bremelanotide), Cosette, original approval 21 June 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder (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 "bremelanotide (PT-141)" 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 "bremelanotide (PT-141)" on 2 Oct 2026.Health Canada · 2026health-products.canada.caAccessed 2 Oct 2026
  5. 5Australia: No approved product found in an ARTG search for "bremelanotide (PT-141)" 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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