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Vyleesi (Autoinjector) (BREMELANOTIDE)
Bremelanotide activates melanocortin receptors, primarily MC1R and MC4R, to potentially improve HSDD, though the exact mechanism is unknown.
At a glance
| Generic name | BREMELANOTIDE |
|---|---|
| Sponsor | Cosette |
| Drug class | Melanocortin Receptor Agonist |
| Target | MC1R, MC4R |
| Modality | Recombinant protein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
Bremelanotide works by activating several melanocortin receptors, with the most significant effects seen at MC1R and MC4R. While it is known that MC4R-expressing neurons are present in many areas of the CNS, the specific way Bremelanotide improves HSDD in women remains unclear.
Approved indications
- Lack or loss of sexual desire
Common side effects
- Nausea
- Flushing
- Injection site reactions
- Headache
- Vomiting
- Cough
- Fatigue
- Hot flush
- Paraesthesia
- Dizziness
- Nasal congestion
Key clinical trials
- Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk (PHASE4)
- A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity (PHASE2)
- 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) (PHASE3)
- A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease (PHASE2)
- Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder (PHASE4)
- Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran (PHASE1)
- 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (PHASE3)
- 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vyleesi (Autoinjector) CI brief — competitive landscape report
- Vyleesi (Autoinjector) updates RSS · CI watch RSS
- Cosette portfolio CI