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A phase III multicentre, randomized, double-blind and active-controlled clinical assessing efficacy of Fexuprazan, vs. Esomeprazole in Chinese Patients with Erosive Esophagitis

Trial Profile

A phase III multicentre, randomized, double-blind and active-controlled clinical assessing efficacy of Fexuprazan, vs. Esomeprazole in Chinese Patients with Erosive Esophagitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2023

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At a glance

  • Drugs Esomeprazole (Primary) ; Fexuprazan (Primary)
  • Indications Erosive oesophagitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Daewoong Pharmaceutical

Most Recent Events

  • 31 Jul 2023 According to a Daewoong Pharmaceuticals, company has submitted the New Drug Application (NDA) for Fexuprazan to the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA), based on the results of Phase 3 clinical trials for GERD treatment conducted on 332 patients with erosive esophagitis in China.
  • 21 Jun 2023 New trial record
  • 09 May 2023 Status changed from recruiting to completed according to results presented at the Digestive Disease Week 2023.

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