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
A phase III trial found that once-daily tegoprazan increased the share of 24-hour heartburn-free days over four weeks among people with non-erosive reflux disease, compared with placebo. The study also reported improvements in daytime and nighttime symptoms; the FDA had received a new drug application for tegoprazan for GERD in January, but the source does not report an agency decision.
A phase III trial found that adults with non-erosive reflux disease (NERD) taking once-daily tegoprazan had more 24-hour 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 the most common reported phenotype of gastroesophageal reflux disease (GERD), but do not establish whether the drug will be approved or how it will be used in practice.
In the double-blind TRIUMpH-NERD trial, 783 patients at 91 U.S. sites were assigned to placebo or tegoprazan at 50 mg or 100 mg once daily. Through week four, the mean share of days without heartburn over a full 24-hour period was 17.3% with placebo, 26.2% with 50 mg, and 30.1% with 100 mg. Trial investigators reported these as relative improvements over placebo of 51% and 74%, respectively; the reported P values were 0.0006 and less than 0.0001.
Daytime and nighttime heartburn-free days, as well as days without both heartburn and regurgitation, also favored tegoprazan. For example, the mean share of days without nighttime heartburn by day 28 was 27% with placebo, compared with 36.1% on 50 mg and 39.9% on 100 mg. An exploratory analysis found more regurgitation-free days in both tegoprazan groups than in the placebo group. These are trial outcomes, not a guarantee that an individual patient will experience relief.
Rates of serious treatment-emergent adverse events were described as similar across the three groups. Events leading to treatment discontinuation occurred in 1.1% of placebo patients, 1.9% of those taking 50 mg, and 1.5% of those taking 100 mg. The report did not provide detailed counts or descriptions of all adverse events in the supplied material.
Symptom Relief in NERD
NERD involves reflux symptoms despite a normal endoscopy, and the source identifies it as the most common GERD phenotype. The trial addresses a treatment gap: presenter Ronnie Fass said symptom relief with standard-dose proton pump inhibitors (PPIs) has been reported in about half of NERD patients, while roughly 35% of people with GERD report dissatisfaction with PPIs. Those figures are background cited by the presenter, not outcomes measured in this tegoprazan trial.
The results may matter to patients and clinicians seeking additional options, particularly because both tested doses improved the study’s principal symptom measure relative to placebo. Still, the data do not show how tegoprazan compares directly with a PPI: the trial arms described in the report were placebo and two tegoprazan doses. Longer-term outcomes, prescribing guidance, and real-world effectiveness are not established by the four-week comparison.
As an affiliate, we earn on qualifying purchases.
Trial Design and Treatment Background
Participants had experienced heartburn for at least six months, had a normal endoscopy during screening, and reported heartburn on at least four days in the one-week screening period. The groups had similar demographic ranges in the report: mean age was 51 to 53, and 65% to 74% were women. Only 6.2% reported 24-hour heartburn-free days at baseline.
Tegoprazan belongs to a class called potassium-competitive acid blockers, or P-CABs. Fass described it as having a rapid onset and said it can raise stomach pH above 4 within 45 minutes after administration. These are statements made during the presentation; the reported trial comparison focused on symptom outcomes, not a direct comparison of onset time against other medicines. In a 20-week extension, the share of 24-hour heartburn-free days was reported as 47.8% with 50 mg and 50.4% with 100 mg; the source excerpt does not provide a placebo comparison for that extension result.
“These findings truly support tegoprazan as a therapeutic option for non-erosive reflux disease.”
— Ronnie Fass, MD, Case Western Reserve University School of Medicine
As an affiliate, we earn on qualifying purchases.
Approval and Longer-Term Questions
The supplied report says a new drug application for tegoprazan for GERD was submitted to the FDA in January, but does not specify the year, the application’s current review status, or whether the agency has made a decision. The trial results alone do not establish approval, availability, or a recommended treatment role.
The article excerpt also does not give full adverse-event details, results broken down by patient subgroup, or enough information to judge how durable symptom improvements are beyond the extension figures provided. The placebo group improved as well; Fass said lifestyle modifications during the study could have contributed, but the reasons were not determined in the report.
non-erosive reflux disease treatment
As an affiliate, we earn on qualifying purchases.
As an affiliate, we earn on qualifying purchases.
FDA Review and Further Evidence
The next regulatory milestone is an FDA decision on the application, if review is ongoing; no decision date or current status is provided in the source. Further reporting should establish whether regulators request additional information, approve the drug, or set any conditions for use.
For the evidence base, readers will need fuller trial results and longer-term safety and effectiveness data. Until those details and the regulatory status are clear, the meeting presentation supports a finding of improved symptom measures versus placebo in this trial—not a conclusion about how tegoprazan should be used for an individual patient.
As an affiliate, we earn on qualifying purchases.
Key Questions
What did the tegoprazan trial find?
In the four-week comparison, the mean share of 24-hour heartburn-free days was 26.2% with 50 mg and 30.1% with 100 mg, versus 17.3% with placebo. The trial also reported improvements in other symptom measures.
Who took part in the study?
The double-blind trial included 783 patients at 91 U.S. sites. Participants had long-standing heartburn, a normal endoscopy at screening, and frequent symptoms during the screening week.
Did the study compare tegoprazan with PPIs?
No PPI comparison arm is described in the supplied report. Participants were assigned to placebo or one of two tegoprazan doses, so the results do not establish how the drug compares directly with a PPI.
Has the FDA approved tegoprazan for GERD?
The source says a new drug application for tegoprazan for GERD was submitted to the FDA in January, but it does not give the year or report an agency decision. Its approval status cannot be confirmed from the supplied material.
Source: rss
Fall Picks
fall essentials
As an affiliate, we earn on qualifying purchases.
