TL;DR
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In a phase III trial of 783 people with non-erosive reflux disease, once-daily tegoprazan was associated with more heartburn-free days over four weeks than placebo. The findings were presented at an American College of Gastroenterology meeting; the source says a U.S. drug application was submitted in January, but does not report its review status or a decision.
A phase III trial found that adults with non-erosive reflux disease (NERD) who took once-daily tegoprazan had more heartburn-free days over four weeks than participants who received placebo. The results, presented by gastroenterologist Ronnie Fass at the American College of Gastroenterology annual meeting, add evidence for a potential treatment for a common form of reflux disease, but do not establish whether the drug is approved or when it might become available in the United States.
The double-blind TRIUMpH-NERD trial enrolled 783 patients at 91 U.S. sites. Participants were assigned to placebo, tegoprazan 50 mg or tegoprazan 100 mg once daily. Through week four, the mean share of days without heartburn over a full 24-hour period was 17.3% with placebo, 26.2% with 50 mg and 30.1% with 100 mg. The report described the results for the two doses as relative improvements of 51% and 74% over placebo, respectively.
Daytime and nighttime heartburn-free days, both key secondary measures, also favored tegoprazan by day 28. The mean percentages of days without daytime heartburn were 36% and 38.4% for the 50-mg and 100-mg groups, compared with 27.4% for placebo. For nighttime heartburn, the corresponding figures were 36.1%, 39.9% and 27%. The researchers also reported improvements in regurgitation-free days and symptom severity in the tegoprazan groups.
During a 20-week extension, the percentage of 24-hour heartburn-free days was 47.8% in the 50-mg group and 50.4% in the 100-mg group. The source does not give a placebo comparison for that extension result. Serious treatment-emergent adverse events were reported at similar rates across the three groups. Events leading to treatment discontinuation occurred in 1.1% of placebo recipients, 1.9% of patients taking 50 mg and 1.5% taking 100 mg.
A Potential Option for NERD
NERD describes reflux symptoms in people whose endoscopy does not show the erosions associated with other forms of GERD. The trial matters because its results point to a possible additional treatment for patients whose symptoms persist or are not adequately controlled with current options. In the four-week comparison, both tegoprazan doses produced a higher average share of heartburn-free days than placebo.
The findings do not mean that most patients became symptom-free. Even in the 100-mg group, the mean measure was 30.1% of days without 24-hour heartburn through week four. Nor does the trial, as summarized in the report, establish how the drug compares directly with proton pump inhibitors (PPIs), or which patients are most likely to benefit. The results support further consideration of tegoprazan, rather than proving it is the right treatment for every person with NERD.
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Trial Design and Treatment Background
Participants had experienced heartburn for at least six months, had a normal endoscopy during screening and reported symptoms on at least four days during a one-week screening period. Only 6.2% reported a heartburn-free 24-hour period at baseline, according to the meeting report. The study population had a mean age of 51 to 53; 65% to 74% were women, and 68% to 74% were white, with 22% to 27% Black.
Fass said GERD affects up to 20% of U.S. adults and that NERD is its most common phenotype. He also cited reports that about 35% of people with GERD are dissatisfied with PPIs, and that standard-dose PPIs provide symptom relief for around half of NERD patients. Tegoprazan is a potassium-competitive acid blocker, a different drug class from PPIs, though both act on stomach acid production. Fass said the drug can raise stomach pH above 4 within 45 minutes; that pharmacology claim is distinct from the clinical symptom results reported in this trial.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, of Case Western Reserve University School of Medicine
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Approval and Longer-Term Results
The report says a new drug application for tegoprazan to treat GERD was submitted to the U.S. Food and Drug Administration in January, but it does not specify the year, the application’s current status, or whether the agency has set a decision date. The meeting summary also does not provide the full trial protocol or results for every safety measure, so the reported adverse-event figures should not be treated as a complete account of risks.
The placebo group also showed improvement, and Parkman asked whether changes such as diet management may have contributed. Fass said there could be several explanations, including lifestyle changes, and noted that placebo responses are not unique to this study. The supplied report does not establish how much any such changes affected the results. The 20-week extension figures are reported for the two tegoprazan groups, without a corresponding placebo figure in the summary.
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FDA Review and Full Trial Data
The next key development is the status of the FDA application: whether it is under review, whether the agency requests additional information, and whether a decision date is announced. The source material provides no update on those steps. Readers should not infer approval from the fact that an application was submitted.
Further details from the trial may clarify the durability of symptom relief, how outcomes compare with existing treatments, and the full safety profile. Until those details and the regulatory status are available, the reported results remain evidence from a clinical trial presentation rather than confirmation that tegoprazan is an approved U.S. treatment for NERD.
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Key Questions
What did the phase III trial find?
Across four weeks, the mean percentage of 24-hour heartburn-free days was 26.2% with tegoprazan 50 mg and 30.1% with 100 mg, versus 17.3% with placebo. The study also reported improved daytime and nighttime heartburn-free days with tegoprazan.
Does the result mean tegoprazan eliminated heartburn?
No. The trial measured the share of days without heartburn. In the 100-mg group, that mean was 30.1% over the first four weeks; the reported results do not show that patients were completely free of symptoms.
Is tegoprazan approved in the United States for NERD?
The source says a drug application for GERD was submitted to the FDA in January, but does not give the year or current review status. It does not report an FDA approval, so approval cannot be confirmed from the supplied information.
How did the study describe safety?
Serious treatment-emergent adverse events were reported at similar rates across the placebo and tegoprazan groups. Treatment discontinuation due to such events ranged from 1.1% to 1.9%; the summary does not provide a complete safety analysis.
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