Vyleesi (autoinjector)

(Bremelanotide)

Peptide

CCosette Pharmaceuticals, Inc.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Menopausal Women3 trials

1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Completed·PPalatin Technologies, Inc·Phase 3·NCT02333071·723 enrolled

2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Completed·PPalatin Technologies, Inc·Phase 3·NCT02338960·714 enrolled

Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

Completed·PPalatin Technologies, Inc·Phase 2·NCT01382719·612 enrolled

Kidney Disease1 trial

A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease

Completed·PPalatin Technologies, Inc·Phase 2·NCT05709444·16 enrolled

Sex1 trial

Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

Completed·IImperial College Healthcare NHS Trust·Phase 4·NCT04179734·40 enrolled

Nausea1 trial

Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

Completed·AAMAG Pharmaceuticals, Inc.·Phase 1·NCT03973047·228 enrolled

Safety and Efficacy1 trial

Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

Completed·PPalatin Technologies, Inc·Phase 2·NCT00425256

2 more indications

Efficacy and Safety1 trial

A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

Completed·KKwang Dong Pharmaceutical co., ltd.·Phase 3·NCT04943068·193 enrolled

Obesity1 trial

A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

Active, not recruiting·PPalatin Technologies, Inc·Phase 2·NCT06565611·108 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 21, 2019

VYLEESI (AUTOINJECTOR)

NDA NDA210557

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Bremelanotide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bremelanotide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA210557). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Vyleesi (autoinjector). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cosette Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Company: CCosette Pharmaceuticals, Inc.

Patent Landscape[4]

Patent Cliff

Nov 5, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9352013Nov 5, 2033

9700592Nov 5, 2033

10286034Nov 5, 2033

11590209Apr 29, 2041