- Sebela Pharmaceuticals® submitted its New Drug Application (NDA) for 바카라사이트 통장 on January 9, 2026. The NDA seeks approval for three indications: Non-Erosive Reflux Disease (NERD), Erosive Esophagitis (EE) Healing, and EE Maintenance
- Once approved, 바카라사이트 통장 will be the first Potassium-Competitive Acid Blocker (P-CAB) to demonstrate superiority in EE healing across all severity grades (LA Grades A-D) and at all time points versus a proton pump inhibitor (PPI)
- In NERD, 바카라사이트 통장 achieved meaningful improvement in 24-hour heartburn, overnight heartburn, and regurgitation, the hallmark symptoms of GERD, versus placebo
- 바카라사이트 통장 has demonstrated rapid acid control within 45 minutes
- Safety and tolerability for 바카라사이트 통장 was favorable across all studies, with adverse events occurring at similar rates to study comparators and mean serum gastrin levels remaining within normal limits (0-180 pg/ml) throughout treatment
- 바카라사이트 통장 has already received marketing authorization in 21 countries worldwide. US approval anticipated in January 2027
[by Sung, Jae Jun] Braintree Laboratories, Inc. a part of Sebela Pharmaceuticals® and a leading manufacturer of gastroenterology pharmaceutical products, announced that it submitted a New Drug Application (NDA) on January 9, 2026 to the U.S. Food and Drug Administration (FDA) for tegoprazan, a novel potassium-competitive acid blocker (P-CAB), for the treatment of adults with gastroesophageal reflux disease (GERD). The NDA seeks simultaneous approval for three indications: treatment of heartburn associated with non-erosive reflux disease (NERD), healing of erosive esophagitis (EE), and maintenance of EE healing.
The NDA submission is supported by robust data from the pivotal Phase 3 TRIUMpH clinical program, which enrolled over 2,000 US patients and demonstrated 바카라사이트 통장's clinical superiority over a PPI across multiple endpoints. All endpoints were evaluated under a prespecified hierarchical multiple testing procedure. In NERD, 바카라사이트 통장 demonstrated superiority over placebo for the percentage of 24-hour heartburn-free days (p<0.0001 and p=0.0006 for 바카라사이트 통장 100mg and 50mg, respectively), as well as for percentage of days without overnight heartburn and percentage of days without regurgitation. In EE, 바카라사이트 통장 demonstrated statistically superior healing compared to lansoprazole at both 2 and 8 weeks across all grades of EE (LA Grades A-D: p<0.0001 and p=0.0083 for 바카라사이트 통장 100mg at weeks 2 and 8, respectively), and in patients with severe disease (LA Grades C and D: p<0.0001 and p=0.0002 for 바카라사이트 통장 100mg at weeks 2 and 8, respectively). In the 24-week maintenance phase, 바카라사이트 통장 showed superior sustained healing compared to PPI therapy in all patients (p<0.0001 and p=0.0145 for 바카라사이트 통장 100mg and 50mg, respectively). Additionally, 바카라사이트 통장 demonstrated superior healing and heartburn relief in patients with severe disease. Sebela plans to present full results from the TRIUMpH program at upcoming medical meetings in 2026 and submit for publication in respected peer-reviewed journals.
"Today's NDA submission for tegoprazan marks a transformative moment in our 40-year commitment to advancing gastroenterology care," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "GERD affects approximately 65 million Americans, and despite the availability of acid suppression therapies, 35% to 54% of patients continue to suffer from inadequate symptom control. Tegoprazan's results from its Phase 3 TRIUMpH program demonstrate superiority to a PPI in sustained healing of EE in even the most severe cases, and clinically meaningful relief of 24-hour heartburn, overnight heartburn and regurgitation in NERD patients. We look forward to working with the FDA to obtain marketing approval as they review our full data package. We expect to bring this important new treatment option to patients and healthcare providers in January next year."
Philip O. Katz, MD,† Professor of Medicine at Weill Cornell Medicine, commented, "The emergence of potassium-competitive acid blockers represents an important advance in acid suppression therapy, offering more rapid onset and sustained gastric pH control compared to proton pump inhibitors. The TRIUMpH program data are particularly noteworthy in demonstrating tegoprazan's potential to provide control of both heartburn and regurgitation in patients with NERD as well as improved healing rates in patients with severe erosive esophagitis. These findings suggest that P-CABs like tegoprazan may help address persistent treatment gaps that have challenged clinicians for years, particularly in patients who remain symptomatic despite conventional PPI therapy."