bremelanotide

Trade name: Vyleesi

Peptideapproved

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

Phase 1
1
Phase 2
7
Phase 3
3
Phase 4
2

Earliest trial started Feb 1, 2006 (NCT00425256)

Timeline

2000s

  1. Jan 1, 2006

    Palatin Technologies — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2014

    Palatin Technologies — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2019

    AMAG Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  3. Jun 21, 2019

    AMAG Pharmaceuticals, Inc. — Earliest FDA Approval

  4. Jun 21, 2019

    AMAG Pharmaceuticals, Inc. — Marketing Organization

  5. Jun 21, 2019

    AMAG Pharmaceuticals, Inc. — NDA Organization

  6. Jun 21, 2019

    Palatin Technologies — Marketing Organization

  7. Jun 21, 2019

    Palatin Technologies — NDA Secondary Org

  8. Jun 21, 2019

    Cosette — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJun 21, 2019

Chemistry & pharmacology

Loading structure…

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

First in class

Sources

Also known as

  • bremelanotide
  • bremelanotide
  • bremelanotide
  • bremelanotide
  • bremelanotide
  • pt-141
  • pt-141
  • pt-141

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06867835Phase 4Jun 26, 2025Cosette Pharmaceuticals, Inc.
NCT06565611Phase 2Aug 5, 2024Palatin Technologies
NCT05709444Phase 2Dec 26, 2022Palatin Technologies
NCT04943068Phase 3May 10, 2021Korea University, Kwang Dong Pharmaceutical co., ltd., Seoul National University
NCT04179734Phase 4Oct 7, 2019AMAG Pharmaceuticals, Inc., Imperial College London, University of London
NCT03973047Phase 1Jun 30, 2019AMAG Pharmaceuticals, Inc.
NCT02338960Phase 3Jan 1, 2015Palatin Technologies, Pharmaceutical Research Associates, Inc. (PRA)
NCT02333071Phase 3Dec 1, 2014Palatin Technologies, Pharmaceutical Research Associates, Inc. (PRA)
NCT01382719Phase 2Jun 1, 2011Palatin Technologies
NCT00425256Phase 2Feb 1, 2006Palatin Technologies, Pfizer
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Palatin TechnologiesFor profit6622006
AMAG Pharmaceuticals, Inc.For profit2122019
Pharmaceutical Research Associates, Inc. (PRA)For profit2012014
Cosette Pharmaceuticals, Inc.For profit1112025
Imperial College LondonAcademic/Hospital1012019
Korea UniversityAcademic/Hospital1012021
Kwang Dong Pharmaceutical co., ltd.For profit1112021
PfizerFor profit1012006
Seoul National UniversityAcademic/Hospital1012021
University of LondonAcademic/Hospital1112019
10 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
AMAG Pharmaceuticals, Inc.For profitMKTGJun 21, 2019
AMAG Pharmaceuticals, Inc.For profitNDAJun 21, 2019
CosetteFor profitMKTGJun 21, 2019
Palatin TechnologiesFor profitMKTGJun 21, 2019
Palatin TechnologiesFor profitNDA2Jun 21, 2019