Bremelanotide
As of the edition of 20 October 2026, Bremelanotide is a protein: marketed, first approved in 2019 (US); acts on MC4R; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Protein
- Brand name
- Vyleesi (autoinjector)
- First approved
- 21 June 2019 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Cosette Pharmaceuticals
- Registered trials
- 8, 0 stopped early
- Disease areas
- Mental health; Pregnancy and women's health; Urinary and reproductive
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MC4R | Melanocortin receptor 4 | P32245 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cosette Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2024 to now |
| AMAG Pharmaceuticals | Originator | 2019 to 2024 |