PT-141 (Bremelanotide)
Bremelanotide acetate (Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
An FDA-approved on-demand injection (Vyleesi) for premenopausal women experiencing persistently low sexual desire that causes distress. Unlike previous sexual dysfunction medications that work on blood flow, it works in the brain to directly activate the pathways that regulate sexual motivation and arousal.
Safety Summary
Nausea is the primary dose-limiting adverse event (~40%) and the main reason for discontinuation (~8%). The incidence and severity of nausea tend to decrease with subsequent doses. Hemodynamic effects (transient BP increase, HR decrease) are the basis for contraindication in uncontrolled hypertension and cardiovascular disease. Focal hyperpigmentation risk is strongly dose-frequency dependent: rare with labeled intermittent use (-8 doses/month) but substantial with daily dosing (~38% in research settings). May persist after discontinuation and may be irreversible, particularly in darker skin. No evidence of tolerance or tachyphylaxis over 52 weeks of intermittent use in the clinical program. No withdrawal syndrome documented. No cancer signal in clinical program (~3,500 subjects) or FAERS data through mid-2025. No clinically significant anti-drug antibody formation. Transient ACTH/cortisol increases observed but not clinically significant at approved doses.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-5]