Daewoong Pharmaceutical’s third-generation gastrointestinal therapeutic, Pexuclue (generic name: Fexuprazan), has reaffirmed its international standing through a series of positive research findings presented at prominent global gastroenterology conferences.
Between May 3 and 6, Daewoong disclosed the latest clinical data on Pexuclue’s efficacy in treating gastroesophageal reflux disease (GERD) and preventing peptic ulcers during the Digestive Disease Week (DDW 2025), held in San Diego, California.
In a groundbreaking Phase 3 trial conducted in India—home to approximately 1.4 billion people and the #4 market for anti-ulcer drugs—Pexuclue demonstrated both safety and effectiveness in patients with erosive esophagitis (EE). Led by local partners, the study showed that Pexuclue was non-inferior to the conventional PPI, Esomeprazole, in an 8-week treatment period. Patients also experienced superior relief from key symptoms such as heartburn and acid reflux.
In addition, 96.2% of patients treated with Pexuclue were rated as 'Much Improved' or 'Very Much Improved' on the CGI-I scale, compared to 87.8% in the control group—a roughly 1.1-fold higher improvement rate.
Building on these promising results, Pexuclue was launched in India in April of this year, marking the first time a Korean-developed P-CAB (potassium-competitive acid blocker) product entered the Indian market.
Dr. Pravin, who presented the trial findings, commented, “Pexuclue effectively stabilizes stomach acid and provides remarkable relief for nighttime reflux symptoms, overcoming the short half-life limitations seen with PPIs.”
Another significant study showcased at DDW 2025 demonstrated that Pexuclue is non-inferior to Lansoprazole, a standard PPI, in preventing digestive ulcers. Over a 24-week period, ulcer occurrence in the Pexuclue group was only 1.16%, significantly lower than the 2.76% observed in the comparator, indicating superior long-term preventive ability.
Professor Chang-Geun Lee of Seoul Asan Medical Center emphasized, “Pexuclue could become a more reliable and long-term option for patients on chronic NSAID therapy, offering better protection against ulcer formation.”
Daewoong’s Clinical Development Director, Dr. Ji-sun Lee, highlighted the significance of these international presentations: “Showcasing Pexuclue’s diverse clinical data at the world’s leading gastroenterology forum underscores its potential as a global therapeutic. We aim to expand its indications and accumulate further data to transform it into a blockbuster drug that improves the quality of life for patients worldwide.”
