Trial Profile
A Pivotal Phase III Study of BEKINDA (RHB-102) 12 mg for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Status:
Planning
Phase of Trial:
Phase III
Latest Information Update: 20 Sep 2018
Price :
$35
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At a glance
- Drugs Ondansetron (Primary)
- Indications Irritable bowel syndrome
- Focus Registrational; Therapeutic Use
- Sponsors RedHill Biopharma
- 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.