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Explore  /  PT-141 (Bremelanotide)
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PT-141 (Bremelanotide)

B
best evidence
Peptide
also called — PT-141 · bremelanotide · brand Vyleesi · a melanocortin (MC4R) agonist · the active derivative of Melanotan II (#32). Developer: Palatin Technologies. INCI: none
sexual desire / arousal (approved: female HSDD)erectile function (off-label)

Reference entry — not sold here. PT-141 is FDA-approved (as Vyleesi) — but only for a narrow indication in women; the popular men's-ED use is off-label and was abandoned in development on safety grounds. A prescription/compounded drug, not a wellness supplement. No dosing published here.

In brief

PT-141 (bremelanotide) is a central-acting melanocortin MC4R agonist and the active derivative of the tanning peptide Melanotan II. It is FDA-approved as Vyleesi for HSDD in premenopausal women — one of the very few consumer-sexual-health peptides with real FDA approval — but the effect is modest, the approval does not cover the popular men's-ED use (that program was abandoned on blood-pressure grounds), and it carries real risks (blood pressure, hyperpigmentation) that hype content omits.

Legal standing, by region
European Union
availability and approval status vary (confirm before relyin

availability and approval status vary (confirm before relying on it).

United States · your region
Approved / prescription

FDA-approved as Vyleesi (June 2019) for acquired, generalized HSDD in premenopausal women (subcutaneous, as-needed). Men's ED / general libido use is off-label — not approved. Compounded PT-141 is widely dispensed via 503A/503B wellness channels at variable quality.

Evidence, by outcome

An honest grade per outcome — drawn from the evidence, not any catalogue. Hype and undemonstrated marketing claims grade low.

OutcomeEvidence base · effectGrade
HSDD in premenopausal women (approved)
Approved + RCT-backed, but the effect is modest
Phase 3 RECONNECT; FDA-approved 2019 · Modest but significant ↑ desire / ↓ distress (FSFI effect ~0.49–0.61; NNT ~12)
B
Erectile dysfunction (men, off-label)
No completed Phase 3; the ED program was abandoned on blood-pressure grounds; not approved
Phase 2 (2007 intranasal, 60% vs 27%); precursor crossover data · Promising erectogenic effect
C
General libido / arousal (both sexes, gray market)
Not studied or approved for this
Extrapolated · Suggestive
D
Safety
Nausea (~40% first dose), flushing, headache, transient BP increase (the reason ED development stopped), focal hyperpigmentation with repeated use; caution in hypertension / CVD
Approved-drug label + trials · Characterised

Identity a synthetic cyclic heptapeptide (7 amino acids, cyclically constrained for stability), a melanocortin-receptor agonist — strongest at MC4R, with some MC1R/MC3R activity. It is a metabolite/derivative of Melanotan II, engineered to be more MC4R-selective (sexual effect) and less MC1R (tanning). ## Development & history - In the 1980s at the University of Arizona, Mac E. Hadley and Victor J. Hruby were developing α-MSH analogs as sunless-tanning agents (to induce protective melanin without UV), synthesising Melanotan-I and Melanotan II.

  • The discovery: while self-experimenting with Melanotan II, one of the scientists accidentally injected roughly twice the intended dose and experienced an ~eight-hour erection, along with nausea and vomiting. That unexpected central effect (later documented in a 1996 pilot trial and a 1998 placebo-controlled crossover study, Wessells et al., J Urology — erections in 8 of 10 men) redirected an entire research line from tanning toward sexual function. Hadley published it as "Discovery that a melanocortin regulates sexual functions in male and female humans" (Peptides, 2005).
  • Palatin Technologies developed bremelanotide (PT-141) from Melanotan II for sexual dysfunction. An intranasal formulation was trialed for erectile dysfunction (Phase 2b; 2007 BJU Int: ~60% of men with mild-moderate ED responded vs 27% placebo) — but the ED program was abandoned because of blood-pressure increases (and PDE5-inhibitor competition).
  • Palatin pivoted to a subcutaneous formulation for HSDD in premenopausal women (no approved drug existed then bar flibanserin). Two Phase 3 RECONNECT trials led to FDA approval of Vyleesi in June 2019 — one of only two FDA-approved drugs for female sexual dysfunction. ## Mechanism (as proposed) a central melanocortin agonist — activates MC4R (and MC3R) in the hypothalamus (paraventricular nucleus, medial preoptic area), driving sexual desire and arousal through dopaminergic and oxytocin pathways and autonomic output to the pelvis. This is fundamentally different from PDE5 inhibitors (sildenafil), which act peripherally on blood flow — PT-141 is better described as a desire enhancer than a blood-flow one, and its effect does not depend on hormone levels or direct stimulation.
Sources — 4 cited
01Hadley ME. Discovery that a melanocortin regulates sexual functions in male and female humans. Peptides. 2005.
02Wessells H, et al. (Melanotan-II / bremelanotide erectile-response crossover trials.) J Urol, 1998; BJU Int, 2007 (intranasal Phase 2).
03Kingsberg SA, et al. (RECONNECT Phase 3 trials of bremelanotide for HSDD.) 2019.
04FDA prescribing information — Vyleesi (bremelanotide), Palatin/AMAG.
Review status
Not yet reviewed

A credentialed reviewer (PharmD / PhD / MD) will be named before this entry is finalised. Until then, treat it as a working draft. Last updated July 2026.

Grades reflect the published evidence, not our interest. No dosing, reconstitution, or administration is published for research compounds — that restraint is deliberate.

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PT-141 (bremelanotide / Vyleesi) — evidence, the discovery story & status · Vallydia