bremelanotide
Trade name: Vyleesi
Approved
Jun 21, 2019
Bremelanotide (formerly PT-141) was developed for the treatment of female sexual dysfunction, hemorrhagic shock, and reperfusion injury. Bremelanotide, a synthetic peptide analog of α-melanocyte-stimulating hormone (α-MSH) is an agonist at melanocortin receptors including the MC3R and MC4R, which are expressed primarily in the central nervous system. Bremelanotide originally was tested for intranasal administration in treating female sexual dysfunction but this application was temporarily discontinued in 2008 after concerns were raised over adverse side effects of increased blood pressure. It appears that development for hemorrhagic shock and reperfusion injury has been discontinued. Palatin Technologies licensed North American development and commercialization rights of bremelanotide to Amag in January 2017. In June 2018, the US Food and Drug Administration (FDA) accepted AMAG Pharmaceuticals’ new drug application for bremelanotide for treatment of hypoactive sexual desire disorder in premenopausal women. If approved, bremelanotide will be available as a self-administered, disposable subcutaneous auto-injector used in anticipation of a sexual encounter. — NCATS
Clinical trial activity
10 trials · 10 clinical orgs · 3 marketing orgs
Earliest trial started Feb 1, 2006 (NCT00425256)
Timeline
2000s
- Jan 1, 2006
Palatin Technologies — Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2014
Palatin Technologies — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2019
AMAG Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)
- Jun 21, 2019
AMAG Pharmaceuticals, Inc. — Earliest FDA Approval
- Jun 21, 2019
AMAG Pharmaceuticals, Inc. — Marketing Organization
- Jun 21, 2019
AMAG Pharmaceuticals, Inc. — NDA Organization
- Jun 21, 2019
Palatin Technologies — Marketing Organization
- Jun 21, 2019
Palatin Technologies — NDA Secondary Org
- Jun 21, 2019
Cosette — Marketing Organization
Indications
Mechanism of action
- Melanocortin receptor 1AGONIST
MC1R agonist
Peptide, alpha-MSH analogue.
- Melanocortin receptor 3AGONIST
MC3R agonist
Peptide, alpha-MSH analogue.
- Melanocortin receptor 4AGONIST
MC4R agonist
Peptide, alpha-MSH analogue.
Approval history
- approvedJun 21, 2019
Chemistry & pharmacology
SMILES
CCCC[C@H](NC(C)=O)C(=O)N[C@H]1CC(=O)NCCCC[C@H](NC(=O)[C@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](CC4=CC=CC=C4)NC(=O)[C@H](CC5=CN=CN5)NC1=O)C(O)=O- Mol. weight
- 1025.1627 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaBremelanotide ↗
- NCATS6Y24O4F92S ↗
- ChEMBLCHEMBL4297533 ↗
- ChEMBLCHEMBL2070241 ↗
Also known as
- bremelanotide
- bremelanotide
- bremelanotide
- bremelanotide
- bremelanotide
- pt-141
- pt-141
- pt-141
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06867835 | Phase 4 | Jun 26, 2025 | Cosette Pharmaceuticals, Inc. |
| NCT06565611 | Phase 2 | Aug 5, 2024 | Palatin Technologies |
| NCT05709444 | Phase 2 | Dec 26, 2022 | Palatin Technologies |
| NCT04943068 | Phase 3 | May 10, 2021 | Korea University, Kwang Dong Pharmaceutical co., ltd., Seoul National University |
| NCT04179734 | Phase 4 | Oct 7, 2019 | AMAG Pharmaceuticals, Inc., Imperial College London, University of London |
| NCT03973047 | Phase 1 | Jun 30, 2019 | AMAG Pharmaceuticals, Inc. |
| NCT02338960 | Phase 3 | Jan 1, 2015 | Palatin Technologies, Pharmaceutical Research Associates, Inc. (PRA) |
| NCT02333071 | Phase 3 | Dec 1, 2014 | Palatin Technologies, Pharmaceutical Research Associates, Inc. (PRA) |
| NCT01382719 | Phase 2 | Jun 1, 2011 | Palatin Technologies |
| NCT00425256 | Phase 2 | Feb 1, 2006 | Palatin Technologies, Pfizer |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Palatin Technologies | For profit | 6 | 6 | 2 | 2006 |
| AMAG Pharmaceuticals, Inc. | For profit | 2 | 1 | 2 | 2019 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 2 | 0 | 1 | 2014 |
| Cosette Pharmaceuticals, Inc. | For profit | 1 | 1 | 1 | 2025 |
| Imperial College London | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Korea University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Kwang Dong Pharmaceutical co., ltd. | For profit | 1 | 1 | 1 | 2021 |
| Pfizer | For profit | 1 | 0 | 1 | 2006 |
| Seoul National University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| University of London | Academic/Hospital | 1 | 1 | 1 | 2019 |
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AMAG Pharmaceuticals, Inc. | For profit | MKTG | Jun 21, 2019 |
| AMAG Pharmaceuticals, Inc. | For profit | NDA | Jun 21, 2019 |
| Cosette | For profit | MKTG | Jun 21, 2019 |
| Palatin Technologies | For profit | MKTG | Jun 21, 2019 |
| Palatin Technologies | For profit | NDA2 | Jun 21, 2019 |