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Nebulized Ensifentrine ;

Phase 2

Non-cystic Fibrosis Bronchiectasis | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: May 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment284
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06559150A Phase II Study of Ensifentrine in Non-Cystic Fibrosis BronchiectasisPHASE2 RECRUITING 284 — — Sep 11, 2024Sep 24, 2027May 13, 202651 United States, Italy +2
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Study Endpoints
Primary Endpoints
Rate of protocol-defined pulmonary exacerbations (number of events per subject-year)
Through study completion (approximately 52 weeks)
Secondary Endpoints
Time to the onset of the first protocol-defined pulmonary exacerbation
Through study completion (approximately 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 for a minimum of 24 weeks and up to a maximum of 52 weeks
Nebulized Placebo SolutionDRUGAdministered by a standard jet nebulizer, twice daily for a minimum of 24 weeks and up to a maximum of 52 weeks
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Eligibility Criteria
Age Range18 Years — 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)
LOWMay 26, 2026NCT06559150primaryCompletionDate: changed
LOWMay 24, 2026NCT06559150studyFirstPostDate: changed