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Bremelanotide (Vyleesi)
Melanocortin

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 / ManufacturerSynthetic
Regulatory Status
FDA-approved (2019)
Active Components
Bremelanotide acetate 1.75 mgGlycerinMetacresol (preservative)Water for injection
StorageStore at 20–25°C, excursions permitted to 15–30°C
Shelf Life24 months
Form FactorPrefilled autoinjector (1.75 mg/0.3 mL)

Clinical Evidence

RECONNECT I & II (phase III, n=1,247 combined): bremelanotide 1.75 mg SC vs placebo significantly increased FSDS-DAO desire domain score (−0.7 mean change, p<0.001) and decreased distress

Clinical report reference

Phase IIb dose-finding: 1.75 mg was identified as optimal balancing efficacy vs nausea

Clinical report reference

Male erectile dysfunction trials: bremelanotide showed efficacy in early trials but development was discontinued for men due to blood pressure signals at higher doses

Clinical report reference

Frequently Asked Questions

Sources & References

Every clinical claim on this page traces to a primary peer-reviewed source.

  1. 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
  2. 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
  3. 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

Reviewed by

Clinical Research Review Board

Endocrinology & Sexual Medicine Review

All clinical claims cross-checked against primary sources. Read our editorial policy →

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Reviewed by Clinical Research Review BoardEndocrinology & Sexual Medicine Review

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