Daewoong Pharmaceutical disclosed on April 10 that it has submitted a Phase 3 clinical trial plan (IND) to the Ministry of Food and Drug Safety (MFDS) to broaden the indications for its gastroesophageal reflux disease treatment, Fexuclue (active ingredient: fexuprazan hydrochloride).
Fexuclue, a domestically developed novel drug approved in South Korea in 2021, is currently prescribed for gastroesophageal reflux disease.
This latest clinical trial aims to assess the drug’s efficacy and safety in patients with gastric ulcers through a comprehensive Phase 3 study.
The study will be conducted as a multinational, multicenter, randomized, double-blind, active-controlled, parallel-group trial. It will involve 384 participants, with some recruited from international locations, including Indonesia, as part of a simultaneous enrollment strategy.
The trial’s primary efficacy endpoint is the cumulative healing rate of gastric ulcers, as confirmed by upper gastrointestinal endoscopy after 8 weeks of treatment.
By introducing new indications and dosage regimens for Fexuprazan 40 mg, the company aims to offer healthcare providers and adult gastric ulcer patients a wider range of treatment options. This expansion is expected to enhance treatment accessibility and contribute to improved quality of life for patients.
Upon completion of the clinical trial, Daewoong Pharmaceutical plans to apply for product approval and pursue commercialization.