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Solabegron

Phase 2

Overactive Bladder | Small molecule | Nephrology |GSK plc|Last Updated: Apr 15, 2015

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-BlindUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment282
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00343486Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder SymptomsPHASE2 COMPLETED 240 — — May 1, 2006 -May 18, 200966 Argentina, Australia +12
NCT00501267A Study To Test The Interaction of Two Medications for Treatment of Overactive BladderPHASE1 COMPLETED 24 — — Jun 1, 2007Aug 1, 2007Apr 15, 20151 United States
NCT00427596A Two-Part Study to Determine: Best Medication Formulation and Food EffectPHASE1 COMPLETED 18 — — Jan 1, 2007Aug 1, 2007Oct 7, 20081 United States
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Study Endpoints
Primary Endpoints
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Absorption rate of solabegron and oxybutynin
as measured by multiple blood draws after repeat dosing
Absorption rate of the tablet formulations as measured several times by blood draws (over 48-hour period) during the Part 1 under fed conditions and Part 2 under fed vs. fasted conditions
Secondary Endpoints
Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.
To assess bladder function
prior to dosing Session 1 and post dose for each session
Toleration of the formulations after single and repeat doses (over 7-day period)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SolabegronDRUG -
solabegron and oxybutyninDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain. * Body mass index in the range of = 19 kg/m2 to \<35 kg/m2. Exclusion Criteria: * Pregnant * Of childbearing potential or willing ...

Countries:ArgentinaAustraliaFinlandFranceGermanyLatviaNetherlandsNew ZealandPolandSloveniaSouth AfricaSouth KoreaSpainTaiwanUnited States
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