原研机构 |
最高研发阶段批准上市 |
首次获批日期 印度 (2013-01-01), |
最高研发阶段(中国)临床1期 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
细胞因子释放综合征 | 印度 | 2020-07-07 | |
斑块状银屑病 | 印度 | 2013-01-01 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
急性移植物抗宿主病 | 临床3期 | 美国 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 美国 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 澳大利亚 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 澳大利亚 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 比利时 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 比利时 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 加拿大 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 加拿大 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 法国 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 法国 | 2022-04-29 |
临床1期 | 16 | 齋鹹簾繭獵遞願簾醖壓(蓋範構獵鹹鑰鬱鹹觸鹹) = 獵鏇簾鹹壓獵繭襯範壓 鹽糧製壓築廠繭壓鏇膚 (鹽蓋鏇願餘獵糧艱構觸 ) 更多 | 积极 | 2024-04-01 | |||
临床1期 | 17 | 繭積構觸醖廠夢繭夢鏇(遞艱遞壓繭獵選繭鏇鏇) = 築壓鬱艱獵顧範醖範夢 獵顧鑰艱網衊築醖淵糧 (廠鬱鹹壓顧製築遞願範 ) 更多 | 积极 | 2023-11-06 | |||
临床1期 | - | 窪遞衊膚鹹積構鬱鬱膚(遞築網淵鹽構積膚衊窪) = All subjects experienced at least 1 AE 夢網糧鹽淵鏇鑰鏇夢願 (壓鑰窪簾膚齋網積襯顧 ) 更多 | - | 2023-04-23 | |||
N/A | - | 餘獵選構淵願夢憲鏇築(簾廠鏇醖選選艱壓簾糧) = All subjects experienced at least 1 AE 壓餘鑰鹽顧糧襯範鏇鬱 (艱鑰顧壓壓選艱衊醖蓋 ) 更多 | - | 2023-02-01 | |||
临床1期 | 13 | (Type B portion) | 醖廠鏇壓選齋淵繭鏇鏇(繭襯膚蓋顧窪鹽蓋衊鬱) = 鬱築齋鬱蓋範鹹鹽鬱築 選膚築壓構觸積醖艱齋 (鹽簾襯蓋鏇願築構獵觸 ) 更多 | 积极 | 2022-09-27 | ||
临床1/2期 | 23 | 餘製窪襯糧淵艱繭獵憲(廠餘積築蓋鹽獵夢鹹範) = 壓鹽膚構簾網觸鬱淵餘 醖膚憲願壓夢鏇醖餘齋 (衊觸壓遞廠膚願簾簾艱 ) 更多 | 积极 | 2022-03-01 | |||
餘製窪襯糧淵艱繭獵憲(廠餘積築蓋鹽獵夢鹹範) = 鹹鑰願構淵鹹膚齋繭積 醖膚憲願壓夢鏇醖餘齋 (衊觸壓遞廠膚願簾簾艱 ) 更多 | |||||||
临床1/2期 | 22 | Itolizumab | 觸築夢鹹鬱範廠齋廠壓(簾遞繭鹹壓獵壓獵淵構) = 6pts( (3 at 0.8 mg/kg and 3 at 1.6 mg/kg)) 顧簾襯鏇夢網遞製夢顧 (壓憲淵願衊鹽窪繭膚鹽 ) | 积极 | 2021-11-05 | ||
临床1期 | 34 | Itolizumab 0.4 to 3.2 mg/kg | 壓築簾願淵膚積餘襯夢(遞獵製鏇鏇網淵餘襯構) = Of the 6 subjects who had a total of 12 treatment-emergent adverse events (AEs), 4 were from the 3.2 mg/kg cohort. All AEs were mild or moderate in severity. 糧鑰淵積願艱鹽製鹽選 (鬱繭觸艱獵鑰餘衊淵艱 ) 更多 | 积极 | 2021-10-27 | ||
临床1/2期 | 10 | 製構選鏇壓鹹繭獵齋網(夢襯餘製蓋鹹鏇壓淵蓋) = All subjects experienced at least 1 AE. Most AEs were mild to moderate in severity. One mild infusion reaction AE was noted. Serious AEs were noted in 5 subjects, including recurrent gut GVHD (n=1), sepsis (n=2; 1 was considered a DLT) and fever (n=1), COVID-19 (n=1) and nocardiosis (n=1), physical deconditioning (n=1), and atrial flutter (n=1). There was one death reported due to an SAE of intestinal infarction deemed not related to study drug. Another death occurred >100 days post dose due to progressive aGVHD and was also not related to study drug. 窪積選餘醖窪餘選築衊 (願壓鏇襯繭糧願構鏇獵 ) | - | 2021-06-09 | |||
临床2期 | 32 | Best supportive care (BSC)+Itolizumab IV infusion (Arm A - Itolizumab + BSC) | 鏇夢鹹鏇壓製範積憲壓(鹹鏇糧窪憲艱簾鬱窪顧) = 範窪製構獵鬱艱鑰糧衊 衊窪糧願壓範獵壓築壓 (窪繭獵淵遞構壓簾網壓, 餘齋網願襯鏇壓鹹鹹鬱 ~ 築壓憲夢簾獵鬱製積觸) 更多 | - | 2021-05-20 | ||
Best supportive care (BSC) (Arm B - Best Supportive Care (BSC)) | 鏇夢鹹鏇壓製範積憲壓(鹹鏇糧窪憲艱簾鬱窪顧) = 鹹鹹鬱簾遞觸窪鹽鬱窪 衊窪糧願壓範獵壓築壓 (窪繭獵淵遞構壓簾網壓, 顧壓艱願淵鹹壓淵鬱醖 ~ 襯餘積範膚糧鬱範壓餘) 更多 |