RESEARCH MATERIAL — NOT EQUIVALENT TO THE APPROVED VYLEESI FORMULATION
Bremelanotide — scientific overview
Bremelanotide is a melanocortin receptor agonist supported by randomized Phase 3 data.
1. Scientific profile
|
Parameter |
Classification |
|
Compound |
Bremelanotide / PT-141 |
|
Class |
Melanocortin receptor agonist |
|
Human evidence |
Randomized Phase 3 trials |
|
US status |
Approved since 2019 |
2. Pharmacodynamics
Bremelanotide acts through central melanocortin signalling.
|
System |
Function |
Context |
|
MC4R
|
Central melanocortin signalling
|
Thought to play an important role in central sexual-response pathways. |
|
CNS
|
Central neural pathways
|
Mechanistically distinct from primarily peripheral PDE-5 inhibition. |
3. RECONNECT Phase 3
Two randomized studies enrolled 1,267 women.
Key findings
Desire
Statistically significant improvement versus placebo was reported.
Distress
Distress related to low desire decreased significantly.
Long-term
An optional 52-week open-label extension assessed longer-term outcomes.
Critical appraisal
A 2024 re-analysis questioned the clinical magnitude and validity of some reported efficacy outcomes.
4. Current status
FDA
US approval since 2019
Indication
Acquired generalized HSDD in premenopausal women
Limitation
Not approved as a general sexual-performance enhancer
5. Research-material distinction
Clinical evidence relates to a defined pharmaceutical formulation and does not establish properties of separately supplied research material.
