Is PT-141 legal?
Medically reviewed by Dr. Jonathan Snipes, MD
Reviewed for clinical accuracy · Last reviewed July 22, 2026 · Review policy
Quick answer
PT-141 is FDA-approved as Vyleesi for HSDD in premenopausal women and is legal with a prescription. Use for other purposes or via compounding is off-label.
- FDA status
- FDA-approved (Vyleesi) for HSDD; off-label otherwise
- Prohibited in sport (WADA)
- No
PT-141 (bremelanotide) is an FDA-approved prescription drug, marketed as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Prescribing it for men or for general libido is off-label, which is legal but outside the approved labeling. Compounded versions are a separate category. It is not a controlled substance and is not specifically listed by WADA.
Frequently asked questions
Is PT-141 legal in the US?+
PT-141 is FDA-approved as Vyleesi for HSDD in premenopausal women and is legal with a prescription. Use for other purposes or via compounding is off-label.
Do you need a prescription for PT-141?+
Yes. PT-141 is a prescription medication, dispensed by a pharmacy with a valid prescription from a licensed clinician.