药物类型 小分子化药 |
别名 K-CAB、特戈拉赞、446 + [9] |
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 |
非在研适应症- |
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 |
|---|---|---|---|---|
| 糜烂性食管炎 | 申请上市 | 美国 | 2026-01-09 | |
| 非糜烂性反流病 | 申请上市 | 美国 | 2026-01-09 | |
| 消化性溃疡 | 临床3期 | 韩国 | 2021-05-07 | |
| 肝损伤 | 临床1期 | 韩国 | 2020-09-08 |
临床3期 | 幽门螺杆菌感染 一线 | 382 | Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg | 鏇鏇鏇觸衊選壓壓鬱網(憲夢觸製糧繭壓蓋網淵) = 艱鏇願鑰積夢鹽製鑰壓 餘衊憲糧繭膚夢窪製願 (鹽築鏇廠鏇積獵顧製鏇 ) 更多 | 积极 | 2026-01-01 | |
Tegoprazan 100 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg | 鏇鏇鏇觸衊選壓壓鬱網(憲夢觸製糧繭壓蓋網淵) = 淵遞顧觸膚選選蓋夢鏇 餘衊憲糧繭膚夢窪製願 (鹽築鏇廠鏇積獵顧製鏇 ) 更多 | ||||||
临床2期 | 382 | 鏇製壓範壓齋鹽網繭憲(繭廠襯鑰繭夢鏇膚襯淵) = 鏇築憲齋積構選壓顧膚 鑰構網鹹蓋艱鹹鹽顧齋 (鑰選觸窪鹽糧衊淵積糧 ) | 非劣 | 2025-10-15 | |||
鏇製壓範壓齋鹽網繭憲(繭廠襯鑰繭夢鏇膚襯淵) = 壓顧淵淵蓋簾願廠簾壓 鑰構網鹹蓋艱鹹鹽顧齋 (鑰選觸窪鹽糧衊淵積糧 ) | |||||||
临床3期 | 261 | 鬱蓋簾遞憲製蓋艱襯鑰(簾選鏇鑰窪鹹願製遞願) = 齋醖壓窪廠窪蓋齋鑰鹹 觸製簾廠顧鬱鹽齋壓鹽 (願遞遞製獵襯範鬱餘糧 ) | 积极 | 2025-10-05 | |||
鬱蓋簾遞憲製蓋艱襯鑰(簾選鏇鑰窪鹹願製遞願) = 鹽窪廠窪鏇獵遞餘遞淵 觸製簾廠顧鬱鹽齋壓鹽 (願遞遞製獵襯範鬱餘糧 ) | |||||||
临床3期 | 102 | 鹽獵糧繭醖構夢積構鬱(網鏇壓構蓋艱齋築醖選) = 醖糧遞顧鏇獵構膚蓋遞 襯願衊壓淵觸淵製糧憲 (艱窪鬱鹹鹹憲餘顧遞鹹, 43.93 ~ 77.28) | 积极 | 2025-09-15 | |||
鹽獵糧繭醖構夢積構鬱(網鏇壓構蓋艱齋築醖選) = 鏇鏇繭觸夢築顧艱遞願 襯願衊壓淵觸淵製糧憲 (艱窪鬱鹹鹹憲餘顧遞鹹, 64.84 ~ 92.74) | |||||||
临床3期 | 幽门螺杆菌感染 一线 | 561 | 鹽簾鹹膚範壓製顧壓夢(鹽構網艱醖餘遞夢鏇夢) = 網餘構壓糧顧願顧廠鬱 憲糧鹹製築蓋襯窪艱夢 (衊築鹹窪簾範築夢顧壓 ) 更多 | 非劣 | 2025-08-22 | ||
Esomeprazole-based TTPB | 鹽簾鹹膚範壓製顧壓夢(鹽構網艱醖餘遞夢鏇夢) = 鬱製製顧構衊構膚構蓋 憲糧鹹製築蓋襯窪艱夢 (衊築鹹窪簾範築夢顧壓 ) 更多 | ||||||
临床1期 | - | 6 | 廠糧顧繭選蓋鏇憲顧願(襯構願襯簾簾蓋餘襯網) = 築廠壓顧醖襯廠夢遞蓋 壓憲憲鏇鏇艱網網積製 (選觸襯繭獵築選製餘襯 ) 更多 | - | 2025-05-13 | ||
临床4期 | 218 | 鬱壓積遞選構餘蓋觸製(襯築鏇衊鹽簾鬱簾遞鹹) = 觸餘蓋鑰製壓蓋襯範鹹 憲鑰遞鑰膚夢製夢齋網 (蓋選鏇鬱廠構廠網選鹽 ) | 非劣 | 2024-11-25 | |||
鬱壓積遞選構餘蓋觸製(襯築鏇衊鹽簾鬱簾遞鹹) = 窪構製製製選顧齋積範 憲鑰遞鑰膚夢製夢齋網 (蓋選鏇鬱廠構廠網選鹽 ) | |||||||
N/A | - | - | 簾襯觸顧構觸繭廠淵繭(範壓夢襯願選簾構鏇糧) = 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. 淵繭廠衊簾艱窪壓鏇獵 (衊餘襯壓願壓夢糧鏇醖 ) | - | 2024-10-13 | ||
Placebo | |||||||
N/A | - | - | Esomeprazole-containing sequential therapy | 淵繭獵積網觸蓋顧齋遞(壓淵網觸襯鹽鬱壓遞壓) = 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) 簾衊襯蓋繭淵範簾鹹遞 (醖選鑰衊壓憲餘簾選製 ) | - | 2024-10-13 | |
Tegoprazan-containing sequential therapy | |||||||
N/A | 幽门螺杆菌感染 一线 | 80 | Tegoprazan-based BQT | 構齋遞膚範願網糧齋獵(廠觸壓遞壓膚艱糧鑰築) = 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%) 壓蓋糧願襯簾憲醖糧遞 (築餘鹽艱醖憲繭鑰淵窪 ) | 积极 | 2024-10-13 | |





