Daewoong Pharmaceutical has received approval from the Ministry of Food and Drug Safety for a domestic Phase 3 clinical trial plan (IND) to expand the indications for its gastroesophageal reflux disease treatment, 'Fexuclue.'

According to a disclosure on the 10th, the MFDS approved the domestic Phase 3 clinical trial for Fexuclue 20mg tablets (active ingredient: fexuprazan hydrochloride), with the indication of 'maintenance therapy after healing of erosive gastroesophageal reflux disease.' The clinical trial application date is January 23, 2026, and the approval date is July 10, 2026.

This clinical trial will be conducted on patients with erosive gastroesophageal reflux disease whose healing has been confirmed via upper gastrointestinal endoscopy after drug treatment. The key clinical trial design is as follows.

• Scale and Duration: A total of 420 participants, conducted over approximately 48 months from the IRB approval date.
• Method: A multi-center, double-blind, randomized, active-controlled, parallel-group Phase 3 clinical trial and an open-label extension study.
• Primary Endpoint: The proportion of patients maintaining endoscopic remission in the upper gastrointestinal tract through 24 weeks after administration of the investigational drug.

Daewoong Pharmaceutical plans to demonstrate non-inferior maintenance therapy efficacy compared to the comparator and confirm long-term safety and effectiveness through this trial. In particular, the goal is to establish a basis for long-term prescriptions by securing long-term safety data in Korean patients, among domestic P-CAB class treatments. The company expects that this indication expansion will broaden treatment options for adult patients and enhance recurrence prevention effects.

However, these are the aspects intended to be verified through the clinical trial and may vary depending on the results. The company intends to apply for product approval after completing the clinical trial to pursue full-scale indication expansion.

Meanwhile, Daewoong Pharmaceutical noted in its investment cautionary statement that 'the statistical probability of a pharmaceutical product receiving final approval after clinical trials is approximately 10%,' and that 'commercialization plans may be altered or discontinued depending on the clinical results.'