Daewoong Pharmaceutical announced on May 15 that it presented the Phase 3 results of its Helicobacter pylori eradication therapy, Pexuclu (ingredient name: Pexuprazan hydrochloride), at the 2026 Digestive Disease Week (DDW 2026).
Pexuclu, a third-generation gastroesophageal reflux disease (GERD) treatment, was launched by Daewoong Pharmaceutical in 2022. It is a potassium-competitive acid blocker (P-CAB) designed to address the slow onset and short half-life issues associated with traditional proton pump inhibitors (PPIs).
Recently, the company received approval from the Ministry of Food and Drug Safety to expand the indications for Pexuclu 40mg to include Helicobacter pylori eradication. Clinical results showed that Pexuclu demonstrated a higher eradication rate compared to the control group in patients with antibiotic resistance to clarithromycin, suggesting it as a potential new treatment option.
Pexuclu's treatment scope has expanded to include not only the treatment of erosive gastroesophageal reflux disease, improvement of gastric mucosal lesions in acute and chronic gastritis, and prevention of NSAID-induced peptic ulcers (gastric and duodenal ulcers), but also the area of Helicobacter pylori eradication therapy.
The clinical trial was conducted as a multicenter, randomized, double-blind study involving 461 patients. The participants received either Pexuprazan (40mg) or lansoprazole (30mg) in combination with two antibiotics (amoxicillin and clarithromycin) for 14 days to evaluate the eradication efficacy.
Detailed analysis revealed that the eradication rate for the Pexuclu-based therapy in the clarithromycin-resistant patient group was 54.76%, approximately 26 percentage points higher than the control group (28.57%), achieving statistical superiority.
In the primary efficacy evaluation for all participants, the Pexuclu group showed an eradication rate of 83.64%, demonstrating non-inferiority compared to the control group (77.93%). The incidence of adverse events did not differ significantly between the two groups.
The company aims to enhance Pexuclu's market competitiveness in the gastrointestinal disease sector through continuous expansion of its indications. Na Jae-jin, head of Daewoong Pharmaceutical's Clinical Medicine Center, stated, "We have confirmed the potential for new options in an environment where antibiotic resistance makes treatment challenging. We will continue research to expand indications."
* This article has been translated by AI.
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