Vyleesi (autoinjector)

(Bremelanotide)

Phase 2Peptide

CCosette Pharmaceuticals, Inc.

Vyleesi (autoinjector) is one of 73 small molecule programs targeting Kidney Disease. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Kidney DiseaseActive, not recruiting

ObesityActive, not recruiting

Kidney DiseasePhase 2

Active, not recruiting

ObesityPhase 2

Active, not recruiting

Competition

Competitive Landscape

392 competitors in Obesity

#DrugCompanyPhaseTrials

Vyleesi (autoinjector)

CCosette Pharmaceuticals, Inc.

Phase 2

1 2

Actemra

Roche

Preclinical

2 3

Avapro

Sanofi

Preclinical

1 4

Amidate

Pfizer

Preclinical

—5

Calciferol

Alnylam Pharmaceuticals

Adenocard

Activella

Colcrys

Alnylam Pharmaceuticals

Preclinical

—9

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 10

Cetrotide

EMD Serono

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

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

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

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

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

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

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

Sex1 trial

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

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

2 more indications

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

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

Regulatory

FDA Approval Timeline[4]

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]
Open Targets Platform — Drug–disease associations for Bremelanotide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210557). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Vyleesi (autoinjector). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cosette Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Phase 2[1]
Company: CCosette Pharmaceuticals, Inc.

Patent Landscape[5]

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

Vyleesi (autoinjector)

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Menopausal Women3 trials

Efficacy and Safety1 trial

Kidney Disease1 trial

Safety and Efficacy1 trial

Sex1 trial

Obesity1 trial

Nausea1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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