Sebela Submits NDA for Tegoprazan for GERD, Seeking Approval for NERD and Erosive Esophagitis

Sebela Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration for tegoprazan, a potassium-competitive acid blocker, for the treatment of adults with gastroesophageal reflux disease (GERD). The application, filed January 9, 2026, seeks approval for 3 indications: treatment of heartburn associated with non-erosive reflux disease (NERD), healing of erosive esophagitis (EE), and maintenance of EE healing.

According to the company, the submission is supported by data from the phase 3 TRIUMpH clinical program, which enrolled more than 2 000 US patients with GERD. The program evaluated tegoprazan across multiple efficacy end points under a prespecified hierarchical testing procedure and compared outcomes with placebo in NERD and with a proton pump inhibitor in EE.

Phase 3 efficacy findings

In the phase 3 NERD study, tegoprazan demonstrated superiority to placebo for the percentage of 24-hour heartburn-free days, with statistically significant results reported for both the 100-mg and 50-mg doses. The drug also showed superiority over placebo for the percentage of days without overnight heartburn and the percentage of days without regurgitation, according to the press release.

In the phase 3 EE study, tegoprazan was statistically superior to lansoprazole for healing at both 2 and 8 weeks across all Los Angeles classification grades of esophagitis (A through D). Superiority was also reported in patients with severe disease (grades C and D). During the 24-week maintenance phase, tegoprazan demonstrated superior sustained healing compared with proton pump inhibitor therapy in the overall study population.

Sebela reported that tegoprazan also demonstrated rapid acid suppression, achieving gastric pH greater than 4 within 45 minutes in pharmacodynamic studies.

Safety and tolerability

Across both pivotal phase 3 studies, treatment-emergent adverse events occurred in fewer than 3% of participants and were generally described as mild and transient. Serious treatment-emergent adverse events occurred in fewer than 2% of patients and at similar rates across tegoprazan and comparator groups. Mean serum gastrin levels remained within the normal range of 0 to 180 pg/mL throughout treatment periods, according to the company.

Clinical context

GERD affects an estimated 65 million people in the US and remains associated with substantial symptom burden despite widespread use of proton pump inhibitors. Sebela cited clinical evidence indicating that 35% to 54% of patients do not achieve complete symptom relief with current therapy, with particularly high unmet need among patients with NERD and those with more severe erosive esophagitis.

The TRIUMpH program consisted of 2 multicenter, double-blind phase 3 studies conducted entirely in the US. The NERD trial enrolled 800 patients and evaluated tegoprazan 50 mg and 100 mg vs placebo over 4 weeks. The EE trial enrolled 1 250 patients, including 463 with Los Angeles grade C or D esophagitis, and evaluated tegoprazan 100 mg vs lansoprazole 30 mg during an initial healing phase, followed by a 24-week maintenance phase comparing tegoprazan 50 mg and 100 mg with lansoprazole 15 mg.

Regulatory outlook

Tegoprazan has received marketing authorization in 21 countries worldwide. Sebela indicated that, if approved, tegoprazan would be the first potassium-competitive acid blocker available in the United States for the treatment of heartburn in NERD and for the healing and maintenance of healing of erosive esophagitis in adults. The company anticipates a potential US approval decision in January 2027.