Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis

Kang Nyeong Lee, Oh Young Lee, Hoon Jai Chun, Jin Il Kim, Sung Kook Kim, Sang Woo Lee, Kyung Sik Park, Kook Lae Lee, Suck Chei Choi, Jae Young Jang, Gwang Ha Kim, In Kyung Sung, Moo In Park, Joong Goo Kwon, Nayoung Kim, Jae Jun Kim, Soo Teik Lee, Hyun Soo Kim, Ki Bae Kim, Yong Chan LeeMyung Gyu Choi, Joon Seong Lee, Hwoon Yong Jung, Kwang Jae Lee, Jie Hyun Kim, Hyunsoo Chung

Research output: Contribution to journalArticlepeer-review


BACKGROUND Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan’s suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIM To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups. RESULTS Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSION Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.

Original languageEnglish
Pages (from-to)6294-6309
Number of pages16
JournalWorld Journal of Gastroenterology
Issue number44
Publication statusPublished - 2022 Nov 28

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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.

All Science Journal Classification (ASJC) codes

  • Gastroenterology


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