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PT-141 (bremelanotide) regulatory status

Current status of PT-141 (bremelanotide) in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of PT-141 (bremelanotide)?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 22, 2026
FDA and compounding
FDA approved as Vyleesi (bremelanotide injection) on June 21, 2019, for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Because bremelanotide is the active ingredient of an approved drug, some 503A pharmacies compound it under the approved drug component pathway, but compounded PT-141 vials and nasal sprays are not FDA approved formulations, have not been tested for potency or sterility by FDA, and the nasal route was abandoned by the sponsor over blood pressure effects. Use in men is off-label.
WADA
Not WADA prohibited
Access path
  1. Prescription from a licensed provider filled at a retail or specialty pharmacy as Vyleesi.
  2. Prescription filled by a 503A compounding pharmacy as compounded bremelanotide (not an FDA approved formulation).
  3. Telehealth clinics that prescribe compounded PT-141 for men or women off-label.

Full PT-141 (bremelanotide) page: evidence, dosing in the literature, and sources

How has the status of PT-141 (bremelanotide) changed over time?

  1. FDA

    FDA approves Vyleesi (bremelanotide) for hypoactive sexual desire disorder

    FDA approved bremelanotide injection (Vyleesi), a melanocortin receptor agonist, for premenopausal women with acquired, generalized hypoactive sexual desire disorder.

    Regulatory: FDA approvedSource: Drugs@FDA: Vyleesi (bremelanotide) NDA 210557

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for PT-141 (bremelanotide) and the source of each dated event.

  1. [1]FDA prescribing information for Vyleesi (bremelanotide injection), via DailyMedFDA, 2025
  2. [2]FDA: Compounding and the FDA, questions and answersFDA, 2026
  3. [3]FDA: Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2 list and withdrawn nominations, current as of April 22, 2026)FDA, 2026
  4. [4]WADA Prohibited ListWADA, 2026
  5. [5]Drugs@FDA: Vyleesi (bremelanotide) NDA 210557FDA, 2019