Peer-Reviewed Research
PT-141, also known as bremelanotide, is a synthetic cyclic peptide and melanocortin receptor agonist. Unlike many investigational peptides, bremelanotide has undergone extensive human clinical development and is FDA-approved (as Vyleesi®) for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Published research has evaluated its pharmacokinetics, mechanism of action, efficacy, safety, and tolerability in both women and men.
Original Human Clinical Research
Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction
Journal: International Journal of Impotence Research
Published: 2004
Study Type: Phase I clinical trial
Summary
This early clinical trial evaluated intranasal PT-141 in healthy men and men with mild-to-moderate erectile dysfunction. Researchers reported statistically significant erectile responses at doses above 7 mg, with onset occurring approximately 30 minutes after administration. PT-141 was generally well tolerated, with flushing and nausea reported as the most common adverse events.
View on PubMed:
https://pubmed.ncbi.nlm.nih.gov/14963471/
Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra
Journal: International Journal of Impotence Research
Published: 2004
Study Type: Phase I clinical trial
Summary
Researchers evaluated subcutaneous PT-141 in healthy men and in men who reported inadequate responses to sildenafil. PT-141 produced statistically significant erectile responses at doses greater than 1 mg and demonstrated an acceptable pharmacokinetic and tolerability profile under the study conditions.
View on PubMed:
https://pubmed.ncbi.nlm.nih.gov/14999221/
An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist
Journal: Journal of Sexual Medicine
Published: 2006
Study Type: Randomized, double-blind, placebo-controlled crossover trial
Summary
This clinical study evaluated intranasal bremelanotide in premenopausal women with female sexual arousal disorder. Compared with placebo, participants reported greater sexual desire, improved subjective genital arousal, and higher satisfaction among those who engaged in sexual activity following treatment.
View on PubMed:
https://pubmed.ncbi.nlm.nih.gov/16839319/
Phase 3 Clinical Development
Safety Profile of Bremelanotide Across the Clinical Development Program
Journal: Journal of Women's Health
Published: 2022
Study Type: Integrated Phase 1–3 clinical safety analysis
Summary
This publication analyzed safety data from approximately 3,500 participants enrolled in 43 completed clinical studies, including the Phase 3 RECONNECT trials. The most frequently reported adverse events included nausea, flushing, headache, and injection-site reactions. The authors concluded that most adverse events were mild to moderate while recommending appropriate cardiovascular precautions.
View on PubMed:
https://pubmed.ncbi.nlm.nih.gov/35147466/
Recent Review Articles
An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder
Journal: Expert Opinion on Pharmacotherapy
Published: 2023
Study Type: Scientific review
Summary
This review summarizes the clinical evidence supporting bremelanotide for hypoactive sexual desire disorder. The authors discuss its melanocortin receptor mechanism, efficacy demonstrated in Phase 3 clinical trials, safety profile, and role as an on-demand treatment option for premenopausal women with HSDD.
View on PubMed:
https://pubmed.ncbi.nlm.nih.gov/36242769/
Clinical trial evidence on emerging pharmacological therapies for hypoactive sexual desire disorder in women: a systematic review and analysis of completed studies registered on ClinicalTrials.gov
Published: 2026
Study Type: Systematic review
Summary
This systematic review examined completed clinical trials investigating treatments for hypoactive sexual desire disorder, including Phase 2 and Phase 3 bremelanotide studies. The review summarizes study designs, participant populations, primary endpoints, and the overall evidence supporting bremelanotide's clinical development.
Read Full Text:
https://pmc.ncbi.nlm.nih.gov/articles/PMC13237691/
Melanocortins in the treatment of male and female sexual dysfunction
Journal: International Journal of Impotence Research
Published: 2007 (Landmark Review)
Summary
This landmark review discusses the development of melanocortin receptor agonists, including PT-141 (bremelanotide), and summarizes early human and preclinical research in male and female sexual dysfunction. It also reviews proposed central nervous system mechanisms underlying melanocortin-mediated sexual responses.
View on PubMed:
https://pubmed.ncbi.nlm.nih.gov/17584134/
Additional PT-141 Publications
Browse current PubMed research:
https://pubmed.ncbi.nlm.nih.gov/?term=bremelanotide+OR+PT-141
Research Disclaimer
The information presented in this Research Library is provided for educational and scientific reference purposes only and is based on published peer-reviewed research. Research findings continue to evolve, and investigational compounds may not be approved for clinical use. All Pearland Peptides products are supplied For Research Use Only and are not intended for human consumption, diagnosis, treatment, cure, or prevention of any disease.