Daewoong Pharmaceutical’s Fexuclue Shows Potential for 7-Day H. Pylori Eradication Therapy

Daewoong Pharmaceutical reported that its gastroesophageal reflux disease treatment Fexuclue achieved an 83.78% eradication rate in a seven-day triple therapy trial for Helicobacter pylori, showing no statistically significant difference compared to standard proton pump inhibitor-based 14-day regimens, reported on October 23, 2026. The researchers aimed to examine the potential substitution value of shortening the Fexuclue triple therapy administration period to seven days.

Fexuclue Shows Similar Eradication Rates to Proton Pump Inhibitors

Patients received either the Fexuclue-based seven-day triple therapy or a traditional proton pump inhibitor-based 14-day regimen.

Among patients who completed the designated treatment and evaluation protocol, the eradication rate reached 83.78% in the Fexuclue seven-day group and 88.89% in the proton pump inhibitor 14-day group. This difference yielded a p-value of 0.737, indicating no statistically significant variance. When evaluating the entire analysis group, the Fexuclue treatment arm yielded an 80.00% eradication rate, while the comparative group recorded 82.05%, maintaining the same statistical trend with a p-value of 1.000. Statistical significance serves as a numerical metric to determine whether differences between treatment groups could have occurred by chance, where p-values below 0.05 are generally interpreted as indicating a statistically significant difference. Helicobacter pylori represents a bacterium infecting the gastric mucosa, and eradication therapy combines gastric acid inhibitors with antibiotics. Treatment success relies heavily on antibiotic resistance alongside patient medication compliance and acid suppression potency, making it critical to reduce treatment duration while maintaining eradication efficacy.

Study Results Appear in Medicine Journal

The findings were presented as posters at several academic gatherings, including HUG 2025, JSHR 2025, and EHMSG 2025. The research manuscript subsequently received clearance from the international journal Medicine on August 10 and was officially published on September 11.

Park clarified that the investigation was not structured as a non-inferiority trial. Consequently, the data does not establish clinical equivalence between the two regimens, and such results do not immediately imply regulatory approval changes or shortened treatment periods. Instead, the study provides data on shortening the administration period beyond the 14-day dosing criteria applied during the Phase 3 clinical trials for Fexuclue’s Helicobacter pylori eradication indication, with Park stating that he expects the findings to serve as a meaningful clinical basis for clinicians deliberating treatment duration and strategy.

Daewoong Pharmaceutical Pursues Label Expansions and New Trials

Park Hyung-chul, head of Daewoong Pharmaceutical’s ETC Marketing Division, stated that the company intends to accumulate further clinical evidence through ongoing research studies and pursue label expansions to broaden the prescription base for the medication. P-CAB agents offer the advantages of rapid onset and administration regardless of mealtimes.

The pharmaceutical firm has advanced other clinical evaluations for the product. In June, the company secured approval for a Phase 3 clinical trial plan covering 384 participants in South Korea and Indonesia to evaluate treatments for gastric ulcers. This followed an approval in July for a separate Phase 3 study involving 420 domestic patients to assess maintenance therapy following the treatment of erosive gastroesophageal reflux disease.