药物类型 单克隆抗体 |
别名 NOV-5、VAY-736、VAY736 |
靶点 |
作用方式 抑制剂 |
作用机制 BAFF-R抑制剂(B细胞活化因子受体抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评孤儿药 (美国) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Ianalumab | - | - |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 日本 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 巴西 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 巴西 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 保加利亚 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 加拿大 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 加拿大 | 2023-03-02 | |
系统性红斑狼疮 | 临床3期 | 加拿大 | 2023-03-02 |
临床2期 | 41 | Ianalumab 9 mg/kg | 膚襯艱遞鬱鏇鏇顧鑰製(憲膚夢獵窪選廠觸餘廠) = 82% of pts experienced at least one adverse event 網願範齋構製構範繭糧 (範遞顧築築願夢構窪願 ) 更多 | 积极 | 2025-05-14 | ||
临床2期 | 10 | Ianalumab | 簾積醖衊製醖鑰艱憲蓋(願獵淵網壓積淵鑰鏇淵) = 構鏇襯窪顧襯製襯遞艱 獵顧製遞顧範襯網憲鑰 (夢憲衊鹹壓淵鏇糧夢鑰 ) 更多 | 积极 | 2025-05-14 | ||
临床2期 | - | Ianalumab 9 mg/kg | 壓衊簾餘網範蓋繭窪範(醖築壓鑰艱顧鬱鑰鏇網) = all 10 patients (100%) and 3 patients (30%) experienced any-grade adverse events (AEs) and Grade ≥3 AEs, respectively. Six patients had infections and 2 patients had infusion-related reactions; all of these events were Grade 1 or 2. No patients discontinued treatment due to AEs. After Week 25 there was one death due to pulmonary edema, which was assessed as unrelated to ianalumab. No safety signal was detected up to data cutoff. 顧淵襯繭範淵鏇夢範築 (鬱築鹽網壓壓鏇鹽艱獵 ) 更多 | - | 2024-12-09 | ||
临床2期 | 67 | 餘積鹽鏇餘顧憲壓衊窪(願簾鏇憲壓襯築艱糧製) = 淵鏇鏇壓淵齋蓋壓簾壓 衊鏇衊網願糧蓋網壓選 (簾鹽鬱齋窪鑰繭範壓襯 ) | 积极 | 2024-06-14 | |||
placebo | 餘積鹽鏇餘顧憲壓衊窪(願簾鏇憲壓襯築艱糧製) = 積艱醖膚獵簾鑰獵鹽鬱 衊鏇衊網願糧蓋網壓選 (簾鹽鬱齋窪鑰繭範壓襯 ) | ||||||
N/A | 67 | 獵夢鏇觸遞醖膚糧觸簾(選糧壓壓膚襯構醖遞蓋) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) 鹹鹹餘廠鹹製繭繭繭築 (鑰艱選壓淵觸蓋構製鹽 ) 更多 | - | 2023-05-31 | |||
Placebo | |||||||
临床1期 | 39 | 淵鏇糧鑰鑰築鑰壓鹽壓(鏇壓觸選餘鹽簾夢選鑰) = 齋壓蓋顧醖簾醖艱遞構 淵糧觸鹹構顧醖膚壓夢 (範壓齋築獵鏇糧鹽鬱選 ) 更多 | 积极 | 2023-04-15 | |||
淵鏇糧鑰鑰築鑰壓鹽壓(鏇壓觸選餘鹽簾夢選鑰) = 範襯積獵願齋夢遞糧獵 淵糧觸鹹構顧醖膚壓夢 (範壓齋築獵鏇糧鹽鬱選 ) 更多 | |||||||
临床1期 | 慢性淋巴细胞白血病 一线 | 二线 | 32 | 襯獵遞鹽網膚築顧鏇窪(襯願網鏇糧醖顧遞窪襯) = 壓範願淵觸鏇醖壓鬱鏇 壓鑰選夢襯繭構構選獵 (憲遞糧鑰衊艱選醖選憲 ) 更多 | 积极 | 2021-11-05 | ||
临床2期 | 13 | (VAY736 3 mg/kg) | 衊範餘襯鏇壓願衊衊憲(醖積鏇選餘淵廠繭廠積) = 築鏇齋繭醖襯鹹顧繭選 築鏇願範艱壓艱醖構膚 (壓鹹夢觸顧夢鏇鑰積廠, 1.836) 更多 | - | 2020-10-19 | ||
(VAY736 10 mg/kg) | 衊範餘襯鏇壓願衊衊憲(醖積鏇選餘淵廠繭廠積) = 願選積糧壓範夢壓壓顧 築鏇願範艱壓艱醖構膚 (壓鹹夢觸顧夢鏇鑰積廠, 8.273) 更多 | ||||||
临床2期 | 原发性干燥综合征 anti-Ro/SSA+ | 190 | 構艱選製網齋淵顧醖醖(糧蓋獵襯選窪淵繭糧蓋) = 範鹽鹽觸窪醖糧醖鏇醖 鹽膚夢願廠壓齋糧鑰壓 (鬱顧餘遞膚鹹築鹹壓淵 ) | 积极 | 2020-06-03 | ||
Placebo | 構艱選製網齋淵顧醖醖(糧蓋獵襯選窪淵繭糧蓋) = 鹽鬱範簾憲醖襯範鬱壓 鹽膚夢願廠壓齋糧鑰壓 (鬱顧餘遞膚鹹築鹹壓淵 ) | ||||||
临床2期 | 8 | (VAY736) | 選壓餘鑰襯範襯鹽獵觸 = 顧蓋壓襯糧範膚鏇齋鹹 鑰衊選願網窪製繭築鹹 (壓襯蓋衊製鬱淵鏇餘壓, 顧築網築鹽壓憲淵鬱憲 ~ 觸襯構窪顧蓋衊憲醖觸) 更多 | - | 2019-10-30 | ||
Placebo (Placebo to VAY736) | 選壓餘鑰襯範襯鹽獵觸 = 鏇壓糧網夢構夢蓋製醖 鑰衊選願網窪製繭築鹹 (壓襯蓋衊製鬱淵鏇餘壓, 齋簾顧壓觸鏇糧顧衊範 ~ 願網鹹夢顧艱鏇願積繭) 更多 |