— Findings support tegoprazan as a therapeutic option for most common phenotype of GERD
October 15, 2026 • 3 min read
Patients with non-erosive reflux disease (NERD) who took once-daily tegoprazan -- a novel, fast-acting, oral potassium-competitive acid blocker (P-CAB) -- had a significant reduction in heartburn frequency, a phase III trial showed.
Among patients randomized to placebo or tegoprazan 50 mg or 100 mg, mean percentages of 24‑hour heartburn‑free days through week 4 were 17.3%, 26.2%, and 30.1%, respectively, translating into relative improvements of 51% (P=0.0006) and 74% (P<0.0001) with tegoprazan over placebo, reported Ronnie Fass, MD, of Case Western Reserve University School of Medicine in Cleveland.
Key secondary endpoints of percentages of days without daytime and nighttime heartburn were also significantly improved with tegoprazan, he said at the American College of Gastroenterologyopens in a new tab or window annual meeting in Nashville, Tennessee.
In an exploratory endpoint, tegoprazan at both doses significantly improved the percentages of regurgitation-free days versus placebo: 31.9% with 50 mg and 33.8% with 100 mg versus 23.6% with placebo (P=0.0012 and P<0.0001).
After a 20-week extension period, the percentage of 24-hour heartburn-free days was 47.8% in the tegoprazan 50-mg group and 50.4% in the 100-mg group.
"These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease," Fass noted.
During a Q&A after the presentation, Henry Parkman, MD, of the Lewis Katz School of Medicine at Temple University in Philadelphia, observed that a high percentage of patients on placebo also improved over time.
"Were any additional things being done at the time of enrollment, like diet management ... that might have led to the decreased heartburn and regurgitation in patients on placebo?" Parkman asked.
Fass said that while there could be a number of reasons for the response on placebo, including lifestyle modifications during the course of the study, the placebo effect "is not unique to this study."
"The good thing is that we were able to show that there was still a big separation between the treatment arms and placebo," he added.
Study Rationale and Design
Fass noted that gastroesophageal reflux disease (GERD) affects up to 20% of U.S. adults, with NERD being the most common phenotype, affecting up to 70% of patients. Of note, about 35% of GERD patients report dissatisfaction with proton pump inhibitors (PPIs).
"If you look at NERD patients, symptom relief with standard-dose PPIs has been reported to be around 50%," Fass said.
"Now, P-CABs and PPIs ... both inhibit the proton pump, but they do differ significantly in relation to their pharmacokinetics and pharmacodynamics," he pointed out. "Tegoprazan is structurally different from the other P-CABs, and it also has unique binding properties."
In addition, "tegoprazan demonstrates rapid onset," Fass explained. "It can achieve a pH above 4 in the stomach within 45 minutes after administration. It provides steady state within 1 day, stable pH control without excessive fluctuations, and it can maintain gastrin levels during the treatment period within the normal range."
The double-blind TRIUMpH-NERDopens in a new tab or window trial was conducted at 91 U.S. sites and included 783 patients (mean age 51-53, 65-74% women, 68-74% white, and 22-27% Black). Just 6.2% of patients reported having 24-hour heartburn-free days at baseline.
To be included in the trial, patients had to have symptoms of heartburn for at least 6 months prior to randomization, have a normal endoscopy during the 1-week screening period, and have at least 4 days of symptoms of heartburn during that period.
Regarding the trial's secondary endpoints, the mean percentages of days without daytime heartburn were 36% and 38.4% for tegoprazan 50 mg and 100 mg, respectively, versus 27.4% with placebo by day 28. Mean percentages of days without nighttime heartburn were 36.1%, 39.9%, and 27%, respectively.
The mean percentages of days without both heartburn and regurgitation also favored tegoprazan, with rates of 24.5% with 50-mg tegoprazan, 27% with 100 mg, and 15.3% with placebo (P=0.0002 and P<0.0001).
"Also, when you look at the mean severity of GERD symptoms, the treatment arms were significantly better in improving severity as compared to placebo -- both heartburn severity and regurgitation severity," Fass reported.
Rates of serious treatment-emergent adverse events (TEAEs) were similar across the three arms, with TEAEs leading to treatment discontinuation occurring in 1.1% of patients on placebo, 1.9% in the tegoprazan 50-mg arm, and 1.5% in the 100-mg arm.
A new drug application for tegoprazanopens in a new tab or window for the treatment of GERD was submitted to the FDA in January.