TL;DR
Get health and wellness essentials delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
In the phase III TRIUMpH-NERD trial, adults with non-erosive reflux disease who took tegoprazan had more heartburn-free days over four weeks than those given placebo. The drug’s application for GERD treatment was submitted to the FDA in January, but the source report does not say whether the agency has made a decision.
A phase III trial of 783 adults with non-erosive reflux disease found that once-daily tegoprazan increased the share of days without heartburn compared with placebo over four weeks. Presented at the American College of Gastroenterology annual meeting, the results offer evidence for a potential treatment option for people with reflux symptoms but no visible esophageal erosions; tegoprazan’s application for gastroesophageal reflux disease treatment has been submitted to the FDA.
Participants were randomly assigned to tegoprazan 50 mg, tegoprazan 100 mg, or placebo. By 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 investigators reported relative improvements over placebo of 51% and 74%, respectively. These figures describe the trial’s measured heartburn-free days, not the proportion of patients whose symptoms were cured.
The trial also found improvements in daytime and nighttime heartburn-free days for both tegoprazan doses compared with placebo. In an exploratory analysis, regurgitation-free days averaged 31.9% with 50 mg and 33.8% with 100 mg, versus 23.6% with placebo. After a 20-week extension, the percentage of 24-hour heartburn-free days was 47.8% in the 50-mg group and 50.4% in the 100-mg group. Those extension results were reported for the tegoprazan groups; the source does not provide a corresponding placebo figure.
Serious treatment-emergent adverse events were described as similar across the 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. The report does not provide a full breakdown of specific adverse events in its summary.
A Potential Option for NERD Symptoms
Non-erosive reflux disease, or NERD, involves reflux symptoms without visible erosions on endoscopy. The study’s findings matter because many people with GERD do not have erosive disease, and symptom relief can remain incomplete with existing treatment. Presenter Ronnie Fass said symptom relief with standard-dose proton pump inhibitors in NERD has been reported at about 50%, and that around 35% of GERD patients report dissatisfaction with PPIs.
Tegoprazan belongs to a class called potassium-competitive acid blockers, or P-CABs. The trial results suggest it may reduce heartburn and regurgitation symptoms more than placebo for this study population. They do not establish how it compares directly with PPIs, since the reported trial compared tegoprazan with placebo, nor do they establish whether the results will translate into routine clinical care.
Products Worth Considering
Therabody Theragun Relief Massage Gun, 3-Speed, Navy
Garmin Venu® 3 Premium Fitness Smartwatch 45mm Black
Blueair Blue Pure 511i Max Smart Air Purifier
As an affiliate, we earn on qualifying purchases.
How the Trial Tested Tegoprazan
The double-blind TRIUMpH-NERD trial was conducted at 91 U.S. sites. Participants had experienced heartburn for at least six months, had a normal endoscopy during screening and reported heartburn on at least four days during the screening week. At baseline, only 6.2% reported 24-hour heartburn-free days.
The report describes tegoprazan as a fast-acting oral P-CAB and says it can raise stomach pH above 4 within 45 minutes after administration. That pharmacology is background offered by the presenter; the central clinical result reported at the meeting was the difference in symptom-free days versus placebo. Fass presented the trial findings at the American College of Gastroenterology’s annual meeting in Nashville.
The source report says a new drug application for tegoprazan for GERD was submitted to the FDA in January. It does not specify the year of that submission in the supplied account or report an agency decision.
“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 the Four-Week Results
The reported results do not establish how tegoprazan performs against an active treatment such as a PPI, or how its benefits and risks compare over longer periods in a controlled comparison. The source also does not give detailed results for specific adverse events or explain the FDA’s review status.
The placebo group improved over time as well. Fass said lifestyle changes during the trial could be one reason, but the report does not identify what participants changed or how much those changes affected symptoms. The study’s results are averages across trial groups and do not predict the response of every individual.
FDA Review and Longer-Term Evidence
The next regulatory milestone is an FDA decision on the GERD drug application submitted in January; the supplied report does not state when a decision is expected or whether the agency has requested further information. Any approval status and authorized use should be checked against FDA announcements, which are not included in the meeting report.
Further evidence could clarify longer-term symptom control, safety and how tegoprazan compares with established treatments. The reported 20-week extension provides additional heartburn-free-day figures for the tegoprazan groups, but the source summary does not provide a placebo comparison for that period. Until more details are available, the phase III results support a treatment signal rather than a conclusion about comparative effectiveness in everyday care.
Key Questions
What did the tegoprazan trial find?
At week four, the mean share of 24-hour heartburn-free days was 26.2% with 50 mg and 30.1% with 100 mg, compared with 17.3% with placebo.
How many people took part?
The double-blind TRIUMpH-NERD trial included 783 patients at 91 U.S. sites. Participants had symptoms consistent with NERD and a normal endoscopy during screening.
Was tegoprazan shown to be better than proton pump inhibitors?
The reported trial compared tegoprazan with placebo, not with a PPI. The results therefore do not establish which treatment is more effective.
Has the FDA approved tegoprazan for GERD?
The source report says a drug application for GERD was submitted to the FDA in January, but it does not report an FDA decision.
What safety results were reported?
Serious treatment-emergent adverse events were described as similar across the groups. Treatment discontinuation due to adverse events occurred in 1.1% to 1.9% of participants, depending on the group; detailed event types were not provided in the source summary.
Source: rss
