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World J Gastroenterol. Jul 7, 2026; 32(25): 119434
Published online Jul 7, 2026. doi: 10.3748/wjg.119434
Comparing fexuprazan and rabeprazole for treating peptic ulcer: A multicenter, randomized controlled trial
Dong Soo Lee, Seung Woo Lee, Sun Hyung Kang, Hee Seok Moon, Jae Kyu Sung, Sae Hee Kim, Dong Kyu Lee, Ki Bae Kim, Sun Moon Kim, Young Sin Cho, Ju Seok Kim
Dong Soo Lee, Seung Woo Lee, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul 03083, South Korea
Sun Hyung Kang, Hee Seok Moon, Jae Kyu Sung, Ju Seok Kim, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon 35015, South Korea
Sae Hee Kim, Department of Internal Medicine, Yuseong Sun Medical Center, Daejeon 34084, South Korea
Dong Kyu Lee, Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon 35233, South Korea
Ki Bae Kim, Department of Internal Medicine, Chungbuk National University School of Medicine, Cheongju 28644, South Korea
Sun Moon Kim, Department of Internal Medicine, Konyang University College of Medicine, Daejeon 35365, South Korea
Young Sin Cho, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan 31151, South Korea
Author contributions: Kim JS and Lee DS designed the study; Lee DS, Lee SW, Kang SH, Moon HS, Sung JK, Kim SH, Lee DK, Kim KB, Kim SM, Cho YS, and Kim JS performed data acquisition, statistical analysis, interpretation of data, and drafting of the manuscript; Lee DS revised the manuscript for important intellectual content; Kim JS supervised the project; all authors read and approved the final manuscript and contributed to the article and approved the submitted version.
Supported by Daewoong Pharmaceutical Co., Ltd. (Seoul, Korea).
Institutional review board statement: This study was approved by the Institutional Review Board of Chungnam National University Sejong Hospital (Approval No. CNUSH IRB 2023-02-020-001).
Clinical trial registration statement: The clinical trial was registered at Cris.nih.go.kr (KCT0008647).
Informed consent statement: All enrolled patients participated in the study after providing informed consent.
Conflict-of-interest statement: There is no potential conflict of interest relevant to this article was reported.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Corresponding author: Ju Seok Kim, Department of Internal Medicine, Chungnam National University College of Medicine, 282 Munhwa-ro, Jung-Gu, Daejeon 35015, South Korea.
showsik@hanmail.net
Received: January 28, 2026
Revised: March 17, 2026
Accepted: April 9, 2026
Published online: July 7, 2026
Processing time: 154 Days and 8.3 Hours
BACKGROUND
Fexuprazan, a novel potassium-competitive acid blocker, has several advantages over proton pump inhibitors and is used to treat various acid-related disorders.
AIM
To compare the efficacy and safety of fexuprazan and rabeprazole in treating patients with peptic ulcer disease (PUD) and confirm the non-inferiority of fexuprazan.
METHODS
This randomized, comparative, multicenter, open study was conducted in eight institutions in South Korea. The non-inferiority (margin of -10%) of fexuprazan 40 mg and rabeprazole 20 mg for 4 weeks or 8 weeks was analyzed in patients with PUD. The primary and secondary endpoints were the peptic ulcer healing rates after 8 weeks and 4 weeks, respectively. Symptom improvement and safety were assessed.
RESULTS
One hundred and seven patients with PUD were randomized, and 102 completed the study: 51 each in the fexuprazan and rabeprazole groups. Regarding the per protocol set, the healing rates after 8 weeks were 100% (51/51) and 98.04% (50/51) in the fexuprazan and rabeprazole groups, and the healing rates after 4 weeks were 98.04% (50/51) and 94.12% (48/51) in the fexuprazan and rabeprazole groups, respectively. For the full analysis set, the healing rates after 8 weeks were 98.08% (51/52) and 98.04% (50/51) in the fexuprazan and rabeprazole groups, and the healing rate after 4 weeks was 96.15% (50/52) and 94.12% (48/51) in the fexuprazan and rabeprazole groups, respectively. The 4-weeks and 8-weeks healing rates confirmed that the non-inferiority of fexuprazan to rabeprazole. The incidence of treatment-emergent adverse events was not different between the two groups, and the degree of increase in serum gastrin levels was similar.
CONCLUSION
Fexuprazan 40 mg showed non-inferiority in ulcer healing rate after 8 weeks in patients with PUD compared to rabeprazole 20 mg.
Core Tip: Fexuprazan, a novel potassium-competitive acid blocker, has several advantages compare to proton pump inhibitors. Fexuprazan 40 mg showed non-inferiority in ulcer healing rate after 8 weeks in patients with peptic ulcer disease compared to rabeprazole 20 mg.
