Tegoprazan is a novel potassium-competitive acid blocker submitted for FDA approval for GERD, offering rapid, sustained acid suppression and superior healing of erosive esophagitis compared with proton pump inhibitors.
Written By: Nikita Chaudhari, BPharm
Reviewed By: Pharmacally Editorial Team
Sebela Pharmaceuticals has submitted a New Drug Application to the U.S. Food and Drug Administration for tegoprazan, a novel potassium-competitive acid blocker, for the treatment of adults with gastroesophageal reflux disease.
The NDA was filed on January 9, 2026, and seeks approval for three indications: treatment of heartburn associated with non-erosive reflux disease, healing of erosive esophagitis, and maintenance of healing of erosive esophagitis. The submission was announced by Braintree Laboratories, a part of Sebela Pharmaceuticals, and is supported by a comprehensive Phase 3 clinical program conducted entirely in the United States.
Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals, stated that the NDA submission represents a major milestone in the company’s long-standing focus on gastroenterology. He highlighted tegoprazan’s superiority over PPIs in sustained healing of erosive esophagitis and meaningful symptom relief in NERD patients, noting the unmet need among patients who remain symptomatic on existing therapies.
About Tegoprazan
Tegoprazan is a once-daily, oral acid-suppressive therapy for the treatment of gastroesophageal reflux disease (GERD). It has received marketing authorization in 21 countries and is positioned as a next-generation alternative to proton pump inhibitors. As a potassium-competitive acid blocker, tegoprazan works by reversibly binding to the gastric proton pump, providing rapid and sustained acid suppression that is not dependent on meal timing. In early pharmacodynamic studies, it achieved gastric pH levels above 4 within 45 minutes, reflecting a fast onset of action. If approved in the United States, tegoprazan would be the first P-CAB to demonstrate superiority over a PPI in healing erosive esophagitis across all severity grades.
Clinical Studies Supporting the NDA
The NDA is supported by the pivotal Phase 3 TRIUMpH clinical program, which enrolled more than 2,000 patients with GERD in the United States.
Phase 3 NERD Study (NCT05587322)
This randomized, double-blind, placebo-controlled study enrolled approximately 800 patients. Tegoprazan at doses of 50 mg and 100 mg demonstrated statistically significant superiority over placebo for the percentage of 24-hour heartburn-free days, days without overnight heartburn, and days without regurgitation.
Phase 3 EE Study (NCT05587309)
This multicentre, double-blind study enrolled around 1,250 patients, including a large subgroup with severe erosive esophagitis. Tegoprazan 100 mg showed superior healing compared with lansoprazole at both 2 and 8 weeks across all Los Angeles grades A through D. In the 24-week maintenance phase, tegoprazan 50 mg and 100 mg demonstrated superior sustained healing compared with PPI therapy.
All endpoints in the TRIUMpH program were assessed under a prespecified hierarchical multiple testing framework.
Safety Profile
Across both pivotal Phase 3 studies, tegoprazan demonstrated a favorable safety and tolerability profile. Treatment-emergent adverse events occurred at rates below 3 percent and were generally mild and transient. Serious adverse events were reported in fewer than 2 percent of patients and were comparable to comparator arms. Mean serum gastrin levels remained within the normal range throughout treatment, addressing a key long-term safety consideration in acid suppression therapy.
Philip O. Katz, MD, Professor of Medicine at Weill Cornell Medicine, commented that potassium-competitive acid blockers represent an important advance in acid suppression, offering faster onset and more consistent pH control compared with PPIs. He noted that the TRIUMpH data suggest tegoprazan may help address long-standing treatment gaps in both NERD and severe erosive esophagitis.
The NDA requests simultaneous approval for all three GERD-related indications. Sebela plans to present full results from the TRIUMpH program at major medical meetings in 2026 and to submit the data for publication in peer-reviewed journals. Tegoprazan has already established regulatory precedent outside the US, with approvals in multiple international markets.
Based on standard FDA review timelines, US approval for tegoprazan is anticipated in January 2027, which would correspond to the expected PDUFA action date. If approved, Sebela plans to commercialize tegoprazan as a new treatment option for adults with GERD, particularly those with inadequate response to proton pump inhibitors.
About GERD
GERD is a chronic and highly prevalent gastrointestinal disorder affecting an estimated 65 million people in the United States. It is associated with significant impairment in quality of life and substantial healthcare burden. Despite widespread use of PPIs, clinical evidence shows that 35 to 54 percent of patients do not achieve complete symptom control, especially those with non-erosive reflux disease or severe erosive esophagitis.
References
Sebela Pharmaceuticals® Announces Submission of New Drug Application to FDA for Tegoprazan for the Treatment of Gastroesophageal Reflux Disease, 12 January 2026, https://sebelapharma.com/assets/media/Tego-NDA-PR-010926_Final.pdf
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Non-Erosive Reflux Disease, ClinicalTrials.gov ID NCT05587322, https://clinicaltrials.gov/study/NCT05587322
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Erosive Esophagitis, ClinicalTrials.gov ID NCT05587309, https://clinicaltrials.gov/study/NCT05587309
Qiao X, Li P. Potassium-competitive acid blockers and advances in the management of patients with acid-related diseases: a narrative review. Front Physiol. 2025 Dec 19;16:1655102. Doi: 10.3389/fphys.2025.1655102. PMID: 41488920; PMCID: PMC12757290.