Abstract
Zastaprazan (JAQBO®) is a next-generation potassium-competitive acid blocker being developed by Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, for the treatment of acid-related diseases. Zastaprazan binds directly to proton pumps in a competitive manner to reduce gastric acid secretion, allowing for a quick onset of action. On 24 April 2024, zastaprazan received approval in South Korea for the treatment of erosive gastroesophageal reflux disease (GERD). Zastaprazan is also undergoing phase III development for the treatment of gastric ulcer and for the prevention of non-steroidal anti-inflammatory drug (NSAID)-induced peptic ulcer. This article summarizes the milestones in the development of zastaprazan leading to this first approval for erosive GERD.
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References
Katzka DA, Pandolfino JE, Kahrilas PJ. Phenotypes of gastroesophageal reflux disease: where Rome, Lyon, and Montreal meet. Clin Gastroenterol Hepatol. 2020;18(4):767–76.
Armstrong D. Potassium-competitive acid blockers and gastroesophageal reflux disease. Gastroenterol Hepatol. 2023;19(5):295–8.
Onconic Therapeutics. Onconic Therapeutics receives MFDS approval for JAQBO, a new treatment for gastroesophageal reflux disease (GERD) [media release]. 25 Apr 2024. https://www.prnewswire.com/in/news-releases/onconic-therapeutics-receives-mfds-approval-for-jaqbo-a-new-treatment-for-gastroesophageal-reflux-disease-gerd-302127478.html.
Onconic Therapeutics. JAQBO 20 mg tablets (zastaprazan citrate): Korean prescribing information. 2024.
Livzon Pharmaceuticals. Voluntary announcement entering into the license agreement [media release]. 10 Mar 2023. http://www1.hkexnews.hk.
Ku JM, Cho JH, Kim K, et al. JP-1366: a novel and potent potassium-competitive acid blocker that is effective in the treatment of acid-related diseases. Pharmacol Res Perspect. 2023;11(3): e01090.
Hwang I, Ji SC, Oh J, et al. Randomised clinical trial: safety, tolerability, pharmacodynamics and pharmacokinetics of zastaprazan (JP-1366), a novel potassium-competitive acid blocker, in healthy subjects. Aliment Pharmacol Ther. 2023;57(7):763–72.
Oh J, Kim H, Cheung DY, et al. Randomised, double-blind, active-controlled phase 3 study to evaluate the efficacy and safety of zastaprazan compared with esomeprazole in erosive oesophagitis [zastaprazan erosive reflux oesophagitis-1 study (ZERO-1)] [abstract no. OP050]. United Eur Gastroenterol J. 2023;11(Suppl 8):54–6.
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During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah A. Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.
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Blair, H.A. Zastaprazan: First Approval. Drugs (2024). https://doi.org/10.1007/s40265-024-02057-w
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DOI: https://doi.org/10.1007/s40265-024-02057-w