Tegoprazan NDA Seeks FDA Approval for 3 GERD Indications

Braintree Laboratories, a part of Sebela Pharmaceuticals, has announced the submission of a New Drug Application (NDA) on January 9, 2026, to the US 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).1

As described in a January 12, 2026, release from the Company, the NDA is supported by data from the phase 3 TRIUMpH clinical program in > 2000 US patients demonstrating tegoprazan's clinical superiority over a PPI across multiple endpoints. The submission seeks simultaneous approval for 3 indications: treatment of heartburn associated with non-erosive reflux disease (NERD), healing of erosive esophagitis (EE), and maintenance of EE healing.1

"Today's NDA submission for tegoprazan marks a transformative moment in our 40-year commitment to advancing gastroenterology care," Alan Cooke, President and CEO of Sebela Pharmaceuticals, said in a statement.1 "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."

Standard PPI treatment is not sufficient for many patients with GERD, especially those with more severe erosive esophagitis and those with NERD. Effective alternatives for these patients are limited, with the most recent advancement being the FDA approval of Phathom Pharmaceuticals’ vonoprazan (Voquezna) as a daily treatment for heartburn associated with NERD in 2024.1,2

Tegoprazan is a novel, once-daily oral medication in the P-CAB class which has been shown to provide rapid onset of action, sustained acid control for longer periods than PPIs, and superior efficacy in healing and maintaining healing of EE. In phase 1 pharmacodynamic studies, tegoprazan demonstrated rapid acid control (pH>4) within 45 minutes.1

The TRIUMpH program comprises 2 phase 3 studies of tegoprazan in US patients with GERD, including both EE and NERD. The phase 3 NERD study was a large, multicenter, double-blind study (n = 800) designed to demonstrate the safety and efficacy of tegoprazan 50 mg and 100 mg versus placebo over 4 weeks. Results showed tegoprazan demonstrated superiority over placebo for the percentage of 24-hour heartburn-free days (P <.0001 and P = .0006 for tegoprazan 100 mg and 50 mg, respectively), as well as for percentage of days without overnight heartburn and percentage of days without regurgitation.1

The Phase 3 EE study was a large, multi-center, double-blind study (n = 1250, including 463 patients with LA Grade C and D esophagitis) evaluating the safety and efficacy of tegoprazan 100 mg versus lansoprazole 30 mg. The study consisted of an initial healing phase (evaluated at 2 and 8 weeks) followed by a 24-week maintenance phase (tegoprazan 50mg and 100 mg vs lansoprazole 15 mg).1

In EE, tegoprazan demonstrated statistically superior healing compared to lansoprazole at both 2 and 8 weeks across all grades of EE (LA Grades A-D: P <.0001 and P = .0083 for tegoprazan 100 mg at weeks 2 and 8, respectively), and in patients with severe disease (LA Grades C and D: P <.0001 and P = .0002 for tegoprazan 100 mg at weeks 2 and 8, respectively).1

In the 24-week maintenance phase, tegoprazan showed superior sustained healing compared to PPI therapy in all patients (P <.0001 and P = .0145 for tegoprazan 100 mg and 50 mg, respectively). Additionally, tegoprazan demonstrated superior healing and heartburn relief in patients with severe disease.1

Across both studies, individual treatment-emergent adverse events occurred at a rate of <3% and were generally mild and transient. The overall rate of serious treatment-emergent adverse events in each study was <2% and similar between tegoprazan and comparator groups. Mean serum gastrin levels for tegoprazan and lansoprazole remained within the normal range (0-180 pg/ml) throughout the treatment periods.1

"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,” Philip Katz, MD, Professor of Medicine at Weill Cornell Medicine, said in a statement.1 “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."

In the press release, Sebela described plans to present full results from the TRIUMpH program at upcoming medical meetings in 2026 and submit for publication in respected peer-reviewed journals.1

References

1. Sebela Pharmaceuticals. Sebela Pharmaceuticals® Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux Disease. January 12, 2026. Accessed January 12, 2026. https://www.prnewswire.com/news-releases/sebela-pharmaceuticals-announces-submission-of-new-drug-application-to-fda-for-tegoprazan-for-the-treatment-of-gastroesophageal-reflux-disease-302657918.html

2. Brooks A. Vonoprazan (Voquezna) Receives FDA Approval for Heartburn Associated with Non-Erosive GERD. HCPLive. July 18, 2024. Accessed January 12, 2026. https://www.hcplive.com/view/vonoprazan-receives-fda-approval-for-heartburn-associated-with-non-erosive-gerd