MedPath

Solabegron

Generic Name
Solabegron
Drug Type
Small Molecule
Chemical Formula
C23H23ClN2O3
CAS Number
252920-94-8
Unique Ingredient Identifier
55P6YH9O6N

Overview

Solabegron (GW-427,353) is a selective β3 adrenoceptor agonist being developed for the treatment of overactive bladder and irritable bowel syndrome.

Indication

Investigated for use/treatment in diabetes mellitus type 2, irritable bowel syndrome (IBS), and urinary incontinence.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates
2024/10/09
NCT06632990
Phase 1
Active, not recruiting
Allyx Therapeutics
A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's
2024/03/13
NCT06309147
Phase 1
Recruiting
Allyx Therapeutics
Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
2023/04/18
NCT05817643
Phase 1
Active, not recruiting
Allyx Therapeutics
A Multiple Ascending Dose Study in Healthy Volunteers and Patients With Alzheimer's Disease
2023/04/07
NCT05804383
Phase 1
Recruiting
Allyx Therapeutics
Evaluating the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923
2021/03/18
NCT04805983
Phase 1
Completed
Yale University
A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)
2018/07/20
NCT03594058
Phase 2
Completed
Velicept Therapeutics, Inc.
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
2018/03/23
NCT03475706
Phase 2
Completed
Velicept Therapeutics, Inc.
Evaluate the Safety, Tolerability and PK of Different Formulations of Orally Administered Solabegron in Healthy Male Subjects
2016/10/19
NCT02938507
Phase 1
Completed
Velicept Therapeutics, Inc.
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
2007/07/16
NCT00501267
Phase 1
Completed
GlaxoSmithKline
A Two-Part Study to Determine: Best Medication Formulation and Food Effect
2007/01/29
NCT00427596
Phase 1
Completed
GlaxoSmithKline

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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