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Udenafil

Phase 3

Dyspnea | Small molecule | Cardiovascular |Co-Diagnostics, Inc.|Last Updated: Jun 20, 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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01364181The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) PatientsPHASE3 COMPLETED 23Mar 1, 2010May 1, 2011Jun 20, 20111 South Korea
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Study Endpoints
Primary Endpoints
change of 6-minute walk distance
8 weeks
Secondary Endpoints
change of mean pulmonary artery pressure
8 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
UdenafilEXPERIMENTALUdenafil 50mg qd po
Interventions
NameTypeDescription
UdenafilDRUGUdenafil 50mg qd po
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Eligibility Criteria
Age Range20 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value Exclusion Criteria: * Acute exacerbation within 4 weeks of the study entry * Coronary heart disease * History of adverse event on PDE-5 inhibitors

Countries:South Korea
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