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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

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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: 02 Jul 2024

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At a glance

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

    • Most Recent Events

    • 28 Jun 2024 According to Pierre Fabre media release, based on the results of two pivotal trials (EMPOWUR and EMPOWUR Extension), the European Commission (EC) has authorized marketing of OBGEMSA (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overactive bladder syndrome in adults. The decision of the EC follows the favorable opinion issued on April 25 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
    • 26 Apr 2024 According to Pierre Fabre media release, CHMP The CHMP positive opinion is based on positive data from two Phase 3 pivotal studies RVT-901-3003 and RVT-901-3004.
    • 26 Apr 2024 According to Pierre Fabre media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of OBGEMSA™ (vibegron under the international non-proprietary name) for the symptomatic treatment of adult patients with overactive bladder syndrome. The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation for OBGEMSA (vibegron).

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