PT-141 (Bremelanotide)

Bremelanotide (PT-141) is approved by the FDA as Vyleesi, an autoinjector, for acquired, generalized hypoactive sexual desire disorder in premenopausal women (2019). Use outside that indication is off-label.

Compounded bremelanotide is prepared in dosage forms that differ from the approved product — intranasal and sublingual routes, and in combination preparations. A compounded preparation is dispensed only where the prescriber determines it is clinically appropriate for an identified individual patient and records that determination on the prescription.

PT-141 is not sold for research use and is not available for direct purchase. It is dispensed only following a clinical consultation, pursuant to a patient-specific prescription, and filled by a licensed 503A compounding pharmacy. A compounded preparation is not an FDA-approved product.