Tegoprazan Demonstrates Superior Healing and Maintenance in Phase 3 Erosive Esophagitis Trial
核心洞察
Sebela Pharmaceuticals (搜索) presented Phase 3 TRIUMpH-EE trial results at DDW 2026, showing tegoprazan's superiority over lansoprazole in healing erosive esophagitis (搜索) across all severity grades.
The novel potassium-competitive acid blocker achieved 84.6% complete healing at 8 weeks versus 78.0% for lansoprazole, with particularly strong benefits in severe disease patients.
Tegoprazan demonstrated superior maintenance of healing at 24 weeks (69.4% vs 50.6%) and better heartburn symptom control, especially in patients with severe erosive esophagitis (搜索).
Sebela Pharmaceuticals (搜索) presented compelling Phase 3 data for tegoprazan at Digestive Disease Week 2026, demonstrating the novel acid blocker's superiority over standard proton pump inhibitor therapy in treating erosive esophagitis (搜索). The TRIUMpH-EE trial results, presented in two oral sessions, showed significant advantages in both healing and maintenance phases across all disease severity grades.
Superior Healing Outcomes Across Disease Severity
The randomized, double-blind, multicenter TRIUMpH-EE study enrolled 1,245 adults with erosive esophagitis (搜索), including 463 patients with severe disease (Los Angeles Grade C/D). Tegoprazan 100 mg once daily demonstrated statistically superior healing compared to lansoprazole 30 mg once daily at both early and late timepoints.
At the primary endpoint of 8 weeks, tegoprazan achieved complete endoscopic healing in 84.6% of patients versus 78.0% for lansoprazole (Δ=6.6%, p=0.0083). The drug showed even more pronounced benefits at 2 weeks, with 76.4% of tegoprazan patients achieving complete healing compared to 67.0% on lansoprazole (Δ=9.4%, p<0.0001).
The therapeutic advantage was particularly striking in patients with severe erosive esophagitis (搜索). At 2 weeks, 74.1% of severe patients treated with tegoprazan achieved complete healing versus only 54.5% on lansoprazole (Δ=19.6%, p<0.0001). This substantial difference persisted at 8 weeks, with healing rates of 83.2% versus 68.0% respectively (Δ=15.2%, p=0.0002).
Sustained Maintenance Benefits
The maintenance phase evaluated patients who achieved complete healing after up to 8 weeks of treatment and were re-randomized to receive tegoprazan 100 mg, tegoprazan 50 mg, or lansoprazole 15 mg once daily. Both doses of tegoprazan demonstrated superior sustained healing over 24 weeks compared to lansoprazole.
Tegoprazan 100 mg maintained complete healing in 69.4% of patients versus 50.6% for lansoprazole (Δ=18.8%, p<0.0001). The 50 mg dose achieved 61.4% sustained healing (Δ=10.8%, p=0.0145). In patients with severe disease, the difference was even more pronounced, with tegoprazan 100 mg achieving 76.4% sustained healing compared to 44.3% for lansoprazole (Δ=32.1%, p<0.0001).
Enhanced Symptom Control
Beyond endoscopic healing, tegoprazan provided superior symptom relief, particularly in patients with severe disease. Through 8 weeks, patients with severe erosive esophagitis (搜索) experienced 60.1% heartburn-free days on tegoprazan versus 53.6% on lansoprazole (Δ=6.5%, p=0.0289).
During the maintenance phase, tegoprazan 100 mg delivered 84.2% heartburn-free days in severe patients compared to 70.4% for lansoprazole (Δ=13.8%, p=0.0018), representing a clinically meaningful improvement in quality of life.
Novel Mechanism of Action
Tegoprazan represents a new class of acid-suppressing medications known as potassium-competitive acid blockers (P-CABs). Unlike traditional proton pump inhibitors, P-CABs provide rapid, reversible, potassium-competitive inhibition of the gastric proton pump (搜索) with a self-regulating mechanism of action.
"These positive results are directly related to the self-regulating mechanism of action of tegoprazan which differentiates it from other products on the market," said Alan Cooke, President and Chief Executive Officer of Sebela Pharmaceuticals (搜索). In Phase 1 pharmacodynamic studies, tegoprazan demonstrated rapid acid control, achieving an intragastric pH above 4 within 45 minutes of dosing.
Safety Profile and Regulatory Status
The safety profile of tegoprazan was comparable to lansoprazole across both study phases. Treatment-emergent adverse events occurred at approximately 3% and were generally mild and transient, with serious events occurring at approximately 2% with similar rates between tegoprazan and comparators. Mean serum gastrin levels remained within the normal range (0-180 pg/mL) throughout treatment periods.
Sebela submitted a New Drug Application to the FDA in January 2026 seeking approval for tegoprazan in treating heartburn associated with non-erosive reflux disease (搜索), healing of erosive esophagitis (搜索), and maintenance of healing in adults. US approval is anticipated in January 2027.
Addressing Unmet Medical Need
The results address a significant unmet need in GERD (搜索) management. The condition affects approximately 65 million people in the United States, and despite proton pump inhibitors being the mainstay of therapy for decades, 35-54% of patients experience incomplete symptom relief. Patients with severe erosive esophagitis (搜索) are at increased risk of complications and often require long-term maintenance therapy.
"Across the TRIUMpH program, tegoprazan has demonstrated the potential to deliver faster and more complete healing, sustained maintenance of healing, and meaningful relief of heartburn and regurgitation in patients with GERD (搜索), including those with more severe disease who often remain symptomatic despite conventional PPI therapy," Cooke noted.
Tegoprazan has already received marketing authorization in 23 countries worldwide and is marketed as K-CAB in several regions outside the United States, including South Korea. The comprehensive TRIUMpH clinical program also includes a separate Phase 3 study in non-erosive reflux disease (搜索), with data expected to be presented at the American College of Gastroenterology 2026 Annual Scientific Meeting.