2. Academic Validation
  3. Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis

Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis

  • Am J Gastroenterol. 2025 Feb 1;120(2):353-361. doi: 10.14309/ajg.0000000000002929.
Jung-Hwan Oh 1,  Hyun-Soo Kim 2,  Dae Young Cheung 3,  Hang Lak Lee 4,  Dong Ho Lee 5,  Gwang Ha Kim 6,  Suck Chei Choi 7,  Yu Kyung Cho 3,  Woo Chul Chung 8,  Ji Won Kim 9,  Eunju Yu 10,  Hyesoo Kwon 10,  Jun Kim 10,  John Kim 10,  Hwoon-Yong Jung 11
Affiliations

Affiliations

  • 1 Division of Gastroenterology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 2 Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • 3 Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
  • 4 Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
  • 5 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 6 Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
  • 7 Department of Internal Medicine, Wonkwang University Hospital, Iksan, South Korea.
  • 8 Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
  • 9 Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
  • 10 Onconic Therapeutics, Seoul, Korea.
  • 11 Department of Gastroenterology, Asan Medical Center, Seoul, South Korea .
PMID: 38976448 DOI: 10.14309/ajg.0000000000002929
Abstract

Introduction: Zastaprazan is a potent potassium-competitive acid blocker developed to treat gastroesophageal reflux disease. The aim of this study was to evaluate the efficacy and safety of zastaprazan compared with esomeprazole in patient with erosive esophagitis (EE).

Methods: A phase III, multicenter, randomized, double-blind, noninferiority clinical study was conducted with 300 subjects with confirmed EE. Subjects were randomized to receive zastaprazan 20 mg or esomeprazole 40 mg once daily up to 8 weeks. The primary end point was the cumulative proportion of subject with healed EE confirmed by endoscopy at week 8. The secondary end points included the healing rate at week 4, symptom response, and quality of life assessment. Safety profiles and serum Gastrin levels were also assessed.

Results: In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) ( P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026). There was no significant difference between groups in healing rates (the per-protocol set) at week 8 and week 4, symptom responses, quality of life assessments, and safety profiles. In addition, serum Gastrin levels increased during treatment in both groups, with a significant difference between the 2 groups ( P = 0.047), but both decreased after treatment.

Discussion: An 8-week therapy of zastaprazan 20 mg is noninferior to esomeprazole 40 mg in subjects with predominantly low-grade EE. The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole.

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