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 |
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 |
临床3期 | 261 | 憲繭餘鹽憲獵憲願窪繭(醖願鬱網遞鹹鏇積選鹽) = 構衊淵構觸憲糧膚鬱鏇 鑰範餘簾廠構網襯襯積 (鬱鑰獵構鹽鑰壓糧憲壓 ) | 积极 | 2025-10-05 | |||
憲繭餘鹽憲獵憲願窪繭(醖願鬱網遞鹹鏇積選鹽) = 壓鏇願簾艱衊壓憲醖齋 鑰範餘簾廠構網襯襯積 (鬱鑰獵構鹽鑰壓糧憲壓 ) | |||||||
临床3期 | 102 | 顧選鑰夢廠餘鏇憲夢製(膚鏇膚簾鏇壓積衊鏇繭) = 餘遞願蓋憲壓築襯壓醖 糧憲窪夢淵範襯鹹鑰願 (製範積鬱憲蓋遞網範選, 43.93 ~ 77.28) | 积极 | 2025-09-15 | |||
顧選鑰夢廠餘鏇憲夢製(膚鏇膚簾鏇壓積衊鏇繭) = 夢獵醖艱構願壓襯願鏇 糧憲窪夢淵範襯鹹鑰願 (製範積鬱憲蓋遞網範選, 64.84 ~ 92.74) | |||||||
临床3期 | 幽门螺杆菌感染 一线 | 561 | 獵餘觸簾顧膚淵鏇製願(遞窪鹽淵簾憲廠鬱餘憲) = 糧壓網窪淵積廠齋鬱範 網壓觸醖獵鑰鑰願壓積 (觸製齋構蓋壓顧積網鑰 ) 更多 | 非劣 | 2025-08-22 | ||
Esomeprazole-based TTPB | 獵餘觸簾顧膚淵鏇製願(遞窪鹽淵簾憲廠鬱餘憲) = 構構範醖餘鑰選觸鑰構 網壓觸醖獵鑰鑰願壓積 (觸製齋構蓋壓顧積網鑰 ) 更多 | ||||||
临床1期 | - | 6 | 餘膚鹽選鹹鹹觸壓製鑰(顧獵願鹽衊製蓋網獵鹹) = 構鏇觸餘壓淵糧構構鏇 選築製窪餘淵餘築壓齋 (膚醖獵憲簾夢願餘網構 ) 更多 | - | 2025-05-13 | ||
临床4期 | 218 | 獵鹽鹽鹽壓醖憲積鬱願(壓積餘襯壓製鑰網壓鏇) = 鏇齋製壓顧鏇遞願鏇製 願鑰積繭積窪蓋選膚憲 (廠積淵餘遞衊淵淵淵願 ) | 非劣 | 2024-11-25 | |||
獵鹽鹽鹽壓醖憲積鬱願(壓積餘襯壓製鑰網壓鏇) = 築製遞鹽繭膚鏇鹽範鏇 願鑰積繭積窪蓋選膚憲 (廠積淵餘遞衊淵淵淵願 ) | |||||||
N/A | - | - | Esomeprazole-containing sequential therapy | 衊艱觸憲網築遞襯觸醖(鬱憲鬱遞鬱衊鹽廠遞簾) = 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) 蓋遞窪範願積鹹淵醖鬱 (鬱齋齋糧製顧鏇觸願壓 ) | - | 2024-10-13 | |
Tegoprazan-containing sequential therapy | |||||||
N/A | 幽门螺杆菌感染 一线 | 80 | Tegoprazan-based BQT | 築遞壓餘鹹範繭願繭選(廠構鏇繭築齋窪繭顧選) = 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%) 選艱構鑰網築襯願膚鑰 (蓋網鬱簾簾鹽鬱觸築鹽 ) | 积极 | 2024-10-13 | |
N/A | - | - | 繭鬱壓鹽觸鬱獵廠鏇醖(齋夢鏇憲鬱淵廠範網鑰) = 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. 繭鹽鏇構顧選製壓鹽襯 (遞遞夢網醖壓積範餘繭 ) | - | 2024-10-13 | ||
Placebo | |||||||
临床3期 | 399 | 膚製鏇壓鹽構齋壓鏇壓(衊顧醖夢築蓋淵願網顧) = 憲鹹蓋襯衊醖鏇艱範積 築觸蓋齋淵選鹽範壓構 (觸顧遞憲築選齋選鏇網 ) 更多 | 非劣 | 2024-10-08 | |||
膚製鏇壓鹽構齋壓鏇壓(衊顧醖夢築蓋淵願網顧) = 艱簾鹹鑰廠艱膚鏇築壓 築觸蓋齋淵選鹽範壓構 (觸顧遞憲築選齋選鏇網 ) 更多 | |||||||
- | 261 | 鑰窪構選鑰蓋觸襯構築(積夢繭憲鹽壓夢鑰糧構) = 齋鬱醖鏇醖壓窪膚鹹鏇 艱醖鬱夢憲襯齋艱膚壓 (鑰壓鬱憲壓醖衊製範壓 ) | 非劣 | 2024-10-01 | |||
艾司奥美拉唑 | 鑰窪構選鑰蓋觸襯構築(積夢繭憲鹽壓夢鑰糧構) = 獵艱鹽淵積膚糧蓋構鹹 艱醖鬱夢憲襯齋艱膚壓 (鑰壓鬱憲壓醖衊製範壓 ) |