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Bremelanotide
FDA ApprovedSince 2019
Also known as Vyleesi
Function
Primary
Hypoactive Sexual Desire Disorder (premenopausal women)
Mechanism
MC1R/MC4R agonist — centrally activates melanocortin pathways modulating sexual desire and arousal.
Evidence
Clinical RCT (Phase III)
Research
Phase III RECONNECT trials
Dosing
Range
1.75 mg PRN
Frequency
As needed (max 1×/24h, ≤8/month)
Route
Subcutaneous (autoinjector)
Cycling
PRN only; max 8 doses/month.
Benefits
- ·Increases sexual desire scores
- ·On-demand dosing
Risks
- ·Nausea (~40%)
- ·Flushing
- ·Transient BP increase
- ·Hyperpigmentation
Contraindications
- ·Uncontrolled hypertension
- ·Known CV disease
Regulatory
FDA-Approved Rx
Functional Groups
Cited Works
- Kingsberg SA et al. Bremelanotide for HSDD: Phase 3 RECONNECT Trials. Obstet Gynecol. 2019;134:899.source