预约演示
更新于：2026-10-23
Zastaprazan citrate
枸橼酸泽普拉生
更新于：2026-10-23
概要
基本信息
药物类型 小分子化药 |
别名 泽普拉生、JP 1366、JP-1366 + [3] |
作用方式- |
作用机制 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 |
非在研机构- |
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)申请上市 |
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
33
项与 枸橼酸泽普拉生 相关的临床试验NCT07730840
A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy of Zastaprazan in PrEventing Upper Gastrointestinal Bleeding in Patients With Transient Ischemic Attack or Ischemic Stroke Receiving Antiplatelet or Anticoagulant Therapy: ZEUS Trial
KCT0012421
A Randomized, Double-Blind, Placebo-Controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy of Zastaprazan in PrEventing Upper Gastrointestinal Bleeding in Patients With Transient Ischemic Attack or Ischemic Stroke Receiving Antiplatelet or Anticoagulant Therapy: ZEUS Trial
CTR20263482
一项在中国健康成年试验参与者中评估JP-1366与利福平、咪达唑仑药物相互作用的多中心、开放、固定序列、序贯设计临床研究
100 项与 枸橼酸泽普拉生 相关的临床结果
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100 项与 枸橼酸泽普拉生 相关的转化医学
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100 项与 枸橼酸泽普拉生 相关的专利（医药）
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20
项与 枸橼酸泽普拉生 相关的文献（医药）2026-12-01Pharmacology Research & Perspectives
Comparative Pharmacokinetics and Safety of Orally Disintegrating and Conventional Tablet Formulations of Zastaprazan in Healthy Subjects
Article
作者: Kim, Hyung‐Gun ; Kang, Seunghyun ; Bae, Moonjung ; Min, Sunyoung ; Hong, Heejoo
ABSTRACT:
Zastaprazan, a potassium‐competitive acid blocker, has been developed as an orally disintegrating tablet (ODT) to improve administration flexibility. This study evaluated the pharmacokinetics and safety of a single 20 mg dose of Zastaprazan ODT administered with or without water compared with the conventional tablet in healthy volunteers. In this open‐label, randomized, single‐dose, 6‐sequence, 3‐period crossover study, 54 healthy volunteers received a conventional tablet with water, an ODT with water, and an ODT without water. Serial blood samples were collected up to 36 h post‐dose, and pharmacokinetic parameters were calculated using a non‐compartmental method. Safety was assessed through adverse events, laboratory tests, vital signs, and electrocardiograms. Fifty‐one subjects completed all periods. The geometric mean ratios (90% confidence intervals) of
Cmax
and AUC
t
were 95.05% (88.38%–102.21%) and 108.00% (100.50%–116.06%) for ODT without water versus the conventional tablet, and 90.85% (84.96%–97.16%) and 101.88% (96.69%–107.36%) for ODT with water versus the conventional tablet, respectively. All 90% confidence intervals were within the predefined bioequivalence range.
Ka
and
Tmax
showed similar patterns across treatments, and no apparent additional early systemic exposure was observed within 30 min following ODT administration. Two mild adverse events were reported in one subject, with no serious adverse events. Zastaprazan ODT administered either with or without water was pharmacokinetically equivalent to the conventional tablet, with no apparent additional early systemic exposure and no clinically meaningful safety concerns.
Trial Registration:ClinicalTrials.gov
: NCT07181538
2026-08-28Journal of Neurogastroenterology and Motility
Effectiveness and Patient Satisfaction With Zastaprazan in Real-world Practice: A Large-Scale Prospective Observational Study
Article
作者: Kim, Yong Sung ; Ahn, Kwang Hyun ; Seo, Seung In
Background/Aims:
: Gastroesophageal reflux disease (GERD) remains a prevalent condition with unmet therapeutic needs. Zastaprazan is a novel potassium-competitive acid blocker (P-CAB) with potent acid suppression, but real-world evidence is limited. This study assesses symptom improvement and patient satisfaction with zastaprazan in patients with GERD.
Methods:
: This multicenter, prospective observational study enrolled adults diagnosed with GERD who received zastaprazan 20 mg daily for 4 weeks. Symptoms were assessed using the Reflux Disease Questionnaire (RDQ). The primary endpoint was the change in the mean GERD score of the RDQ. Secondary endpoints included the mean total RDQ score, patient satisfaction, compliance, and effectiveness stratified by prior medication use and diagnostic method.
Results:
: Among 5499 participants, the mean GERD score significantly decreased from 2.07 ± 1.12 to 0.44 ± 0.63 at week 4 (change: -1.63 ± 1.07, P < 0.0001). Symptom improvement was observed in treatment-naïve patients (n = 4906, -1.64 ± 1.08, P < 0.0001) and those previously treated with histamine-2 receptor antagonists, proton pump inhibitors, or P-CABs (n = 593, -1.60 ± 1.03, P < 0.0001). The switching group (within 2 days) also showed significant improvement (n = 304, -1.53 ± 1.05, P < 0.0001). Over 90% reported satisfaction, compliance was 93%, and only 2.25% required concomitant medications. Safety was excellent, with only 3 cases of mild adverse reactions (0.05%) and no serious events.
Conclusion:
Zastaprazan was associated with clinically meaningful symptom improvement in GERD patients, regardless of prior medication history, including proton pump inhibitors or other P-CABs, with high patient satisfaction, and a favorable safety profile.
2026-07-15Gut and Liver
Randomized, Double-Blind, Active-Controlled, Parallel, Phase 3 Clinical Trial for Evaluating the Efficacy and Safety of Zastaprazan in Patients with Gastric Ulcers
Article
作者: Jee, Sam Ryong ; Lee, Keemyung ; Park, Sung Chul ; Jung, Hye-Kyung ; Park, Jong-Jae ; Huh, Chealwung ; Lee, Hang Lak ; Shim, Ki-Nam ; Kim, Taeoh ; Chun, Hoonjai ; Jung, Sung Woo ; Choi, Cheol Woong ; Moon, Hee Seok ; Kim, Sung Soo ; Park, Chan Hyuk ; Kwon, Hyesoo ; Cho, Jinwoong ; Kim, Hyunjin ; Kim, John ; Park, Kyung Sik ; Kim, Kyoung Oh ; Cho, Yu Kyung ; Park, Moo In ; Kim, Jun ; Kim, Hyun-Soo ; Kim, Byung-Wook ; Kim, Sun Moon ; Jung, Da Hyun ; Kim, Gwang Ha ; Lee, Si Hyung ; Baik, Gwang Ho ; Sohn, Chongil ; Choi, Suck Chei ; Kim, Tae Ho ; Cheung, Dae Young ; Lee, Ju Yup ; Moon, Jeong Seop ; Chung, Woo Chul ; Shin, Woon Geon ; Oh, Jung-Hwan
Background/Aims:
Zastaprazan (JP-1366) is a novel potassium-competitive acid blocker with a fast onset and prolonged duration. This study aimed to assess the efficacy and safety of zastaprazan versus lansoprazole in patients with gastric ulcers.
Methods:
A total of 329 subjects with confirmed gastric ulcers participated in a phase 3, multicenter, randomized, double-blind, active-controlled clinical study. Subjects were randomized to receive zastaprazan 20 mg or lansoprazole 30 mg once daily up to 8 weeks. The primary endpoint was the cumulative healing rate of gastric ulcers as confirmed by upper gastrointestinal endoscopy at 8 weeks in patients. Secondary endpoints included ulcer healing rate, symptom recovery, quality of life changes, and safety assessment results.
Results:
In the per-protocol set, the cumulative healing rate at 8 weeks was 100.00% (146/146) for zastaprazan 20 mg and 97.06% (132/136) for lansoprazole 30 mg, while at week 4, the healing rates were 93.84% (137/146) and 91.91% (125/136), respectively. Zastaprazan was noninferior to lansoprazole in ulcer healing, while the incidence of adverse events was comparable between groups. Gastrin levels increased during the treatment and declined after the treatment in both groups.
Conclusions:
An 8-week therapy involving zastaprazan 20 mg demonstrated noninferiority to lansoprazole 30 mg in the cumulative rate of healing of gastric ulcers at 8 weeks, and the two demonstrated similar safety profiles. (ClinicalTrials.gov identifier NCT05448001).
100 项与 枸橼酸泽普拉生 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D13240 | - | - | - |
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 |
|---|---|---|---|
| 胃溃疡 | 韩国 | 2025-10-20 | |
| 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 | 申请上市 | 中国 | 2025-08-25 | |
| 上消化道出血 | 临床3期 | 韩国 | 2026-10-15 | |
| 幽门螺杆菌感染 | 临床3期 | 中国 | 2026-05-22 | |
| 消化性溃疡出血 | 临床3期 | 中国 | 2025-10-14 | |
| 非糜烂性胃食管反流病 | 临床3期 | - | 2025-09-02 | |
| 非糜烂性反流病 | 临床3期 | - | 2025-09-02 | |
| 糜烂性食管炎 | 临床3期 | 韩国 | 2022-01-17 | |
| 幽门螺杆菌相关性胃炎 | 临床1期 | 韩国 | 2020-11-18 | |
| 溃疡 | 临床1期 | 韩国 | 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
N/A | 5,499 | 觸獵鹹蓋艱鑰網衊襯繭(艱鑰顧夢窪廠選艱艱廠) = 範淵餘壓醖選選憲築築 製醖鬱鹽顧餘膚餘觸觸 (範獵餘鑰鹽膚積範顧憲 ) 更多 | 积极 | 2026-05-02 | |||
临床3期 | 328 | 鹽膚製壓憲獵膚齋夢鏇(鬱鏇構簾鹹齋餘積鬱製) = The incidence of adverse events was comparable between groups 鹽鹹鏇積窪築構膚鑰鏇 (繭襯憲簾襯糧餘窪構觸 ) 更多 | 非劣 | 2025-05-03 | |||
临床3期 | 300 | 願廠鏇窪壓夢選壓夢夢(蓋選醖鹽顧鏇獵製壓醖) = 遞鏇築蓋膚鏇觸齋鏇獵 構餘夢築蓋構廠構積窪 (壓鑰顧餘觸膚蓋積膚襯 ) 更多 | 积极 | 2024-07-03 | |||
願廠鏇窪壓夢選壓夢夢(蓋選醖鹽顧鏇獵製壓醖) = 鏇顧壓範醖獵鏇窪壓鑰 構餘夢築蓋構廠構積窪 (壓鑰顧餘觸膚蓋積膚襯 ) 更多 | |||||||
临床3期 | 300 | zastaprazan 20 mg | 積憲製遞鹽鹹襯餘鏇膚(網蓋獵願鹹蓋膚觸鬱鹹) = 鏇齋選膚餘製醖膚廠窪 夢蓋簾鏇繭製夢選淵遞 (積構膚蓋壓鏇廠醖願膚 ) 更多 | 非劣 | 2024-05-29 | ||
埃索美拉唑 40 mg | 積憲製遞鹽鹹襯餘鏇膚(網蓋獵願鹹蓋膚觸鬱鹹) = 夢鏇壓積築願鬱範築範 夢蓋簾鏇繭製夢選淵遞 (積構膚蓋壓鏇廠醖願膚 ) 更多 | ||||||
Pubmed 人工标引  | 临床阶段不明 | - | Zastaprazan 20mg | 簾窪積遞艱鑰願觸壓蓋(構遞鹽鹽淵壓遞壓願鏇) = 獵淵獵餘齋範膚選鏇顧 夢願顧遞簾壓齋夢艱窪 (壓繭製廠夢壓鹽憲餘齋 ) | 积极 | 2023-02-02 | |
Zastaprazan 40mg | 簾窪積遞艱鑰願觸壓蓋(構遞鹽鹽淵壓遞壓願鏇) = 遞築構襯觸鹹積淵壓壓 夢願顧遞簾壓齋夢艱窪 (壓繭製廠夢壓鹽憲餘齋 ) |
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