Braintree, Mass. – October 11, 2026 -- Braintree Laboratories, part of Sebela Pharmaceuticals, reported that its investigational P-CAB tegoprazan delivered statistically significant gains over placebo in both heartburn and regurgitation in the 783-patient Phase 3 TRIUMpH-NERD study. The company describes it as the first P-CAB to show clinical improvement in both hallmark non-erosive reflux disease (NERD) symptoms in a prospective U.S. Phase 3 trial.
Both tegoprazan doses meet primary and key secondary endpoints
TRIUMpH-NERD (NCT05587322) was a randomized, double-blind, placebo-controlled, multicenter study. Patients received tegoprazan 50 mg, tegoprazan 100 mg or placebo once daily for four weeks, followed by a 20-week extension. The primary endpoint was the percentage of 24-hour heartburn-free days through Week 4. Days without nighttime heartburn was a key secondary endpoint, and regurgitation was a prespecified exploratory endpoint.
Least-squares mean 24-hour heartburn-free days through Week 4 were 17.3% with placebo, 26.2% with 50 mg (p=0.0006) and 30.1% with 100 mg (p0.0001). These are relative increases of 51% and 74% over placebo. Days without nighttime heartburn reached 36.1% and 39.9% for the two doses versus 27.0% for placebo.
Combined symptom-free days rise 60% and 76% over placebo
For days free of both heartburn and regurgitation, tegoprazan showed relative improvements of 60% (50 mg) and 76% (100 mg) over placebo through Week 4. Treatment differences appeared from Day 1. At Day 28, heartburn-free day rates were 38.9% for 50 mg and 45.6% for 100 mg, against 26.7% for placebo.
During the 20-week open-label extension, mean 24-hour heartburn-free days averaged 48% with 50 mg and 50% with 100 mg. Days without regurgitation showed similar results.
Trial enrolled sicker patients than prior NERD studies
Only 6.2% of enrolled patients had 24-hour heartburn-free days at baseline. In other NERD studies of PPIs and P-CABs, the company cites baseline rates of 12.9% to 22.6%.
Presenting author Ronnie Fass of Case Western Reserve University School of Medicine said effective NERD treatment must address both heartburn and regurgitation. A survey of 500 GERD patients cited by the company found regurgitation was the most common symptom overall. It was the primary complaint for 83% of patients who are or have been treated with a PPI.
Presidential Award analysis shows tegoprazan healing edge over lansoprazole
A separate post hoc analysis of the TRIUMpH-EE program (NCT05587309) won an ACG Presidential Award. Presented by Walter Chan of Harvard Medical School, it reclassified baseline erosive esophagitis (EE) under Lyon Consensus 2.0. LA Grades B-D were defined as conclusive GERD and Grade A as inconclusive.
In the 1,245-patient modified intention-to-treat population, healed EE among conclusive GERD patients was higher with tegoprazan than lansoprazole at Week 2 (75.4% vs 60.7%, p0.0001). The gap persisted cumulatively by Week 8 (83.4% vs 72.7%, p=0.0005). Both 50 mg and 100 mg were superior to lansoprazole for maintaining healing at Week 24. No statistically significant differences emerged in inconclusive GERD.
Safety profile shows individual adverse events near 3%
Across TRIUMpH, individual treatment-emergent adverse events occurred at roughly 3% and were generally mild and transient. Serious events occurred at approximately 2%, with similar rates between tegoprazan and comparators. Mean serum gastrin stayed within the normal range of 0-180 pg/mL for both tegoprazan and lansoprazole.
Braintree submitted a New Drug Application for tegoprazan to the U.S. in January 2026. Tegoprazan holds marketing authorization in 24 countries and is sold as K-CAB in several regions outside the U.S., including South Korea.