Tegoprazan Phase 3 Data in Non-Erosive Reflux Disease, With Ronnie Fass, MD

Once-daily tegoprazan, an investigational potassium-competitive acid blocker (P-CAB), significantly increased heartburn-free days compared with placebo in adults with non-erosive reflux disease (NERD) in the phase 3 TRIUMpH-NERD trial. The results were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee.¹

Results showed both the 50 mg and 100 mg doses also improved nighttime heartburn and regurgitation, with differences from placebo apparent from the first day of treatment.¹

NERD accounts for up to 70% of patients with gastroesophageal reflux disease (GERD), and symptom relief with standard-dose proton pump inhibitors (PPIs) is about 50%.^1,2 Ronnie Fass, MD, of MetroHealth Medical Center in Cleveland, Ohio, told HCPLive these patients are harder to treat than once assumed.

“We do see that there is an area of unmet need here,” Fass explained. “That’s where tegoprazan and other P-CABs come in very nicely, because of their unique pharmacokinetic and pharmacodynamic characteristics.”

TRIUMpH-NERD Phase 3 Trial Design

TRIUMpH-NERD randomly assigned 783 adults at 91 US sites in a 1:1:1 ratio to tegoprazan 50 mg, tegoprazan 100 mg, or placebo once daily for 4 weeks. Eligible patients had ≥ 6 months of heartburn, no mucosal breaks on endoscopy, and heartburn on ≥ 4 days of any 7-day screening window. Central readers confirmed the absence of erosive esophagitis using full procedural videos.¹

After the 4-week treatment phase, 699 patients entered a 20-week extension phase, with placebo patients re-randomized to either tegoprazan dose. Mean age was 51.9 years, and 68.6% of patients were women.¹

Tegoprazan Improves Heartburn-Free and Nighttime Heartburn-Free Days

Least-squares mean percentages of 24-hour heartburn-free days through week 4, the primary endpoint, were 17.3% with placebo, 26.2% with tegoprazan 50 mg, and 30.1% with tegoprazan 100 mg. These figures were relative improvements over placebo of 51% (P = .0006) and 74% (P <.0001).¹

Days without nighttime heartburn, the key secondary endpoint, reached 27.0%, 36.1%, and 39.9%, respectively (P = .0017 and P <.0001 vs placebo).¹ Fass noted nighttime symptoms are important to control because patients with nocturnal GERD are more likely to develop severe erosive esophagitis, Barrett’s esophagus, and esophageal adenocarcinoma.

Regurgitation and Combined Symptom Relief in NERD

Regurgitation-free days rose from 23.6% with placebo to 31.9% and 33.8% with tegoprazan 50 mg and 100 mg, respectively.¹ Fass noted regurgitation is less common than heartburn but more difficult to treat and highly disruptive to quality of life.

The largest relative gains came in days free of both heartburn and regurgitation, which rose from 15.3% with placebo to 24.5% and 27% with tegoprazan, increases of 60% and 76%. Both doses also lowered mean heartburn and regurgitation severity scores over weeks 1 to 4.¹

Extension Phase Results and Gastrin Safety Data

Symptom control continued to improve through the extension phase. By weeks 5 to 24, heartburn-free days reached 47.8% with continuous tegoprazan 50 mg and 50.4% with 100 mg.¹

Rates of treatment-emergent adverse events were similar across arms during the treatment phase (22.9% placebo, 27.0% tegoprazan 50 mg, 22.9% tegoprazan 100 mg). Mean serum gastrin rose but stayed within normal limits (<180 ng/L) and returned to baseline within 2 weeks of stopping treatment.¹ Fass said these gastrin findings should reassure physicians concerned about long-term acid suppression.

Tegoprazan FDA Review and the Growing P-CAB Landscape

Vonoprazan became the first P-CAB approved in the US for heartburn associated with NERD in July 2024.⁴ Sebela Pharmaceuticals submitted a new drug application for tegoprazan in January 2026 covering NERD, healing of erosive esophagitis, and maintenance of healing, with a decision anticipated in January 2027.³

“As more P-CABs come to the market, knowing what they bring to the table as compared to PPIs, my belief is that they will take a bigger and bigger piece of the market,” said Fass.

Editors’ note: Fass reports relevant disclosures with BrainTree Labs/Sebela.

References

1. Fass R, Sharma P, Schnoll-Sussman FH, et al. Tegoprazan significantly improves heartburn and regurgitation in a randomized, double-blind, placebo-controlled phase 3 study in patients with non-erosive reflux disease. Presented at: American College of Gastroenterology 2026 Annual Scientific Meeting; October 9-14, 2026; Nashville, TN.

2. Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG clinical guideline for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2022;117(1):27-56. doi:10.14309/ajg.0000000000001538

3. Sebela Pharmaceuticals announces submission of new drug application to FDA for tegoprazan for the treatment of gastroesophageal reflux disease. News release. Sebela Pharmaceuticals. January 12, 2026. Accessed October 16, 2026. https://www.prnewswire.com/news-releases/sebela-pharmaceuticals-announces-submission-of-new-drug-application-to-fda-for-tegoprazan-for-the-treatment-of-gastroesophageal-reflux-disease-302657918.html

4. Vonoprazan receives FDA approval for heartburn associated with non-erosive GERD. HCPLive. July 18, 2024. Accessed October 16, 2026. https://hcplive.com/view/vonoprazan-receives-fda-approval-for-heartburn-associated-with-non-erosive-gerd