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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. Results were presented at the American College of Gastroenterology meeting; the trial also reported improvement in daytime and nighttime heartburn, while longer-term and regulatory details remain important to follow.
A phase III trial found that adults with non-erosive reflux disease who took once-daily tegoprazan had more heartburn-free days over four weeks than participants taking placebo, according to results presented October 15 at the American College of Gastroenterology annual meeting. The findings concern a common form of gastroesophageal reflux disease (GERD), in which patients have reflux symptoms but a normal endoscopy.
In the double-blind TRIUMpH-NERD trial, 783 patients at 91 U.S. sites were randomly assigned to placebo or tegoprazan at 50 mg or 100 mg once daily. 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 report said those results represented relative improvements over placebo of 51% and 74%, respectively; both comparisons were statistically significant.
Daytime and nighttime heartburn-free days, as well as days free of both heartburn and regurgitation, also favored tegoprazan. In an exploratory measure, regurgitation-free days averaged 23.6% with placebo, compared with 31.9% at 50 mg and 33.8% at 100 mg. The study presenter, Ronnie Fass of Case Western Reserve University School of Medicine, also reported better symptom-severity scores in the treatment groups. These are trial findings, not a guarantee that an individual patient will experience the same level of relief.
After a further 20-week extension, the reported share of 24-hour heartburn-free days was 47.8% in the 50-mg group and 50.4% in the 100-mg group. The source report said serious treatment-emergent adverse events were similar across the three groups. Adverse events leading to treatment discontinuation occurred 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
The results address a treatment gap for people whose reflux symptoms persist despite existing options. Fass said symptom relief with standard-dose proton pump inhibitors (PPIs) has been reported in about 50% of NERD patients, and the report cited dissatisfaction with PPIs among some people with GERD. The trial suggests tegoprazan may offer another approach, but it does not establish how the drug will perform in routine care or whether it will be approved for this use.
Tegoprazan is a potassium-competitive acid blocker (P-CAB), a class that reduces stomach acid through a mechanism involving the proton pump. Fass described it as fast-acting and said it can raise stomach pH above 4 within 45 minutes of administration. Those pharmacologic details help explain the interest in the medicine, but the clinical result reported here is the difference in symptom-free days—not proof that faster action alone caused the improvement.
How the Trial Was Structured
Participants had to report heartburn for at least six months, have a normal endoscopy during screening and experience heartburn on at least four days during the one-week screening period. Only 6.2% reported having 24-hour heartburn-free days at baseline. Participants had a mean age of 51 to 53; depending on the treatment arm, 65% to 74% were women, 68% to 74% were White and 22% to 27% were Black.
GERD affects up to 20% of U.S. adults, Fass said, and he described NERD as the most common GERD phenotype, affecting up to 70% of patients. The report said a new drug application for tegoprazan to treat GERD was submitted to the FDA in January. It did not provide a decision date or details about the application’s review status.
“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
Questions on Long-Term Benefit
The reported results do not establish how well tegoprazan works beyond the trial period or whether its benefits and safety profile will be similar in broader patient populations. Although the report includes results from a 20-week extension, it does not explain the extension’s design, how many patients completed it or whether there was a comparison group during that period.
The placebo group also improved: its mean share of 24-hour heartburn-free days was 17.3% through week four, and the report notes improvement over time. Fass said lifestyle modifications could be one explanation, while acknowledging that the placebo response was not unique to this study. The available report does not identify which changes participants made or measure their effect separately. FDA review details, a decision timeline and any final approved labeling are also not specified.
FDA Review and Further Data
The next regulatory milestone is the FDA’s review of the new drug application for tegoprazan for GERD, which the source report said was submitted in January. No agency decision or timetable was provided. The FDA’s determination would establish whether the medicine can be marketed in the United States for the proposed use and what approved directions and safety information would apply.
Further reporting can clarify the application’s status and provide additional details about the 20-week extension, including completion rates and longer-term outcomes. Until those details and the regulatory decision are available, the phase III findings show a statistically significant improvement against placebo over four weeks, but do not by themselves settle the drug’s place in care.
Key Questions
What did the phase III trial find?
Over four weeks, participants taking tegoprazan had a higher mean percentage of 24-hour heartburn-free days than those taking placebo: 26.2% at 50 mg and 30.1% at 100 mg, compared with 17.3% with placebo.
What is non-erosive reflux disease?
Non-erosive reflux disease is a form of GERD in which a person has reflux symptoms but a normal endoscopy. Trial participants were required to have a normal endoscopy during screening.
Did the study report safety findings?
The report said serious treatment-emergent adverse events were similar across the study groups. Adverse events leading to treatment discontinuation occurred in 1.1% with placebo, 1.9% with tegoprazan 50 mg and 1.5% with 100 mg. The figures do not replace a full review of the drug’s safety data.
Is tegoprazan approved in the United States for GERD?
The source report said a new drug application for tegoprazan for GERD was submitted to the FDA in January, but it did not report an FDA decision. The drug’s approval status for this use is not established by the trial results.
Source: rss
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