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In a phase III trial involving 783 people with non-erosive reflux disease, once-daily tegoprazan was associated with more heartburn-free days over four weeks than placebo. The results were presented at the American College of Gastroenterology annual meeting; the FDA review status and a decision timeline were not reported.
A phase III trial found that adults with non-erosive reflux disease who took tegoprazan had more 24-hour heartburn-free days over four weeks than those given placebo. The findings, presented by Ronnie Fass of Case Western Reserve University School of Medicine at the American College of Gastroenterology annual meeting on October 15, add trial evidence for a potential treatment for a common form of gastroesophageal reflux disease (GERD).
The double-blind TRIUMpH-NERD trial enrolled 783 patients at 91 U.S. sites. Participants were assigned to once-daily tegoprazan at 50 mg or 100 mg, or to placebo. Through week four, the mean share of days without heartburn at any time in a 24-hour period was 17.3% with placebo, 26.2% with 50 mg and 30.1% with 100 mg. The trial report described those tegoprazan results as relative improvements of 51% and 74% over placebo, respectively.
Daytime and nighttime heartburn-free days, other key secondary measures, also favored both tegoprazan doses by day 28. The mean share of days without daytime heartburn was 27.4% with placebo, compared with 36% at 50 mg and 38.4% at 100 mg. For nighttime heartburn-free days, the rates were 27%, 36.1% and 39.9%, respectively. An exploratory measure of regurgitation-free days was 23.6% with placebo, 31.9% with 50 mg and 33.8% with 100 mg.
During a 20-week extension, the share of 24-hour heartburn-free days reached 47.8% in the 50-mg group and 50.4% in the 100-mg group. The report did not provide a placebo comparison for that extension figure. Serious treatment-emergent adverse event rates were described as similar across groups. 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 occur without visible esophageal injury on endoscopy. The trial presenter said non-erosive reflux disease is the most common GERD phenotype, and that around 35% of GERD patients report dissatisfaction with proton pump inhibitors (PPIs). He cited prior reports that standard-dose PPIs relieve symptoms in about half of NERD patients. Those figures provide context for the study; they do not show that tegoprazan will work for every patient or outperform PPIs, since this trial compared it with placebo.
The measured differences could matter to patients who continue to have symptoms, including at night. Still, the four-week results describe group averages, and the percentage of heartburn-free days remained below one-third in both tegoprazan groups during that period. The findings do not establish how individuals will respond, whether benefits persist beyond the reported extension, or how the drug compares directly with existing treatments.
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How the Trial Was Set Up
Participants had experienced heartburn for at least six months, had a normal endoscopy during a one-week screening period, and reported heartburn on at least four days in that period. At baseline, just 6.2% reported any 24-hour heartburn-free days. The group’s mean age ranged from 51 to 53 across the study arms; women made up 65% to 74% of each arm. The report listed 68% to 74% of participants as white and 22% to 27% as Black.
Tegoprazan is an oral potassium-competitive acid blocker (P-CAB). Fass said it has a rapid onset and can raise stomach pH above 4 within 45 minutes of administration. These are statements about the drug’s pharmacology, not outcomes that establish how quickly trial participants felt symptom relief. The study’s reported clinical comparison measured symptom-free days over time.
The presentation also addressed improvement in the placebo group. Henry Parkman of Temple University asked whether lifestyle or diet changes during enrollment could have contributed. Fass said there could be several reasons, including lifestyle modifications, and noted that placebo responses occur in other studies. He said the treatment groups still separated from placebo.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, Case Western Reserve University School of Medicine
Questions Beyond Four Weeks
The meeting report does not provide the full trial publication, detailed statistical confidence intervals, or a direct comparison with PPIs. It also does not give a placebo result for the 20-week extension, so the extension figures alone cannot establish whether the advantage over placebo continued over that period. Although the report says serious adverse event rates were similar, it does not give a detailed breakdown of event types or longer-term safety data.
The results come from adults meeting the trial’s symptom and endoscopy criteria. How well they apply to people with erosive disease, less frequent symptoms or different treatment histories is not established by this report. The size of the placebo response also leaves open how much improvement may come from factors such as changes in behavior during a study.
FDA Review and Further Data
A new drug application for tegoprazan to treat GERD was submitted to the FDA in January, according to the report. It does not specify the year of submission, the application’s current review status or an expected agency decision date. The agency’s review will determine whether the drug can be marketed in the United States for this use.
Further details from the trial, including a full account of adverse events and results beyond the reported follow-up, would help clinicians and patients assess the findings. Until regulatory and comparative evidence is available, the meeting results show a difference from placebo in this study rather than establishing tegoprazan’s place against other GERD treatments.
Key Questions
What did the trial find?
Over four weeks, the mean share of 24-hour heartburn-free days was higher with tegoprazan than placebo: 26.2% with 50 mg and 30.1% with 100 mg, compared with 17.3% with placebo.
Who took part in the study?
The double-blind trial enrolled 783 patients at 91 U.S. sites. Participants had a history of heartburn, a normal endoscopy during screening and symptoms on at least four days in that screening period.
Was tegoprazan compared with proton pump inhibitors?
No. The reported trial arms were tegoprazan 50 mg, tegoprazan 100 mg and placebo. The results do not show how tegoprazan compares directly with PPIs.
What is known about safety?
The report said serious treatment-emergent adverse event rates were similar across the three groups. Treatment discontinuations due to these events ranged from 1.1% to 1.9%; the report did not provide a detailed event breakdown.
Has the FDA approved tegoprazan for GERD?
The report says a new drug application for GERD was submitted to the FDA in January, but does not specify the year, review status or decision timeline. It does not report an FDA approval.
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