FDA-approved product exists

Bremelanotide

Also known as: PT-141

FDA-approved

Bremelanotide has FDA-approved prescription products (VYLEESI (AUTOINJECTOR) (NDA210557)). Bremelanotide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 10 registered ClinicalTrials.gov studies cite Bremelanotide (9 completed, 1 active not recruiting); registration is not evidence of approval, efficacy, or safety. CompoundedGuide is verifying compounding status, safety signals, and current evidence. This is not medical advice.

What we've verified

Product status: FDA-approved: VYLEESI (AUTOINJECTOR) (NDA210557)
Still checking: Compounding status, shortage status, safety signals

Verified sources

openFDA Drugs@FDA P0 · retrieved 2026-07-25
503B Bulks List and Interim Categories P0 · retrieved 2026-07-25
ClinicalTrials.gov API v2 P0 · retrieved 2026-07-25

Research and evidence

FDA-approved product exists cite Bremelanotide. Registration is not evidence of approval, efficacy, or safety.

Browse every trial and publication for Bremelanotide →

For developers

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