TL;DR
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In the phase III TRIUMpH-NERD trial, once-daily tegoprazan increased the average share of 24-hour heartburn-free days over four weeks compared with placebo. The results were presented at the American College of Gastroenterology meeting; the source report says a U.S. drug application was submitted in January, but does not report an FDA decision.
A once-daily dose of tegoprazan increased the share of days without heartburn compared with placebo in a phase III trial of people with non-erosive reflux disease, researchers reported October 15 at the American College of Gastroenterology meeting. The four-week results offer evidence for a potential treatment in a common form of gastroesophageal reflux disease, but do not establish whether the drug will be approved or how it will compare with existing therapies in broader use.
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 percentage of 24-hour heartburn-free days was 17.3% with placebo, 26.2% with 50 mg and 30.1% with 100 mg. The investigators reported relative improvements over placebo of 51% and 74%, respectively; these are the study’s stated comparisons, not percentage-point differences.
Daytime and nighttime heartburn-free days also favored both tegoprazan doses. Regurgitation-free days, an exploratory endpoint, averaged 23.6% with placebo, compared with 31.9% on 50 mg and 33.8% on 100 mg. The report also said symptom severity improved more in the active-treatment groups than in the placebo group. During 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 supplied report does not provide a placebo comparison for that extension result.
Serious treatment-emergent adverse events were reported at similar rates 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. These trial figures describe the participants and period studied; they do not by themselves establish safety for all patients or longer-term use.
A Potential Option for NERD Symptoms
Non-erosive reflux disease, or NERD, involves reflux symptoms without visible erosions on endoscopy. A treatment that increases symptom-free days could matter to patients whose heartburn continues despite existing options. The trial included patients with normal endoscopies and frequent symptoms during screening, making its results relevant to that defined group.
Ronnie Fass of Case Western Reserve University School of Medicine, who presented the findings, said standard-dose proton pump inhibitors provide symptom relief for about half of NERD patients. That figure was part of his presentation, rather than a comparison conducted within this trial. Tegoprazan was tested against placebo here, not directly against a proton pump inhibitor, so the results do not show that it is more effective than current standard treatments.
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How the Trial Defined NERD
Participants had a history of heartburn symptoms for at least six months, a normal endoscopy during screening and symptoms on at least four days in the screening week. At baseline, 6.2% reported 24-hour heartburn-free days. The study population had a mean age of about 51 to 53 years; 65% to 74% were women, and 68% to 74% were White, with 22% to 27% Black, across the treatment groups.
Tegoprazan is an oral potassium-competitive acid blocker, or P-CAB, which suppresses stomach acid through a mechanism related to, but distinct from, proton pump inhibitors. Fass described it as fast-acting and said it can raise stomach pH above 4 within 45 minutes. Those pharmacologic details were presented by the investigator; the principal clinical outcome reported here is the difference in heartburn-free days.
The report states that a new drug application for tegoprazan to treat GERD was submitted to the U.S. Food and Drug Administration in January. It does not specify the year in that sentence, and the reported trial results do not amount to an FDA approval.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, Case Western Reserve University School of Medicine
non-erosive reflux disease treatment
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Approval and Longer-Term Results
The report does not give the FDA’s current review status, an expected decision date or the details of any agency feedback. It also does not identify the year of the January application submission. Approval, labeling and availability therefore remain unclear from the reported information.
The four-week comparison showed a benefit on the trial’s heartburn-free-day measure, but the supplied results do not establish how tegoprazan performs against proton pump inhibitors or other active treatments. The extension figures are reported for the two tegoprazan groups without a corresponding placebo figure, and the report does not provide detailed longer-term safety results. The placebo group’s improvement was also raised during the meeting discussion; the extent to which lifestyle changes contributed was not determined in the account.
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FDA Review and Full Data
The next major regulatory development would be an FDA decision or public update on the application described in the report. No decision date is provided. Further information on the full trial results, including detailed safety findings, the extension period and any peer-reviewed publication, would help clinicians and regulators assess the evidence beyond the four-week placebo-controlled comparison.
Until those details and the agency’s position are available, the findings should be understood as clinical-trial evidence, not confirmation that tegoprazan is approved or available for this use in the United States.
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Key Questions
What did the phase III trial find?
Through week four, patients taking tegoprazan had a higher mean percentage of 24-hour heartburn-free days than patients 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 patients have reflux symptoms but no visible erosions on endoscopy. Trial participants were required to have a normal endoscopy during screening.
Was tegoprazan better than proton pump inhibitors?
The trial described in the report compared tegoprazan with placebo, not with proton pump inhibitors. The results do not establish that tegoprazan is more effective than those medicines.
Is tegoprazan approved in the United States for GERD?
The report says a new drug application was submitted to the FDA in January, but gives no current review status or decision. It does not report that the drug has been approved for GERD in the United States.
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