Tegoprazan Shows Superior Maintenance of Healing in Phase III TRIUMpH Study of Gastroesophageal Reflux Disease

Author(s):

Key Takeaways

Tegoprazan showed statistically superior maintenance of healing in erosive esophagitis patients compared to lansoprazole, with a favorable safety profile.
The TRIUMpH program includes two Phase III studies for GERD, evaluating tegoprazan's efficacy and safety in both erosive and non-erosive reflux disease.
Sebela plans to submit FDA filings for both EE and NERD indications in Q4 2025, emphasizing tegoprazan's potential in long-term GERD management.

In the Phase III TRIUMpH program, tegoprazan met primary endpoints and outperformed lansoprazole in maintaining healing of erosive esophagitis over 24 weeks, including in patients with the most severe disease.

© Satjawat - © Satjawat - stock.adobe.com

Image Credit: © Satjawat - stock.adobe.com

Summary

The TRIUMpH Phase III program demonstrated that tegoprazan maintained healing in GERD patients over 24 weeks with statistical superiority to lansoprazole, including in those with severe erosive esophagitis (LA Grades C/D). Both doses of tegoprazan met the primary endpoint and showed a favorable safety profile. The study enrolled over 2,000 participants across two large, multicenter, double-blind trials (EE and NERD), with Sebela planning FDA submissions for both indications in Q4 2025.

Sebela Pharmaceuticals has shared positive, topline results from its Phase III TRIUMpH clinical program investigating tegoprazan, a novel potassium-competitive acid blocker (P-CAB), for the treatment of gastroesophageal reflux disease (GERD). This latest readout comes from the 24-week maintenance phase of the pivotal program.¹

Tegoprazan achieved statistically superior maintenance of healing in all patients across all grades (LA Grades A–D) of erosive esophagitis (EE), and in the most severe patients (LA Grades C/D) versus lansoprazole.

Study design and primary results

After an initial healing phase of up to 8 weeks, patients with healed EE were randomized to maintenance treatment with tegoprazan 100 mg, tegoprazan 50 mg, or lansoprazole 15 mg for 24 weeks.

More detailed findings from the 24-week maintenance phase show:

The study’s primary endpoint was met, with both tegoprazan doses demonstrating non-inferiority to lansoprazole in maintaining healing at 24 weeks across all LA Grades (A–D).
Tegoprazan 100 mg and 50 mg were also statistically superior to lansoprazole 15 mg in sustaining healing over the 24-week period.

Favorable safety profile

Tegoprazan’s safety profile was favorable, with low rates of treatment-emergent adverse events and adverse events of special interest. Additionally, no new safety signals were identified.

In a press release, Alan Cooke, president and CEO of Sebela Pharmaceuticals, said: "These results reinforce the potential of tegoprazan to redefine long-term management of GERD. We are excited that tegoprazan not only delivers superior and sustained healing across the full spectrum of erosive esophagitis, including more challenging severe cases, but also provides durable control of heartburn with a safety profile comparable to existing therapies. We look forward to advancing tegoprazan in the US to better serve the needs of patients living with GERD."

Overview of the TRIUMpH program

TRIUMpH consists of two Phase III studies evaluating tegoprazan in patients with GERD, including EE and non-erosive reflux disease (NERD). Both studies were conducted entirely in the US.

The Phase III EE trial (NCT05587309) was a large, multicenter, double-blind study enrolling 1,250 patients, including 463 with LA Grade C/D erosive esophagitis.²

This study evaluated the safety and efficacy of tegoprazan compared to lansoprazole for healing EE, maintaining healing, and relieving heartburn.
During the healing phase, patients received treatment for up to 8 weeks.
The primary endpoint of the healing phase was the proportion of patients with complete endoscopic healing by week 8.
Patients who achieved healing entered a 24-week maintenance phase.
A secondary endpoint in both phases was the percentage of days without heartburn over a 24-hour period.

NERD study supports broader GERD indication

Similar in design, the Phase III NERD trial (NCT05587322) was also a large, multicenter, double-blind study that enrolled 800 participants with NERD.³

The primary endpoint was the percentage of 24-hour heartburn-free days during the placebo-controlled treatment phase.
Additional key endpoints included the percentage of days without overnight heartburn and the percentage of days without regurgitation.

In the press release, Prakash Gyawali, MD, MRCP, professor of medicine and director of the neurogastroenterology and motility program at Washington University, added: "These maintenance data establish the sustained clinical value of tegoprazan in GERD, even in the most severe categories of erosive esophagitis. Overall, these findings support the promise of tegoprazan as an important new tool to improve lives of GERD patients by providing healing and symptom relief."

Next steps for FDA submission

Sebela plans to file both EE and NERD indications with the FDA in Q4 2025 based on findings from the TRIUMpH program.

References

1. Sebela Pharmaceuticals® Announces Successful Completion of Phase 3 TRIUMpH Program of Tegoprazan in GERD with Positive 24-Week Maintenance Phase Results. Sebela Pharmaceuticals. News release. August 7, 2025. Accessed Augusr 7, 2025. https://www.prnewswire.com/news-releases/sebela-pharmaceuticals-announces-successful-completion-of-phase-3-triumph-program-of-tegoprazan-in-gerd-with-positive-24-week-maintenance-phase-results-302524332.html

2. A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients with Erosive Esophagitis. ClinicalTrials.gov. Updated January 13, 2025. Accessed August 7, 2025. https://clinicaltrials.gov/study/NCT05587309

3. A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease. ClinicalTrials.gov. Updated July 24, 2024. Accessed August 7, 2025. https://clinicaltrials.gov/study/NCT05587322

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