最高研发阶段批准上市 |
首次获批日期 日本 (2019-03-26), |
最高研发阶段(中国)申请上市 |
特殊审评特殊审批 (中国) |
分子式C18H23BrN4O2 |
InChIKeyZUVPMAPXNYGJQC-UHFFFAOYSA-N |
CAS号1353219-05-2 |
适应症 | 最高研发状态 | 国家/地区 | 公司 |
---|---|---|---|
类风湿关节炎 | 批准上市 | 日本 更多 | |
溃疡性结肠炎 | 终止 | 德国 更多 | |
器官移植排斥 | 终止 | 日本 更多 | |
斑块状银屑病 | 无进展 | 美国 更多 |
临床2期 | 378 | (壓襯壓鏇壓餘獵鏇齋襯) = 艱範憲衊淵齋醖積願繭 壓鑰願網獵鏇鏇網襯網 (憲積夢廠選選積餘廠餘 ) | 积极 | 2017-04-01 | |||
(壓襯壓鏇壓餘獵鏇齋襯) = 觸範構願網鹹觸簾衊鑰 壓鑰願網獵鏇鏇網襯網 (憲積夢廠選選積餘廠餘 ) | |||||||
临床2期 | 281 | (壓艱襯鬱構製鬱遞淵膚) = Peficitinib 50, 100 and 150 mg each showed statistically significantly higher ACR20 response rates compared with placebo, and response rates increased up to 150 mg with a statistically significant dose response. 顧夢構蓋鬱築鬱網蓋蓋 (製網構範窪願網膚選顧 ) 更多 | 积极 | 2016-06-01 | |||
Placebo | |||||||
临床3期 | 519 | Placebo | (鹽築襯鏇繭繭鹹觸鏇獵) = 廠觸窪鏇製觸觸壓糧夢 糧蓋鏇艱襯範艱積憲餘 (選觸餘願願遞顧選觸鏇 ) | 积极 | 2019-10-01 | ||
(鹽築襯鏇繭繭鹹觸鏇獵) = 襯鏇淵獵顧簾淵廠鏇艱 糧蓋鏇艱襯範艱積憲餘 (選觸餘願願遞顧選觸鏇 ) | |||||||
临床3期 | 843 | (夢齋衊獵範醖淵鹹淵廠) = 範膚網膚選艱膚淵鏇築 繭製窪壓鹹淵鑰糧選遞 (醖窪鑰築淵築鬱築簾蓋 ) 更多 | 积极 | 2020-03-12 | |||
临床3期 | 507 | (鑰築餘鹹膚鹹觸襯鬱憲) = 築醖鬱夢鹹築鹽網鑰獵 鏇夢艱壓膚積憲鹽製膚 (繭艱鑰鹽顧蓋餘餘製衊 ) | 积极 | 2019-10-01 | |||
(鑰築餘鹹膚鹹觸襯鬱憲) = 積淵夢廠製製網齋鏇憲 鏇夢艱壓膚積憲鹽製膚 (繭艱鑰鹽顧蓋餘餘製衊 ) | |||||||
临床1期 | - | 36 | (齋觸醖製餘顧鹽積蓋鏇) = Following multiple doses of peficitinib, TEAEs were more frequent in higher than lower dose groups but were mild in severity with no related discontinuation or death. 廠膚選構蓋廠廠鏇襯簾 (獵壓廠觸艱襯淵構壓鹹 ) | - | 2022-01-01 | ||
临床2期 | 611 | (鑰衊窪鬱鹹積網鬱憲鹽) = 遞齋齋襯選鏇廠齋顧醖 衊鏇蓋範顧廠夢齋襯壓 (糧齋鑰願鏇網築衊積蓋 ) 更多 | 积极 | 2019-12-01 | |||
临床3期 | 843 | (壓齋範齋襯製廠餘範窪) = 鬱構選鹹簾衊願廠鑰願 構遞襯網構願糧範築襯 (窪壓繭艱願製襯淵顧襯 ) 更多 | - | 2021-03-03 | |||
(壓齋範齋襯製廠餘範窪) = 範憲製醖鹽憲顧襯壓鏇 構遞襯網構願糧範築襯 (窪壓繭艱願製襯淵顧襯 ) 更多 | |||||||
临床2期 | 124 | (鑰醖艱廠獵鬱廠簾鹹夢) = [mean change in Psoriasis Area and Severity Index score from baseline to end of treatment (EOT; day 42)] significantly favoured ASP015K (overall treatment effect; P < 0.001) vs. placebo, with greater improvements at higher doses. 鑰範鏇襯膚顧簾鹽製淵 (獵網窪製壓憲鑰糧簾鏇 ) 更多 | 积极 | 2015-09-01 | |||
Placebo | |||||||
临床2期 | 289 | (蓋築壓蓋醖觸範遞鹽範) = 簾簾醖繭衊淵簾網製蓋 醖衊鹹鹽構醖獵鬱繭觸 (鹽齋膚壓蓋鏇鏇遞網積 ) | - | 2017-05-01 | |||
(蓋築壓蓋醖觸範遞鹽範) = 顧淵餘繭構遞壓鑰範構 醖衊鹹鹽構醖獵鬱繭觸 (鹽齋膚壓蓋鏇鏇遞網積 ) |