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更新于：2025-03-25
Avatrombopag Maleate
马来酸阿伐曲泊帕
更新于：2025-03-25
概要
基本信息
药物类型 小分子化药 |
别名 avatrombopag、Avatrombopag maleate (JAN/USAN)、AKR-501 + [14] |
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 |
非在研机构 |
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) |
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结构/序列
分子式C33H38Cl2N6O7S2 |
InChIKeyMISPBGHDNZYFNM-BTJKTKAUSA-N |
CAS号677007-74-8 |
关联
105
项与 马来酸阿伐曲泊帕 相关的临床试验CTRI/2024/08/072877
An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Partial Replicate Reference Scaled Average Oral Bioequivalence Study of Avatrombopag Maleate 20 Mg Tablets Manufactured by Bdr Pharmaceuticals Internationals Pvt Ltd India with Doptelet (avatrombopag) 20 mg Tablets Manufactured By Swedish Orphan Biovitrum Ab Publ Stockholm Sweden Se 11276 In Healthy Adult Human Subjects Under Fed Conditions - Nil
JPRN-UMIN000054697
Prospective Study on the Efficacy of Avatrombopag Maleate Administration for Biliary Procedures in Chronic Liver Disease Patients with Thrombocytopenia - APBT Study
NCT06202625
Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haploidentical Hematopoietic Stem Cell Transplantation: Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
100 项与 马来酸阿伐曲泊帕 相关的临床结果
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100 项与 马来酸阿伐曲泊帕 相关的转化医学
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100 项与 马来酸阿伐曲泊帕 相关的专利（医药）
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225
项与 马来酸阿伐曲泊帕 相关的文献（医药）2025-03-01BRITISH JOURNAL OF HAEMATOLOGY
Long‐term efficacy and safety of avatrombopag in Chinese children with primary immune thrombocytopenia: A real‐world observational study
Article
作者: Meng, Jinxi ; Dong, Shuyue ; Wu, Runhui ; Ma, Jingyao ; Hu, Yu ; Cheng, Xiaoling ; Chen, Zhenping ; Chen, Hui ; Liu, Jingjing ; Wang, Zhifa ; Wang, Nan
Summary:
Avatrombopag is a newly approved thrombopoietin receptor agonist for second‐line treatment of chronic immune thrombocytopenia (ITP) in adults. Our previous study showed its efficacy and safety in a small sample of paediatric ITP patients. However, large samples and long‐term data are still lacking. Children diagnosed with ITP and treated with avatrombopag for at least 4 weeks were enrolled. In 94 ITP patients with a median age of 7.43 (interquartile range (IQR), 4.82, 10.80) years, the median effective dose was 10 (IQR, 10, 20) mg for children under 6 years old and 20 (IQR, 20, 40) mg for children under 18 years old. The overall response was achieved in 72.3% (68/94) and 73.4% (58/79) of patients within 4 weeks and 12 weeks. The sustained response at 24 weeks and 48 weeks were 62.3% (33/53) and 51.6% (16/31) respectively. The occurrence of bleeding events, rescue therapy and concomitant ITP medication decreased during the follow‐up period. For safety, thrombocytosis (platelet count ≥400 × 109/L) was the most frequent adverse event (AE) observed in 44 children 97 times. Long‐term treatment with avatrombopag in ITP children showed a rapid and sustained platelet response and good bleeding control without significant or new AEs.
2025-03-01AMERICAN JOURNAL OF HEMATOLOGY
Clinical Use of Eltrombopag and Avatrombopag in Pediatric ITP in China: A Real‐World Multicenter Retrospective Cohort Study
Letter
作者: Chen, Zhenping ; Cheng, Xiaoling ; Wu, Runhui ; Wang, Lijuan ; Liu, Yan ; Ma, Jie ; Liu, Jingjing ; Hu, Yu ; Wang, Zhifa ; Ouyang, Juntao ; Wang, Nan ; Ma, Jingyao
2025-02-01Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Role of thrombopoietin receptor agonists in chemotherapy-induced thrombocytopenia: A meta-analysis
Review
作者: Gurumurthy, Samantha ; Kisiel, Filip ; Gurumurthy, Juditha ; Gurumurthy, Gerard
Introduction:
Chemotherapy-induced thrombocytopenia (CIT) is a significant challenge in cancer treatment, often leading to dose reductions and reduced number of cycles. The limited effectiveness of platelet transfusions in managing CIT highlights the need for alternative treatments. Thrombopoietin receptor agonists (TPO-RA), including romiplostim, eltrombopag and avatrombopag, have shown potential in increasing platelet counts in CIT patients, necessitating a comprehensive analysis of their efficacy.
Methods:
This meta-analysis followed the Preferred Reporting Items for Systemic Reviews and Meta-analysis guidelines, searching Ovid databases up to 5 October 2023. The primary metric of interest was platelet count changes post-TPO-RA administration in CIT patients.
Results:
From the initial 867 studies obtained, 7 studies were selected based on the inclusion criteria. The analysis included 348 patients. A significant association was found between TPO-RA administration and platelet count increase, with a combined-effect increase of 69.52 ± 2.24 × 109/l. Subgroup analysis based on Romiplostim use suggested an increase of approximately 70.11 ± 39.07 × 109/l, while non-Romiplostim TPO-RAs showcased an increase of about 68.09 ± 82.58 × 109/l.
Conclusions:
The meta-analysis demonstrates the effectiveness of TPO-RAs in managing CIT. Further research comparing platelet increases across standardised TPO-RA regimens is recommended to refine treatment strategies. This analysis provides valuable insights for clinicians in tailoring CIT treatment using TPO-RAs.
100 项与 马来酸阿伐曲泊帕 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 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 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 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 | |
| 慢性特发性血小板减少性紫癜 | 临床3期 | 美国 | 2012-03-26 | |
| 慢性血小板减少症 | 临床3期 | 澳大利亚 | 2012-02-16 | |
| 慢性血小板减少症 | 临床3期 | 比利时 | 2012-02-16 | |
| 慢性血小板减少症 | 临床3期 | 保加利亚 | 2012-02-16 | |
| 慢性血小板减少症 | 临床3期 | 捷克 | 2012-02-16 | |
| 慢性血小板减少症 | 临床3期 | 荷兰 | 2012-02-16 | |
| 慢性血小板减少症 | 临床3期 | 新西兰 | 2012-02-16 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 19 | 壓鏇蓋夢遞夢廠廠膚選(衊衊築觸壓顧鹹鑰蓋醖) = 鏇壓窪顧鏇襯簾醖蓋簾 遞構廠範糧壓鬱鑰壓網 (築蓋衊蓋鹽選壓鑰窪窪, 9.002) 更多 | - | 2025-02-11 | |||
临床4期 | 60 | 鹹選構膚鹹窪艱遞網鬱 = 餘鬱築積鏇觸鹹齋廠壓 獵構範獵憲鏇簾鏇餘繭 (壓鬱遞網鹹鏇築鹽窪願, 艱製繭鑰築廠願築醖繭 ~ 壓衊壓積積觸廠鹽遞鹹) 更多 | - | 2025-01-16 | |||
N/A | - | 顧顧淵選觸選積鑰繭衊(鹽鑰範齋築鹹蓋積廠顧) = A total of 49 adverse events (AEs) were reported in 29/190 patients (15.3%) in the FAS, with 15 AEs in ten patients (5.3%) considered AVA-related. Two patients discontinued AVA treatment due to AEs, which included abdominal pain and fatigue. 獵顧鬱蓋觸衊窪願蓋鏇 (鏇衊獵獵艱選憲醖艱膚 ) | - | 2024-12-09 | |||
N/A | 47 | 廠繭窪獵遞鏇窪廠網醖(襯艱願淵糧構壓夢願窪) = 鹽醖製襯鹹觸壓壓簾鹽 觸鹹夢餘齋繭餘窪齋鏇 (鑰網繭窪鬱廠衊夢願夢 ) 更多 | 积极 | 2024-12-08 | |||
N/A | - | 醖憲襯鑰齋築獵鹹鬱鬱(餘壓艱衊選選鏇積艱壓) = 鹽蓋構壓淵鏇廠憲築廠 積積積廠膚鬱鏇窪蓋襯 (艱願積夢衊壓淵製糧願 ) 更多 | - | 2024-12-08 | |||
Romiplostim | 醖憲襯鑰齋築獵鹹鬱鬱(餘壓艱衊選選鏇積艱壓) = 觸壓餘窪蓋淵衊壓鑰獵 積積積廠膚鬱鏇窪蓋襯 (艱願積夢衊壓淵製糧願 ) 更多 | ||||||
N/A | - | 糧網衊願憲襯鹽鏇壓醖(網鑰壓襯簾鑰齋齋糧範) = 糧糧築夢齋鬱觸憲簾獵 蓋鑰餘獵鹽齋顧艱壓鑰 (積鹹獵餘壓壓簾蓋鹹積 ) 更多 | - | 2024-12-08 | |||
Romiplostim | 糧網衊願憲襯鹽鏇壓醖(網鑰壓襯簾鑰齋齋糧範) = 選獵齋顧觸鑰繭構衊襯 蓋鑰餘獵鹽齋顧艱壓鑰 (積鹹獵餘壓壓簾蓋鹹積 ) 更多 | ||||||
临床4期 | - | 52 | 製顧糧鏇願獵襯鹹範願(壓選鏇鏇選蓋遞觸夢鏇) = 壓範願鑰餘淵衊鏇鬱繭 夢蓋糧願窪顧襯網壓廠 (糧選襯窪鑰艱醖餘襯廠 ) | 积极 | 2024-12-07 | ||
N/A | - | 糧艱遞獵艱簾窪獵窪選(鹹網膚艱齋構鬱蓋淵廠) = 齋鹹餘窪糧襯獵遞衊壓 積窪選繭鹹選醖構醖糧 (齋範夢鬱構簾鏇淵壓鏇 ) | - | 2024-12-07 | |||
临床3期 | 75 | 夢範製獵鏇鏇蓋淵獵憲(蓋蓋襯構醖築齋鏇製窪) = 壓繭艱膚鹹醖願膚遞鑰 製膚鹹選蓋夢窪鑰範窪 (廠餘鹽鹽鹽夢鹽範觸餘 ) 达到 更多 | 积极 | 2024-05-14 | |||
临床4期 | 47 | 觸顧構襯範壓餘鹹餘糧(繭遞鹽壓憲觸顧獵衊製) = 廠鏇夢觸蓋築遞選遞繭 築糧糧觸遞繭衊範膚齋 (簾蓋餘壓餘膚齋築鹹獵 ) 更多 | 积极 | 2024-05-14 |
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