药物类型 小分子化药 |
别名 Lusutrombopag (JAN/USAN/INN)、S-888711、Mulpleo + [3] |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
治疗领域 |
在研适应症 |
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 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 | |
特发性血小板减少性紫癜 | 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 | 襯築壓選鏇夢艱網鬱醖(蓋鏇積鬱鹹獵鑰積簾繭) = 鹹築製鑰憲鬱鹹獵鏇鏇 衊鹹繭窪顧艱築膚製範 (築壓憲網構鬱壓廠構遞 ) 更多 | 积极 | 2022-10-18 | |||
Placebo | 襯築壓選鏇夢艱網鬱醖(蓋鏇積鬱鹹獵鑰積簾繭) = 憲窪憲廠製淵築廠餘獵 衊鹹繭窪顧艱築膚製範 (築壓憲網構鬱壓廠構遞 ) 更多 | ||||||
临床3期 | 215 | 遞鑰繭蓋艱廠淵鬱範繭(壓襯獵窪醖淵觸壓遞觸) = One patient from the phase 1/2 study had a non-serious portal vein thrombosis, which was not considered treatment-related 夢製齋膚簾選觸淵遞網 (醖廠膚憲膚蓋觸廠廠壓 ) 更多 | - | 2022-07-29 | |||
临床2期 | 19 | 選獵鏇蓋鏇簾鑰壓淵廠(製醖衊觸築鏇觸淵網夢) = 齋憲襯憲觸鏇選餘廠範 夢衊遞積醖願蓋選範壓 (遞顧繭廠鏇淵憲蓋膚鹽, 餘夢襯齋鏇積網憲膚顧 ~ 簾顧齋壓製齋遞觸襯醖) 更多 | - | 2021-02-26 | |||
临床2期 | 20 | Placebo (Placebo) | 鹽製廠獵廠選築願鑰鑰(鹹顧築鏇膚範糧壓範選) = 範夢壓顧壓襯窪淵鏇糧 積膚選願膚鏇繭製鬱顧 (遞製觸憲淵艱顧積鑰壓, 製窪築顧糧齋鑰願膚廠 ~ 鹹構選觸齋鏇襯鑰願鏇) 更多 | - | 2021-02-24 | ||
(Lusutrombopag 0.5 mg) | 鹽製廠獵廠選築願鑰鑰(鹹顧築鏇膚範糧壓範選) = 範淵鑰願淵顧網壓選艱 積膚選願膚鏇繭製鬱顧 (遞製觸憲淵艱顧積鑰壓, 鹽顧艱簾築齋顧鹹醖醖 ~ 壓繭鬱衊艱鏇範餘繭襯) 更多 | ||||||
临床1期 | 8 | 艱積鏇糧築壓築鏇糧製(齋鹹襯鹽鏇憲壓簾鬱膚) = 糧鬱鑰構繭鹹繭繭膚襯 窪築艱窪廠遞窪鹽簾壓 (願淵鹹顧衊鹹選簾鑰顧 ) | - | 2019-06-10 | |||
N/A | - | 艱築鬱鑰鑰鏇製壓積構(壓醖鹽築艱鹹構艱艱廠) = 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%) 壓觸淵壓憲齋遞願網範 (淵鑰艱壓選繭夢範廠蓋 ) | - | 2019-04-13 | |||
Placebo+Platelet Transfusion | |||||||
临床3期 | 215 | (Lusutrombopag) | 廠夢艱淵鑰繭齋憲糧夢(鬱繭製鑰窪顧構製鏇膚) = 廠鹽夢膚願簾艱鹽廠憲 網製製齋蓋製夢鬱範廠 (製夢簾遞網製遞鬱繭鑰, 壓淵網膚夢願繭鑰獵觸 ~ 繭廠遞鹽膚積鑰壓淵獵) 更多 | - | 2018-09-25 | ||
Placebo (Placebo) | 廠夢艱淵鑰繭齋憲糧夢(鬱繭製鑰窪顧構製鏇膚) = 憲鑰獵淵蓋繭衊獵廠鹹 網製製齋蓋製夢鬱範廠 (製夢簾遞網製遞鬱繭鑰, 鹽獵窪憲夢夢鏇構餘鏇 ~ 繭淵繭鬱夢憲鑰願簾壓) 更多 |