Short answer: PT-141 (bremelanotide) differs from Melanotan II only at its tail end: a free acid instead of an amide.12 Bremelanotide is FDA approved as Vyleesi, a 1.75 mg as-needed injection for premenopausal women with low sexual desire; the label says it is not for men.1 Melanotan II has never been approved, and FDA notes reports of melanoma and other serious events.3
| PT-141 (bremelanotide, Vyleesi) | Melanotan II | |
|---|---|---|
| Structure | Ac-Nle-cyclo(Asp-His-D-Phe-Arg-Trp-Lys)-OH: free acid at the end1 | The same ring of amino acids with an amide (-NH2) at the end2 |
| FDA status | Approved as Vyleesi (initial approval 2019)1 | Never approved; nominated for compounding, then withdrawn3 |
| Approved use | Premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD); not for men, postmenopausal women or to enhance performance1 | None |
| Label or study dosing | 1.75 mg under the skin at least 45 minutes before sexual activity; no more than 1 dose in 24 hours; more than 8 a month not recommended1 | 0.025 mg/kg under the skin in two small erectile dysfunction studies45 |
| Half-life | About 2.7 hours (range 1.9 to 4.0); peak at about 1 hour1 | No published human figure in the sources we checked |
| Nausea | 40% vs 1.3% on placebo in phase 31 | Common; 4 of 19 injections caused severe nausea in one study5 |
| Skin darkening | Focal hyperpigmentation in 1% with up to 8 doses a month; 38% after 8 daily doses in another study1 | Tanning was its original purpose2 |
| Blood pressure | Up to 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after a dose1 | Not reported in the abstracts cited here |
Very close. Melanotan II is a ring-shaped peptide written Ac-Nle-Asp-His-D-Phe-Arg-Trp-Lys-NH2.2 The Vyleesi label describes bremelanotide as the same ring with a free acid at the end instead of the amide.1 Melanotan II was first studied for tanning, and its early trials found erections as a side effect; bremelanotide was developed for sexual function.24
Two 24-week phase 3 trials (RECONNECT) enrolled 1,267 premenopausal women with HSDD. Bremelanotide raised desire scores and lowered related distress more than placebo, and nausea, flushing and headache each affected 10% or more.6 In the pooled label data, nausea was 40% vs 1.3%, flushing 20.3% vs 0.3% and headache 11.3% vs 1.9%.1
The label does not allow use with uncontrolled high blood pressure or known heart disease, and says Vyleesi can sharply lower blood levels of naltrexone taken by mouth.1
Human data are small and old: a 3-man pilot study and two crossover studies of 10 men each with erectile dysfunction.245 FDA notes published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism.3 No study has compared the two directly. These are study protocols, not personalized advice; confirm any dosing with your prescriber.
More detail: Vyleesi side effects, the Vyleesi dosing schedule, and the PT-141 (Bremelanotide) and Melanotan II guides.