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A Pivotal Phase III Study of BEKINDA (RHB-102) 12 mg for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Trial Profile

A Pivotal Phase III Study of BEKINDA (RHB-102) 12 mg for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Planning
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2018

At a glance

  • Drugs Ondansetron (Primary)
  • Indications Irritable bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors RedHill Biopharma
  • Most Recent Events

    • 12 Sep 2018 According to a RedHill Biopharma media release, the company concluded a positive End-of-Phase II/Pre-Phase III (Type B) meeting with the U.S. FDA to discuss planned endpoints and design of the trial to support potential NDA filing.
    • 09 Apr 2018 According to a RedHill Biopharma media release, the company plans to meet with the FDA in the second quarter of 2018 to discuss the design of the trial.
    • 16 Jan 2018 According to a RedHill Biopharma media release, the company plans to meet with the FDA in the first half of 2018 to discuss the design of the trial.
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