Correspondence to Author: Piyush Agarwal^1*,Brajesh Kumar Jha¹, Jaganmohan Somagoni¹, Sanjana Dawra¹, Sanketh Kumar Chakilam¹, Swarup Rajendra Wani¹, Rupa Banerjee², Rakesh Patel³,B Ravi Shankar⁴, Geun Seog Song⁵. 

1. Global Clinical Management, Dr. Reddy’s Laboratories Ltd, Hyderabad, India,
2. Asian Institute of Gastroenterology, Hyderabad, Telangana, India,
3. Ashirwad Hospital and Research Centre, Ulhasnagar, Maharashtra, India.
4. Yashoda Hospitals, Secunderabad, Telangana, India.
5. Division of Clinical Development, HK Inno.N Corp., Sungnam 13453, Korea

DOI: 10.52338/jjogastro.2025.4829

Abstract:

Background: Tegoprazan is a highly selective potassium-competitive acid blocker (P-CAB) that delivers rapid relief and maintains an intragastric pH above 4 after both single and multiple doses.
Objective: This study was aimed to determine the efficacy and safety of Tegoprazan in treating erosive gastroesophageal reflux disease (eGERD) over a treatment period of 8 weeks.
Methods: The present study was a randomized, double-blind, active-controlled, parallel-group multi-center, multi-country phase 3 clinical trial to evaluate efficacy and safety of Tegoprazan 50 mg tablet in comparison to Esomeprazole 40 mg tablet in patients with eGERD. The study planned to enroll male and non-pregnant female patients (18-65 years of age) with endoscopically confirmed eGERD classified as Los Angles (LA) grades A-D. Following a screening period of approximately 14 days, eligible patients were randomized in 1:1 ratio to one of the two double-blind treatment groups. The primary endpoint was the cumulative endoscopic healing rate of eGERD by 8 weeks based on the upper gastrointestinal (GI) endoscopy. Symptoms, safety, and tolerability were also assessed. This trial is registered at Clinical Trial Registry of India (CTRI) and South African National Clinical Trial Registry (SANCTR).
Results: Between November 2023 and July 2024, in a competitive recruitment process spanning three countries, 255 patients were enrolled: 179 from India, 69 from Russia, and 7 from South Africa. At week 8, cumulative endoscopic healing rate for Tegoprazan was 99.1% [95% CI: 95.25:99.98] and with Esomeprazole was 97.2 % [95% CI:92.17:99.43], demonstrating the non-inferiority of Tegoprazan to Esomeprazole, with a p-value <0.0001. Treatment emergent adverse events (TEAEs) were comparable in both groups and Tegoprazan was well tolerated. TEAEs that occurred in ≥1% of patients were headache, diarrhea, nausea, and abdominal pain.
Conclusion: Tegoprazan was non-inferior to Esomeprazole and safe for patients with eGERD

Keywords: Tegoprazan, Potassium competitive acid blocker, Gastroesophageal Reflux, Esophagitis, Endoscopy

Citation:

Piyush Agarwal, Efficacy and Safety of Tegoprazan in Patients with Erosive Gastroesophageal Reflux Disease- A Multicountry, Prospective, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study. Japanese Journal of Gastroenterology 2025.