● TIER 1 — FDA-approved / recognizedGRADE ASexual health
Bremelanotide (PT-141)
MC4R agonist. Research verification: Yes (TGA pending). 2 human study record(s) in the FitClinicMD studies database.
GOALS · Sexual function
FDA status
Approved: Vyleesi (acquired HSDD, premenopausal women).
Compounding (503A/503B)
Approved product.
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
MC4R agonist.
Human evidence · 2
RECONNECT: two phase 3 RCTs, n≈1,267 women. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.
Men with ED, sildenafil failures: phase 2. Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.
Reference only. This page summarizes publicly available regulatory and research information about Bremelanotide (PT-141). It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.