Braintree, Massachusetts, USA, October 11, 2026
Sebela Pharmaceuticals has announced positive Phase 3 clinical results for tegoprazan, an investigational oral treatment being developed for adults with gastroesophageal reflux disease (GERD), including non-erosive reflux disease (NERD). Detailed findings from the TRIUMpH-NERD study were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. The randomized, double-blind, placebo-controlled study evaluated tegoprazan at doses of 50 mg and 100 mg once daily in adults experiencing reflux symptoms without visible erosive damage to the esophagus. Both doses demonstrated statistically significant improvements in the percentage of heartburn-free days and days without nighttime heartburn compared with placebo. The treatment also improved regurgitation-free days and days without both heartburn and regurgitation. The findings suggest that tegoprazan may offer a comprehensive approach to managing the major symptoms of NERD, an area where some patients continue to experience symptoms despite available treatments. Sebela submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in January 2026 seeking approval for NERD and erosive esophagitis indications. Tegoprazan remains investigational in the United States pending regulatory review.
Phase 3 TRIUMpH-NERD Trial Shows Symptom Improvement
The TRIUMpH-NERD Phase 3 trial enrolled 783 adults and compared tegoprazan 50 mg, tegoprazan 100 mg and placebo, administered once daily for four weeks. Participants then entered a 20-week extension phase to evaluate longer-term symptom outcomes. The primary endpoint measured the percentage of 24-hour heartburn-free days through Week 4, while the key secondary endpoint assessed days without nighttime heartburn. Results showed that the least-squares mean percentage of heartburn-free days was 26.2% with tegoprazan 50 mg and 30.1% with tegoprazan 100 mg, compared with 17.3% with placebo. These differences represented relative increases of 51% and 74%, respectively, over placebo. Both doses achieved statistical significance, with p-values of 0.0006 and below 0.0001. The study also reported significant improvements in nighttime heartburn-free days, reaching 36.1% with the 50 mg dose and 39.9% with the 100 mg dose, compared with 27.0% with placebo. Treatment effects were observed from the first day, and heartburn-free days continued to improve during the four-week treatment period. These results provide evidence of symptom relief in adults with NERD, although individual treatment responses may vary.
Tegoprazan Targets Acid Production Through P-CAB Technology
Tegoprazan belongs to a class of medicines called potassium-competitive acid blockers (P-CABs), which suppress gastric acid secretion by reversibly inhibiting the gastric proton pump through potassium-competitive binding. Unlike conventional proton pump inhibitors (PPIs), P-CABs have demonstrated rapid acid-control activity, making them an area of interest in the treatment of acid-related gastrointestinal disorders. In Phase 1 pharmacodynamic studies, tegoprazan achieved an intragastric pH above 4 within approximately 45 minutes of dosing. In the TRIUMpH-NERD study, prespecified exploratory analyses showed that tegoprazan significantly increased the percentage of days without regurgitation and days free of both heartburn and regurgitation compared with placebo. The combined symptom-free endpoint improved by 60% with tegoprazan 50 mg and 76% with tegoprazan 100 mg relative to placebo. During the 20-week extension, the mean percentage of 24-hour heartburn-free days was approximately 48% and 50% with the 50 mg and 100 mg doses, respectively. These results support further evaluation of tegoprazan as a potential treatment for multiple hallmark GERD symptoms, although the extension phase and the initial placebo-controlled period differ in study design and should be interpreted accordingly.
Advertisement
FDA Review Could Expand GERD Treatment Options
Sebela’s broader TRIUMpH clinical program includes studies in both non-erosive reflux disease and erosive esophagitis (EE). Separate Phase 3 analyses of erosive esophagitis have reported improvements in esophageal healing and maintenance of healing compared with lansoprazole, a conventional PPI. The company submitted its NDA to the FDA in January 2026, seeking approval for heartburn associated with NERD, healing of erosive esophagitis and maintenance of erosive esophagitis healing in adults. The FDA’s review will determine whether the evidence supports approval for these proposed uses. Across the clinical program, the company reported that adverse events were generally mild and transient, with serious events occurring at similar rates between tegoprazan and comparator groups. Continued regulatory assessment will consider efficacy, safety and manufacturing information. If approved, tegoprazan could provide another treatment option for adults with GERD, particularly those who need better control of heartburn or regurgitation. Until the FDA reaches a decision, the medicine should be described as investigational in the United States. The Phase 3 findings represent an important development in gastroenterology research and highlight continued efforts to improve treatment for patients with persistent reflux symptoms.
Source: Sebela Pharmaceuticals press release
