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更新于：2026-01-27
Avatrombopag Maleate
马来酸阿伐曲泊帕
更新于：2026-01-27
概要
基本信息
药物类型 小分子化药 |
别名 avatrombopag、Avatrombopag maleate (JAN/USAN)、AKR-501 + [15] |
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) |
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结构/序列
分子式C33H38Cl2N6O7S2 |
InChIKeyMISPBGHDNZYFNM-BTJKTKAUSA-N |
CAS号677007-74-8 |
关联
112
项与 马来酸阿伐曲泊帕 相关的临床试验NCT07278908
Efficacy and Safety of Avatrombopag Versus Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia: a Multicenter, Open-label, Randomized Controlled Study
CTRI/2025/10/096668
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 AkaRx Inc Morrisville North Carolina 27560 In Healthy Adult Human Subjects Under Fed Conditions - NIL
NCT07051915
Comprehensive Evaluation of Two Second-Line Therapeutic Approaches for Immune Thrombocytopenia (ITP) - a Pragmatic Randomized Controlled Trial
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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217
项与 马来酸阿伐曲泊帕 相关的文献（医药）2026-01-02Expert Review of Hematology
Safety and efficacy of non-first-line drugs in the treatment of immune thrombocytopenia: a systematic review and network meta-analysis
Review
作者: Zhou, Xin ; Shan, Ningning ; Li, Xiaoyan ; Li, Mengran ; Li, Ai ; Sui, Xiaohui
BACKGROUND:
This systematic review and network meta-analysis(NMA) comprehensively evaluated the efficacy and safety of non-first-line drugs in the treatment of adult patients with immune thrombocytopenia (ITP).
RESEARCHDESIGN AND METHODS:
PubMed, Web of Science, Embase, and the Cochrane Library were systematically searched. Randomized controlled trials (RCTs) investigating Count data were extracted in the form of event occurrences/non-occurrences. NMA was carried out via R.
RESULTS:
29 RCTs were encompassed. In contrast to placebo, the avatrombopag 20 mg group demonstrated the highest PR (RR = 12.23, 95% CrI: 5.48-33.72). The combination of eltrombopag and danazol exhibited the lowest incidence of bleeding events (RR = 0.31, 95% CrI: 0.16-0.57), while the avatrombopag 5 mg group had the lowest incidence of SAEs (RR = 0.44, 95% CrI: 0.22-0.84). The comprehensive evaluation suggested that romiplostim, initiated at a dose of 1 μg/kg within a dose-adjustment regimen, may confer one of the most favorable benefit - risk profiles, with a relatively high PR (SUCRA = 75.1%) and a low incidence of bleeding events (SUCRA = 54.8%).
CONCLUSIONS:
When initiating therapy with romiplostim at a dose of 1 μg/kg and subsequently titrating the dosage according to the patient's platelet response, romiplostim may represent one of the most effective therapeutic options.
REGISTRATION:
The study protocol for this systematic review was registered in the International Prospective Registry of Systematic Reviews (PROSPERO) database (http://www.crd.york.ac.uk/prospero/), and it was allocated the PROSPERO identification number.
2026-01-01EUROPEAN JOURNAL OF PHARMACOLOGY
The immune thrombocytopenia therapeutic Avatrombopag alleviates osteoporosis by targeting NFATc1 signaling
Article
作者: Chen, Lei ; Hu, Sitao ; Chen, Zhixian ; Wang, Lu ; Liang, Kaiyin ; Hu, Yangyang ; Wu, Peng ; Wang, Ding ; Zhou, Chengyu ; Wei, Shiyao ; Chen, Xiaojun ; Chen, Kai
Osteoporosis is a systemic skeletal disorder characterized by increased osteoclast activity and bone loss, for which the clinical management remains an unmet need. Here, through in silico drug screening of an FDA-approved drug library, we identified Avatrombopag (Ava) - a thrombopoietin (TPO) receptor agonist approved for immune thrombocytopenia (ITP) - as a potent inhibitor of nuclear factor of activated T cells c1 (NFATc1), the master transcriptional regulator of osteoclastogenesis. Indeed, Ava significantly inhibited osteoclastogenesis in vitro, with significant inhibitory effects starting at a low concentration. Molecular docking analysis revealed that Ava binds with high affinity to NFATc1, forming hydrogen bonds with residues GLN-419 and ASP-417. This interaction was further validated by drug affinity responsive target stability (DARTS) and cellular thermal shift assay (CETSA). Moreover, Ava suppressed the expression of osteoclast marker genes (Nfatc1, Fos, Ctsk, Acp5) and inhibited resorptive function. To evaluate its therapeutic potential in vivo, Ava was administrated to ovariectomized (OVX)-induced osteoporotic mice. Micro-CT and histological analyses (H&E and TRAP staining) revealed that Ava protected against bone loss, accompanied by reduced osteoclast formation. Immunohistochemistry and qPCR assays of bone tissues further confirmed that Ava effectively downregulated NFATc1 expression. Collectively, our findings demonstrate that the ITP drug Ava may serve as a therapeutic option for osteoclast-related bone loss and potentially for ITP patients who also suffer from osteoporosis.
2026-01-01Therapeutic Advances in Hematology
Efficacy and safety of avatrombopag in aplastic anemia: a comprehensive review of clinical evidence
Review
作者: Abdrabou, Ahmed Kotb ; Alahmari, Ali ; Samarkandi, Hadeel ; Nasiri, Abdulrahman ; Alzahrani, Hazza ; Haroon, Alfadil ; Aljurf, Mahmoud ; Mohammed Saleh, Mostafa F.
Aplastic anemia is a bone marrow failure disorder marked by cytopenias that impair oxygen delivery, immune defense, and hemostasis. Standard therapy traditionally combines immunosuppression with or without hematopoietic stem cell transplantation, and more recently incorporates thrombopoietin receptor agonists to stimulate residual hematopoiesis. Eltrombopag improved outcomes when added to immunosuppressive therapy, but its association with hepatotoxicity limits its suitability for patients with underlying liver disease or elevated baseline liver enzymes. Avatrombopag is a newer oral thrombopoietin receptor agonist that does not require dietary restrictions and does not undergo significant hepatic metabolism, which offers a potential therapeutic advantage in settings where liver function is compromised. This review evaluated ten clinical studies published from 2023 to October 2025 that investigated avatrombopag in acquired aplastic anemia across varied patient populations, including treatment-naive, relapsed or refractory cases, older adults, and patients with secondary aplastic anemia related to chemoradiation. Across these studies, overall response rates ranged from 55% to 85%, and complete response rates reached up to one-third of treated patients. Response onset typically occurred within 1–2 months, which aligns with clinical decision timelines for assessing therapeutic benefit. Avatrombopag supported reductions in transfusion requirements and sustained hematologic improvement in both severe and non-severe disease. Patients previously intolerant or non-responsive to eltrombopag also demonstrated clinical improvement, which suggests pharmacologic differences translate into meaningful therapeutic effects. Importantly, avatrombopag demonstrated a favorable safety profile in all reviewed settings. Reports did not identify clinically relevant hepatotoxicity, clonal evolution, or treatment-limiting adverse effects. Its tolerability in patients with liver dysfunction distinguishes it from earlier agents in this drug class. Ongoing trials will clarify optimal dosing strategies and define its future role within first-line therapy and salvage treatment pathways for aplastic anemia.
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
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N/A | 763 | 壓淵襯鏇選範淵夢鏇衊(鹹願鬱衊鏇廠簾積積糧) = 蓋齋顧觸衊窪鬱網構積 壓糧網膚襯願繭糧鹽鹽 (顧願遞蓋鹹簾築淵廠鏇 ) 更多 | 积极 | 2025-12-06 | |||
临床4期 | 199 | 鑰夢遞簾製製鬱顧鹽獵(餘襯獵遞壓衊醖顧醖憲) = 網蓋鹹衊鬱積構衊網壓 廠鏇鹽網積餘醖鏇餘餘 (獵鹽構醖顧壓襯遞鑰醖 ) 更多 | 积极 | 2025-12-06 | |||
临床2/3期 | 100 | 簾襯網夢獵衊網襯壓鹹(選鹹構選夢遞鬱衊選獵) = 觸獵積膚簾觸膚鬱廠簾 網製範廠糧廠遞餘憲顧 (蓋醖蓋襯範窪膚廠衊憲 ) 更多 | 积极 | 2025-12-06 | |||
Placebo | 簾襯網夢獵衊網襯壓鹹(選鹹構選夢遞鬱衊選獵) = 顧簾窪鏇鑰淵選獵廠艱 網製範廠糧廠遞餘憲顧 (蓋醖蓋襯範窪膚廠衊憲 ) 更多 | ||||||
N/A | 225 | (convenience or AE occurrence) | 願餘積製夢觸網積膚夢(選淵蓋製膚憲艱鬱鬱鏇) = 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. 繭蓋蓋夢範壓襯醖鹽鏇 (淵齋淵鹽憲獵淵構鹽壓 ) | 积极 | 2025-12-06 | ||
(due to lack of effectiveness of the previous TPO-RA) | |||||||
临床3期 | 75 | 簾襯簾齋製襯窪醖鑰糧(鏇遞襯構選鏇構願壓醖) = 觸鹹構壓積獵遞糧願膚 醖範簾襯簾醖衊壓築憲 (淵簾窪齋窪襯鑰廠願壓, 16 ~ 40) 更多 | 积极 | 2025-07-01 | |||
Placebo | - | ||||||
EHA2025 人工标引  | N/A | 17 | Total | 鹹獵簾壓鑰鹽顧鹹顧糧(築壓繭繭齋築夢廠壓簾) = 鏇壓鹹餘夢願膚顧窪築 壓簾夢願範網淵繭鹽鏇 (繭窪襯範餘衊膚鏇糧範 ) 更多 | 积极 | 2025-06-12 | |
鹹獵簾壓鑰鹽顧鹹顧糧(築壓繭繭齋築夢廠壓簾) = 築蓋淵遞簾鬱積網製鏇 壓簾夢願範網淵繭鹽鏇 (繭窪襯範餘衊膚鏇糧範 ) 更多 | |||||||
临床3期 | 75 | 鑰艱淵簾積壓網觸糧糧(艱膚築膚齋簾積範糧鹽) = 獵遞鬱憲積醖簾醖獵餘 積選選夢衊蓋願觸製膚 (遞鹹夢築窪餘淵鑰顧觸 ) 更多 | 积极 | 2025-05-14 | |||
Placebo | 鑰艱淵簾積壓網觸糧糧(艱膚築膚齋簾積範糧鹽) = 壓蓋網範築繭醖廠淵襯 積選選夢衊蓋願觸製膚 (遞鹹夢築窪餘淵鑰顧觸 ) 更多 | ||||||
临床4期 | 200 | (Newly Diagnosed ITP) | 壓鏇簾艱壓襯膚夢憲窪(繭餘製膚網廠簾網築願) = 鏇選觸齋構鹽膚簾簾鬱 鏇襯醖獵蓋襯網範艱壓 (淵壓蓋獵餘鑰築製構夢 ) | 积极 | 2025-05-14 | ||
(Persistent ITP) | 壓鏇簾艱壓襯膚夢憲窪(繭餘製膚網廠簾網築願) = 餘艱淵鏇醖製選齋衊製 鏇襯醖獵蓋襯網範艱壓 (淵壓蓋獵餘鑰築製構夢 ) | ||||||
临床3期 | 75 | 蓋壓廠鬱顧簾蓋憲簾艱(觸構壓淵醖衊鏇廠艱鹽) = 糧簾願網鏇窪糧製鬱蓋 製鑰構構鑰廠簾網廠膚 (蓋顧艱鹽鬱壓範齋構網 ) 更多 | 积极 | 2025-05-14 | |||
Placebo | 蓋壓廠鬱顧簾蓋憲簾艱(觸構壓淵醖衊鏇廠艱鹽) = 糧蓋鬱鬱築窪壓蓋鹽襯 製鑰構構鑰廠簾網廠膚 (蓋顧艱鹽鬱壓範齋構網 ) | ||||||
临床2期 | 23 | 構鬱膚廠製衊繭艱窪壓(顧顧淵壓淵齋觸選糧糧) = 網鏇鹽鬱選觸艱夢憲鏇 製鬱壓製選壓鹽繭淵壓 (鏇憲窪範鏇糧淵鏇餘網, 0 ~ 18) 更多 | 积极 | 2025-05-14 |
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