Overseas medical staff are reviewing clinical research results on the prevention of NSAID-induced peptic ulcers using Pexuclu (Pexuprazan). Photo by Daewoong Pharmaceutical
Research results demonstrating the global competitiveness of the third-generation gastrointestinal disease treatment, Pexuclu, have been announced in succession.
On May 9, Daewoong Pharmaceutical announced that it had presented clinical research data on the efficacy of Pexuclu in treating gastroesophageal reflux disease (GERD) in Indian patients, as well as data on the prevention of peptic ulcers in patients taking NSAIDs (non-steroidal anti-inflammatory drugs), at Digestive Disease Week 2025 (DDW 2025), the world’s largest international conference on digestive diseases, held in San Diego, United States, from May 3 to May 6.
India, with a population of approximately 1.4 billion, is the world’s most populous country and the fourth-largest anti-ulcer drug market, where demand for gastrointestinal disease treatments is rapidly increasing. According to 2023 data from the global market research firm IMS, the annual market size exceeds KRW 1.4 trillion.
In this strategic market, Daewoong Pharmaceutical also announced the results of a local partner’s Phase 3 clinical trial evaluating the efficacy of Pexuclu in treating erosive esophagitis (EE) in Indian patients. According to the study, Pexuclu demonstrated non-inferiority in the 8-week treatment rate compared to esomeprazole, a proton pump inhibitor (PPI), and showed efficacy in improving major symptoms such as heartburn and acid regurgitation.
Furthermore, in the CGI-I (Clinical Global Impression of Improvement) assessment, which evaluates symptom improvement, the proportion of patients rated as “very much improved” or “much improved” at the end of week 8 was 96.2% in the Pexuclu group and 87.8% in the control group, indicating that Pexuclu achieved approximately 1.1 times higher symptom improvement and confirming its overall clinical efficacy. Based on the efficacy and safety demonstrated in these local clinical trials, Pexuclu became the first domestically developed P-CAB (potassium-competitive acid blocker) to be successfully launched in the Indian market in April.
Dr. Pravin from India, who presented the research at DDW 2025, stated, “Pexuclu, a P-CAB that can serve as an alternative to PPIs, has demonstrated consistent symptom control day and night through its sustained acid suppression mechanism. In particular, Pexuclu’s outstanding efficacy in alleviating nighttime symptoms addresses the issue of symptom recurrence at night caused by the short half-life of PPIs.”
Non-steroidal anti-inflammatory drugs are commonly prescribed to patients with chronic diseases such as rheumatoid arthritis and osteoarthritis, but they suppress the production of protective substances in the gastric mucosa, weakening the stomach lining. As a result, repeated exposure to gastric acid and digestive enzymes can damage the gastric mucosa, leading to peptic ulcers. To prevent such side effects, acid-suppressing agents are used in combination, and until now, second-generation treatments such as PPIs (proton pump inhibitors) have been primarily used. Recently, third-generation treatments like Pexuclu, a P-CAB developed by Daewoong Pharmaceutical, which offer faster and more stable acid suppression, have been attracting attention.
In the clinical study announced at DDW 2025, Pexuclu demonstrated non-inferiority to the existing PPI lansoprazole in preventing peptic ulcers. In particular, at the 24-week mark, the ulcer incidence rate was 1.16% (2 out of 172) in the Pexuclu group and 2.76% (5 out of 181) in the control group, indicating that Pexuclu tended to be more effective. These results demonstrate that Pexuclu is a more stable and reliable option for preventing ulcers in patients who require long-term NSAID therapy, further highlighting its clinical value.
Lee Changkeun, professor of rheumatology at Asan Medical Center in Seoul, who participated in the clinical trial, stated, “Pexuclu will become a more effective and safer option for preventing peptic ulcers in patients with musculoskeletal disorders who require long-term NSAID use.”
Lee Jisun, head of clinical development at Daewoong Pharmaceutical, said, “The domestic and international clinical results presented at the world’s largest gastroenterology conference are a symbolic achievement that demonstrates the potential for expanding Pexuclu’s indications and its position as a next-generation treatment for gastrointestinal diseases. Furthermore, by securing differentiated data to prove the efficacy and strengths of Pexuclu, we will do our utmost to ensure that Pexuclu grows into a global blockbuster new drug that improves the quality of life for patients worldwide.”
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