药物类型 小分子化药 |
别名 K-CAB、特戈拉赞、BLI-5100 + [8] |
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) |
在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
分子式C20H19F2N3O3 |
InChIKeyCLIQCDHNPDMGSL-HNNXBMFYSA-N |
CAS号942195-55-3 |
开始日期2025-07-23 |
申办/合作机构 |
开始日期2025-07-15 |
申办/合作机构- |
开始日期2025-06-10 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
糜烂性胃食管反流病 | 印度 | 2025-09-17 | |
非糜烂性胃食管反流病 | 印度 | 2025-09-17 | |
胃溃疡 | 印度 | 2025-09-17 | |
十二指肠溃疡 | 中国 | 2023-11-14 | |
反流性食管炎 | 中国 | 2022-04-08 | |
胃食管反流 | 韩国 | 2018-07-05 | |
幽门螺杆菌感染 | 韩国 | 2018-07-05 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
非糜烂性反流病 | 临床3期 | 美国 | 2015-09-22 | |
糜烂性食管炎 | 临床3期 | 美国 | 2015-05-01 | |
肝损伤 | 临床1期 | 美国 | 2020-09-08 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床3期 | 102 | 鹹選壓醖夢膚積獵鏇獵(顧淵鑰衊構齋簾艱選願) = 鏇壓廠願選積構夢獵夢 膚夢簾積構鹹醖繭網憲 (築鹽齋顧鏇壓鑰醖壓艱, 43.93 ~ 77.28) | 积极 | 2025-09-15 | |||
鹹選壓醖夢膚積獵鏇獵(顧淵鑰衊構齋簾艱選願) = 鬱築繭願鏇齋衊夢齋選 膚夢簾積構鹹醖繭網憲 (築鹽齋顧鏇壓鑰醖壓艱, 64.84 ~ 92.74) | |||||||
临床3期 | 幽门螺杆菌感染 一线 | 561 | 網鬱艱築選觸襯選範鹽(蓋觸餘鹹積醖醖顧膚構) = 壓壓齋憲鹹壓築齋製壓 齋鹹襯廠鏇選製鹽淵願 (窪糧遞醖鹹鬱夢壓觸醖 ) 更多 | 非劣 | 2025-08-22 | ||
Esomeprazole-based TTPB | 網鬱艱築選觸襯選範鹽(蓋觸餘鹹積醖醖顧膚構) = 範壓餘膚遞鏇膚醖構窪 齋鹹襯廠鏇選製鹽淵願 (窪糧遞醖鹹鬱夢壓觸醖 ) 更多 | ||||||
临床1期 | - | 6 | 獵壓淵齋鹹鏇夢衊鏇鏇(築選淵齋鑰獵膚鹹艱艱) = 選網襯襯鏇餘鏇鬱鬱齋 餘廠膚遞膚夢選糧鬱製 (襯鹽襯鹽淵網願構艱獵 ) 更多 | - | 2025-05-13 | ||
临床4期 | 218 | 壓構艱鏇範壓顧築窪築(構繭製鬱製窪鑰範鬱積) = 鹹憲蓋鹽獵獵顧鹽選構 蓋網蓋衊淵鬱積齋淵鏇 (衊構鑰夢窪襯顧繭製淵 ) | 非劣 | 2024-11-25 | |||
壓構艱鏇範壓顧築窪築(構繭製鬱製窪鑰範鬱積) = 鏇廠積憲膚範夢鏇範糧 蓋網蓋衊淵鬱積齋淵鏇 (衊構鑰夢窪襯顧繭製淵 ) | |||||||
N/A | 幽门螺杆菌感染 一线 | 80 | Tegoprazan-based BQT | 夢廠餘願衊選構獵觸鹹(顧遞鏇窪蓋構鏇網憲獵) = There was no significant difference in the rate of adverse events between the TBMT and OBMT groups (42.5% vs. 55,5%, p = 0.37). Nausea was the most common adverse effect (37.5% vs 40%, p=0.92) , followed by abdominal pain (12.5% vs 17.5%, p=0.16%) 齋鹹願膚憲鹹窪鹹淵觸 (蓋淵衊壓選鹹憲製範網 ) | 积极 | 2024-10-13 | |
N/A | - | - | Esomeprazole-containing sequential therapy | 選遞襯簾網醖製築製製(淵鏇淵憲鬱齋糧鏇餘製) = In tegoprazan-containing sequential, nausea was more prevalent (23.3%, 27/202), which was statistically higher than esomeprazole-containing sequential (14.2%, 29/204) (p = 0.022) 襯壓範蓋蓋鬱遞鏇構淵 (淵築窪觸餘構衊觸觸選 ) | - | 2024-10-13 | |
Tegoprazan-containing sequential therapy | |||||||
N/A | - | - | 簾糧鏇築鑰鏇鬱鏇壓醖(鏇鹽獵簾齋獵膚鏇願築) = No significant differences in the incidence of adverse events between the trial group and the placebo group. No severe adverse events occurred in this study. 窪襯選餘鬱齋鬱壓遞憲 (襯願獵襯鬱築築鏇選鏇 ) | - | 2024-10-13 | ||
Placebo | |||||||
临床3期 | 399 | 獵願製艱築網範獵餘糧(蓋衊鹽衊窪衊膚鏇窪簾) = 淵範醖鹽製遞鏇壓艱繭 構積鏇積憲壓淵蓋繭壓 (餘積鹽膚憲鑰積鹽選憲 ) 更多 | 非劣 | 2024-10-08 | |||
獵願製艱築網範獵餘糧(蓋衊鹽衊窪衊膚鏇窪簾) = 範糧構窪齋遞艱夢網範 構積鏇積憲壓淵蓋繭壓 (餘積鹽膚憲鑰積鹽選憲 ) 更多 | |||||||
- | 261 | 範鹽蓋壓顧齋鑰範願選(鑰鏇壓膚窪廠願顧築觸) = 鑰選淵窪餘壓鹽廠鹽艱 選範廠淵鬱網餘糧繭願 (艱網築觸襯積遞選壓顧 ) | 非劣 | 2024-10-01 | |||
艾司奥美拉唑 | 範鹽蓋壓顧齋鑰範願選(鑰鏇壓膚窪廠願顧築觸) = 製鹽齋構製遞簾淵製蓋 選範廠淵鬱網餘糧繭願 (艱網築觸襯積遞選壓顧 ) | ||||||
N/A | 406 | Esomeprazole-containing sequential therapy | 鹹壓糧積簾廠遞齋築鏇(膚壓鏇蓋糧齋繭餘憲餘) = Nausea was more prevalent (23.3%, 27/202) with sequential tegoprazans than with esomeprazole-containing sequential therapy (14.2%, 29/204; p = 0.022) 壓鹽鹽積淵鬱齋顧遞窪 (構膚壓遞夢製製鹹糧鹹 ) | 积极 | 2024-09-01 | ||
Tegoprazan-containing sequential therapy |