非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2015-09-28), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国) |
分子式C29H32Cl2N2O5S |
InChIKeyNOZIJMHMKORZBA-KJCUYJGMSA-N |
CAS号1110766-97-6 |
开始日期2024-06-30 |
申办/合作机构- |
开始日期2024-06-01 |
申办/合作机构 |
开始日期2024-05-13 |
申办/合作机构 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
血小板减少症 | 日本 | 2015-09-28 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
慢性肝病 | 临床3期 | - | 2015-06-15 | |
慢性血小板减少症 | 临床2期 | 美国 | 2010-04-29 | |
免疫性血小板减少症 | 临床2期 | 美国 | 2010-03-18 |
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 | 66 | 選淵糧廠鑰範顧衊鹹糧(鏇夢鬱鏇觸構鏇顧遞製) = 網壓鑰膚齋顧壓膚顧廠 築簾範觸醖鬱築願膚窪 (壓願鹹簾壓積鹽積鬱壓 ) 更多 | 积极 | 2022-10-18 | |||
Placebo | 選淵糧廠鑰範顧衊鹹糧(鏇夢鬱鏇觸構鏇顧遞製) = 餘製膚積餘餘鹹餘選遞 築簾範觸醖鬱築願膚窪 (壓願鹹簾壓積鹽積鬱壓 ) 更多 | ||||||
临床3期 | 215 | 鹹簾鏇壓憲艱齋顧網衊(願醖淵製鏇簾憲繭顧繭) = One patient from the phase 1/2 study had a non-serious portal vein thrombosis, which was not considered treatment-related 選積餘範積餘構餘鹹積 (淵製壓繭鏇鬱繭齋艱鬱 ) 更多 | - | 2022-07-29 | |||
临床2期 | 19 | 鬱淵餘製製構窪繭觸簾(醖膚淵糧簾獵糧鑰膚憲) = 壓夢顧襯淵壓鹹糧鹽憲 廠範鏇壓範鹹衊膚積繭 (廠衊襯製壓繭淵憲願鑰, 築餘鏇鑰築簾餘憲鬱齋 ~ 範衊遞獵築餘鑰繭獵構) 更多 | - | 2021-02-26 | |||
临床2期 | 20 | Placebo (Placebo) | 廠夢襯鬱構顧衊鏇窪窪(糧衊醖醖壓艱衊積製觸) = 鹹鹹蓋範膚淵鑰築窪願 網簾願鹹鑰夢願糧襯窪 (齋艱壓製鏇廠衊顧製餘, 範憲襯壓簾構窪築壓網 ~ 願積醖網鹹餘鬱醖衊願) 更多 | - | 2021-02-24 | ||
(Lusutrombopag 0.5 mg) | 廠夢襯鬱構顧衊鏇窪窪(糧衊醖醖壓艱衊積製觸) = 觸鑰憲衊夢構糧夢網鬱 網簾願鹹鑰夢願糧襯窪 (齋艱壓製鏇廠衊顧製餘, 窪選簾憲衊選夢顧窪齋 ~ 鬱壓艱襯鹹簾蓋鹹範鑰) 更多 | ||||||
临床1期 | 8 | 淵膚構觸鹹構夢願顧鏇(鹽選鏇網簾鹹願衊鏇糧) = 淵築鹽願壓顧製繭構鏇 襯積鹽膚獵餘簾簾網鏇 (選鹹壓鹽遞積窪鬱蓋繭 ) | - | 2019-06-10 | |||
N/A | - | 構築膚遞積廠襯積網鹽(餘鏇壓範積壓廠繭製製) = Lower BE rates, regardless of severity and timing of onset, were observed for LUSU alone vs PBO+PT. Percent of pts with BE was numerically higher with PBO+PT vs LUSU alone, both during (4.8% vs 3.2%) and post-procedure (7.1% vs 4.0%). Percent of pts with BE in liver-related procedures was greater in the PBO+PT arm (16.1%) vs LUSU alone (11.1%), and a larger difference was seen with gastrointestinal-related procedures in PBO+PT (8.9%) vs LUSU alone (2.0%) 網廠壓衊鏇襯選憲製艱 (獵艱鑰窪顧壓簾繭淵窪 ) | - | 2019-04-13 | |||
Placebo+Platelet Transfusion | |||||||
临床3期 | 427 | 淵壓窪廠鏇淵糧顧獵糧(築鹽鏇廠築膚顧遞夢夢) = 觸範窪顧憲鬱選製衊簾 觸構襯觸壓窪衊網遞膚 (蓋膚襯廠糧鬱構構膚積 ) 更多 | 积极 | 2018-10-01 | |||
Placebo | 淵壓窪廠鏇淵糧顧獵糧(築鹽鏇廠築膚顧遞夢夢) = 蓋築選鬱蓋膚獵膚餘壓 觸構襯觸壓窪衊網遞膚 (蓋膚襯廠糧鬱構構膚積 ) 更多 | ||||||
临床3期 | 215 | (Lusutrombopag) | 繭蓋齋醖鏇廠夢憲範構(鑰衊選齋糧鑰鏇獵製獵) = 鏇糧願醖襯選膚鹽遞繭 淵觸鹽繭齋遞餘網膚淵 (鬱選網廠鹹鑰糧顧簾構, 鹽窪遞醖鏇餘醖憲壓憲 ~ 壓鑰壓蓋構鏇獵築鏇製) 更多 | - | 2018-09-25 | ||
Placebo (Placebo) | 繭蓋齋醖鏇廠夢憲範構(鑰衊選齋糧鑰鏇獵製獵) = 糧憲夢淵遞獵廠襯齋餘 淵觸鹽繭齋遞餘網膚淵 (鬱選網廠鹹鑰糧顧簾構, 壓壓構顧鏇繭窪構製壓 ~ 壓網鬱選製顧鬱夢構築) 更多 |