Bremelanotide

Overview

Bremelanotide is a melanocortin receptor agonist peptide studied in sexual-desire disorders. The relevant clinical populations, outcome measures, and treatment settings must be distinguished from other melanocortin compounds.

Evidence quality

WPF’s atlas lists clinical-trial reviews of pharmacological options for hypoactive sexual desire disorder, as well as prescribing-pattern and formulation studies. A review or utilization trend does not by itself establish an individual treatment effect or extend findings to unstudied populations.

Safety concerns

The Directory has no published source-linked citations or jurisdiction-specific regulatory record here. Trial endpoints, enrolled populations, contraindications, and adverse events require appraisal of primary and official records before a clinical or regulatory claim is made.

Citations as of this version

• Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder. (2025)
• Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. (2024)
• Melanocortin Receptor Agonist Bremelanotide Induces Cell Death and Growth Inhibition in Glioblastoma Cells <i>via</i> Suppression of Survivin Expression. (2024)
• An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder. (2023)
• Safety Profile of Bremelanotide Across the Clinical Development Program. (2022)
• Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. (2022)
• Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. (2022)
• The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women. (2022)
• Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent. (2021)
• LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of performance and image enhancing drugs. (2021)
• Failure of a Meta-analysis: A Commentary on Glen Spielmans's "Re-Analyzing Phase III Bremelanotide Trials for 'Hypoactive Sexual Desire Disorder in Women'". (2021)
• The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. (2021)
• Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. (2021)
• Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder. (2020)
• Ultra-sensitive quantification of the therapeutic cyclic peptide bremelanotide utilizing UHPLC-MS/MS for evaluation of its oral plasma pharmacokinetics. (2020)
• Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. (2019)
• Bremelanotide (Vyleesi) for hypoactive sexual desire disorder. (2019)
• Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. (2019)
• Bremelanotide: First Approval. (2019)
• Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. (2019)
• Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. (2017)
• Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. (2017)
• Re: Bremelanotide for Female Sexual Dysfunctions in Premenopausal Women: A Randomized, Placebo-Controlled Dose-Finding Trial. (2016)
• Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. (2016)
• Bremelanotide. (2012)
• Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study. (2008)
• Bremelanotide: an overview of preclinical CNS effects on female sexual function. (2007)
• An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist. (2006)
• Bremelanotide. (2006)
• PT-141 Palatin. (2004)

Regulatory status as of this version

• United States — FDA: approved — VYLEESI (bremelanotide) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty, and not due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or drug substance. Not indicated for HSDD in postmenopausal women or in men.
• European Union — EMA: not_approved