Melanocortin receptor agonist; synthetic cyclic analog of alpha-melanocyte-stimulating hormone (alpha-MSH)
PT-141 (Bremelanotide)
Approvedaka Bremelanotide, Vyleesi, PT-141
Bremelanotide is a synthetic cyclic analog of alpha-MSH that non-selectively activates melanocortin receptors. FDA approval rested on the two phase-3 RECONNECT randomized, double-blind, placebo-controlled trials; commonly reported adverse effects include nausea, flushing, injection-site reactions and headache, and it can cause transient increases in blood pressure.
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Mechanism
Bremelanotide is a non-selective agonist of melanocortin receptors (MC1R-MC5R, with the exception of MC2R), acting principally at MC4R (and MC3R) within the central nervous system. Per the FDA prescribing information, the precise mechanism by which it improves sexual desire and reduces distress in HSDD is unknown.
Regulatory Status by Region
- United States (FDA)Approved June 21, 2019 as Vyleesi (bremelanotide) for acquired, generalized HSDD in premenopausal women; prescription medicine.
- Australia (TGA)Not registered on the ARTG; no approved bremelanotide/Vyleesi product in Australia. Compounded or imported PT-141 is unapproved.
- European Union (EMA)No EMA marketing authorisation; not an approved medicine in the EU (European commercialisation rights licensed to Gedeon Richter were terminated in 2016 and no EU approval followed).
- WADANot specifically named on the WADA Prohibited List. As an approved medicine it is not captured by the S0 non-approved-substances clause, and it does not fall within a listed prohibited class; athletes should nonetheless verify current status.
Key Studies
- Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (RECONNECT) (opens in a new tab) (Kingsberg SA, et al. Obstet Gynecol. 2019 Nov;134(5):899-908. PMID: 31599840.)
- VYLEESI (bremelanotide injection) US Prescribing Information (FDA label) (opens in a new tab) (FDA, 2019, application 210557.)
- Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide (opens in a new tab) (J Womens Health / related, PMID: 35230162.)
Related Clinical Trials
- Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast MilkPhase 4 · Completed
- A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of ObesityPhase 2 · Active Not Recruiting
- A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney DiseasePhase 2 · Completed
- A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)Phase 3 · Completed
- Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire DisorderPhase 4 · Completed
- Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With ZofranPhase 1 · Completed
- 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire DisorderPhase 3 · Completed
- 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire DisorderPhase 3 · Completed
Latest research
- Comprehensive characterization of bremelanotide acetate and its degradants by LC-HRMS/MS and predicting epimerization through computational modelling. (opens in a new tab)
Analytical methods : advancing methods and applications · Aug 20, 2026
- Goldilocks-Inspired Design of Mid-Size Macrocycles for Selective Targeting of Human Melanocortin Receptors. (opens in a new tab)
Journal of medicinal chemistry · Aug 13, 2026
Common Questions
- What is PT-141 (Bremelanotide)?
- PT-141 (bremelanotide) is a melanocortin-receptor agonist approved by the US FDA in June 2019 under the brand name Vyleesi for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is administered as a single-use subcutaneous autoinjector before anticipated sexual activity, and it is not approved by the EMA or Australia's TGA.
- Is PT-141 (Bremelanotide) approved for medical use?
- PT-141 (Bremelanotide) is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved June 21, 2019 as Vyleesi (bremelanotide) for acquired, generalized HSDD in premenopausal women; prescription medicine. European Union (EMA): No EMA marketing authorisation; not an approved medicine in the EU (European commercialisation rights licensed to Gedeon Richter were terminated in 2016 and no EU approval followed). Australia (TGA): Not registered on the ARTG; no approved bremelanotide/Vyleesi product in Australia. Compounded or imported PT-141 is unapproved.
- How does PT-141 (Bremelanotide) work?
- Bremelanotide is a non-selective agonist of melanocortin receptors (MC1R-MC5R, with the exception of MC2R), acting principally at MC4R (and MC3R) within the central nervous system. Per the FDA prescribing information, the precise mechanism by which it improves sexual desire and reduces distress in HSDD is unknown.
- Is PT-141 (Bremelanotide) legal in Australia?
- PT-141 (Bremelanotide) in Australia (TGA): Not registered on the ARTG; no approved bremelanotide/Vyleesi product in Australia. Compounded or imported PT-141 is unapproved.
- Is PT-141 (Bremelanotide) banned in sport?
- PT-141 (Bremelanotide) under the World Anti-Doping Agency (WADA) code: Not specifically named on the WADA Prohibited List. As an approved medicine it is not captured by the S0 non-approved-substances clause, and it does not fall within a listed prohibited class; athletes should nonetheless verify current status.