Daewoong Pharmaceutical announced that its reflux disease treatment, Pexuclu (ingredient name: Pexuprazan hydrochloride), achieved a 92.0% eradication rate in a study targeting Helicobacter pylori treatment among patients who completed the therapy, as reported on September 17.
Helicobacter pylori is a bacterium that resides in the stomach lining and is a major cause of chronic gastritis, gastric and duodenal ulcers, and an increased risk of stomach cancer. When an infection is confirmed, eradication therapy is conducted using a combination of proton pump inhibitors (PPIs) and antibiotics.
The study involved 93 patients with no prior experience of eradication therapy. It evaluated the efficacy and safety of a simultaneous therapy that administered Pexuclu along with three antibiotics—clarithromycin, amoxicillin, and metronidazole—over a 10-day period. The overall eradication rate among all registered patients was 90.3%, while the rate for the 88 patients who completed the treatment, excluding those who withdrew before treatment, failed follow-up, or had poor medication adherence, was 92.0%.
Traditionally, Helicobacter pylori eradication therapy has relied on a standard triple therapy involving a PPI and two antibiotics, amoxicillin and clarithromycin, administered over 14 days. However, rising antibiotic resistance to clarithromycin and others has led to concerns about decreasing eradication rates, prompting calls for a change in treatment strategies. In this context, the study found that 80.0% of patients with clarithromycin-resistant mutations successfully eradicated the bacteria.
In previous phase III clinical trials, Pexuclu-based therapy demonstrated non-inferiority in eradication efficacy compared to existing PPI-based therapies, with safety profiles similar to the control group. This latest study is seen as providing additional evidence for the efficacy of Pexuclu in Helicobacter pylori eradication therapy. No severe adverse reactions or liver function abnormalities were observed during the study period.
The research was conducted by a team led by Professors Kim Nam-hoon and Kang Seok-in from the Gastroenterology Department at Inje University Ilsan Paik Hospital and was presented as a poster at the 32nd Japanese Helicobacter Society Conference (JSHR 2026) on July 4. The related paper was published online in the official journal of the Japanese Gastroenterological Association, Digestion, on August 26.
Park Hyung-cheol, head of the ETC Marketing Division at Daewoong Pharmaceutical, stated, "This study further confirms the potential of Pexuclu-based combination therapy as a first-line treatment for Helicobacter pylori eradication. We will continue to secure evidence that can be utilized in clinical practice to expand the therapeutic applications of Pexuclu."
* This article has been translated by AI.
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