Only 6.2% of patients in Sebela’s TRIUMpH-NERD trial entered the study with a heartburn-free day at baseline, a burden heavier than the 12.9%–22.6% range seen in comparable NERD trials of PPIs and P-CABs. That context matters for reading what came next: tegoprazan 100 mg produced a 74% relative increase in 24-hour heartburn-free days over placebo through week 4, and tegoprazan 50 mg a 51% relative increase, both reaching statistical significance (p=0.0006 and p<0.0001, respectively).
The TRIUMpH-NERD study enrolled 783 adults in a randomized, double-blind, placebo-controlled design. Both doses met the primary endpoint (24-hour heartburn-free days through week 4) and the key secondary endpoint (nights without heartburn). The trial also captured regurgitation as a prespecified exploratory endpoint, and both doses outperformed placebo there too. For the combined endpoint of days free of both symptoms, the relative improvements were 60% and 76% over placebo for 50 mg and 100 mg, respectively. That dual-symptom finding carries clinical weight: among 500 GERD patients surveyed, 83% of those on or previously on a PPI identified regurgitation as their primary complaint, the symptom PPIs handle least reliably. By week 4, 38.9% and 45.6% of patients on the two doses had heartburn-free days, versus 26.7% on placebo. During the 20-week open-label extension, heartburn-free days averaged roughly 48%–50% across both doses.
A separate ACG Presidential Award went to a post hoc analysis of the TRIUMpH erosive esophagitis (EE) program. Investigators reclassified patients using Lyon Consensus 2.0 criteria, separating conclusive GERD (LA Grades B–D) from inconclusive (LA Grade A). Among the 415 patients with conclusive GERD on tegoprazan 100 mg, healing at weeks 2 and 8 and maintenance of healing at week 24 were statistically superior to lansoprazole (n=399). Tegoprazan 50 mg was also superior to lansoprazole at week 24 maintenance.
Tegoprazan remains investigational in the U.S. Sebela submitted its NDA to the FDA on January 9, 2026, covering GERD indications including NERD and EE. The P-CAB class already has an FDA-approved representative in the U.S.: vonoprazan (VOQUEZNA), approved for erosive esophagitis in November 2023. Whether the ACG data gives regulators anything new to weigh on the NERD question specifically will be clearer once the agency’s review of that NDA is complete.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
