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Sebela Reports Positive Phase 3 Data for Tegoprazan in GERD Treatment

Sebela Pharmaceuticals has reported successful Phase 3 results for tegoprazan, a potassium-competitive acid blocker designed to treat non-erosive reflux disease. Data presented at the American College of Gastroenterology 2026 meeting show the drug significantly reduces both heartburn and regurgitation compared to placebo in patients with chronic symptoms.

The TRIUMpH-NERD study, which enrolled 783 adults, met its primary and secondary endpoints by demonstrating statistically significant improvements in 24-hour heartburn-free days and nighttime relief. Treatment effects were observed as early as the first day of administration, with sustained progress through a 20-week extension period. These results are critical for a patient population that often finds current PPI-based therapies insufficient for controlling combined symptoms.

In a separate analysis recognized by an ACG Presidential Award, researchers evaluated the TRIUMpH-EE program using Lyon 2.0 Consensus criteria. The data indicated that tegoprazan provided superior healing and maintenance of esophageal health compared to lansoprazole in patients with conclusive GERD. Braintree Laboratories, a subsidiary of Sebela, submitted a New Drug Application to the FDA earlier this year, with a regulatory decision anticipated in January 2027.

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