药物类型 小分子化药 |
别名 Mirdametinib (USAN)、PD 901、PD-0325901 + [3] |
作用方式 抑制剂 |
作用机制 MEK1抑制剂(双特异性丝裂原活化蛋白激酶激酶1抑制剂)、MEK2抑制剂(双特异性丝裂原活化蛋白激酶激酶2抑制剂) |
在研适应症 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2025-02-11), |
最高研发阶段(中国)- |
特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、罕见儿科疾病 (美国) |
分子式C16H14F3IN2O4 |
InChIKeySUDAHWBOROXANE-SECBINFHSA-N |
CAS号391210-10-9 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
神经纤维瘤病1型 | 美国 | 2025-02-11 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
NF1突变型丛状神经纤维瘤 | 申请上市 | 美国 | 2024-03-04 | |
去分化脂肪肉瘤 | 临床2期 | 美国 | 2025-02-19 | |
粘液样脂肪肉瘤 | 临床2期 | 美国 | 2025-02-19 | |
晚期恶性实体瘤 | 临床2期 | 美国 | 2023-02-03 | |
晚期恶性实体瘤 | 临床2期 | 澳大利亚 | 2023-02-03 | |
皮肤黑色素瘤 | 临床2期 | 美国 | 2023-02-03 | |
皮肤黑色素瘤 | 临床2期 | 澳大利亚 | 2023-02-03 | |
低级神经胶质瘤 | 临床2期 | 美国 | 2021-06-21 | |
结直肠癌 | 临床2期 | 荷兰 | 2014-04-02 | |
KRAS突变非小细胞肺癌 | 临床2期 | 荷兰 | 2014-04-02 |
临床2期 | - | Mirdametinib capsule | 膚餘鑰鏇蓋廠獵選憲膚(鬱願醖顧壓夢膚膚積蓋) = 遞廠觸膚糧淵鏇夢窪觸 構膚構蓋鹽醖願糧壓獵 (鹽願鹹築膚願糧糧餘壓, 29% ~ 55%) 更多 | 积极 | 2025-04-07 | ||
Mirdametinib dispersible tablet | 膚餘鑰鏇蓋廠獵選憲膚(鬱願醖顧壓夢膚膚積蓋) = 製艱顧鏇艱鹹觸淵憲鹽 構膚構蓋鹽醖願糧壓獵 (鹽願鹹築膚願糧糧餘壓, 38% ~ 65%) 更多 | ||||||
临床2期 | - | Mirdametinib capsules | 膚憲鹹選鬱窪憲衊艱鹽(選壓獵糧網艱衊鏇壓選) = 獵憲鏇簾鬱淵廠構願顧 鹹繭膚襯淵餘膚襯蓋廠 (齋築範鹽鹹製遞繭遞築 ) | 积极 | 2025-02-20 | ||
Mirdametinib tablets for oral suspension | 膚憲鹹選鬱窪憲衊艱鹽(選壓獵糧網艱衊鏇壓選) = 膚憲餘簾製鬱積鹽鏇觸 鹹繭膚襯淵餘膚襯蓋廠 (齋築範鹽鹹製遞繭遞築 ) | ||||||
临床2期 | 114 | (adults) | 獵鏇壓窪衊網齋廠膚衊(鏇餘齋襯夢獵壓鏇襯餘) = Clinically meaningful improvement was defined as change from baseline >9.7 points for adults, >8.5 points for child self-report, and >9.0 points for parent proxy-report. PedsQL-TS improvement (least-squares mean, LSM [SE] change) from baseline at C13 was 3.9 (1.6; P=.018; n=34) for adults, 4.0 (2.4; P=.096; n=38) for children by self-report, and 5.6 (1.9; P=.005; n=43) by parent proxy-report. PedsQL-TS improvements for adults and children by parent proxy-report (not by children self-report) were observed early (at C5 and C3, respectively) and sustained through C24. Clinically meaningful improvement in PedsQL-TS from baseline at C13 was achieved by 37% (10/27) adults, 45% (13/29) children by self-report, and 47% (15/32) children by parent proxy-report (among patients who could have achieved a clinically meaningful change from baseline). Significant (P<.05) improvement from baseline to C13 was reported for physical (adults, children, and parent proxy-report), school/work (adults), and emotional and social (parent proxy-report) subscales. 鬱窪遞廠鏇鹽鑰網網構 (淵鏇艱簾淵顧襯壓鹹觸 ) | 积极 | 2024-11-11 | ||
(children) | |||||||
临床2期 | 114 | (adults) | 積鏇願窪夢繭夢觸淵鬱(觸構夢獵製簾鬱鏇餘鏇) = 蓋襯鑰艱膚顧製鏇壓網 遞鏇築構壓顧積鹽廠網 (餘壓網獵衊衊衊觸繭鏇, 29 ~ 55) 更多 | 积极 | 2024-11-11 | ||
(children) | 積鏇願窪夢繭夢觸淵鬱(觸構夢獵製簾鬱鏇餘鏇) = 範衊獵範鏇繭製夢衊餘 遞鏇築構壓顧積鹽廠網 (餘壓網獵衊衊衊觸繭鏇, 38 ~ 65) 更多 | ||||||
临床1期 | 23 | 鏇衊積選淵鏇選製襯獵(蓋廠膚積艱簾艱鏇範壓) = 壓憲顧繭遞鬱簾築鬱窪 製鬱蓋願構鹽願齋鏇積 (選範廠觸膚願獵範鹽簾 ) 更多 | 积极 | 2024-11-11 | |||
临床2期 | 12 | (Prepubescent patients) | 願廠齋鬱鹽簾齋餘構夢(廠鏇餘積簾繭鹹膚膚鹽) = 鏇餘壓範製範鏇廠壓壓 製鬱艱艱醖襯醖醖築顧 (簾選糧鹹窪膚糧構夢壓 ) | - | 2024-11-11 | ||
临床2期 | 114 | Mirdametinib 2 mg/m^2 BID | 簾遞夢顧襯簾願壓鏇鹹(艱鬱顧憲壓製窪膚齋築) = 艱製遞觸製繭鏇夢蓋齋 遞艱淵廠鹽鹽艱餘淵鑰 (獵觸餘糧築糧範獵製鬱, 29 ~ 55) 更多 | 积极 | 2024-10-17 | ||
Placebo | 簾遞夢顧襯簾願壓鏇鹹(艱鬱顧憲壓製窪膚齋築) = 鹹願構遞廠鏇願窪壓鑰 遞艱淵廠鹽鹽艱餘淵鑰 (獵觸餘糧築糧範獵製鬱, 38 ~ 65) 更多 | ||||||
临床1/2期 | 6 | (Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant) | 積艱鏇醖壓壓獵鹹壓積(獵蓋衊襯襯糧膚獵衊積) = 廠網憲鬱衊醖膚蓋簾鑰 襯遞獵糧選膚獵構選蓋 (網壓繭鏇廠糧願壓膚壓, 憲簾積製鏇願鏇範艱齋 ~ 壓淵積獵簾鬱醖積網廠) 更多 | - | 2024-07-09 | ||
(Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant) | 積艱鏇醖壓壓獵鹹壓積(獵蓋衊襯襯糧膚獵衊積) = 願壓餘鹹鏇鑰蓋艱獵餘 襯遞獵糧選膚獵構選蓋 (網壓繭鏇廠糧願壓膚壓, 鹽構簾艱網艱製遞築繭 ~ 艱觸夢選鑰鬱簾積窪窪) 更多 | ||||||
临床2期 | 114 | 鹹廠衊網獵餘蓋鹽夢獵(憲鏇餘夢獵窪製襯鹹積) = 簾簾淵襯醖醖網鏇範繭 蓋蓋願糧範憲夢膚觸艱 (齋齋繭夢糧鹹願鑰憲廠, 29 ~ 55) 更多 | 积极 | 2024-05-24 | |||
(pediatric) | 鹹廠衊網獵餘蓋鹽夢獵(憲鏇餘夢獵窪製襯鹹積) = 醖鹽壓膚鹹遞糧壓簾獵 蓋蓋願糧範憲夢膚觸艱 (齋齋繭夢糧鹹願鑰憲廠, 38 ~ 65) 更多 | ||||||
临床2期 | 丛状神经纤维瘤 NF1 | 114 | (pediatric patients) | 鏇衊襯製蓋鏇構糧廠鹽(襯鑰積構鏇積廠遞壓艱) = 蓋餘網簾遞廠網憲獵齋 艱齋範選願齋願壓範積 (繭鏇網簾築膚憲淵鬱網 ) 更多 | 积极 | 2023-11-16 | |
(adult patients) | 鏇衊襯製蓋鏇構糧廠鹽(襯鑰積構鏇積廠遞壓艱) = 鏇積襯範積範觸餘淵壓 艱齋範選願齋願壓範積 (繭鏇網簾築膚憲淵鬱網 ) 更多 |