TL;DR
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A phase III trial found that adults with non-erosive reflux disease taking once-daily tegoprazan had more heartburn-free days over four weeks than those taking placebo. The results were presented at the American College of Gastroenterology meeting; the FDA application for GERD treatment was submitted in January, but the source does not report an agency decision.
A phase III trial of 783 people with non-erosive reflux disease found that once-daily tegoprazan increased the share of days without heartburn over four weeks compared with placebo. The findings, presented at the American College of Gastroenterology annual meeting, add evidence for a potential treatment for a common form of gastroesophageal reflux disease, but do not establish whether U.S. regulators will approve the drug.
Participants were randomly assigned to placebo, tegoprazan 50 mg or tegoprazan 100 mg. Through week four, the mean percentage of 24-hour heartburn-free days was 17.3% with placebo, 26.2% with the 50-mg dose and 30.1% with the 100-mg dose. The trial report described those results as relative improvements of 51% and 74% over placebo, respectively; the reported comparisons were statistically significant.
Daytime and nighttime heartburn-free days also favored both tegoprazan doses. For daytime symptoms, the mean percentages by day 28 were 27.4% with placebo, 36% with 50 mg and 38.4% with 100 mg. For nighttime symptoms, they were 27%, 36.1% and 39.9%, respectively. The study also reported fewer days with regurgitation in both treatment groups than in the placebo group.
The double-blind TRIUMpH-NERD trial ran at 91 U.S. sites. Eligible participants had at least six months of heartburn symptoms, a normal endoscopy during screening and symptoms on at least four days of the one-week screening period. Just 6.2% reported 24-hour heartburn-free days at baseline, according to the presentation.
More Symptom-Free Days in NERD
Non-erosive reflux disease is a form of GERD in which reflux symptoms occur without visible erosions on endoscopy. The trial report cited NERD as the most common GERD phenotype and noted that symptom relief with standard-dose proton pump inhibitors has been reported in about half of NERD patients. That leaves room for additional treatment options, although this study does not show how tegoprazan compares directly with a proton pump inhibitor.
The difference in heartburn-free days may matter to people whose symptoms persist or return during existing treatment. The findings also covered daytime and nighttime symptoms and regurgitation, rather than heartburn alone. Still, the averages do not mean every participant became symptom-free: even in the higher-dose group, the mean share of 24-hour heartburn-free days was 30.1% through week four.
The report said serious treatment-emergent adverse events were similar across the three groups. Treatment discontinuations due to adverse events occurred in 1.1% of placebo participants, 1.9% of those taking 50 mg and 1.5% of those taking 100 mg. These trial figures provide short-term safety information, but do not by themselves settle the drug’s longer-term risks or its suitability for individual patients.
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Trial Design and Drug Review
Tegoprazan is a potassium-competitive acid blocker, or P-CAB, a class of medicines that reduces stomach acid. In the presentation, investigator Ronnie Fass said the drug has a rapid onset and can raise stomach pH above 4 within 45 minutes after administration. Those are statements about its pharmacology, not proof that every patient will experience rapid symptom relief.
The trial included adults with symptoms and a normal endoscopy, making its results specific to the NERD population studied. The source report says an application for tegoprazan to treat GERD was submitted to the FDA in January, but does not give the year or provide an agency review timeline. The meeting results therefore add to the evidence being discussed while the regulatory outcome remains unknown.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, Case Western Reserve University School of Medicine
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Approval and Longer-Term Results
The meeting report does not provide a full peer-reviewed publication, detailed confidence intervals for the main outcomes or results beyond the reported extension. It also does not specify the year of the January FDA submission or describe the application’s current status. Although the source reports an extension lasting 20 weeks, it does not explain whether those findings establish continued benefit for all participants or provide a full account of longer-term safety.
The placebo group also improved, and Fass said lifestyle changes during the study could be one possible reason. The report does not establish what caused that response. The results are averages from a trial population and cannot predict an individual patient’s response or replace information about treatment choices from a qualified clinician.
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FDA Review and Full Publication
The next key development is the FDA’s decision on the tegoprazan application for GERD. The source material does not state when the agency may act or whether it has requested further data. A full publication of the trial would allow closer review of the statistical analysis, adverse events, participant subgroups and the 20-week extension.
Until regulatory and publication details are available, the reported findings show a short-term advantage over placebo on measured symptoms, not an approved treatment or a guarantee of relief. People considering changes to GERD care should discuss options with a qualified health professional.
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Key Questions
What did the trial find?
Participants taking tegoprazan had a higher mean percentage of 24-hour heartburn-free days through week four than participants taking placebo: 26.2% with 50 mg and 30.1% with 100 mg, compared with 17.3% with placebo.
What is non-erosive reflux disease?
NERD is a form of gastroesophageal reflux disease in which people have reflux symptoms but a normal endoscopy does not show visible erosions. The trial enrolled patients meeting specific symptom and screening criteria.
Is tegoprazan approved in the United States for GERD?
The source says a new drug application for tegoprazan for GERD was submitted to the FDA in January, but does not specify the year or report an FDA decision. The trial results alone do not establish approval.
Were adverse events different between the groups?
The report said serious treatment-emergent adverse events were similar across the placebo and tegoprazan groups. Adverse events led to treatment discontinuation in 1.1% of placebo participants, 1.9% of those taking 50 mg and 1.5% of those taking 100 mg.
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