Daewoong Pharmaceutical's gastrointestinal drug "Fexuclu" demonstrated eradication efficacy in a phase 3 clinical trial for Helicobacter pylori, known as a causative bacterium of stomach cancer. In particular, it showed a higher eradication rate in the antibiotic-resistant patient group, suggesting potential as a new treatment alternative.
Daewoong Pharmaceutical said on the 15th that it presented phase 3 results for first-line Helicobacter pylori eradication therapy with the gastroesophageal reflux disease treatment "Fexuclu (ingredient name fexuprazan hydrochloride)" at Digestive Disease Week (DDW 2026) in the United States. DDW is the world's largest academic conference in the field of gastroenterology.
Jeong Hoon-yong, a professor of gastroenterology at Asan Medical Center who led the study, said, "Fexuclu-based therapy confirmed efficacy and safety compared with existing treatment in first-line Helicobacter eradication therapy," and added, "In particular, the higher eradication rate observed in the clarithromycin-resistant patient group is meaningful in real-world clinical practice."
The trial enrolled 461 patients infected with Helicobacter pylori. After administering fexuprazan or lansoprazole together with antibiotics, the study compared and evaluated eradication outcomes.
In the overall patient population, the eradication rate of the Fexuclu-based regimen was 83.64%, demonstrating noninferiority compared with the control lansoprazole-based regimen (77.93%). In particular, among clarithromycin-resistant patients, the eradication rate with the Fexuclu-based regimen was 54.76%. This is about 26 percentage points higher than the control (28.57%).
Helicobacter pylori is cited as a causative bacterium that induces chronic gastritis, gastric ulcers, and stomach cancer. Recently, as antibiotic resistance has spread and eradication treatment failures have increased, the need for new treatment alternatives has grown.
Based on these clinical results, Daewoong Pharmaceutical recently obtained additional approval from the Ministery of Food and Drug Safety for the Helicobacter pylori eradication indication for Fexuclu 40 mg.
Accordingly, Fexuclu's scope of application has expanded from its existing indications for gastroesophageal reflux disease, gastritis, and prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers to include Helicobacter pylori eradication therapy.
Na Jae-jin, head of the clinical medicine center at Daewoong Pharmaceutical, said, "It is meaningful that we identified the potential for a new treatment option at a time when eradication therapy is becoming more difficult due to antibiotic resistance," and added, "We will continue research to expand Fexuclu's various indications going forward."