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Sebela Pharmaceuticals Advances GERD Treatment with Tegoprazan

Sebela Pharmaceuticals, known for its commitment to innovative gastroenterology solutions, has recently submitted a New Drug Application (NDA) to the FDA for tegoprazan, a pioneering potassium-competitive acid blocker (P-CAB) aimed at treating gastroesophageal reflux disease (GERD). This submission, made on January 9, 2026, seeks approval for three significant indications: the treatment of heartburn from non-erosive reflux disease (NERD), the healing of erosive esophagitis (EE), and the maintenance of healing related to EE.

Key Clinical Advances

The NDA is supported by robust data from the comprehensive Phase 3 TRIUMpH program involving over 2,000 U.S. patients. Results have shown that tegoprazan significantly outperformed traditional proton pump inhibitors (PPIs) in numerous clinical endpoints, which included substantial relief from hallmark GERD symptoms like heartburn and regurgitation. Notably, in patients suffering from NERD, tegoprazan achieved impressive results with respect to 24-hour heartburn-free days compared to placebo treatments.

According to the findings, tegoprazan exhibited marked superiority in healing erosive esophagitis, addressing all severity grades effectively. It demonstrated a statistically relevant healing improvement compared to lansoprazole at both the 2- and 8-week marks. Full results from the TRIUMpH clinical trials are expected to be shared at key medical conferences throughout the year and are intended for publication in esteemed medical journals.

Addressing Unmet Needs

Alan Cooke, President and CEO of Sebela Pharmaceuticals, emphasized the transformative nature of this NDA submission. He noted that GERD affects around 65 million Americans, with a significant portion of those patients—35% to 54%—reporting ongoing symptoms despite existing treatments. Cooke expressed optimism about bringing tegoprazan to healthcare providers and patients in January 2027.

Dr. Philip O. Katz from Weill Cornell Medicine remarked on the importance of potassium-competitive acid blockers, highlighting their faster and more effective action compared to conventional PPIs. The TRIUMpH study outcomes underscore tegoprazan's potential to fill significant treatment gaps for patients who have struggled to achieve symptom control with traditional therapies.

General Perspectives on GERD

GERD is a common gastrointestinal disorder recorded among nearly 65 million Americans, impacting their daily lives and wellness. Despite the prevalent use of PPIs for over two decades, a troubling number of patients continue suffering from symptoms, indicating a pressing need for alternative therapies like tegoprazan.

The TRIUMpH program includes two pivotal Phase 3 studies specifically designed for a diverse cohort of U.S. patients. These trials assess the efficacy of tegoprazan in treating both erosive esophagitis and the non-erosive variety, ultimately aiming to establish a compelling narrative for improved GERD management.

Comprehensive Treatment and Safety Profile

Throughout both Phase 3 studies, the safety profile of tegoprazan showed favorable outcomes, with adverse events occurring similarly among treated and control groups. Additionally, mean serum gastrin levels remained stable and within normal ranges throughout treatment periods, suggesting a safe application for long-term use.

Future Directions

Sebela Pharmaceuticals is keen to partner with the FDA throughout the review process as they aim for tegoprazan to reach the market in the U.S. Their commitment to advancing healthcare through innovative solutions, combined with the promising results from the TRIUMpH program, positions them favorably to make a significant impact on the treatment landscape of GERD. This anticipated approval highlights Sebela’s dedication to improving patient outcomes and consistently addressing unmet medical needs in gastroenterology.

As the timeline progresses, healthcare providers will eagerly await further details and potential launch dates, marking a new era in GERD treatment with the potential introduction of tegoprazan onto the market.