Tegoprazan

An interview with Masaki Sudo, President & CEO of RaQualia Pharma Inc., has been published by The Worldfolio , a global news media agency specializing in industrial and business coverage. The article highlights the core strengths of Japan’s pharmaceutical industry, including its adaptation to emerging therapeutic modalities. It also presents RaQualia’s focused therapeutic areas and upcoming key milestones, as well as future business development plans for tegoprazan. The Worldfolio: How RaQualia Turns Molecules into Meaning https://www.theworldfolio.com/interviews/how-raqualia-turns-molecules-into-meaning/6983/ Cookie Policy We use cookies to provide you with a better browsing experience. Please confirm that you agree to our use of cookies by clicking Yes. If you continue to browse this website even without agreeing to our use of cookies, we consider that you have consented to our use of cookies. Privacy Policy © RaQualia Pharma Inc. All rights reserved.

Topline Results Announced from U.S. Phase 3 Trial (Maintenance Therapy) for K-CAB (a Novel GERD Treatment) … Significant Progress Toward FDA Filing HK inno.N’s Novel Drug K-CAB Succeeds in U.S. Phase 3 Trial … Moving Toward FDA Submission - K-CAB (tegoprazan) demonstrated statistically superior remission maintenance rates compared with lansoprazole in all patients with erosive esophagitis (EE) and in those with moderate to severe disease - Safety and tolerability profiles were comparable to lansoprazole; serum gastrin levels remained within the normal range - A New Drug Application (NDA) will be submitted to the U.S. FDA for both erosive esophagitis (EE) and non-erosive reflux disease (NERD) in Q4 2025 Photo caption: Left – HK inno.N BI, Right – Sebela CI HK inno.N’s novel treatment for gastroesophageal reflux disease (GERD), K-CAB (active ingredient: tegoprazan), achieved positive results in a U.S. Phase 3 clinical trial for maintenance therapy, clearing the final hurdle toward filing a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). Based on these results, HK inno.N’s partner, Sebela Pharmaceuticals, plans to initiate the NDA submission process within this year. HK inno.N announced on August 8 that Sebela Pharmaceuticals released topline results on August 7 (local time) from the U.S. Phase 3 trial—named TRIUMpH—which evaluated maintenance therapy following treatment for erosive esophagitis (EE) using K-CAB (hereinafter “tegoprazan”), a novel GERD therapy. The TRIUMpH trial was conducted by Braintree Laboratories, Inc., the gastroenterology subsidiary of Sebela Pharmaceuticals, which entered into a U.S. technology transfer agreement with HK inno.N in 2021. The study enrolled patients with EE who had achieved complete healing after up to 8 weeks of initial therapy. Participants were randomly assigned to receive tegoprazan 100 mg or 50 mg (a P-CAB) or lansoprazole 15 mg (a PPI) for 24 weeks of maintenance therapy. For the primary endpoint—the 24-week remission maintenance rate—all tegoprazan dose groups demonstrated not only non-inferiority but also statistical superiority over the lansoprazole group across the full patient population (LA grades A–D). In patients with moderate to severe EE (LA grades C–D), both tegoprazan doses showed significant improvement over the lansoprazole group, with statistical superiority confirmed for the tegoprazan 100 mg group. Additionally, both tegoprazan doses demonstrated non-inferiority to lansoprazole in the percentage of 24-hour heartburn-free days. Based on these findings, Sebela plans to submit an NDA to the U.S. FDA in Q4 2025 for the treatment of both EE and NERD. Results from the TRIUMpH Phase 3 trial will be published in leading peer-reviewed journals and presented at major international gastroenterology conferences. Alan Cooke, CEO of Sebela Pharmaceuticals, said, “Tegoprazan demonstrated an excellent maintenance effect across the entire patient population, including those with moderate to severe EE. It also maintained sustained symptom control for heartburn. With a safety profile comparable to current therapies, tegoprazan has the potential to become an innovative treatment option addressing unmet needs of U.S. patients.” Dr. Prakash Gyawali, Professor of Medicine and Director of the Neurogastroenterology and Motility Program at Washington University, added, “These maintenance therapy data demonstrate the clinical value of tegoprazan in GERD, particularly for patients with moderate to severe erosive esophagitis. The results support tegoprazan as a promising new therapy that can facilitate healing and symptom relief.” Dal-won Kwak, CEO of HK inno.N, commented, “We are pleased that K-CAB has successfully completed the maintenance therapy trial, following its previous success in Phase 3 studies for the treatment of EE and NERD. Entering the U.S. market—the world’s largest for pharmaceuticals—is now within reach. We will work closely with our partner to ensure a smooth FDA submission process.” Meanwhile, the incidence of individual treatment-emergent adverse events (TEAEs) in the study was below 3%, with most events mild and transient. Serious TEAEs occurred in less than 1% of patients, and the incidence was similar across the tegoprazan, PPI, and placebo groups. Mean serum gastrin levels remained within the normal range (0–180 pg/ml) throughout the maintenance therapy period. In April, Sebela announced that tegoprazan (marketed in Korea as K-CAB) met both primary and secondary endpoints in Phase 3 trials for the treatment of EE and NERD. Tegoprazan demonstrated a superior healing effect over a PPI (lansoprazole) in EE patients of all grades (LA A–D) after 2 and 8 weeks of treatment. In NERD patients, tegoprazan achieved significant improvement over placebo in treating acid regurgitation, as well as 24-hour and overnight heartburn symptoms. Tegoprazan is the active ingredient in K-CAB, Korea’s 30th domestically developed novel drug. As a P-CAB class therapy for GERD, K-CAB was launched in Korea in March 2019 and has reached cumulative prescription sales totaling KRW 810.1 billion as of the first half of 2025. With advantages such as rapid onset of action and proven safety for up to six months of use, K-CAB is ranked No. 1 in outpatient prescription sales among peptic ulcer treatments in Korea. HK inno.N has signed technology transfer or product export agreements with 54 countries, and the product has been launched in 17 of them to date. ⸻ About TRIUMpH TRIUMpH consists of two Phase 3 clinical trials for tegoprazan in U.S. patients with GERD, covering erosive esophagitis (EE) and non-erosive reflux disease (NERD). Both were multicenter, double-blind trials involving diverse U.S. patient populations. Phase 3 EE Study (NCT05587309) This large-scale, multicenter, double-blind study enrolled 1,250 patients (including 463 with LA grades C/D) to compare the safety and efficacy of tegoprazan and lansoprazole in EE healing, maintenance of healing, and heartburn relief. ▷ Primary endpoints: - Healing phase (up to 8 weeks): proportion of patients achieving complete endoscopic healing - Maintenance phase (24 weeks): proportion of patients maintaining complete endoscopic healing ▷Secondary endpoint: - Percentage of 24-hour heartburn-free days Phase 3 NERD Study (NCT05587322) This large-scale, multicenter, double-blind study enrolled 800 patients to compare tegoprazan with placebo. ▷Primary endpoint: percentage of 24-hour heartburn-free days ▷Secondary endpoints: percentage of days without overnight heartburn and percentage of days without regurgitation ⸻ Gastroesophageal Reflux Disease (GERD) GERD is a chronic condition in which stomach contents reflux into the esophagus, causing symptoms such as heartburn and acid regurgitation, and potentially leading to complications in severe cases. Approximately 65 million people in the U.S. are affected, yet 35–54% of patients do not achieve complete symptom relief with existing proton pump inhibitors (PPIs), underscoring the need for new treatments. GERD is classified into EE and NERD based on endoscopic findings. - EE: Mucosal lesions or esophagitis are visible on endoscopy. - NERD: No mucosal lesions are visible, despite symptoms. ⸻ P-CAB (Potassium-Competitive Acid Blocker) / K-CAB (Tegoprazan) P-CABs directly and competitively bind to potassium ions in the proton pump, blocking gastric acid secretion without the need for acid activation. They can be taken regardless of meals, providing rapid and potent acid suppression from the first dose, with effects lasting longer than PPIs. PPI (Proton Pump Inhibitor / e.g., Lansoprazole) PPIs irreversibly inhibit the gastric proton pump after being activated by gastric acid. They must be taken before meals, and maximum efficacy is typically achieved after several days of administration. ⸻ HK inno.N Corporation Founded in 1984 as the pharmaceutical division of CJ CheilJedang, HK inno.N became CJ Healthcare in 2014, joined the Kolmar Group in 2018, and rebranded as HK inno.N in 2020. The company develops innovative pharmaceuticals with high market value, exemplified by K-CAB, Korea’s 30th novel drug. In addition, HK inno.N operates in health and beauty sectors, including beverages, functional foods, and cosmetics. www.inno-n.com Sebela Pharmaceuticals® Sebela Pharmaceuticals is a U.S. company specializing in gastroenterology and women’s health. Its subsidiary, Braintree Laboratories, has been a leader in colonoscopy preparation products for over 40 years and is developing multiple late-stage gastroenterology therapies, including tegoprazan. Sebela recently obtained FDA approval for Miudella®, the first non-hormonal intrauterine device (IUD) for contraception in 40 years, and is advancing LevoCept®, a hormonal IUD, in late-stage development. www.sebelapharma.com