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Solabegron

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment282

FDA Designations

No designations recorded

Clinical trial landscape

Solabegron · 4 trials · 2 indications

Phase 2 1Phase 1 3
NCT00343486Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder SymptomsOveractive Bladder
COMPLETED240 Analytics
PHASE2COMPLETED
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
Overactive BladderUnlock trial analytics

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
colonic emptying rate by radiolabeled scintigraphy
throughout the study

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 -
PlaceboDRUG -
Solabegron (GW427353)DRUG -
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Solabegron

What is Solabegron used for?

Solabegron is an investigational small molecule being developed for overactive bladder and irritable bowel syndrome (IBS). It is in Phase 1 clinical development, with completed trials in these indications. The drug is not approved and remains under clinical investigation.

Who makes Solabegron?

Solabegron is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for overactive bladder and irritable bowel syndrome.

What phase is Solabegron in?

Solabegron is in Phase 1 clinical development. It has completed three trials, including a Phase 2 study in overactive bladder and two Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Solabegron in?

Solabegron has completed three clinical trials: NCT00343486, a Phase 2 dose-ranging study in female patients with overactive bladder symptoms; NCT00401479, a Phase 1 study on gastrointestinal transit in healthy volunteers; and NCT00427596, a Phase 1 study on medication formulation and food effect.

Is Solabegron the same as GW427353?

Solabegron is also known as GW427353, as referenced in clinical trial records. This alternative name may appear in scientific literature and study documentation. Both names refer to the same investigational drug being developed by GSK plc.