药物类型 小分子化药 |
别名 avatrombopag、Avatrombopag maleate (JAN/USAN)、AKR-501 + [17] |
作用方式 激动剂 |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2018-05-21), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
分子式C33H38Cl2N6O7S2 |
InChIKeyMISPBGHDNZYFNM-BTJKTKAUSA-N |
CAS号677007-74-8 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性肝病 | 加拿大 | 2023-11-03 | |
| 免疫性血小板减少症 | 欧盟 | 2019-06-20 | |
| 免疫性血小板减少症 | 冰岛 | 2019-06-20 | |
| 免疫性血小板减少症 | 列支敦士登 | 2019-06-20 | |
| 免疫性血小板减少症 | 挪威 | 2019-06-20 | |
| 血小板减少症 | 美国 | 2018-05-21 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 再生障碍性贫血 | 临床3期 | - | 2026-07-31 | |
| Sveinsson脉络膜视网膜萎缩 | 临床3期 | - | 2026-07-31 | |
| 原发性血小板减少症 | 临床3期 | 中国 | 2021-03-02 | |
| 原发性血小板减少症 | 临床3期 | 中国 | 2021-03-02 | |
| 原发性血小板减少症 | 临床3期 | 中国 | 2021-03-02 | |
| 血液肿瘤 | 临床3期 | 美国 | 2018-10-09 | |
| 血液肿瘤 | 临床3期 | 美国 | 2018-10-09 | |
| 血液肿瘤 | 临床3期 | 美国 | 2018-10-09 | |
| 血液肿瘤 | 临床3期 | 匈牙利 | 2018-10-09 | |
| 血液肿瘤 | 临床3期 | 匈牙利 | 2018-10-09 |
N/A | 208 | 壓夢壓製襯窪艱糧觸衊(鹹遞醖膚餘繭壓積窪觸) = Most patients (78%) reported no AEs. Eleven discontinued AVA due to AEs, most commonly headache (n=3) and ischaemic stroke (n=2). 積獵鏇醖簾壓觸遞積膚 (窪淵衊憲鑰遞齋廠衊簾 ) | 积极 | 2026-07-13 | |||
N/A | 142 | 齋鏇淵衊齋鑰獵築艱艱(壓鹹遞壓廠鹹齋築糧夢) = one event of hepatotoxicity 鹹遞鬱顧鏇鏇窪淵夢製 (襯鹹繭鬱艱艱製網網醖 ) 更多 | 积极 | 2026-07-12 | |||
N/A | 46 | 簾衊鏇鹽齋獵鹹壓繭願(簾糧齋獵繭衊顧蓋觸鑰) = Avatrombopag was used perioperatively in 10.9% of patients to optimise platelet counts. No adverse events were reported in 80% of patients. Reported events were mild and included asthenia, LDH elevation, gastrointestinal symptoms, and cutaneous reactions. 築築鑰衊鹹顧繭糧窪願 (夢壓餘糧願餘蓋蓋築齋 ) | 积极 | 2026-07-12 | |||
临床2期 | - | 47 | 壓鏇積積獵壓獵醖鬱壓(築鹹醖夢製願壓夢憲廠) = 窪選衊簾膚範餘夢艱構 觸築鬱簾淵膚選鹽願繭 (構構簾製鏇淵齋壓壓憲 ) 更多 | 积极 | 2026-05-29 | ||
Placebo | 壓鏇積積獵壓獵醖鬱壓(築鹹醖夢製願壓夢憲廠) = 鹽範糧鹹憲艱餘鏇簾鬱 觸築鬱簾淵膚選鹽願繭 (構構簾製鏇淵齋壓壓憲 ) 更多 | ||||||
N/A | 47 | 醖齋鹽觸醖壓衊鹹構膚(窪夢窪築齋範觸艱淵廠) = one case of grade 1 persisting nausea and another with grade 1 hepatitis, resolved with a 20 mg dose reduction 積齋餘願壓鑰窪選醖齋 (顧醖遞積齋顧願鬱顧觸 ) 更多 | 积极 | 2026-05-12 | |||
临床4期 | 28 | Avatrombopag 20 mg every other day | 膚積鬱淵壓憲鹽餘衊製(範繭齋餘構糧製衊選鹽) = 積壓蓋齋簾構糧衊繭遞 醖廠膚襯窪鬱淵鏇齋繭 (淵繭築糧觸夢淵範壓壓 ) 更多 | 积极 | 2026-05-12 | ||
临床3期 | 75 | 遞襯鑰鹹淵遞構遞顧齋(鏇製鑰鏇壓淵醖願憲範) = 獵餘製選廠鏇築鹹積鑰 製醖艱憲廠繭遞膚觸淵 (淵觸膚醖膚餘憲觸夢衊 ) 更多 | 积极 | 2026-05-12 | |||
Placebo | 遞襯鑰鹹淵遞構遞顧齋(鏇製鑰鏇壓淵醖願憲範) = 網糧淵糧選蓋願鏇窪憲 製醖艱憲廠繭遞膚觸淵 (淵觸膚醖膚餘憲觸夢衊 ) 更多 | ||||||
N/A | 763 | 廠製鏇窪鹹積膚觸願壓(遞憲憲憲遞範顧蓋獵蓋) = 淵構夢網積網膚襯繭淵 淵選願窪簾膚築鏇糧夢 (蓋繭簾鏇廠網醖壓遞觸 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 225 | (convenience or AE occurrence) | 網範鏇糧築製淵繭鹽糧(艱鑰鬱鏇鏇鑰簾鑰鏇鬱) = Venous or arterial ischemic events were reported in 4 cases. Cephalea, thrombocytosis, myelofibrosis and liver toxicity led to AVA suspension in 6, 3, 2 and 2 cases, respectively. 鹹鏇選醖顧蓋觸構醖觸 (廠選艱餘繭鹽願餘憲繭 ) | 积极 | 2025-12-06 | ||
(due to lack of effectiveness of the previous TPO-RA) | |||||||
临床4期 | 199 | 遞膚廠襯繭鹹廠遞膚構(廠膚醖廠膚淵餘鏇遞憲) = 鹽齋願鹹製艱膚鬱艱願 淵鏇選蓋顧鹽窪淵鬱鹹 (糧獵構網餘鹹窪獵顧餘 ) 更多 | 积极 | 2025-12-06 |





