HK inno.N's K-CAB shows positive US Phase 3 results for NERD

HK inno.N has announced positive results from its Phase 3 clinical trial for K-CAB (tegoprazan) targeting non-erosive gastroesophageal reflux disease (NERD) in the United States. The findings were presented by US partner Sebela Pharmaceuticals at the American College of Gastroenterology (ACG) 2026 annual meeting.

The TRIUMpH-NERD study, involving 783 American adult patients, met both primary and secondary endpoints. Tegoprazan doses of 50mg and 100mg significantly improved the proportion of days without 24-hour heartburn and nighttime heartburn compared to a placebo. These improvements were maintained throughout a 20-week extension period.

Additionally, a post-hoc analysis of tegoprazan’s Phase 3 data for erosive esophagitis (EE) received the ACG Presidential Award. This analysis demonstrated that tegoprazan achieved a 75.4% healing rate at week 2 compared to 60.7% for lansoprazole in patients with definitive reflux disease. These results provide critical clinical evidence as Sebela Pharmaceuticals awaits the outcome of its New Drug Application (NDA) currently under review by the U.S. Food and Drug Administration (FDA).