Bremelanotide (Vyleesi)
AMAG Pharmaceuticals / Palatin Technologies
Bremelanotide (PT-141 / Vyleesi®) is a cyclic heptapeptide analog of α-melanocyte-stimulating hormone (α-MSH) that activates melanocortin receptors, primarily MC4R and MC3R in the central nervous system. Unlike phosphodiesterase inhibitors (sildenafil, tadalafil) that act peripherally on blood flow, bremelanotide works centrally through hypothalamic pathways involved in sexual arousal and desire. The FDA approved Vyleesi in June 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women based on two pivotal phase III trials (RECONNECT) showing statistically significant increases in desire and decreases in distress. It is administered as a subcutaneous autoinjector at least 45 minutes before anticipated sexual activity, with a limit of one dose per 24 hours and no more than 8 doses per month. Bremelanotide was originally investigated as a tanning agent (it is structurally related to Melanotan-II) before the sexual-function effects were identified. The melanocortin receptor system's role in both pigmentation and sexual behavior explains this dual pharmacology.
Specifications
| Origin / Manufacturer | Synthetic |
| Regulatory Status | FDA-approved (2019) |
| Active Components | Bremelanotide acetate 1.75 mgGlycerinMetacresol (preservative)Water for injection |
| Storage | Store at 20–25°C, excursions permitted to 15–30°C |
| Shelf Life | 24 months |
| Form Factor | Prefilled autoinjector (1.75 mg/0.3 mL) |
Clinical Evidence
Clinical report reference
Clinical report reference
Clinical report reference
Frequently Asked Questions
Sources & References
Every clinical claim on this page traces to a primary peer-reviewed source.
- 1Kingsberg SA, Clayton AH, Pfaus JG. The Female Sexual Response and the Pathophysiology of Hypoactive Sexual Desire Disorder. Journal of Sexual Medicine. 2015;12(8):1484-1498. PMID:26037691
- 2Clayton AH, Althof SE, Kingsberg S, et al.. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women's Health. 2016;12(3):325-337. doi:10.2217/whe-2016-0018 PMID:27181403
- 3Kingsberg SA, Clayton AH, Portman D, et al.. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics & Gynecology. 2019;134(5):899-908. doi:10.1097/AOG.0000000000003500 PMID:31599840
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Melanotan II
Research-Grade
A synthetic analog of α-MSH that binds melanocortin receptors, inducing melanogenesis (tanning) along with libido and appetite-suppression effects. Pre-PT-141 ancestor molecule.
PT-141 (Bremelanotide)
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