TL;DR
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In a phase III U.S. trial, once-daily tegoprazan increased the share of 24-hour heartburn-free days among people with non-erosive reflux disease compared with placebo through week four. The results were presented at an American College of Gastroenterology meeting; longer-term findings and FDA review remain relevant next steps.
A phase III trial found that adults with non-erosive reflux disease had more heartburn-free days when taking once-daily tegoprazan than when taking placebo, according to results presented October 15 at the American College of Gastroenterology annual meeting. By week four, the 50-mg and 100-mg groups had higher average rates of 24-hour heartburn-free days, a result that may support another treatment option for people with reflux symptoms but no visible esophageal erosions.
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. At baseline, only 6.2% reported 24-hour heartburn-free days. To qualify, patients needed a history of heartburn for at least six months, a normal endoscopy during screening and symptoms on at least four days during the screening week.
Through week four, the mean percentage of 24-hour heartburn-free days was 17.3% with placebo, 26.2% with 50 mg tegoprazan and 30.1% with 100 mg. Presenter Ronnie Fass, MD, of Case Western Reserve University School of Medicine, reported these as relative improvements of 51% and 74% over placebo, respectively. The trial also found significantly higher percentages of days without daytime or nighttime heartburn in both tegoprazan groups.
For an exploratory measure, regurgitation-free days averaged 23.6% with placebo, compared with 31.9% on 50 mg and 33.8% on 100 mg. The mean percentage of days free of both heartburn and regurgitation was 15.3% with placebo, 24.5% with 50 mg and 27% with 100 mg. Fass also reported improved symptom severity in the treatment groups. Serious treatment-emergent adverse-event rates were described as similar across groups; adverse events leading to treatment discontinuation occurred in 1.1% of placebo recipients, 1.9% of those on 50 mg and 1.5% of those on 100 mg.
A Potential Option for Persistent Reflux
The findings address a treatment gap for people with non-erosive reflux disease (NERD), a GERD subtype in which symptoms occur without erosions visible on endoscopy. Fass said that standard-dose proton pump inhibitors provide symptom relief for about half of NERD patients, and the report notes that some people with GERD remain dissatisfied with PPIs. A treatment that improves symptom-free days over placebo could be relevant to patients whose symptoms continue despite existing approaches.
However, these results show an average difference in symptom days over four weeks, not that the drug eliminates heartburn or works for every patient. Whether the measured benefit translates into meaningful improvement for individuals, and how it compares with available treatments in broader use, requires further evidence and regulatory review.
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How Tegoprazan Was Tested
Tegoprazan is an oral potassium-competitive acid blocker, or P-CAB, a class that reduces stomach acid through a mechanism related to, but pharmacologically different from, proton pump inhibitors. Fass described tegoprazan as fast-acting and said it can raise stomach pH above 4 within 45 minutes after a dose. Those are properties presented as part of the study rationale; the trial’s reported primary result was the difference in heartburn-free days.
The trial enrolled adults with frequent symptoms and a normal screening endoscopy, making its findings specific to the NERD population studied, not necessarily to all people with GERD. The source report says an application for tegoprazan to treat GERD was submitted to the U.S. Food and Drug Administration in January, but does not specify the year or provide a decision from the agency.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, presenting the trial findings
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Questions Beyond Four Weeks
The results reported here do not establish how well tegoprazan works over longer periods for all patients, how it performs against active treatments such as PPIs, or whether the difference in symptom-free days amounts to a meaningful benefit for each person. A 20-week extension was reported: 24-hour heartburn-free days reached 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 or enough detail to assess its design and interpretation.
The report also does not provide a full breakdown of common adverse events, the trial’s complete statistical analysis or subgroup outcomes. Fass said the placebo response may have several explanations, including lifestyle changes during the study, but the source does not establish what caused it. The trial’s findings and presentation do not by themselves establish FDA approval or availability.
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FDA Review and Longer-Term Evidence
The next regulatory milestone is the FDA’s review of the tegoprazan application for GERD, which the report says was submitted in January without specifying the year. The agency’s decision date and any requirements for additional data are not provided. Further reporting may clarify the application’s status, the evidence reviewed by regulators and whether the requested use includes NERD specifically.
Longer-term and comparative evidence will also help put the four-week results in context, including sustained symptom control, safety over extended use and performance relative to established therapies. Until those details are available, the presented trial supports a treatment signal versus placebo in the studied population, rather than a definitive conclusion about how tegoprazan should be used.
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Key Questions
What did the 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% with 50 mg and 30.1% with 100 mg, versus 17.3% with placebo.
Who was included in the study?
The 783 participants had at least six months of heartburn symptoms, a normal endoscopy during screening and symptoms on at least four days during the screening week. The results apply most directly to patients meeting those study criteria.
Did tegoprazan eliminate heartburn?
No. The trial reported group averages for the percentage of symptom-free days. Even in the 100-mg group, the mean was 30.1% of days through week four; the finding does not mean every participant became symptom-free.
Has the FDA approved tegoprazan for GERD?
The source report says a new drug application was submitted to the FDA in January, but it does not specify the year or report an FDA decision. The meeting results alone do not establish approval.
Source: rss
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