Tegoprazan, a next-generation potassium-competitive acid blocker (P-CAB), is designed for rapid acid suppression and sustained gastric pH control.
Once-daily tegoprazan (50 or 100 mg) achieves endoscopic healing of erosive esophagitis that is non-inferior to esomeprazole 40 mg, with comparable safety and tolerability.
Tegoprazan, a next-generation potassium-competitive acid blocker (P-CAB), is designed for rapid acid suppression and sustained gastric pH control. Its fast onset and prolonged acid inhibition make it a promising therapeutic option for acid-related gastrointestinal disorders, including erosive esophagitis (EE).
This study aimed to establish the non-inferior efficacy of tegoprazan compared with esomeprazole, a widely used proton pump inhibitor (PPI), in patients diagnosed with EE.
This randomized clinical trial was conducted involving 302 Korean adults with endoscopically confirmed EE classified as Los Angeles Grades A–D. Subjects were assigned to get tegoprazan 50 mg, tegoprazan 100 mg, or esomeprazole 40 mg once everyday for 4 or 8 weeks. The key outcome measure was the cumulative endoscopic healing rate of EE up to 8 weeks. Secondary assessments encompassed symptom improvement, safety, and tolerability.
By week 8, EE healing was achieved in 98.9% of patients treated with tegoprazan 50 mg, 98.9% with tegoprazan 100 mg, and 98.9% with esomeprazole 40 mg. Both tegoprazan doses met the criteria for non-inferiority versus esomeprazole. The frequency and nature of adverse events were similar across all treatment arms, indicating a favorable safety profile for tegoprazan.
Once-daily tegoprazan at both 50 mg and 100 mg achieved non-inferior healing rates of erosive oesophagitis compared with esomeprazole 40 mg, while providing similar improvements in reflux symptoms, high treatment compliance, and a favourable safety and tolerability profile over 4 and 8 weeks.
Alimentary Pharmacology & Therapeutics
Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis
Kwang Jae Lee et al.
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