HK Innoen's New Drug 'K-CAB' Unveils U.S. Phase 3 Results at World’s Largest Gastroenterology Conference

On May 6, HK Innoen announced that the Phase 3 clinical trial results for K-CAB (active ingredient: Tejoprazan), its new drug for gastroesophageal reflux disease (GERD), had been presented, paving the way for its launch in the U.S. market.

2026 Digestive Disease Week (DDW) in the United States, Tegoprazan Erosive Esophagitis (EE) research results presentation scene. HK Innoen

HK Innoen's U.S. partner, Sebela Pharmaceuticals, presented research findings on K-CAB for the treatment and maintenance therapy of erosive esophagitis (EE) at the 2026 Digestive Disease Week (DDW), the world’s largest gastroenterology conference, held on May 4 and 5 (local time). Following the release of key results last year, Sebela unveiled the full results for the first time at this conference.

This announcement is considered the first to demonstrate the superiority of a P-CAB class therapy over a PPI class therapy. The results are based on Sebela's pivotal Phase 3 clinical trial, the 'TRIUMpH Program', disclosed last year.

The Phase 3 clinical trial for erosive esophagitis involved a large-scale study enrolling 1,250 EE patients. Participants received either 100 mg of Tejoprazan or 30 mg of lansoprazole, a PPI-class drug, and the efficacy and safety of the two treatments were compared at both the 2-week and 8-week marks.

The company explained that 100 mg of Tejoprazan demonstrated superior therapeutic effects compared to 30 mg of lansoprazole in treating erosive esophagitis. At 8 weeks, the complete healing rate was 84.6% for Tejoprazan and 78.0% for lansoprazole, clearly demonstrating both non-inferiority and superiority. At 2 weeks, the rates were 76.4% and 67.0%, respectively, further confirming the significant superiority of Tejoprazan.

In particular, the effect of Tejoprazan was even more pronounced in patients with severe erosive esophagitis (LA grades C·D). At 2 weeks, the healing rate was 74.1% for Tejoprazan compared to 54.5% for lansoprazole, and at 8 weeks, 83.2% versus 68.0%, demonstrating superiority at both time points. In addition, Tejoprazan achieved non-inferiority in the proportion of days without 24-hour heartburn over eight weeks in the overall patient population, and showed significant superiority over lansoprazole among those with severe EE.

This is evaluated as the first case in which a P-CAB class therapy has demonstrated superiority over a PPI. The company highlighted that Tejoprazan was the first to clearly confirm superior efficacy compared to PPIs, which had not been definitively established for other P-CABs. Because these results were derived from a large-scale clinical trial in the United States, Tejoprazan is now considered to have established the basis for a new treatment paradigm in the global GERD therapy market.

Tejoprazan showed a similar rate of adverse events and serum gastrin levels compared to lansoprazole. The company expects Tejoprazan, as a next-generation GERD therapy with both safety and efficacy, to attract significant attention from both the medical field and investment markets.

Tejoprazan also demonstrated differentiated superiority in maintenance therapy compared to existing treatments. In the primary endpoint—the 24-week maintenance of treatment effect—Tejoprazan delivered excellent results across all LA grades, confirming its clinical competitiveness for long-term therapy. The drug proved not only initial treatment efficacy but also sustained effect, and its consistent superiority across all patient groups supports the company's claim that Tejoprazan can be used widely for GERD patients regardless of disease severity.

Kim Hyunsoo, President of the Korean Society of Gastroenterology and Professor of Gastroenterology at Yonsei University Wonju College of Medicine, who attended the presentation, commented, "With the confirmed superiority of K-CAB over PPIs, we anticipate an innovative shift in GERD treatment. This will likely serve as a significant turning point in the global perception of acid suppressant therapy."

Park Muin, President of the Korean Society of Neurogastroenterology and Motility and Professor of Gastroenterology at Kosin University College of Medicine, stated, "It is impressive that K-CAB demonstrated consistent excellence not only in treatment but also during the maintenance therapy phase. We expect K-CAB to provide a new solution for GERD treatment and to influence future paradigm shifts in this field."

An HK Innoen official stated, "In addition to data accumulated from clinical experience in Korea over the past seven years since launch, K-CAB now has clinical data from Western populations. These results confirm K-CAB's value and solidify its status as a leading global P-CAB product."

This content was produced with the assistance of AI translation services.