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Solabegron

Phase 2

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

Solabegron development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jun 2006

Solabegron target and mechanism

Molecular targetADRB3
Target classAgonist
ModalitySmall molecule

Also known as Solabegron (GW427353)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment318

FDA Designations

No designations recorded

Solabegron clinical trials

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?

Solabegron is an investigational small molecule developed by GSK plc for irritable bowel syndrome and overactive bladder. It is a beta-3 adrenergic receptor agonist that has been studied in Phase 1 and Phase 2 clinical trials. It is not approved for any indication and remains in clinical development.

What is solabegron used for in overactive bladder?

Solabegron has been studied for the treatment of overactive bladder symptoms. A Phase 2 dose-ranging trial evaluated solabegron versus placebo in female patients with overactive bladder. It is investigational and has not been approved for this or any other use.

What does solabegron target?

Solabegron targets the beta-3 adrenergic receptor, also known as ADRB3. It acts as an agonist at this receptor. This mechanism has been explored in conditions such as overactive bladder and irritable bowel syndrome.

Who is developing solabegron?

Solabegron is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored clinical trials of solabegron in overactive bladder and irritable bowel syndrome.

What phase is solabegron in?

Solabegron is in Phase 1 clinical development according to the available data, though a Phase 2 trial has also been completed. It is investigational and has not received FDA approval. Further development status has not been disclosed.

What clinical trials is solabegron in?

Solabegron has been studied in completed trials including NCT00501267, NCT00427596, NCT00401479, and NCT00343486. These trials evaluated drug interactions, formulation, gastrointestinal transit, and dose-ranging in overactive bladder and irritable bowel syndrome. No active trials are currently listed.

Is solabegron the same as GW427353?

Yes, solabegron is also known as GW427353. The combination of solabegron and oxybutynin has also been referred to in study contexts. Solabegron is the primary name used for this investigational drug.