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Glycopyrrolate

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 9, 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 Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06545500A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPDPHASE2 COMPLETED 46Aug 16, 2024Jan 8, 2025Feb 9, 20267 United States
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Study Endpoints
Primary Endpoints
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Baseline (pre-dose for each treatment period) and Day 7
Secondary Endpoints
Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours
Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)
Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)
Baseline (pre-dose for each treatment period) and Day 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Level AEXPERIMENTALThe treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Dose Level BEXPERIMENTALThe treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Dose Level CEXPERIMENTALThe treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Dose Level DPLACEBO_COMPARATORThe treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to
Interventions
NameTypeDescription
Glycopyrrolate (85 μg)DRUGAdministered by a standard jet nebulizer, twice daily for 7 consecutive days
Glycopyrrolate (42.5 μg)DRUGAdministered by a standard jet nebulizer, twice daily for 7 consecutive days
Glycopyrrolate (14 μg)DRUGAdministered by a standard jet nebulizer, twice daily for 7 consecutive days
PlaceboDRUGAdministered by a standard jet nebulizer, twice daily for 7 consecutive days
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Males are eligible to participate if they agree to use contraception 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 not pregnant, not breastfeeding, and ≥ 1 of ...

Countries:United States
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