Daewoong Pharmaceutical (069620.KS) has expanded the indication of its gastroesophageal reflux disease (GERD) treatment Fexuclue to include Helicobacter pylori eradication therapy. The move draws attention as a potential new treatment option amid declining efficacy of existing therapies due to rising antibiotic resistance.
Daewoong Pharmaceutical said Tuesday that it has received additional approval from the Ministry of Food and Drug Safety for Fexuclue 40mg (active ingredient: fexuprazan hydrochloride) for the indication of "antibiotic combination therapy for Helicobacter pylori eradication."
With this approval, Fexuclue has expanded its application scope to include H. pylori eradication treatment, in addition to its existing indications for erosive GERD treatment, improvement of acute and chronic gastritis, and prevention of peptic ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs).
Helicobacter pylori is a major gastrointestinal pathogen with a domestic prevalence of approximately 50% in Korea. Active eradication treatment is recommended as the bacterium is linked to chronic gastritis, gastric and duodenal ulcers, and gastric cancer. However, rising resistance rates to major antibiotics such as clarithromycin have reduced the success rate of existing treatments, posing a growing burden in clinical settings.
Against this backdrop, treatment strategies that stably suppress gastric acid to enhance antibiotic efficacy have become increasingly important. Existing proton pump inhibitors (PPIs) have limitations, including slow onset of action and efficacy variations depending on the timing of administration.
Fexuclue, a potassium-competitive acid blocker (P-CAB), offers rapid and potent acid suppression along with dosing convenience independent of meals. The company expects these characteristics to contribute to improved eradication rates in antibiotic combination therapy.
The indication expansion was based on results from a domestic multicenter Phase 3 clinical trial conducted from February 2024 to April 2025. The study compared the efficacy and safety of fexuprazan and existing PPIs when administered with two antibiotics.
Differentiated results were particularly confirmed in patients with antibiotic resistance. In patients with clarithromycin resistance, the eradication rate of the Fexuclue-based regimen was 54.76%, about 26 percentage points higher than the 28.57% rate of the existing lansoprazole-based regimen. The results are considered meaningful given that resistance is difficult to confirm in advance in actual clinical practice.
"With this approval, Fexuclue has expanded its scope beyond GERD to the treatment of infectious gastrointestinal diseases," a Daewoong Pharmaceutical official said. "We plan to broaden treatment options based on clinical evidence and strengthen our global competitiveness."
