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Nebulized Ensifentrine

Phase 2

Non-cystic Fibrosis Bronchiectasis | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Aug 6, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment284

FDA Designations

No designations recorded

Clinical trial landscape

Nebulized Ensifentrine · 1 trial · 1 indication

Phase 2 1
NCT06559150A Phase II Study of Ensifentrine in Non-Cystic Fibrosis BronchiectasisNon-cystic Fibrosis Bronchiectasis
RECRUITING284 Analytics
PHASE2RECRUITING
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis BronchiectasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of protocol-defined pulmonary exacerbations (number of events per subject-year)
Through study completion (up to 52 weeks)

Secondary Endpoints

Time to the onset of the first protocol-defined pulmonary exacerbation
Through study completion (up to 52 weeks)
Change from Baseline in Evaluating Respiratory Symptoms (E-RS) Cough and Sputum Domain score
Baseline, Week 6, Week 12, and Week 24
Change from Baseline in Saint George's Respiratory Questionnaire (SGRQ) total score
Baseline, Week 6, Week 12, and Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Arm 1: EnsifentrineEXPERIMENTAL -
Treatment Arm 2: PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Nebulized Ensifentrine Suspension; 3 mgDRUGAdministered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks
Nebulized Placebo SolutionDRUGAdministered by a standard jet nebulizer, twice daily up to a maximum of 52 weeks
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Males are eligible to participate if they agree to use contraception as described in the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication * Females are eligible to participate if they are no...

Countries:United StatesItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMAug 6, 2026NCT06559150lastUpdatePostDate: changed
MEDIUMAug 6, 2026NCT06559150lastUpdatePostDate: changed

Frequently asked questions about Nebulized Ensifentrine

What is Nebulized Ensifentrine used for?

Nebulized Ensifentrine is an investigational small molecule being developed for the treatment of non-cystic fibrosis bronchiectasis, a chronic respiratory condition. It is administered as a nebulized suspension at a dose of 3 mg. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Nebulized Ensifentrine?

Nebulized Ensifentrine is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with non-cystic fibrosis bronchiectasis.

What phase is Nebulized Ensifentrine in?

Nebulized Ensifentrine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is actively recruiting participants to assess the treatment for non-cystic fibrosis bronchiectasis.

What clinical trials is Nebulized Ensifentrine in?

Nebulized Ensifentrine is being studied in a Phase 2 clinical trial registered as NCT06559150. This randomized, double-blind, placebo-controlled study is recruiting 284 participants with non-cystic fibrosis bronchiectasis across the United States, Italy, Spain, and the United Kingdom. The trial is currently active and enrolling adults aged 18 years and older.

Is Nebulized Ensifentrine the same as Nebulized Ensifentrine Suspension?

Yes, Nebulized Ensifentrine is also known as Nebulized Ensifentrine Suspension, 3 mg. These names refer to the same investigational drug product being developed by Merck & Company, Inc. for the treatment of non-cystic fibrosis bronchiectasis.