Daewoong Pharmaceutical: "Fexuclu Demonstrates Superior Eradication Rate in Clarithromycin-Resistant Patients"

Announcement of Phase 3 Results for Helicobacter Eradication

Daewoong Pharmaceutical announced on May 15, 2026, that it presented the Phase 3 clinical trial results for "Fexuclu" (ingredient: fexuprazan hydrochloride), its treatment for gastroesophageal reflux disease, as a first-line eradication therapy for Helicobacter pylori at Digestive Disease Week 2026 (DDW 2026) in the United States.

Daewoong Pharmaceutical clinical researcher (right) is explaining the results of the Pexuclu study to overseas medical staff. Daewoong Pharmaceutical

The clinical trial demonstrated that Fexuclu showed a non-inferior eradication effect and similar safety profile compared to the conventional standard treatment based on proton pump inhibitors (PPIs). Notably, among patients with antibiotic resistance to clarithromycin, Fexuclu showed a higher eradication rate compared to the control group. The company stated that the results prove its potential as a new treatment option for patients with antibiotic resistance.

Based on the successful Phase 3 results, Daewoong Pharmaceutical recently received approval from the Ministry of Food and Drug Safety to add the Helicobacter pylori eradication indication for Fexuclu 40mg. With this, Fexuclu's indications now cover the 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 (gastric and duodenal ulcers); and now, Helicobacter pylori eradication therapy. Daewoong Pharmaceutical plans to continue expanding Fexuclu's indications to strengthen its competitiveness in the gastrointestinal disease market.

This clinical trial was conducted as a multicenter, randomized, double-blind study to demonstrate non-inferiority and confirm safety compared to the existing therapy. The researchers administered a triple therapy for 14 days to a total of 461 patients, using either fexuprazan (40mg) or lansoprazole (30mg) in combination with two antibiotics (amoxicillin and clarithromycin), followed by precise evaluation of eradication outcomes.

According to the detailed data, Fexuclu's therapeutic effect was especially notable in the patient group with clarithromycin resistance. In this group, the eradication rate for the Fexuclu-based regimen was 54.76%, which is approximately 26 percentage points higher than the 28.57% eradication rate for the control group using the lansoprazole-based regimen, demonstrating statistical superiority. These results suggest that Fexuclu’s rapid and potent gastric acid suppression may positively impact antibiotic treatment efficacy.

For the primary efficacy evaluation across all participants, the Fexuclu group achieved an eradication rate of 83.64%, demonstrating non-inferiority compared to the control group’s 77.93%. This trial confirmed that Fexuclu is as effective as standard therapy, while also showing differentiated efficacy among patients with antibiotic (clarithromycin) resistance who typically have lower eradication success rates. The incidence of adverse events showed no significant difference between the two groups, and overall safety was comparable.

Meanwhile, Helicobacter pylori infection is known to be a major cause of various gastrointestinal diseases, including chronic gastritis, peptic ulcers, and gastric cancer, with a high domestic prevalence rate of approximately 50%. In clinical practice, first-line eradication therapy is often administered without prior confirmation of antibiotic resistance, highlighting the ongoing need for effective treatment options for patients with resistance.

Professor Jung Hoon-Yong of the Department of Gastroenterology at Asan Medical Center, who led the study, explained, "This research confirmed the efficacy and safety of Fexuclu-based treatment in first-line Helicobacter eradication therapy compared to existing treatments. Especially, the higher eradication rate in the clarithromycin-resistant patient group is significant in terms of expanding treatment options in real-world practice."

Nah Jaejin, Head of Clinical Medicine Center at Daewoong Pharmaceutical, commented, "This study is meaningful not only because Fexuclu demonstrated an eradication effect comparable to the standard therapy, but also because it confirmed its potential as a new treatment option in clinical practice where eradication therapy is becoming more challenging due to antibiotic resistance. We will continue to focus our efforts on research to further expand Fexuclu’s indications and provide new treatment options for patients."

This content was produced with the assistance of AI translation services.