Sebela reports Phase 3 tegoprazan results showing improved heartburn-free days in NERD, alongside post hoc findings on erosive esophagitis healing.
Written By: Neha Vishwakarma, PharmD
Reviewed By: Pharmacally Editorial Team
Braintree Laboratories, part of Sebela Pharmaceuticals, reported positive Phase 3 TRIUMpH-NERD results for tegoprazan in adults with non-erosive reflux disease (NERD) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. Both doses significantly improved heartburn-free days and days without nighttime heartburn versus placebo over four weeks. The company also reported improvements in regurgitation-related endpoints and longer-term observations from a 20-week extension.
A separate post hoc analysis of the TRIUMpH erosive esophagitis (EE) trial received an ACG Presidential Award. Together, the findings add to the evidence supporting Sebela’s U.S. New Drug Application (NDA) for tegoprazan, which remains investigational in the United States.
Tegoprazan and the Unmet Need in GERD
NERD is a form of gastroesophageal reflux disease (GERD) characterized by reflux symptoms without visible esophageal erosions. Proton pump inhibitors (PPIs) remain standard therapy, but some patients experience incomplete symptom relief, particularly for regurgitation.
Tegoprazan is an oral potassium-competitive acid blocker (P-CAB) that reversibly inhibits the gastric proton pump. Phase 1 studies showed that it raised intragastric pH above 4 within 45 minutes of dosing. Marketed as K-CAB in several countries, tegoprazan is not approved in the United States.
TRIUMpH-NERD Trial Results
The randomized, double-blind, placebo-controlled trial (NCT05587322) enrolled 783 adults who 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; the key secondary endpoint was days without nighttime heartburn. Regurgitation was a prespecified exploratory endpoint.
Only 6.2% of patients had heartburn-free days at baseline, indicating substantial symptom burden.
Endpoint, least-squares mean through Week 4 | Placebo | 50 mg | 100 mg |
24-hour heartburn-free days | 17.3% | 26.2% | 30.1% |
Days without nighttime heartburn | 27.0% | 36.1% | 39.9% |
For heartburn-free days, tegoprazan improved outcomes by 8.9 percentage points with 50 mg and 12.8 points with 100 mg versus placebo, representing relative increases of approximately 51% and 74%, respectively (p=0.0006 and p<0.0001).
Days without nighttime heartburn increased by 9.1 and 12.9 percentage points, respectively (p=0.0017 and p<0.0001). Both doses also significantly improved regurgitation-free days and days free of both heartburn and regurgitation. The company reported relative improvements of 60% and 76% over placebo for the combined endpoint.
Treatment effects were reported from Day 1. By Day 28, heartburn-free days reached 38.9% with 50 mg and 45.6% with 100 mg, versus 26.7% with placebo. During the subsequent open-label extension, average heartburn-free days were 48% and 50%, respectively. These extension findings are descriptive and are not equivalent to continued placebo-controlled comparisons.
Post Hoc Analysis of Erosive Esophagitis
The separate TRIUMpH-EE trial (NCT05587309) was reanalysed using Lyon Consensus 2.0 criteria. The analysis classified Los Angeles (LA) Grades B to D as conclusive GERD and Grade A as inconclusive GERD.
Among 1,245 patients in the modified intention-to-treat population with conclusive GERD, tegoprazan 100 mg achieved higher EE healing rates than lansoprazole at Week 2 (75.4% versus 60.7%; p<0.0001) and cumulatively by Week 8 (83.4% versus 72.7%; p=0.0005). Both tegoprazan doses also outperformed lansoprazole for maintenance of healing at Week 24 in this subgroup (p≤0.0019). No significant differences were reported in the inconclusive GERD subgroup.
These post hoc findings suggest that disease classification may be relevant when interpreting treatment outcomes, but they do not establish a definitive predictive treatment effect or apply automatically to all patients with GERD.
Safety and Regulatory Status
Across the TRIUMpH program, the company reported individual treatment-emergent adverse events at approximately 3% and serious events at approximately 2%, with generally mild and transient events and similar rates across comparator groups. Mean serum gastrin levels remained within the reported normal range of 0–180 pg/mL. These findings do not establish safety beyond the studies’ duration and scope.
Sebela submitted an NDA in January 2026 for heartburn associated with NERD, EE healing, and maintenance of EE healing in adults. The company anticipates potential U.S. approval in January 2027, but this is not a confirmed FDA decision date. Approval remains pending.
Reference
Sebela Pharmaceuticals to Present Positive Phase 3 Tegoprazan Data in Non-Erosive Reflux Disease (NERD) at the American College of Gastroenterology (ACG) 2026 Meeting, Sebela Pharmaceuticals, 11 October 2026
A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Non-Erosive Reflux Disease, ClinicalTrials.gov ID NCT05587322
About the Writer
Neha Vishwakarma (LinkedIn) is a Pharm.D professional with experience in clinical pharmacy, pharmacovigilance, and clinical research. She has hands-on experience in ADR assessment, ICSR processing, medication safety, and clinical data evaluation. Her research background in surgical site infections and antibiotic use supports her focus on evidence-based healthcare writing.