药物类型 小分子化药 |
别名 indinavir、Indinavir anhydrous、Indinavir sulfate (USP) + [10] |
作用方式 抑制剂 |
作用机制 HIV-1 protease抑制剂(HIV蛋白酶抑制剂) |
在研适应症 |
非在研适应症- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1996-03-13), |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (日本) |
分子式C36H49N5O8S |
InChIKeyNUBQKPWHXMGDLP-BDEHJDMKSA-N |
CAS号157810-81-6 |
开始日期2014-12-22 |
申办/合作机构- |
开始日期2008-09-05 |
申办/合作机构 |
开始日期2008-06-01 |
申办/合作机构 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| HIV感染 | 美国 | 1996-03-13 |
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1/2期 | HIV感染 nonnucleoside reverse transcriptase inhibitors (NNRTIs) | 18 | Indinavir/Ritonavir 600/100 mg | 蓋窪鏇糧鬱鬱築蓋獵夢(鬱廠構積遞衊繭壓繭鹽) = 憲齋製顧鏇衊餘餘夢鬱 糧壓衊淵獵積願鏇餘衊 (憲簾艱艱艱鑰淵鹹繭衊 ) 更多 | - | 2012-10-01 | |
临床2期 | 42 | peripheral blood stem cell transplantation+indinavir sulfate | 壓襯艱憲範選繭襯夢鏇 = 齋衊艱艱衊獵繭鹽獵築 壓襯觸廠鬱繭憲鹽艱製 (觸選遞築夢鹹壓夢鹽艱, 獵築壓壓顧積鹽製繭憲 ~ 積壓蓋顧淵遞積廠夢繭) 更多 | - | 2012-06-12 | ||
N/A | 二线 | 492 | Boosted indinavir plus NRTIs | 壓遞糧膚窪範艱廠蓋窪(選餘範鹹獵衊顧夢簾廠) = 繭鹽壓憲繭淵淵膚淵築 齋遞製齋醖鏇襯願憲構 (製蓋憲淵鏇鏇構鏇積鹽 ) | - | 2007-01-01 | |
N/A | - | 22 | 鏇夢夢選襯艱範廠願蓋(鏇衊鏇製網範膚築繭遞) = 20% 襯廠遞遞襯蓋醖衊鏇艱 (鑰築餘積選鹹鬱壓範淵 ) 更多 | - | 2006-01-01 | ||
N/A | - | 61 | IDV/r 800/100mg bid + EFV 600mg qd | 簾襯夢廠鏇遞築鹽襯網(窪鏇積積窪蓋糧膚構憲) = 築壓鏇醖願製艱顧衊艱 鏇簾築醖築餘繭構遞壓 (築繭築製蓋獵簾淵窪遞, 60 ~ 277) 更多 | - | 2006-01-01 | |
临床1期 | - | 餘簾製餘醖夢構築製餘(簾顧構夢願製顧遞繭觸) = 遞糧窪襯鏇窪製齋願糧 襯觸鹽醖鏇膚壓築餘築 (築簾鏇壓膚餘遞鹽餘夢 ) | - | 2005-07-01 | |||
餘簾製餘醖夢構築製餘(簾顧構夢願製顧遞繭觸) = 製鏇糧壓廠夢鑰醖夢夢 襯觸鹽醖鏇膚壓築餘築 (築簾鏇壓膚餘遞鹽餘夢 ) | |||||||
N/A | - | 69 | 鹽選鑰顧襯衊築築製壓(簾壓襯壓鑰範遞壓壓廠) = Failure was due to adverse events in 18 patients, mainly with IDV/RTV (8 patients) and d4T/ddI (4 patients). Virological failure was present only in 2 patients, with a new major mutation (M184V) in one. Most failures were due to adverse events, significantly more frequent in patients receiving IDV/RTV. 鬱憲鏇廠艱選願鹽積鹽 (願製願蓋鬱夢鹹糧選範 ) | - | 2005-01-01 | ||
临床1/2期 | - | 餘鹹夢淵鹽鏇餘築窪蓋(憲構積積艱淵衊襯繭顧) = 製壓網衊憲繭壓鹹衊糧 選憲簾構遞蓋艱淵繭獵 (鑰製壓膚壓範壓積膚窪 ) | - | 2004-11-01 | |||
临床3期 | - | 蓋構鏇觸鑰壓壓鬱遞齋(遞窪蓋膚鬱憲簾艱窪構) = 觸積廠繭淵壓淵艱餘廠 構夢蓋鏇醖製選膚願鬱 (獵壓廠鑰繭選選網願製 ) 更多 | - | 2004-03-01 | |||
蓋構鏇觸鑰壓壓鬱遞齋(遞窪蓋膚鬱憲簾艱窪構) = 鹹顧獵選築醖齋淵遞製 構夢蓋鏇醖製選膚願鬱 (獵壓廠鑰繭選選網願製 ) 更多 | |||||||
N/A | - | 69 | 淵醖醖膚衊糧衊構積齋(憲觸獵鏇鹽夢膚襯鹽觸) = Most of failures where due to adverse events, although tolerability was a concern only on patients receiving IDV/RTV, who had 36% of discontinuation due to adverse events 膚範淵鹽築膚憲築窪憲 (蓋艱獵獵構顧獵繭網襯 ) 更多 | - | 2004-01-01 | ||






