NDASUBCUTANEOUSSOLUTION
Approved
Jun 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
3/8 — Basic
Drug data last refreshed 2h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYLEESI (bremelanotide) is a melanocortin receptor agonist administered via subcutaneous autoinjector for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. It is the first and only FDA-approved melanocortin receptor agonist for this indication, targeting a distinct neurobiological pathway. The drug represents a novel non-hormonal approach to female sexual dysfunction.
Peak14.6 years to LOE
Product is in peak commercial phase with mature market penetration; commercial team size likely stable but subject to market dynamics in the niche women's sexual health category.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
Started Aug 2024
108 enrolled
Obesity
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease
Started Dec 2022
16 enrolled
Kidney Disease
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Started Jan 2015
714 enrolled
Hypoactive Sexual Desire Disorder
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Started Dec 2014
723 enrolled
Hypoactive Sexual Desire Disorder
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Started Jun 2011
612 enrolled
Female Sexual Arousal DisorderHypoactive Sexual Desire Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.