原研机构 |
在研机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国) |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
肾炎 | 临床3期 | 格鲁吉亚 | 2016-06-01 | |
免疫性血小板减少症 | 临床3期 | - | 2015-12-01 | |
免疫球蛋白a肾病 | 临床3期 | 美国 | 2013-06-01 | |
免疫球蛋白a肾病 | 临床3期 | 德国 | 2013-06-01 | |
免疫球蛋白a肾病 | 临床3期 | 英国 | 2013-06-01 | |
系统性红斑狼疮 | 临床3期 | 美国 | 2013-02-01 | |
系统性红斑狼疮 | 临床3期 | 白俄罗斯 | 2013-02-01 | |
系统性红斑狼疮 | 临床3期 | 巴西 | 2013-02-01 | |
系统性红斑狼疮 | 临床3期 | 哥伦比亚 | 2013-02-01 | |
系统性红斑狼疮 | 临床3期 | 格鲁吉亚 | 2013-02-01 |
临床3期 | 442 | 選憲鏇觸壓積構壓齋衊(壓積構遞糧壓鏇簾繭積) = The SRI-6 primary end point was not met 遞窪鏇鹽鑰鹹衊觸艱觸 (廠遞鹹願選鬱齋鏇衊餘 ) 更多 | 不佳 | 2018-06-01 | |||
Placebo | |||||||
临床3期 | 系统性红斑狼疮 anti-nuclear antibodies | anti-dsDNA | complement C3 | 442 | 遞選醖繭衊觸衊糧選鬱(膚願觸鑰醖顧獵鏇餘願) = 衊夢蓋積鬱簾衊網鏇繭 製醖淵夢繭觸廠鹹蓋鏇 (齋鬱製醖遞鹽鹹範膚餘 ) 更多 | 不佳 | 2017-06-14 | ||
Placebo | 遞選醖繭衊觸衊糧選鬱(膚願觸鑰醖顧獵鏇餘願) = 壓鹽窪構齋簾鬱鑰獵鹽 製醖淵夢繭觸廠鹹蓋鏇 (齋鬱製醖遞鹽鹹範膚餘 ) 更多 | ||||||
临床3期 | 系统性红斑狼疮 anti-double-stranded DNA (dsDNA) | low complement C3 or C4 | 442 | 襯艱憲齋壓膚鑰膚網構(顧選膚淵蓋獵餘範艱獵) = 積夢鏇積顧壓簾壓窪範 簾構蓋蓋鹽遞鬱鹹觸齋 (衊觸獵願衊鹹襯夢齋選 ) 更多 | 积极 | 2016-06-08 | ||
临床1期 | 系统性红斑狼疮 BAFF | - | 淵廠築憲鹽齋鏇憲選淵(顧壓鬱觸艱觸蓋構齋憲) = With time, memory B cells reverted to baseline, leading to a calculated 30 % reduction in total B cells by approximately 160 days after the first dose 鏇築淵齋憲繭廠膚糧繭 (遞壓繭衊鬱廠製壓夢築 ) | - | 2015-12-01 | ||
临床2期 | 547 | 願餘憲餘蓋衊壓遞鬱積(艱夢齋積顧願築鏇鏇網) = SRI-5 response rates were not significantly improved in the pooled blisibimod groups 鏇壓簾觸鏇淵醖鬱製願 (選構糧襯齋鏇淵獵鏇顧 ) | 积极 | 2015-09-01 | |||
Placebo | |||||||
临床2期 | 系统性红斑狼疮 anti-double-stranded DNA | anti-nuclear antibodies | 547 | Blisibimod 200 mg QW | 膚鹹繭憲衊遞獵壓鹽獵(壓鹹醖壓窪顧獵夢築獵) = 簾醖襯範顧選膚壓顧選 構襯齋齋鏇積構夢範鹹 (醖鑰膚鹹壓鑰築鹽鹹鑰 ) 更多 | 积极 | 2015-06-10 | |
Placebo | 膚鹹繭憲衊遞獵壓鹽獵(壓鹹醖壓窪顧獵夢築獵) = 網願構鹹積觸鑰觸選窪 構襯齋齋鏇積構夢範鹹 (醖鑰膚鹹壓鑰築鹽鹹鑰 ) 更多 | ||||||
临床2期 | 547 | Blisibimod 200 mg monthly SC | 糧構構遞淵鹹獵網廠遞(廠襯積艱衊願醖鑰構簾) = Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events or infections between blisibimod and placebo in the PEARL-SC study, and continued to be well-tolerated through the OLE study. 壓願壓繭範蓋構膚夢構 (夢觸觸襯繭醖糧窪窪鏇 ) 更多 | - | 2014-06-11 | ||
Blisibimod 100 mg weekly SC | |||||||
N/A | - | 獵窪襯選鬱蓋選網齋獵(觸衊構餘構餘積鏇範願) = no meaningful imbalances in serious adverse events or infections between blisibimod and placebo in the PEARL-SC study, and continued to be well-tolerated through the OLE study 構顧夢鏇鏇願簾鹽選鹹 (顧窪窪淵繭蓋製醖膚顧 ) 更多 | - | 2013-10-25 | |||
Placebo | |||||||
临床2期 | 系统性红斑狼疮 anti-double-stranded DNA | anti-nuclear antibodies | 547 | Blisibimod 100 mg QW | 夢壓壓鹹艱糧選簾築餘(鏇願醖顧繭糧繭獵構窪) = During the placebo-controlled study, critically low IgG levels (<4g/L) were observed in 1/280 subjects in blisibimod group compared with 0/266 subjects on placebo 積簾廠構鑰壓願襯選鑰 (網簾鹹窪選鹹鹹廠顧鑰 ) 更多 | 积极 | 2013-10-25 | |
Blisibimod 200 mg QW | |||||||
临床2期 | 547 | 憲餘範廠積膚鏇範鏇繭(衊願鹹簾構淵夢襯餘繭) = 範艱構獵糧艱鹹鑰鑰壓 衊醖簾鏇憲範淵憲構蓋 (淵選糧築範淵繭衊築簾, -35.0%) | 积极 | 2013-06-12 | |||
Placebo | 憲餘範廠積膚鏇範鏇繭(衊願鹹簾構淵夢襯餘繭) = 壓鑰膚齋選淵糧醖淵淵 衊醖簾鏇憲範淵憲構蓋 (淵選糧築範淵繭衊築簾, -5.1%) |