Daewoong Pharmaceutical has received approval from the Ministry of Food and Drug Safety for its Phase 3 clinical trial plan (IND) to add a new indication, 'gastric ulcer treatment,' to its gastroesophageal reflux disease drug 'Fexuclu.'

According to a Daewoong Pharmaceutical disclosure on the 23rd, the Ministry of Food and Drug Safety (MFDS) approved the Phase 3 clinical trial plan to add the gastric ulcer treatment indication for Fexuclu 40mg tablets (active ingredient: fexuprazan hydrochloride). The application date for this clinical trial is April 10, 2026, and the approval date is June 23, 2026.

This clinical trial is a multinational, multicenter, randomized, double-blind, active-controlled, parallel-group Phase 3 study designed to evaluate the efficacy and safety of fexuprazan (DWP14012) in patients with gastric ulcers. Daewoong Pharmaceutical plans to recruit a total of 384 subjects and conduct the trial over approximately 21 months from the approval date, with some subjects being recruited in Indonesia.

The company intends to evaluate the cumulative healing rate of gastric ulcers, confirmed via upper gastrointestinal endoscopy, up to the 8-week mark through this trial. Based on this, the company plans to demonstrate non-inferiority compared to the active comparator, confirm additional efficacy and safety, and then apply for product approval after the trial is completed to actively pursue the expansion of the gastric ulcer treatment indication.

Daewoong Pharmaceutical stated, "By adding a new indication along with dosage and administration guidelines to fexuprazan 40mg, we expect to provide medical professionals and adult gastric ulcer patients with a wider range of drug options and expand treatment opportunities."

Meanwhile, Fexuclu, which is the 34th domestically developed new drug under the Pharmaceutical Affairs Act, has been sold in South Korea since receiving product approval in 2021. The company noted that the statistical probability of an investigational drug ultimately receiving final product approval is approximately 10%, and cautioned investors that unexpected results may arise during the clinical trial and product approval processes.