Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease

Summary

The goal of this clinical trial was to evaluate the effectiveness and safety of fexuprazan 40 mg for relieving symptoms of gastroesophageal reflux disease (GERD) in adults. The study also compared fexuprazan with esomeprazole 40 mg, a commonly used treatment for GERD. The main questions this study aimed to answer were: * Did fexuprazan reduce GERD symptoms such as heartburn and acid regurgitation? * Was fexuprazan safe and well tolerated compared with esomeprazole? Researchers compared fexuprazan with esomeprazole to determine whether fexuprazan provided similar symptom relief and safety. Participants in the study: * Were randomly assigned to receive fexuprazan 40 mg or esomeprazole 40 mg once daily * Took the study medication for 4 weeks, with treatment extended up to 8 weeks if symptoms did not improve * Attended scheduled clinic visits for evaluations * Completed symptom questionnaires and a daily symptom diary * Were monitored for side effects and overall safety throughout the study

Timeline

Start

2024-09-23

Primary completion

2024-10-10

Completion

2024-12-13

Publications

• Background Yang AY, Yoo H, Shin W, Lee YS, Lee H, Kim SE, Kim A. Size-reduced fexuprazan 20 mg demonstrated the optimal bioavailability and bioequivalence with the reference formulation. Transl Clin Pharmacol. 2023 Mar;31(1):40-48. doi: 10.12793/tcp.2023.31.e3. Epub 2023 Mar 22.
• Background Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16.
• Background Shin W, Yang AY, Park H, Lee H, Yoo H, Kim A. A Comparative Pharmacokinetic Study of Fexuprazan 10 mg: Demonstrating Bioequivalence with the Reference Formulation and Evaluating Steady State. Pharmaceuticals (Basel). 2023 Aug 11;16(8):1141. doi: 10.3390/ph16081141.
• Background Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.
• Background Kim SI, Lee YC, Cha W, Jung AR, Jang JY, Choi JS, Lee DK, Lee HH, Kwon MS, Lee YS, Eun YG. Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5873-5883. doi: 10.1007/s00405-024-08877-6. Epub 2024 Aug 8.
• Background Zhuang Q, Liao A, He Q, Liu C, Zheng C, Li X, Liu Y, Wang B, Liu S, Zhang Y, Lin R, Chen H, Deng M, Tang Y, He C, Dai W, Tang H, Gong L, Li L, Xu B, Yang C, Zhou B, Su D, Guo Q, Li B, Zhou Y, Wang X, Fei S, Wu H, Wei S, Peng Z, Wang J, Li Y, Wang H, Deng T, Ding S, Li F, Chen M, Xiao Y. The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study. J Gastroenterol Hepatol. 2024 Apr;39(4):658-666. doi: 10.1111/jgh.16471. Epub 2024 Jan 22.
• Background Kang N, Kang MG, Lee SE, Kang SY, Jo EJ, Lee JH, Kim SH, Bahn JW, Lee BJ, Song WJ. Efficacy and Safety of Fexuprazan Versus Esomeprazole for Gastroesophageal Reflux Disease-Related Chronic Cough: A Randomized, Double-Blind, Active-Controlled Exploratory Trial. Lung. 2025 Apr 29;203(1):59. doi: 10.1007/s00408-025-00815-5.
• Background Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.
• Background Oh J, Yang E, Jang IJ, Lee H, Yoo H, Chung JY, Lee S, Oh J. Pharmacodynamic and Pharmacokinetic Drug Interactions between Fexuprazan, a Novel Potassium-Competitive Inhibitor, and Aspirin, in Healthy Subjects. Pharmaceutics. 2023 Feb 7;15(2):549. doi: 10.3390/pharmaceutics15020549.
• Background Hwang JG, Jeon I, Park SA, Lee A, Yu KS, Jang IJ, Lee S. Pharmacodynamics and pharmacokinetics of DWP14012 (fexuprazan) in healthy subjects with different ethnicities. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1648-1657. doi: 10.1111/apt.16131. Epub 2020 Oct 27.
• Background Sunwoo J, Oh J, Moon SJ, Ji SC, Lee SH, Yu KS, Kim HS, Lee A, Jang IJ. Safety, tolerability, pharmacodynamics and pharmacokinetics of DWP14012, a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2018 Jul;48(2):206-218. doi: 10.1111/apt.14818. Epub 2018 Jun 4.
• Background Lee SP, Sung IK, Lee OY, Choi MG, Huh KC, Jang JY, Chun HJ, Kwon JG, Kim GH, Kim N, Rhee PL, Kim SG, Jung HY, Lee JS, Lee YC, Jung HK, Kim JG, Kim SK, Sohn CI. Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis. J Neurogastroenterol Motil. 2025 Jan 31;31(1):86-94. doi: 10.5056/jnm24032. Epub 2024 Dec 13.
• Background Hafiz RA, Wong C, Paynter S, David M, Peeters G. The Risk of Community-Acquired Enteric Infection in Proton Pump Inhibitor Therapy: Systematic Review and Meta-analysis. Ann Pharmacother. 2018 Jul;52(7):613-622. doi: 10.1177/1060028018760569. Epub 2018 Feb 18.
• Background Strand DS, Kim D, Peura DA. 25 Years of Proton Pump Inhibitors: A Comprehensive Review. Gut Liver. 2017 Jan 15;11(1):27-37. doi: 10.5009/gnl15502.
• Background Rettura F, Bronzini F, Campigotto M, Lambiase C, Pancetti A, Berti G, Marchi S, de Bortoli N, Zerbib F, Savarino E, Bellini M. Refractory Gastroesophageal Reflux Disease: A Management Update. Front Med (Lausanne). 2021 Nov 1;8:765061. doi: 10.3389/fmed.2021.765061. eCollection 2021.
• Background Kim SE, Kim N, Oh S, Kim HM, Park MI, Lee DH, Jung HC. Predictive factors of response to proton pump inhibitors in korean patients with gastroesophageal reflux disease. J Neurogastroenterol Motil. 2015 Jan 1;21(1):69-77. doi: 10.5056/jnm14078.
• Background Weijenborg PW, Cremonini F, Smout AJ, Bredenoord AJ. PPI therapy is equally effective in well-defined non-erosive reflux disease and in reflux esophagitis: a meta-analysis. Neurogastroenterol Motil. 2012 Aug;24(8):747-57, e350. doi: 10.1111/j.1365-2982.2012.01888.x. Epub 2012 Feb 6.
• Background Yadlapati R, Gyawali CP, Pandolfino JE; CGIT GERD Consensus Conference Participants. AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review. Clin Gastroenterol Hepatol. 2022 May;20(5):984-994.e1. doi: 10.1016/j.cgh.2022.01.025. Epub 2022 Feb 2.
• Background ASGE Standards of Practice Committee; Desai M, Ruan W, Thosani NC, Amaris M, Scott JS, Saeed A, Abu Dayyeh B, Canto MI, Abidi W, Alipour O, Amateau SK, Cosgrove N, Elhanafi SE, Forbes N, Kohli DR, Kwon RS, Fujii-Lau LL, Machicado JD, Marya NB, Ngamruengphong S, Pawa S, Sheth SG, Thiruvengadam NR, Qumseya BJ; ASGE Standards of Practice Committee Chair. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: summary and recommendations. Gastrointest Endosc. 2025 Feb;101(2):267-284. doi: 10.1016/j.gie.2024.10.008. Epub 2024 Dec 17.
• Background Zhang D, Liu S, Li Z, Wang R. Global, regional and national burden of gastroesophageal reflux disease, 1990-2019: update from the GBD 2019 study. Ann Med. 2022 Dec;54(1):1372-1384. doi: 10.1080/07853890.2022.2074535.
• Background Shaqran TM, Ismaeel MM, Alnuaman AA, Al Ahmad FA, Albalawi GA, Almubarak JN, AlHarbi RS, Alaqidi RS, AlAli YA, Alfawaz KS, Daghriri AA. Epidemiology, Causes, and Management of Gastro-esophageal Reflux Disease: A Systematic Review. Cureus. 2023 Oct 21;15(10):e47420. doi: 10.7759/cureus.47420. eCollection 2023 Oct.
• Background Nirwan JS, Hasan SS, Babar ZU, Conway BR, Ghori MU. Global Prevalence and Risk Factors of Gastro-oesophageal Reflux Disease (GORD): Systematic Review with Meta-analysis. Sci Rep. 2020 Apr 2;10(1):5814. doi: 10.1038/s41598-020-62795-1.
• Background Lee KN, Lee OY, Chun HJ, Kim JI, Kim SK, Lee SW, Park KS, Lee KL, Choi SC, Jang JY, Kim GH, Sung IK, Park MI, Kwon JG, Kim N, Kim JJ, Lee ST, Kim HS, Kim KB, Lee YC, Choi MG, Lee JS, Jung HY, Lee KJ, Kim JH, Chung H. Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis. World J Gastroenterol. 2022 Nov 28;28(44):6294-6309. doi: 10.3748/wjg.v28.i44.6294.
• Background Maret-Ouda J, Markar SR, Lagergren J. Gastroesophageal Reflux Disease: A Review. JAMA. 2020 Dec 22;324(24):2536-2547. doi: 10.1001/jama.2020.21360.
• Background Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018 Mar;67(3):430-440. doi: 10.1136/gutjnl-2016-313589. Epub 2017 Feb 23.
• Background Hojo M, Nagahara A, Hahm KB, Iwakiri R, Watanabe T, Rani AA, Zhu Q, Chan FKL, Sollano JD, Kamiya T, Yamaguchi S, Motoya S, Fock KM, Fukudo S, Kachintorn U, Suzuki H, Murakami K; The International Gastroenterology Consensus Symposium Study Group. Management of Gastroesophageal Reflux Disease in Asian Countries: Results of a Questionnaire Survey. Digestion. 2020;101(1):66-79. doi: 10.1159/000504749. Epub 2019 Dec 4.

Drugs

Indications