PT-141: Regulatory Status
Current legal and regulatory status for PT-141 across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to PT-141 overviewUnited States
FDA Approved
Prescription required
Recent Regulatory Action
AMAG Pharmaceuticals acquired by Covis Pharma (2020); Vyleesi distribution continues.
FDA-approved as Vyleesi (bremelanotide, 2019) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Self-administered subcutaneous injection. Not for daily use — maximum 8 doses per month.
What This Means
Reclassification is not the same as FDA approval.
Even if PT-141 moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.