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Clinical Trial
. 2024 Apr;39(4):658-666.
doi: 10.1111/jgh.16471. Epub 2024 Jan 22.

The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study

Qianjun Zhuang  1 , Aijun Liao  2 , Qingling He  3 , Chengxia Liu  4 , Changqing Zheng  5 , Xing Li  6 , Youli Liu  7 , Bangmao Wang  8 , Side Liu  9 , Yan Zhang  10 , Rong Lin  11 , Huixin Chen  12 , Min Deng  13 , Yanping Tang  14 , Chiyi He  15 , Weijie Dai  16 , Haitao Tang  17 , Lei Gong  18 , Liangping Li  19 , Baohong Xu  20 , Changqing Yang  21 , Bingxi Zhou  22 , Dongxing Su  23 , Qinghong Guo  24 , Bin Li  25 , Yongjian Zhou  26 , Xiaoyang Wang  27 , Sujuan Fei  28 , Huili Wu  29 , Sichen Wei  30 , Zhihong Peng  31 , Jianning Wang  32 , Yanqing Li  33 , Hong Wang  34 , Tianwei Deng  35 , Shigang Ding  36 , Fangfang Li  37 , Minhu Chen  1 , Yinglian Xiao  1
Affiliations
Clinical Trial

The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study

Qianjun Zhuang et al. J Gastroenterol Hepatol. 2024 Apr.

Abstract

Background and aim: Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE).

Methods: This was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group.

Results: A total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm.

Conclusion: This study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole. Trial registration number NCT05813561.

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