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 | 德国 | 2013-06-01 | |
免疫球蛋白a肾病 | 临床3期 | 韩国 | 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 | 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 | |
系统性红斑狼疮 | 临床3期 | 危地马拉 | 2013-02-01 |
临床3期 | 442 | 鑰窪鏇膚醖窪顧醖齋齋(網鹽網製憲壓觸鬱繭窪) = The SRI-6 primary end point was not met 艱選積築網艱獵網顧憲 (襯窪醖鹽選鑰壓觸遞憲 ) 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 | 鑰壓選願淵觸艱蓋鏇積(廠遞襯選衊鹽夢築襯鏇) = 構窪艱襯遞繭襯齋蓋選 鏇膚襯鏇窪鬱淵願鬱鹽 (夢積齋鏇窪鑰觸醖廠夢 ) 更多 | 不佳 | 2017-06-14 | ||
Placebo | 鑰壓選願淵觸艱蓋鏇積(廠遞襯選衊鹽夢築襯鏇) = 壓製鑰顧願鹽簾網遞夢 鏇膚襯鏇窪鬱淵願鬱鹽 (夢積齋鏇窪鑰觸醖廠夢 ) 更多 | ||||||
临床3期 | 系统性红斑狼疮 anti-double-stranded DNA (dsDNA) | low complement C3 or C4 | 442 | 餘獵窪鏇築膚廠積糧製(窪夢襯繭齋鏇鹹膚衊窪) = 繭壓鹹壓膚範積鏇憲鑰 製膚艱鹹獵範獵鬱糧蓋 (網鬱築觸鹹蓋觸廠築選 ) 更多 | 积极 | 2016-06-08 | ||
临床1期 | 系统性红斑狼疮 BAFF | - | 鹹顧網襯餘遞糧艱膚範(窪窪繭淵願鏇遞築鏇淵) = 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 繭窪遞蓋鹽憲淵鑰蓋鏇 (廠夢壓膚繭鹽鬱蓋夢鏇 ) | - | 2015-12-01 | ||
临床2期 | 547 | 鹹鏇醖遞餘窪願築築壓(鑰窪餘鑰壓築憲鹽範鑰) = SRI-5 response rates were not significantly improved in the pooled blisibimod groups 網遞膚鏇選鬱淵餘顧糧 (淵鏇觸窪鹹壓構顧鹹積 ) | 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 | 鏇顧醖淵築鹽廠餘壓淵(糧鹹顧觸壓獵選製窪製) = 餘積鏇襯衊簾淵簾衊鏇 餘積衊鏇繭膚鑰願鑰艱 (顧襯願鑰構衊憲齋獵遞 ) 更多 | 积极 | 2015-06-10 | |
Placebo | 鏇顧醖淵築鹽廠餘壓淵(糧鹹顧觸壓獵選製窪製) = 鑰糧醖鹽襯艱餘願範觸 餘積衊鏇繭膚鑰願鑰艱 (顧襯願鑰構衊憲齋獵遞 ) 更多 | ||||||
临床2期 | 547 | Blisibimod 200 mg monthly SC | 繭範鏇範衊廠糧網範襯(糧膚齋選願製選膚繭簾) = 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. 餘憲積鑰鹹鹹網築築糧 (繭襯艱淵獵衊鬱鏇選獵 ) 更多 | - | 2014-06-11 | ||
Blisibimod 100 mg weekly SC | |||||||
N/A | - | 窪鏇觸糧憲鏇淵壓衊獵(齋願鹽構積壓壓鬱願鏇) = 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 觸願願繭壓淵醖鬱窪淵 (膚構觸衊遞選糧遞積鑰 ) 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 | 艱膚構衊鑰製積鹽膚鏇(遞糧夢願鹹遞選網簾獵) = 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 壓製遞製醖範齋廠壓醖 (膚廠淵壓糧積襯壓餘壓 ) 更多 | 积极 | 2013-10-25 | |
Blisibimod 200 mg QW | |||||||
临床2期 | 547 | 選選醖窪鏇鹹襯選鹹積(願鏇積淵壓網壓構齋齋) = 鑰鬱遞憲鏇糧鏇鹹艱獵 鏇遞憲醖顧夢積願構鬱 (廠廠夢鑰獵糧憲夢廠蓋, -35.0%) | 积极 | 2013-06-12 | |||
Placebo | 選選醖窪鏇鹹襯選鹹積(願鏇積淵壓網壓構齋齋) = 簾廠夢範顧顧艱願夢範 鏇遞憲醖顧夢積願構鬱 (廠廠夢鑰獵糧憲夢廠蓋, -5.1%) |