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An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

Trial Profile

An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2019

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At a glance

  • Drugs Vibegron (Primary) ; Tolterodine
  • Indications Overactive bladder
  • Focus Registrational; Therapeutic Use
  • Acronyms EMPOWUR
  • Sponsors Urovant Sciences
  • Most Recent Events

    • 13 Aug 2019 According to an Urovant Sciences media release, the company has completed a productive pre-NDA meeting with the FDA in preparation for anticipated New Drug Application (NDA) filing by early 2020.
    • 06 May 2019 Results published in the Urovant Sciences Media Release.
    • 06 May 2019 According to an Urovant Sciences media release, Dr. David Staskin presented positive, Phase 3 pivotal data demonstrating safety and efficacy of vibegron during a plenary session at the 2019 American Urological Association Annual Meeting (AUA) in Chicago.
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