更新于：2024-05-01
Eltrombopag Diolamine
艾曲波帕乙醇胺
更新于：2024-05-01
概要
基本信息
药物类型 小分子化药 |
别名 ELTROMBOPAG、ELTROMBOPAG OLAMINE、艾曲泊帕乙醇胺 + [9] |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
在研适应症 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-11-20), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (日本)、优先审评 (澳大利亚)、突破性疗法 (美国)、加速批准 (美国) |
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结构
分子式C27H29N5O5 |
InChIKeyLQQUHOUXABUDJA-OUFJFOJPSA-N |
CAS号496775-62-3 |
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关联
234
项与 艾曲波帕乙醇胺 相关的临床试验High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
艾曲泊帕乙醇胺干混悬剂在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验
100 项与 艾曲波帕乙醇胺 相关的临床结果
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100 项与 艾曲波帕乙醇胺 相关的转化医学
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100 项与 艾曲波帕乙醇胺 相关的专利（医药）
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884
项与 艾曲波帕乙醇胺 相关的文献（医药）2024-03-01Biomedical reports
Thrombopoietin receptor agonists use and risk of thrombotic events in patients with immune thrombocytopenic purpura: A systematic review and meta‑analysis of randomized controlled trials.
Article
作者: Nan Shen ; Jibing Qiao ; Yazhou Jiang ; Jingjing Yan ; Rang Wu ; Hanjun Yin ; Suyue Zhu ; Jianqin Li
Thrombopoietin receptor agonists (TPO-RAs) have a role in second-line immune thrombocytopenic purpura (ITP) treatment, binding to and activating thrombopoietin receptors on megakaryocyte membranes in the bone marrow. This promotes megakaryocyte maturation and increases platelet production. Despite a 2-6% incidence of thrombotic events during TPO-RA treatment, it remains uncertain whether TPO-RAs elevate thrombosis rates. A comprehensive search of electronic databases was conducted using the relevant search criteria. To assess the risk of bias, the included studies were assessed using the revised Cochrane Risk of Bias Assessment Tool 2.0, and a meta-analysis was performed using RevMan 5.4.1. A total of 1,698 patients with ITP were included from randomized controlled trials (RCTs). There were 26 thromboembolic events in the TPO-RAs group and 4 in the control group. However, there was no significant difference in the incidence of thrombotic events between the two groups [odds ratio (OR)=1.76, 95% confidence interval (CI): 0.78-4.00, P=0.18], even if the duration of treatment was >12 weeks (OR=2.46, 95% CI: 0.81-7.43, P=0.11). Subgroup analysis showed that none of the four drugs significantly increased the incidence of thrombotic events (romiplostim: OR=0.92, 95% CI: 0.14-6.13, P=0.93; eltrombopag: OR=2.32, 95% CI: 0.64-8.47, P=0.20; avatrombopag: OR=4.15, 95% CI: 0.20-85.23, P=0.36; and hetrombopag: OR=0.76, 95% CI: 0.03-18.76, P=0.87). There was also no significant difference in the results of the double-blinded placebo-controlled RCTs (OR=1.21, 95% CI: 0.41-3.58, P=0.73). Compared to patients with ITP who did not receive TPO-RA treatment, those receiving TPO-RA treatment did not exhibit a significantly increased risk of thrombotic events.
2024-02-06The Lancet. Haematology
Consideration of ATG-free therapy with eltrombopag and cyclosporine for severe aplastic anaemia.
Article
作者: Emma M Groarke
2024-02-06The Lancet. Haematology
Activity and safety of eltrombopag in combination with cyclosporin A as first‑line treatment of adults with severe aplastic anaemia (SOAR): a phase 2, single-arm study.
Article
作者: Phillip Scheinberg ; Carlo Finelli ; Efreen H Montaňo-Figueroa ; Carlos Vallejo ; Lalita Norasetthada ; Rodrigo T Calado ; Mehmet Turgut ; Régis Peffault de Latour ; Ulrike Kriemler-Krahn ; Jens Haenig ; Joan Clark ; Junho Jang
BACKGROUND:
Antithymocyte globulin (ATG)-based immunosuppression is standard in front-line treatment for people with severe aplastic anaemia without a histocompatible donor or who are 40 years or older. However, ATG requires in-hospital administration, is associated with infusion-related toxicities and has limited availability worldwide. In this study, we investigated the activity and safety of an ATG-free regimen of eltrombopag with cyclosporin A as a potential treatment for patients with severe aplastic anaemia who might not have access to or cannot tolerate horse-ATG.
METHODS:
SOAR was a multicentre, single-arm phase 2 trial investigating eltrombopag and cyclosporin in adult (≥18 years) patients with severe aplastic anaemia who were treatment-naive and had an Eastern Cooperative Oncology Group performance status of less than 2. Participants were recruited from 20 hospitals in ten countries. Eltrombopag was initiated at 150 mg (100 mg in patients of Asian ethnicity) and cyclosporin at 10 mg/kg per day (adjusted to a trough of 200-400 μg/L) orally from day 1 to 6 months. The primary outcome was an overall haematological response rate by 6 months in the intention-to-treat population. This is the final report of the primary analysis period. The trial was registered with ClinicalTrials.gov, NCT02998645, and has been completed.
FINDINGS:
54 patients were enrolled between May 11, 2017, and March 23, 2020. 34 (63%) patients were male and 20 (37%) were female. 22 (41%) were Asian, 22 (41%) were White, one (2%) was Native American or Alaska Native, one (2%) was Black or African American, and eight (15%) were other race or ethnicity. 35 patients (65%) completed 6 months of treatment with eltrombopag and cyclosporin and six (11%) completed the cyclosporin tapering period up to month 24. Overall haematological response rate by month 6 of treatment was 46% (25 of 54; 95% CI 33-60). The most reported adverse events were increased serum bilirubin (in 22 patients [41%]), nausea (16 [30%]), increased alanine aminotransferase concentration (12 [22%]), and diarrhoea (12 [22%]). Eight patients died on-treatment, but no deaths were considered related to the treatment.
INTERPRETATION:
Eltrombopag and cyclosporin was active as front-line treatment of severe aplastic anaemia, with no unexpected safety concerns. This approach might be beneficial where horse-ATG is not available or not tolerated.
FUNDING:
Novartis Pharmaceuticals.
100 项与 艾曲波帕乙醇胺 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 慢性丙型肝炎 | 批准上市 | 列支敦士登 更多 | |
| 血小板减少症 | 批准上市 | 中国 更多 | |
| 再生障碍性贫血 | 批准上市 | 中国 更多 | |
| 特发性血小板减少性紫癜 | 批准上市 | 中国 更多 | |
| 骨髓增生异常综合征 | 临床2期 | 日本 更多 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 105 | (鬱淵網獵選網糧衊壓艱) = 願艱築膚築製餘衊窪夢 遞齋繭襯膚醖醖蓋鹽構 (積艱膚構齋網艱獵構鑰, 21.9 ~ 40.2) 达到 更多 | 积极 | 2022-05-12 | |||
临床2期 | 44 | (arm A) | (範餘選觸蓋淵艱簾網鬱) = 2 pts 壓夢顧淵選齋遞繭製糧 (鹹襯遞鏇製願夢夢憲願 ) 更多 | 积极 | 2021-11-05 | ||
(arm B) | |||||||
临床2期 | 急性髓性白血病 一线 | 110 | (糧簾觸範廠繭網廠糧範) = 鏇繭廠鏇鏇網膚網鑰廠 憲鑰繭壓遞構壓糧繭襯 (積窪夢餘餘壓糧糧夢繭 ) 更多 | 积极 | 2022-11-15 | ||
Placebo | (糧簾觸範廠繭網廠糧範) = 鑰膚願鬱範鏇觸鏇夢憲 憲鑰繭壓遞構壓糧繭襯 (積窪夢餘餘壓糧糧夢繭 ) 更多 | ||||||
临床2期 | 20 | (齋鑰衊製膚繭繭衊鏇製) = 壓選淵齋壓觸願憲餘醖 網製夢醖襯壓鬱廠廠餘 (憲憲壓鏇願鹽網築願鑰 ) 更多 | 积极 | 2022-06-10 | |||
临床3期 | 98 | (範顧糧衊鹽鏇願糧鏇鹽) = 壓糧淵鏇簾顧顧遞淵餘 壓鬱膚選選遞願醖遞顧 (遞艱衊簾築鹹鹽憲觸製 ) 更多 | 不佳 | 2022-04-21 | |||
(範顧糧衊鹽鏇願糧鏇鹽) = 願鹽醖壓齋簾襯鹽觸壓 壓鬱膚選選遞願醖遞顧 (遞艱衊簾築鹹鹽憲觸製 ) 更多 | |||||||
临床3期 | 197 | immunosuppressive therapy+Eltrombopag | (製鏇淵願壓積膚鹹衊獵) = 膚齋鹹夢願構簾鏇遞構 醖遞襯網鑰膚艱範夢襯 (範齋衊壓憲製淵簾積製 ) 更多 | 优效 | 2022-01-06 | ||
immunosuppressive therapy | (製鏇淵願壓積膚鹹衊獵) = 鏇鹽鹹觸鹹鏇簾膚製齋 醖遞襯網鑰膚艱範夢襯 (範齋衊壓憲製淵簾積製 ) 更多 | ||||||
临床2期 | 再生障碍性贫血 一线 | 54 | (憲選鏇鹽構鑰膚艱鑰衊) = 觸獵鬱襯獵鹽顧壓築簾 窪淵餘膚壓鬱網夢膚淵 (齋鏇醖構鹽餘淵築願鬱, 32.6 ~ 60.4) 达到 更多 | 积极 | 2021-11-05 | ||
临床2期 | 10 | (築觸窪顧網衊餘艱簾範) = 構齋積選選願醖衊糧築 齋艱製襯淵蓋顧襯衊顧 (鏇繭鏇蓋獵鹹膚鑰鏇膚 ) 更多 | 积极 | 2022-05-12 | |||
临床2期 | 66 | 顧遞範繭範鹽廠襯遞積(艱糧糧願顧膚網齋膚窪) = 獵襯襯顧選製衊艱憲壓 顧鹹壓遞衊糧窪簾糧壓 (壓遞鏇蓋遞夢壓糧網願 ) 更多 | 积极 | 2022-11-15 | |||
顧遞範繭範鹽廠襯遞積(艱糧糧願顧膚網齋膚窪) = 蓋鑰窪醖繭獵鬱糧艱顧 顧鹹壓遞衊糧窪簾糧壓 (壓遞鏇蓋遞夢壓糧網願 ) 更多 | |||||||
临床1/2期 | 再生障碍性贫血 一线 | 127 | immunosuppression+Eltrombopag | (憲顧淵鏇鬱繭餘齋廠鹹) = 醖築構構觸糧製顧餘觸 鏇糧衊窪顧鹽獵齋膚衊 (願襯顧簾鹹糧襯廠鏇簾 ) | 不佳 | 2021-02-01 | |
immunosuppression | (憲顧淵鏇鬱繭餘齋廠鹹) = 網選膚鑰壓遞鹹廠積鹽 鏇糧衊窪顧鹽獵齋膚衊 (願襯顧簾鹹糧襯廠鏇簾 ) |
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