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Trial Profile

A Confirmatory Phase III Study of BEKINDA 24 mg for Acute Gastroenteritis or Gastritis

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 20 Sep 2018

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At a glance

Drugs Ondansetron (Primary)
Indications Gastritis; Gastroenteritis
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.
09 Apr 2018 According to a RedHill Biopharma media release, the company is currently in discussions with the FDA on the design of this confirmatory phase III study to support a potential New Drug Application (NDA).
11 Oct 2017 New trial record

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