Sebela Pharmaceuticals Completes Phase 3 Study of Tegoprazan for GERD with Positive Results

What's Happening?

Sebela Pharmaceuticals has announced the successful completion of the Phase 3 TRIUMpH clinical program for tegoprazan, a novel potassium-competitive acid blocker, in treating gastroesophageal reflux disease (GERD). The study involved a 24-week maintenance phase following an initial healing phase of up to 8 weeks. Patients with healed erosive esophagitis (EE) were randomized to receive maintenance treatment with tegoprazan or lansoprazole. The study met its primary endpoint, demonstrating non-inferiority of tegoprazan to lansoprazole in maintaining healing at 24 weeks. Tegoprazan also showed statistical superiority in maintaining healing in severe EE cases. The safety profile was favorable, with low rates of adverse events. Sebela plans to file a New Drug Application with the FDA for both EE and non-erosive reflux disease (NERD) indications in Q4 2025.

Why It's Important?

The successful completion of the Phase 3 study for tegoprazan is significant as it offers a potential new treatment option for GERD, a condition affecting approximately 65 million people in the U.S. Current treatments, primarily proton pump inhibitors, fail to provide complete relief for a substantial portion of patients. Tegoprazan's ability to maintain healing and control heartburn with a safety profile comparable to existing therapies could address this unmet need. The introduction of tegoprazan may redefine long-term management of GERD, providing improved outcomes for patients and potentially impacting the pharmaceutical market for gastrointestinal treatments.

What's Next?

Sebela Pharmaceuticals plans to file for FDA approval for tegoprazan in Q4 2025. The company intends to present the study results at leading gastroenterology conferences and submit them to peer-reviewed journals. If approved, tegoprazan could become a key player in the GERD treatment market, offering a new option for patients who do not respond adequately to current therapies. The company is also focused on advancing tegoprazan in the U.S. market to better serve patients with GERD.