Peptides›Other›Bremelanotide

Bremelanotide

/ Synthetic cyclic heptapeptide analog of alpha-MSH; non-selective melanocortin receptor agonist

TIER 1 · ClinicalN = 0 · TESTING PENDINGLAST REVIEW 2026·04·20

ALIAS · PT-141 · Vyleesi

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Research use onlyAny dose figures below describe what specific cited studies used, reported factually. Nothing on this page is guidance for human use.READ FIRST →

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§ A · Identity

Primary sequence— sequence not captured —

MW · —CLASS · Synthetic cyclic heptapeptide analog of alpha-MSH; non-selective melanocortin receptor agonistCATEGORY · Other

FDA-approved as Vyleesi (2019) for hypoactive sexual desire disorder in premenopausal women. Only approved peptide for sexual-function indication.

§ B · Mechanism of action

Bremelanotide is a synthetic cyclic heptapeptide analog of alpha-melanocyte-stimulating hormone (α-MSH), acting as a non-selective agonist at melanocortin receptors with preference for MC3 and MC4 subtypes. The mechanism for improving sexual desire is thought to involve central nervous system activation of sexual arousal pathways, distinct from vasodilator mechanisms of PDE5 inhibitors.

§ C · Human clinical evidence

Phase 3 RECONNECT program in premenopausal women with hypoactive sexual desire disorder supported FDA approval in 2019 as Vyleesi. Administered subcutaneously on an as-needed basis prior to anticipated sexual activity.

§ D · Primary literature

PubMed27285762Clayton AH et al. — Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial · Journal of Women's Health · human-phase-3-rctRandomized trial in premenopausal women with female sexual dysfunction reported improvement in Female Sexual Function Index scores at 1.25-1.75 mg bremelanotide. Supported subsequent FDA approval of bremelanotide (Vyleesi) for hypoactive sexual desire disorder in premenopausal women (2019).Limitations: Nausea was a common adverse event; practical use has been mixed since approval.2016

PubMed10602369Wessells H et al. — Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study · Journal of Urology · human-phase-2Double-blind crossover study reported Melanotan II induced erections in men with psychogenic erectile dysfunction.Limitations: Small study; historical work — later derivative bremelanotide (PT-141) was developed toward FDA approval for HSDD in women.2000

§ F · Safety signal

Most common adverse event: nausea (~40% of participants), often limiting continued use. Other: flushing, injection-site reactions, headache, focal hyperpigmentation. Transient blood pressure increases have been reported — labeling advises caution in patients with cardiovascular risk factors.

§ H · Regulatory status

Regulatory status

FDA status:: FDA-approved
Compounding:: Not eligible for compounding (approved, not in shortage)

§ I · Notable gaps and controversies

Commercial uptake post-approval has been modest. Practical use is constrained by nausea and the as-needed injection route. Historical work on the parent compound Melanotan II (Wessells 2000) provides mechanistic context but does not directly support bremelanotide dosing.