Ohtuvayre

(Ensifentrine)

Phase 3Small molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Ohtuvayre is one of 41 small molecule programs targeting Inflammation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Breast CancerRecruiting

Breast CancerPhase 3

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Ohtuvayre

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Inflammation

NCT05270525

Q3 2027

Phase 3Recruiting

Breast Cancer

NCT04542057

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease3 trials

A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Completed·NNuance Pharma (shanghai) Co., Ltd·Phase 3·NCT05743075·526 enrolled

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

Completed·VVerona Pharma plc·Phase 2·NCT07132983·33 enrolled

A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD

Completed·VVerona Pharma plc·Phase 2·NCT07016412·497 enrolled

Inflammation1 trial

Effect of Ensifentrine on Sputum Markers of Inflammation in COPD

Recruiting·VVerona Pharma plc·Phase 2·NCT05270525·56 enrolled

Tics1 trial

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects

Completed·NNuance Pharma (shanghai) Co., Ltd·Phase 1·NCT05758428·28 enrolled

Treatment1 trial

Effect of Ensifentrine Treatment on CAT Score

Completed·VVerona Pharma plc·Phase 3·NCT06460493·20 enrolled

Safety and Efficacy1 trial

A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD

Completed·VVerona Pharma plc·Phase 3·NCT04535986·763 enrolled

1 more indication

Breast Cancer1 trial

ASCENT-04: Sacituzumab Govitecan 1L mTNBC

Recruiting· Gilead logo

Gilead·Phase 3·NCT04542057·579 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 26, 2024

OHTUVAYRE

NDA NDA217389

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Ensifentrine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ensifentrine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ensifentrine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217389). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Ohtuvayre. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[5]

Patent Cliff

Aug 21, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9062047Aug 21, 2031

9956171Sep 15, 2035

10945950Sep 15, 2035

12409180Feb 20, 2043

12251384Jun 25, 2044

Ohtuvayre

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease3 trials

Inflammation1 trial

Tics1 trial

Treatment1 trial

Safety and Efficacy1 trial

Breast Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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