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Ensifentrine twice daily

Phase 3

COPD | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Apr 18, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06460493Effect of Ensifentrine Treatment on CAT ScorePHASE3 COMPLETED 20Jun 11, 2024Dec 3, 2024Apr 18, 20251 United States
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Study Endpoints
Primary Endpoints
The Proportion of CAT Score Responders in the Full Analysis Set at Week 12
12 Weeks

Responders are defined as an improvement (decrease) from baseline of ≥2 points. The COPD Assessment Test(tm) (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12.

Secondary Endpoints
The Proportion of CAT Score Responders in the Full Analysis Set at Week 6
6 Weeks
Mean Change From Baseline - CAT Score in the Full Analysis Set
At week 6 and week 12
Mean Change From Baseline - CAT Individual Item (1, Cough) in the Full Analysis Set
At week 6 and week 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EnsifentrineEXPERIMENTALInhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy.
Interventions
NameTypeDescription
Ensifentrine 3 mg twice dailyDRUGAll subjects will receive ensifentrine.
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Capable of giving informed consent. * Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years. * Established clinical history of moderate to severe COPD. * Pre- and post-albuterol FEV1/FVC ratio of \< 0.70. * Post-albuterol FEV1 ≥ 30 % and ≤ 75%...

Countries:United States
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