预约演示
更新于：2025-08-18
Zastaprazan citrate
更新于：2025-08-18
概要
基本信息
药物类型 小分子化药 |
别名 JP 1366、JP-1366、OCN-101 + [1] |
作用方式 抑制剂 |
作用机制 ATPase抑制剂(ATP酶抑制剂)、钾离子竞争性酸阻滞剂(钾离子竞争性酸阻滞剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 韩国 (2024-04-24), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C28H34N4O8 |
InChIKeyLYCCRSPDKSGPRQ-UHFFFAOYSA-N |
CAS号2936619-43-9 |
关联
17
项与 Zastaprazan citrate 相关的临床试验CTR20250611
一项评价注射用JP-1366在健康受试者中的安全性耐受性及药代动力学药效动力学特征的单多次给药剂量递增I期临床研究
CTR20244931
[14C]JP-1366在健康男性研究参与者中的物质平衡研究
CTR20243824
JP-1366片与耐信®在反流性食管炎受试者中的多中心、随机、双盲双模拟、阳性平行对照的III期临床研究
100 项与 Zastaprazan citrate 相关的临床结果
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100 项与 Zastaprazan citrate 相关的转化医学
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100 项与 Zastaprazan citrate 相关的专利（医药）
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10
项与 Zastaprazan citrate 相关的文献（医药）2025-05-01ANNALS OF INTERNAL MEDICINE
Gastroenterology/Hepatology: What You May Have Missed in 2024
Review
作者: Samnani, Sunil ; Bretthauer, Michael ; Jamal, Imran ; Song, Yi Nong ; Cintosun, Amber
This article highlights selected major advances in gastroenterology and hepatology from 2024 that are relevant for internal medicine specialists. In colorectal cancer (CRC) screening, new developments include a head-to-head comparison of different fecal immunochemical tests and a new blood-based DNA screening test, benefits and harms of artificial intelligence-assisted colonoscopy, and adenoma detection rate improvement and risk for cancer. Treatment options for metabolic dysfunction-associated steatotic liver disease now include resmetirom, a recently approved drug for treatment of patients with moderate-to-severe fibrosis, and liver transplantation may now be an option in patients with unresectable colorectal liver metastases. Also featured are new data on the efficacy of indomethacin and pancreatic stent placement for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography and news on the efficacy and safety of zastaprazan, a new potassium-competitive acid blocker for reflux esophagitis. Finally, a recent randomized trial is highlighted that has dispelled concerns about potential harms of proton-pump inhibitors for stress ulcer prophylaxis in patients receiving invasive mechanical ventilation.
2025-02-01AMERICAN JOURNAL OF GASTROENTEROLOGY
Randomized, Double-Blind, Active-Controlled Phase 3 Study to Evaluate Efficacy and Safety of Zastaprazan Compared With Esomeprazole in Erosive Esophagitis
Article
作者: Kim, John ; Lee, Dong Ho ; Lee, Hang Lak ; Yu, Eunju ; Kim, Hyun-Soo ; Jung, Hwoon-Yong ; Kim, Jun ; Kim, Gwang Ha ; Choi, Suck Chei ; Chung, Woo Chul ; Kwon, Hyesoo ; Kim, Ji Won ; Cheung, Dae Young ; Oh, Jung-Hwan ; Cho, Yu Kyung
INTRODUCTION::
Zastaprazan is a potent potassium-competitive acid blocker developed to treat gastroesophageal reflux disease. The aim of this study was to evaluate the efficacy and safety of zastaprazan compared with esomeprazole in patient with erosive esophagitis (EE).
METHODS::
A phase III, multicenter, randomized, double-blind, noninferiority clinical study was conducted with 300 subjects with confirmed EE. Subjects were randomized to receive zastaprazan 20 mg or esomeprazole 40 mg once daily up to 8 weeks. The primary end point was the cumulative proportion of subject with healed EE confirmed by endoscopy at week 8. The secondary end points included the healing rate at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were also assessed.
RESULTS::
In the full analysis set, the cumulative healing rate at week 8 were 97.92% (141/144) for zastaprazan and 94.93% (131/138) (P = 0.178) for esomeprazole. The healing rate at week 4 in the zastaprazan group was higher than the esomeprazole group (95.14% [137/144] vs 87.68% [121/138]; P = 0.026). There was no significant difference between groups in healing rates (the per-protocol set) at week 8 and week 4, symptom responses, quality of life assessments, and safety profiles. In addition, serum gastrin levels increased during treatment in both groups, with a significant difference between the 2 groups (P = 0.047), but both decreased after treatment.
DISCUSSION::
An 8-week therapy of zastaprazan 20 mg is noninferior to esomeprazole 40 mg in subjects with predominantly low-grade EE. The healing rate at week 4 appears to be higher for zastaprazan than esomeprazole.
2025-01-01Translational and clinical pharmacology
Evaluation of drug-drug interaction potentials between JP-1366 and celecoxib using physiologically based pharmacokinetic modeling
Article
作者: Lim, Hyeong-Seok ; Choi, Seung Chan ; Kim, John
Zastaprazan (JP-1366) is a new potassium-competitive acid blocker being developed for treating gastrointestinal reflux disease. It is an orally administered small molecule that inhibits gastric H+ and K+-ATPases differently from proton pump inhibitors, which act quickly and have dose-dependent effects on acid secretion. Celecoxib, a selective cyclooxygenase 2 inhibitor, will likely be used with zastaprazan in clinical settings and trials. The objective of current physiologically based pharmacokinetic (PBPK) modeling study is to predict drug-drug interaction (DDI) risk between zastaprazan (perpetrator) and celecoxib (victim). A human PBPK model for zastaprazan was built using experimental physicochemical properties and in silico predictions. The model was optimized with clinical pharmacokinetic (PK) data from a phase 1 study (Protocol No. JP-1366-105). The PBPK model for celecoxib was constructed using the data from previous studies and in silico predictions. The final PBPK model encompassing zastaprazan and celecoxib was used to quantitatively predicted DDI risks in humans. The final PBPK models accurately predicted zastaprazan's PK profiles after single dose in human, and it also well predicted plasma celecoxib concentrations over time. At doses of 20 mg of zastaprazan citrate (JAQBO® tablet) and 200 mg of celecoxib, multiple oral doses of zastaprazan every 24 hours for 7 days did not increase celecoxib's area under the curve (AUC) and maximum plasma concentration (Cmax), with ratios of 1 in both AUC and Cmax, indicating no effect of zastaprazan on celecoxib's PK. The PBPK modeling approach provides scientific predictions of DDIs between zastaprazan and celecoxib, guiding future clinical development.
24
项与 Zastaprazan citrate 相关的新闻（医药）2025-08-17
·信狐药迅
2025-08-15
抗体药物偶联物引进/卖出上市批准临床2期
2025-08-15
·抗体圈
引进/卖出临床3期临床1期
100 项与 Zastaprazan citrate 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糜烂性胃食管反流病 | 韩国 | 2024-04-24 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 反流性食管炎 | 临床3期 | 中国 | 2024-12-05 | |
| 反流性食管炎 | 临床3期 | 中国 | 2024-12-05 | |
| 胃溃疡 | 临床3期 | 美国 | 2022-09-19 | |
| 糜烂性食管炎 | 临床3期 | 美国 | 2022-01-17 | |
| 消化性溃疡出血 | 临床1期 | 中国 | 2025-02-26 | |
| 幽门螺杆菌相关性胃炎 | 临床1期 | 美国 | 2020-11-18 | |
| 溃疡 | 临床1期 | 美国 | 2017-12-22 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 300 | 製艱壓願顧艱廠壓遞獵(鬱衊衊廠襯蓋積構積醖) = 廠鬱壓鑰醖齋膚壓鏇築 鏇網鏇獵鬱憲蓋構繭衊 (製衊範獵餘獵遞範憲製 ) 更多 | 积极 | 2024-07-03 | |||
製艱壓願顧艱廠壓遞獵(鬱衊衊廠襯蓋積構積醖) = 夢製鹹網積衊膚襯衊選 鏇網鏇獵鬱憲蓋構繭衊 (製衊範獵餘獵遞範憲製 ) 更多 | |||||||
临床3期 | 300 | zastaprazan 20 mg | 壓網範齋憲選獵鹹鏇鹹(願壓蓋窪積鏇壓醖願鹹) = 鑰鏇鬱糧淵憲網齋製鹽 獵艱顧糧鹽糧選鑰餘築 (鏇選築繭鬱鹹鏇鬱醖積 ) 更多 | 非劣 | 2024-05-29 | ||
埃索美拉唑 40 mg | 壓網範齋憲選獵鹹鏇鹹(願壓蓋窪積鏇壓醖願鹹) = 蓋構艱衊鹽製簾簾蓋鑰 獵艱顧糧鹽糧選鑰餘築 (鏇選築繭鬱鹹鏇鬱醖積 ) 更多 | ||||||
Pubmed 人工标引  | 临床阶段不明 | - | Zastaprazan 20mg | 鹹壓廠築艱範網淵簾糧(鏇餘鏇糧獵獵構鏇積衊) = 襯築壓膚衊夢艱遞夢遞 膚窪窪選製鑰獵艱遞顧 (製鹹廠窪艱選鬱衊膚獵 ) | 积极 | 2023-02-02 | |
Zastaprazan 40mg | 鹹壓廠築艱範網淵簾糧(鏇餘鏇糧獵獵構鏇積衊) = 鏇壓積餘餘鹹遞範鹹衊 膚窪窪選製鑰獵艱遞顧 (製鹹廠窪艱選鬱衊膚獵 ) |
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