HK inno.N (195940.KQ) announced Thursday that it presented U.S. Phase 3 clinical trial results for its next-generation gastroesophageal reflux disease (GERD) drug K-CAB (ingredient name: tegoprazan), a potassium-competitive acid blocker (P-CAB), at Digestive Disease Week (DDW) 2026, the world's largest gastroenterology conference.
Sebela Pharmaceuticals, HK inno.N's U.S. partner, presented the Phase 3 clinical study results for tegoprazan's treatment of erosive esophagitis and maintenance therapy. Sebela disclosed the key results last year but released the full results for the first time at this conference. Sebela submitted a New Drug Application (NDA) for tegoprazan to the U.S. Food and Drug Administration (FDA) in January this year.
Sebela compared the efficacy and safety of the two drugs at 2 weeks and 8 weeks after administering either 100 mg of tegoprazan or 30 mg of lansoprazole, a proton pump inhibitor (PPI), to 1,250 patients with erosive esophagitis. The complete healing rate at 8 weeks was 84.6% for tegoprazan and 78.0% for lansoprazole, demonstrating both non-inferiority and superiority of tegoprazan. At the 2-week point, tegoprazan also showed significant superiority with a healing rate of 76.4% compared to 67.0% for lansoprazole.
The efficacy of tegoprazan was even more pronounced in patients with severe erosive esophagitis (LA grades C and D). Healing rates were 74.1% versus 54.5% at 2 weeks and 83.2% versus 68.0% at 8 weeks, demonstrating superiority over lansoprazole at both time points. In the proportion of 24-hour heartburn-free days over 8 weeks, tegoprazan secured non-inferiority across the entire patient group and showed significant superiority over lansoprazole in severe erosive esophagitis patients. Safety measures, including adverse event rates, were comparable to those of PPIs.
This marks the first case of a P-CAB class treatment demonstrating superiority over PPIs. "The significance lies in the fact that tegoprazan has confirmed treatment superiority over PPIs for the first time, which existing P-CABs had failed to clearly demonstrate," an HK inno.N official said. "Moreover, these results were derived from a large-scale clinical trial in the United States, providing grounds for tegoprazan to present a new paradigm in the global GERD treatment market."
Tegoprazan also demonstrated differentiated superiority over existing treatments in maintenance therapy. In the primary endpoint evaluation of 24-week treatment efficacy maintenance rate, tegoprazan showed excellent results across all LA grade patient groups. This is an achievement that not only existing PPI treatments but also other P-CAB class treatments had failed to deliver. "It is impressive that consistent excellence has been secured not only in treatment but also through the maintenance therapy stage," said Park Moo-in, chairman of the Korean Society of Neurogastroenterology and Motility and professor of gastroenterology at Kosin University College of Medicine.
