Sebela Reports Positive Phase 3 Data for Tegoprazan in GERD Treatment

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.