Daewoong Pharmaceutical said on the 4th that it received additional approval from the Ministery of Food and Drug Safety to expand the treatment range of the gastroesophageal reflux disease drug "Fexuclu 40 mg (ingredient name fexuprazan hydrochloride)" to include combination antibiotic therapy for Helicobacter pylori eradication.
With this approval, Fexuclu has expanded its indications beyond the existing ▲ treatment of erosive gastroesophageal reflux disease ▲ improvement of gastric mucosal lesions in acute and chronic gastritis ▲ prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers, to include Helicobacter pylori eradication therapy. Daewoong Pharmaceutical plans to use this to strengthen its competitiveness in the gastrointestinal disease market.
Helicobacter pylori infection has a prevalence of about 50% in Korea and is known to be a major cause of chronic gastritis, gastric ulcers, duodenal ulcers, and gastric cancer. As a result, eradication therapy is strongly recommended, but recently, rising antibiotic resistance has raised concerns about declining treatment success rates.
In particular, as resistance to clarithromycin, an antibiotic used in first-line therapy, increases, the medical field needs diverse treatment options. In eradication therapy, the key is to stably suppress gastric acid so antibiotics can act effectively, but existing proton pump inhibitor (PPI) drugs have limitations, including delayed onset of action and variability in effectiveness depending on dosing time.
Fexuclu is a next-generation potassium-competitive acid blocker (P-CAB) that inhibits gastric acid secretion, offering rapid and strong acid suppression and the convenience of dosing regardless of meals. These characteristics are said to help maintain a stable intragastric pH in combination antibiotic therapy, thereby enhancing eradication efficacy.
The addition of this treatment indication was based on the results of a phase 3 clinical trial conducted at multiple centers in Korea from Feb. 2024 to Apr. 2025. The study compared the efficacy and safety of fexuprazan or a conventional PPI administered with two antibiotics in patients with Helicobacter pylori infection.
A differentiated effect was confirmed particularly in the clarithromycin-resistant patient group. The eradication rate of the Fexuclu-based combination therapy was 54.76%, about 26 percentage points higher than that of the control regimen based on the esophagitis drug (lansoprazole) at 28.57%, showing a statistically significant difference.
Park Sung-soo, CEO of Daewoong Pharmaceutical, said, "This expansion of the treatment range is significant in that Fexuclu has extended beyond gastroesophageal reflux disease and gastritis into the treatment of infectious gastrointestinal diseases," adding, "We will continue to build clinical evidence to provide patients with diverse treatment options and strengthen our global competitiveness."