[CLSTR]
< Back to situations

Monitor this situation.

[SITUATION] · [QUIET] · [BUSINESS]

2 clusters · 6 sources · 5 days · First seen · Last updated

Tegoprazan Phase 3 clinical trial results

Overview

Clinical trial data for tegoprazan, an investigational potassium-competitive acid blocker (P-CAB), has shown positive results in treating non-erosive gastroesophageal reflux disease (NERD).

Results from the Phase 3 TRIUMpH-NERD study, presented at the American College of Gastroenterology 2026 annual meeting, indicated that both 50mg and 100mg once-daily doses significantly increased the number of heartburn-free and regurgitation-free days in 783 American adult patients compared to a placebo. These improvements were observed from the first day of treatment and maintained through a 20-week extension period.

A post-hoc analysis regarding erosive esophagitis (EE) also received the ACG Presidential Award, demonstrating a 75.4% healing rate at week 2 for tegoprazan compared to 60.7% for lansoprazole. US partner Sebela Pharmaceuticals is currently awaiting the outcome of a New Drug Application (NDA) for the drug, which is under review by the U.S. Food and Drug Administration (FDA).

Entities

American College of Gastroenterology · Sebela Pharmaceuticals · HK inno.N · K-CAB · U.S. Food and Drug Administration

Timeline

  1. [HEALTH] 2 sources
    Tegoprazan shows efficacy in Phase 3 NERD clinical trials

    Phase 3 trial data shows tegoprazan, an investigational P-CAB, significantly improves heartburn and regurgitation symptoms in adults with non-erosive reflux disease compared to a placebo.

  2. [BUSINESS] 4 sources
    HK inno.N's K-CAB shows positive US Phase 3 results for NERD

    HK inno.N's K-CAB (tegoprazan) met primary and secondary endpoints in a US Phase 3 trial for non-erosive gastroesophageal reflux disease, strengthening its position for FDA approval.

Sources

biotimes.co.kr · biz.heraldcorp.com · consultantlive.com · joseilbo.com · mdmag.com · thebionews.net