Phase 3 data presented at DDW 2026 show 83.64% overall eradication and 54.76% in clarithromycin-resistant patients, outperforming lansoprazole
A clinical researcher from Daewoong Pharmaceutical (right) explains the research results of Fexuclue to an international medical professional.(Photo=Daewoong Pharmaceutical)
Daewoong Pharmaceutical announced on May 15 the results of its Phase 3 clinical trial on Fexuclue as a first-line eradication therapy for Helicobacter pylori at the Digestive Disease Week (DDW 2026) in the United States.
According to the clinical data, Fexuclue recorded an eradication rate of 54.76% in the patient group with clarithromycin resistance. This figure is approximately 26 percentage points (p) higher than the 28.57% shown by the control group administered lansoprazole.
In the primary efficacy evaluation for the entire patient group, Fexuclue also demonstrated an eradication rate of 83.64%, showing efficacy comparable to existing standard treatments. The incidence rate of adverse events also showed no significant difference from the control group, earning it a passing mark for safety.
The prevalence of Helicobacter pylori in Korea reaches approximately 50% and is cited as a cause of major gastrointestinal diseases such as stomach cancer. In actual medical practice, it is often difficult to confirm antibiotic resistance in advance, leading to a high demand for treatments that are also effective for resistant patients.
Professor Jeong Hun-yong of the Department of Gastroenterology at Asan Medical Center Seoul, who led the clinical trial, explained, “The high eradication rate confirmed in the clarithromycin-resistant patient group is highly significant in that it expands treatment options in actual clinical practice.”
Based on these clinical trial results, Daewoong Pharmaceutical recently obtained approval from the Ministry of Food and Drug Safety (MFDS) for an additional indication for Fexuclue 40mg for H. pylori eradication. With this, Fexuclue has been able to expand its scope to include eradication therapy, in addition to its existing indications for erosive gastroesophageal reflux disease and gastritis treatment.
Na Jae-jin, Head of the Clinical Medicine Center at Daewoong Pharmaceutical, emphasized, “We have confirmed the potential for Fexuclue to address the unmet needs in the medical field where eradication is becoming difficult due to antibiotic resistance,” and added, “We plan to continue concentrating our capabilities on research for expanding to various other indications.”
Choi Mun-hee
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