Trial Profile

Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 05 May 2023

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At a glance

28 Apr 2023 According to a RedHill Biopharma media release, discussions with potential commercialization partners ongoing.
16 Feb 2023 According to a RedHill Biopharma media release, following a positive pre-MAA meeting it plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda) for oncology support in adults and children over the age of 12, Data to support the submission was generated from several clinical studies including this trial.
26 Feb 2020 Results assessing effect of ondansetron on the corrected QTc (n=147) published in the American Journal of Emergency Medicine.

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