Is PT-141 (Bremelanotide) FDA-Approved?

Is PT-141 FDA-approved? Yes — the compound PT-141, known generically as bremelanotide, is FDA-approved under the brand name Vyleesi, for one specific condition in one specific group of patients.

Bremelanotide (Vyleesi) is FDA-approved to treat premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It is not approved for men, for postmenopausal women, for erectile dysfunction, or as a general libido enhancer.

What Is PT-141 (Bremelanotide)?

Bremelanotide is a synthetic peptide that acts as a melanocortin receptor agonist. Rather than acting on the vascular system the way erectile-dysfunction drugs do, it works through melanocortin pathways in the central nervous system that are involved in sexual response. It is administered by subcutaneous injection using a prefilled autoinjector.

Source: FDA prescribing information for VYLEESI (bremelanotide injection), NDA 210557.

What Is It FDA-Approved For?

The FDA approved Vyleesi on June 21, 2019, for premenopausal women with acquired, generalized HSDD. The label draws clear limits: it is not indicated to treat HSDD in postmenopausal women or in men, or to enhance sexual performance.

Source: FDA approval letter and Drug Trials Snapshots: VYLEESI.

Are Research-Labeled "PT-141" and "PTP-141" Products FDA-Approved?

No. A vial labeled "PT-141" or "PTP-141" for research use is not the FDA-approved Vyleesi product. Products sold outside the regulated prescription supply chain have not been reviewed by the FDA for identity, purity, potency, sterility, or clinical effectiveness.

Source: FDA questions and answers about drug compounding; FDA warning letters regarding unapproved peptide products.