Ohtuvayre

(Ensifentrine)

Phase 3Small molecule

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

Ohtuvayre is one of 30 small molecule programs targeting Breast Cancer. 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

706 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

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 4

Tianeptine

Pfizer

Preclinical

1 5

Ablavar

LLantheus Medical Imaging

Preclinical

2 6

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 7

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

2 8

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 9

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 10

Sertraline ODT

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

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Chronic Obstructive Pulmonary Disease

NCT05270525

Q3 2027

Phase 3Recruiting

Breast Cancer

NCT04542057

Q2 2029

Phase 3Not yet recruiting

Pulmonary Disease, Chronic Obstructive

NCT07874815

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease4 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 Randomized, Double-Blind, Placebo-Controlled, Two-period Cross-over Study of the Effect of Ensifentrine on Sputum Markers of Inflammation in Subjects With COPD

Active, not recruiting·VVerona Pharma plc·Phase 2·NCT05270525·70 enrolled

Show 1 more trial

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

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

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

Pulmonary Disease, Chronic Obstructive1 trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine (MK-5884) Versus Placebo for the Prevention of COPD Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (ENHANCE-3)

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07874815·2,136 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 — 9 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

Q1 2027

Q3 2027

Q2 2029

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease4 trials

Safety and Efficacy1 trial

Tics1 trial

Treatment1 trial

Pulmonary Disease, Chronic Obstructive1 trial

Breast Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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