PT-141 (Bremelanotide)

What it is

Bremelanotide is a melanocortin-receptor agonist (acting primarily at MC4R) derived from alpha-melanocyte-stimulating hormone; the research designation PT-141 refers to the same molecule.S1

Marketed as

As an approved product it is marketed for a specific female sexual-desire disorder. Under the name PT-141, the same molecule is promoted gray-market for broad libido and sexual enhancement in both sexes — these broader uses are marketing claims and unapproved promotion, not established or approved effects.S1

Regulatory status (US)

Bremelanotide is FDA-approved as Vyleesi, with its only approved indication being acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.S1 Material sold as "PT-141" for other uses or populations is off-label or unapproved / compounded, not the approved product.S1

Around the world

The approved product addresses a narrow, specific indication; the broader "PT-141" libido market operates through gray-market and compounded channels rather than approved labeling.S1

Evidence

Approval was based on trials in its specific HSDD indication; unlike PDE5 inhibitors, it acts centrally (on melanocortin pathways) rather than on vascular smooth muscle.S1 Evidence for the broad gray-market libido claims is not the basis of the approval and should not be presented as established.S1

Anti-doping

Bremelanotide is a melanocortin agonist rather than a GH secretagogue; its specific anti-doping status should be verified against the current WADA List rather than assumed (see caveat).S2

Safety

Within its approved use, safety is governed by the Vyleesi FDA label, which notes effects such as nausea and transient blood-pressure changes.S1 Gray-market "PT-141" falls outside that regulated oversight, with the usual unapproved-peptide concerns around identity, purity, and use.S1

What's changing

No specific regulatory change is confirmed here; the standing distinction to track is the approved HSDD product versus the gray-market "PT-141" libido market.S1