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MK0594

Phase 2

Urinary Incontinence | Small molecule | Nephrology |VYNE Therapeutics Inc.|Last Updated: May 19, 2021

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment557
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00290563Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)PHASE2 COMPLETED 557 — — Feb 21, 2006Sep 24, 2007May 19, 2021 - —
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Study Endpoints
Primary Endpoints
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Duration of Trial
Secondary Endpoints
The incidence of dry mouth.
Duration of Treatment
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Duration of Treatment
Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.
Duration of Treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0594DRUG -
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Eligibility Criteria
Age Range40 Years — 74 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients with predominantly urge incontinence overactive bladder episodes * Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards Exclusion Criteria: * History of Diabetes insipidus, uncontrolled hypergl...

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