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In the phase III TRIUMpH-NERD trial, patients taking tegoprazan had more 24-hour heartburn-free days over four weeks than patients taking placebo. The study also reported improvements in daytime and nighttime heartburn and similar rates of serious treatment-emergent adverse events across the groups; U.S. FDA review status and a decision date were not reported.
A phase III trial found that adults with non-erosive reflux disease who took once-daily tegoprazan had a higher share of heartburn-free days over four weeks than those given placebo. At the two tested doses, 50 mg and 100 mg, the improvement was reported at the American College of Gastroenterology annual meeting; the findings add trial evidence for a medicine whose application for gastroesophageal reflux disease has been submitted to the U.S. Food and Drug Administration.
In the double-blind TRIUMpH-NERD trial, 783 patients at 91 U.S. sites were randomized to placebo, tegoprazan 50 mg or tegoprazan 100 mg once daily. Through week four, the mean percentage of 24-hour heartburn-free days was 17.3% with placebo, 26.2% with 50 mg and 30.1% with 100 mg. The report described the results for tegoprazan as relative improvements over placebo of 51% and 74%, respectively; the comparisons were statistically significant.
Daytime and nighttime symptoms also improved on the trial’s secondary measures. By day 28, mean percentages of days without daytime heartburn were 27.4% with placebo, 36% with 50 mg and 38.4% with 100 mg. For days without nighttime heartburn, the respective figures were 27%, 36.1% and 39.9%. An exploratory analysis found more regurgitation-free days with either tegoprazan dose than with placebo. These are trial averages, not a guarantee of symptom relief for an individual patient.
After a 20-week extension, the share of 24-hour heartburn-free days was 47.8% in the 50-mg group and 50.4% in the 100-mg group. The report did not give a placebo comparison for that extension result. Serious treatment-emergent adverse-event rates were described as similar across the three groups. Adverse events led to treatment discontinuation in 1.1% of placebo recipients, 1.9% of those taking 50 mg and 1.5% of those taking 100 mg.
A Potential Option for NERD Symptoms
The findings address a treatment gap for people with non-erosive reflux disease (NERD), a common form of GERD in which reflux symptoms occur without visible erosions on endoscopy. The study’s comparison with placebo suggests tegoprazan may reduce symptom frequency for some patients, including daytime and nighttime heartburn. The size of the average benefit and the four-week primary assessment provide useful evidence, but do not establish how an individual will respond or how the drug compares directly with other treatments.
The report cited dissatisfaction with proton pump inhibitors (PPIs) among some people with GERD and said symptom relief with standard-dose PPIs in NERD has been reported at about 50%. Tegoprazan belongs to a different class, potassium-competitive acid blockers, which also inhibit acid production. The trial results may be relevant to future treatment choices, but availability for GERD in the United States depends on the FDA process; the supplied report does not give a decision date or outcome.
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How the Trial Tested Tegoprazan
Patients qualified if they had experienced heartburn for at least six months, had a normal endoscopy during screening and reported heartburn on at least four days in the screening week. Only 6.2% reported a heartburn-free day at baseline. Participants had a mean age of 51 to 53; 65% to 74% were women, and the reported racial composition varied by treatment arm.
Presenter Ronnie Fass of Case Western Reserve University School of Medicine described tegoprazan as fast-acting, citing data that it can raise stomach pH above 4 within 45 minutes. That is a pharmacologic measure, not the same outcome as symptom relief. The trial’s primary finding was based on patients’ heartburn-free days, while the presentation also reported symptom severity and regurgitation measures.
Fass said the study supports tegoprazan as a treatment option for NERD. During the meeting discussion, Henry Parkman of Temple University asked whether lifestyle changes during the study could have contributed to placebo-group improvement. Fass said there could be several explanations, including lifestyle modifications, and noted that a placebo response is not unique to this study.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, Case Western Reserve University School of Medicine
Questions on Approval and Long-Term Benefit
The meeting report does not provide the FDA’s review status, a possible decision date or whether the agency has requested additional information. It says a new drug application for tegoprazan for GERD was submitted in January, but does not specify the year in that statement. The trial findings alone do not establish that the drug is approved or available for this use in the United States.
The four-week placebo-controlled results show an average difference between groups, while the extension figures supplied cover only the tegoprazan arms. The report does not provide a placebo comparison for the extension or enough detail to establish longer-term comparative effectiveness. It also notes placebo-group improvement, with possible lifestyle changes raised as one explanation, but does not establish what caused it. The source summary does not include detailed rates for all non-serious adverse events.
FDA Review and Further Evidence
The next regulatory milestone is the FDA’s review of the submitted GERD application, but no decision timing or agency action is included in the report. If the agency issues a decision or requests further information, that would clarify whether tegoprazan can be marketed for GERD in the United States.
For a fuller assessment of the trial, readers will need access to the complete study results, including detailed safety data, methods and longer-term comparisons. The meeting presentation establishes a placebo-controlled symptom benefit over four weeks; it does not settle how the treatment performs against existing therapies or which patients are most likely to benefit.
Key Questions
What did the phase III trial find?
Over four weeks, the mean share of 24-hour heartburn-free days was 26.2% with tegoprazan 50 mg and 30.1% with 100 mg, compared with 17.3% with placebo. The study also reported improvements in daytime and nighttime heartburn measures.
What is non-erosive reflux disease?
NERD is a form of gastroesophageal reflux disease in which people have reflux symptoms but no visible erosions on endoscopy, according to the trial description. The study enrolled participants with a normal endoscopy and recurring heartburn.
Was tegoprazan approved by the FDA for GERD?
The supplied report says a new drug application for tegoprazan for GERD was submitted to the FDA in January. It does not state whether the FDA has approved the application or provide a decision date.
What safety results were reported?
Serious treatment-emergent adverse-event rates were described as similar across placebo and both tegoprazan groups. Adverse events led to discontinuation in 1.1% of placebo recipients, 1.9% of the 50-mg group and 1.5% of the 100-mg group. The report summary does not provide full details on non-serious events.
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