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DNK333 twice daily

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Novartis AG|Last Updated: Feb 1, 2011

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_CONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01287325Efficacy of DNK333 in Patients With COPD and CoughPHASE1 COMPLETED 28Sep 1, 2003 -Feb 1, 20112 Netherlands, United Kingdom
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Study Endpoints
Primary Endpoints
Self-reported cough
At 2 weeks
Secondary Endpoints
Sensitivity to capsaicin challenge
At 2 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DNK333EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DNK333 100 mg twice dailyDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range35 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Mild to moderate COPD * Forced expiratory volume in 1 second (FEV1) ≥30% predicted * FEV1/FVC (forced vital capacity) \<70% * Significant amount of cough and minimal amount of sputum production, both as judged by self reporting Exclusion criteria: * Upper or lower airway inf...

Countries:NetherlandsUnited Kingdom
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