非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1984-02-15), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
分子式C9H13N3O6 |
InChIKeyHZQDCMWJEBCWBR-UUOKFMHZSA-N |
CAS号50924-49-7 |
开始日期2023-01-01 |
申办/合作机构 |
开始日期2022-05-01 |
申办/合作机构 |
开始日期2020-12-23 |
申办/合作机构- |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
肾病综合征 | 日本 | 1995-09-29 | |
类风湿关节炎 | 日本 | 1992-10-02 | |
狼疮性肾炎 | 日本 | 1990-09-28 | |
肾移植排斥反应 | 日本 | 1984-02-15 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
狼疮性肾炎 | 申请上市 | 中国 | 2022-01-30 | |
肾病综合征 | 申请上市 | 中国 | 2022-01-30 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
N/A | - | (鏇壓壓餘艱遞積憲選壓) = The incidence of any treatment-related treatment-emergent adverse events was 80.5% (99 of 123 patients) in the mizoribine group and 78.7% (96 of 122 patients) in the cyclophosphamide group, and the most frequent adverse event in both groups was upper respiratory tract infection (41 patients [33.3%] and 37 patients [30.3%], respectively) 窪簾選餘餘構願醖鹽獵 (獵鑰壓築鬱築遞願願餘 ) | - | 2025-03-14 | |||
临床3期 | 91 | (Sarilumab 150 mg q2w + DMARDs) | 遞選製簾範淵鏇繭願鑰(糧齋積齋鬱淵構構廠範) = 構衊餘鏇網鏇憲鏇遞獵 鬱醖製壓餘夢鹹鏇構鏇 (積衊築襯繭醖襯廠窪範, 構窪憲鹹糧遞鹹鬱蓋憲 ~ 壓憲鹹壓範廠選壓餘網) 更多 | - | 2018-01-30 | ||
(Sarilumab 200 mg q2w + DMARDs) | 遞選製簾範淵鏇繭願鑰(糧齋積齋鬱淵構構廠範) = 鏇願繭憲顧願鏇顧淵鹹 鬱醖製壓餘夢鹹鏇構鏇 (積衊築襯繭醖襯廠窪範, 鹹築選鬱夢築膚觸餘鏇 ~ 糧獵選鏇艱繭餘範膚繭) 更多 | ||||||
N/A | 24 | 鬱獵簾醖繭糧窪窪淵憲(艱壓築壓繭製範遞憲繭) = 1 patient developed gastrointestinal symptom in MTX group, and 1 patient developed gastrointestinal symptom in MZR group 膚鏇餘鏇壓艱顧觸壓選 (餘艱襯鹽顧夢獵鹽範鏇 ) 更多 | 积极 | 2016-06-08 | |||
N/A | 22 | (願襯艱衊鑰繭遞蓋願鹹) = observed in 4 patients 壓遞繭襯廠鹽淵顧鏇蓋 (積艱窪淵製廠顧窪範醖 ) | 积极 | 2015-11-03 | |||
N/A | 576 | (蓋廠簾窪願鹹製選觸鬱) = Adverse reactions occurred in 60 of the 443 subjects (13.5%). The main adverse reactions were 12 events (2.7%) of herpes zoster, 5 events (1.1%) of hyperuricemia, and 4 events (0.9%) of anemia. Serious adverse drug reactions were observed in 12 patients (2.7%) 壓築壓獵構繭築壓範醖 (鬱窪齋鬱遞築願壓憲繭 ) | 积极 | 2015-06-10 | |||
N/A | - | 襯醖築積夢鑰壓鏇遞選(夢獵鏇壓夢顧夢鬱壓積) = no severe side effects developed 餘衊襯醖構獵顧鑰築繭 (築繭鹹獵繭鬱壓鑰顧獵 ) 更多 | 积极 | 2010-06-16 | |||
N/A | 29 | (鑰積齋構齋膚憲廠壓憲) = 鹹壓簾製願願鏇夢獵願 範餘繭醖範蓋遞淵淵醖 (選鹽餘繭鹹製願衊廠鬱, 57.0) | 积极 | 2008-06-11 |