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A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

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Trial Profile

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Vibegron (Primary)
  • Indications Overactive bladder
  • Focus Registrational; Therapeutic Use
  • Acronyms COURAGE
  • Sponsors Sumitomo Pharma America; Urovant Sciences

Most Recent Events

  • 29 Apr 2025 According to a Sumitomo Pharma media release, data from this study presented at the 2025 American Urological Association Annual Meeting.
  • 29 Apr 2025 Results presented in the Sumitomo Pharma Media Release.
  • 23 Dec 2024 According to a Sumitomo Pharma media release, the company announced today that the U.S. Food and Drug Administration has approved GEMTESA (vibegron) for the treatment of men with overactive bladder symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia. The approval is based on the results from this study.

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