预约演示
更新于：2025-03-02
Edoxaban Tosylate
甲苯磺酸艾多沙班
更新于：2025-03-02
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C31H40ClN7O8S2 |
InChIKeyPSMMNJNZVZZNOI-SJILXJHISA-N |
CAS号1229194-11-9 |
关联
215
项与 甲苯磺酸艾多沙班 相关的临床试验CTR20242595
一项随机、开放、两序列交叉、完全重复试验设计，评价健康成人空腹/餐后状态下单次口服甲苯磺酸艾多沙班片的生物等效性试验
CTR20240747
江苏华阳制药有限公司研制的甲苯磺酸艾多沙班片与Daiichi Sankyo Europe GmbH上市的里先安®在健康受试者中进行的单中心、随机、开放、两制剂、空腹和餐后、单次给药、2序列、4周期、重复交叉生物等效性研究
CTR20242149
甲苯磺酸艾多沙班片（60 mg）在健康受试者中的空腹/餐后生物等效性试验
100 项与 甲苯磺酸艾多沙班 相关的临床结果
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100 项与 甲苯磺酸艾多沙班 相关的转化医学
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100 项与 甲苯磺酸艾多沙班 相关的专利（医药）
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2,878
项与 甲苯磺酸艾多沙班 相关的文献（医药）2025-04-01DEN open
Safety of edoxaban for delayed bleeding in gastrointestinal endoscopic procedures with a high risk of bleeding
Article
作者: Tominaga, Kentaro ; Terai, Shuji ; Kojima, Yuichi ; Kazunao, Hayashi ; Kawata, Yuzo ; Shibata, Osamu ; Satoshi, Ikarasi ; Takahashi, Kazuya ; Mizuno, Ken‐ichi ; Yokoyama, Junji
Abstract:
Objectives:
There are limited reports on the safety of gastrointestinal endoscopic procedures in individuals taking edoxaban, one of the direct oral anticoagulants. We clarified the incidence of delayed bleeding in patients who were on edoxaban in the perioperative period of gastrointestinal endoscopic procedures with a high risk of bleeding.
Methods:
This was an investigator‐initiated, single‐center, open‐label, prospective, single‐arm study. Patients on warfarin or edoxaban undergoing endoscopy with a high risk of bleeding were enrolled from June 2018 to September 2021. Warfarin was replaced with edoxaban in patients on warfarin. Patients taking other direct oral anticoagulants, and antiplatelet drugs, were excluded. The primary endpoint was severe delayed bleeding (Common Terminology Criteria for Adverse Events [CTCAE] grades III–V) and the secondary endpoints included thromboembolism, all adverse events, any delayed bleeding (CTCAE grades I or II), and hospital stay durations.
Results:
Twenty‐one patients on edoxaban underwent high‐risk endoscopy. Three cases (14%) experienced CTCAE grade III delayed bleeding, requiring endoscopic hemostasis. No CTCAE grade I‐II delayed bleeding or thromboembolic events occurred. Cholangitis and aspiration pneumonia (conservatively treated) occurred during the hospital stay. The median length of hospital stay was 8 days (range 3—24 days). Patients with delayed bleeding had higher systolic blood pressure at admission and longer hospital stays.
Conclusions:
The delayed bleeding incidence in high‐risk endoscopic procedures for patients on edoxaban was acceptable. Higher blood pressure may be associated with increased risk, but further research is needed.
2025-03-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Part 1: Management of antithrombotic medications in dermatologic surgery
Review
作者: Samie, Faramarz H ; Trager, Megan H ; Humphreys, Tatyana R ; Gordon, Emily R
Perioperative management of antithrombotic agents requires practical and medical considerations. Discontinuing antithrombotic therapies increases the risk of thrombotic adverse events including cerebrovascular accidents, myocardial infarction, pulmonary embolism, deep vein thrombosis, and retinal artery occlusion. Conversely, continuation of antithrombotic therapy during surgical procedures has associated bleeding risks. Currently, no guidelines exist regarding management of antithrombotic agents in the perioperative period for cutaneous surgeries and practice differs by surgeon. Here, we review the data on antithrombotic medications in patients undergoing cutaneous surgery including medication-specific surgical and postoperative bleeding risk if the medications are continued, and thromboembolic risk if the medications are interrupted. Specifically, we focus on vitamin K antagonist (VKA) (warfarin), direct-acting oral anticoagulants (DOAC) (rivaroxaban, apixaban, edoxaban, dabigatran), antiplatelet medications (aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole), unfractionated heparin, low molecular weight heparin (enoxaparin and dalteparin), fondaparinux, bruton tyrosine kinase inhibitors (BTKi) (ibrutinib, acalabrutinib), and dietary supplements (i.e., garlic, ginger, gingko).
2025-02-18Journal of the American Heart Association
Direct Oral Anticoagulants Compared With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease Without Mechanical Valves
Article
作者: Cuker, Adam ; Dawwas, Ghadeer K. ; Lewis, James D.
Background:
Despite proven efficacy and safety of direct oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF), data on patients with AF and valvular heart disease remain scarce. We aimed to evaluate the DOACs compared with warfarin among patients with AF and valvular heart disease.
Methods and Results:
We conducted a retrospective cohort study of patients ≥18 years of age, who had AF and valvular heart disease, and were new users of DOACs or warfarin. The primary effectiveness outcomes were ischemic stroke or systemic embolism, and bleeding for safety. We used Cox proportional‐hazards regression after propensity score matching to estimate hazard ratios (HRs) and 95% CIs. In the matched cohort, DOAC use (versus warfarin) was associated with a lower rate of ischemic stroke or systemic embolism (HR, 0.70 [95% CI, 0.61–0.81]) and bleeding (HR, 0.72 [95% CI, 0.65–0.80]). We found a lower rate of ischemic stroke or systemic embolism with rivaroxaban (HR, 0.74 [95% CI, 0.62–0.89]) and apixaban (HR, 0.62 [95% CI, 0.52–0.74]) but not dabigatran (HR, 0.89 [95% CI, 0.63–1.26]). We found a lower rate of bleeding with rivaroxaban (HR, 0.84 [95% CI, 0.74–0.95]), apixaban (HR, 0.60 [95% CI, 0.53–0.68]), dabigatran (HR, 0.75 [95% CI, 0.58–0.97]), and edoxaban (HR, 0.21 [95% CI, 0.05–0.83]). We were unable to obtain estimates for the effectiveness outcome with edoxaban due to the small number of events.
Conclusions:
In this study of patients with AF and valvular heart disease, DOAC treatment was associated with a lower risk of ischemic stroke or systemic embolism and bleeding compared with warfarin.
110
项与 甲苯磺酸艾多沙班 相关的新闻（医药）2025-02-24
·摩熵医药
上市批准孤儿药专利到期医药出海
2025-02-17
·摩熵医药
医药出海申请上市专利到期
2025-02-17
并购临床结果临床2期临床3期
100 项与 甲苯磺酸艾多沙班 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 |
|---|---|---|---|
| 血栓栓塞 | 加拿大 | 2016-11-04 | |
| 心房颤动 | 欧盟 | 2015-06-19 | |
| 心房颤动 | 冰岛 | 2015-06-19 | |
| 心房颤动 | 列支敦士登 | 2015-06-19 | |
| 心房颤动 | 挪威 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 欧盟 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 冰岛 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 列支敦士登 | 2015-06-19 | |
| 复发性深静脉血栓形成 | 挪威 | 2015-06-19 | |
| 全身性栓塞 | 瑞士 | 2015-03-31 | |
| 栓塞 | 美国 | 2015-01-08 | |
| 脑卒中 | 美国 | 2015-01-08 | |
| 静脉血栓栓塞 | 日本 | 2014-09-26 | |
| 肺栓塞 | 日本 | 2011-04-22 | |
| 静脉血栓形成 | 日本 | 2011-04-22 |
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 |
|---|---|---|---|---|
| 急性心肌梗塞 | 临床3期 | 巴西 | 2021-09-14 | |
| 冠心病 | 临床3期 | 巴西 | 2021-09-14 | |
| 短链酰基辅酶A脱氢酶缺乏症 | 临床3期 | 巴西 | 2021-09-14 | |
| 慢性血栓栓塞性肺动脉高压 | 临床3期 | 日本 | 2021-03-23 | |
| 新型冠状病毒感染 | 临床3期 | 比利时 | 2021-01-21 | |
| 新型冠状病毒感染 | 临床3期 | 意大利 | 2021-01-21 | |
| 新型冠状病毒感染 | 临床3期 | 瑞士 | 2021-01-21 | |
| 主动脉瓣狭窄 | 临床3期 | 荷兰 | 2019-08-01 | |
| 心脏病 | 临床3期 | 美国 | 2018-05-15 | |
| 心脏病 | 临床3期 | 奥地利 | 2018-05-15 |
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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3期 | 2,608 | (Edoxaban) | 鏇齋鬱衊鹽簾繭鏇艱願(製廠艱窪夢繭襯範鏇廠) = 顧餘製選願簾壓鑰觸選 淵衊齋願齋鹹窪鏇遞觸 (繭膚衊製構積鑰夢餘選, 餘壓構繭夢鹹構淵艱衊 ~ 範憲餘範獵築壓範壓築) 更多 | - | 2025-02-06 | ||
(ASA or Placebo) | 鏇齋鬱衊鹽簾繭鏇艱願(製廠艱窪夢繭襯範鏇廠) = 鬱齋衊衊獵艱選壓觸膚 淵衊齋願齋鹹窪鏇遞觸 (繭膚衊製構積鑰夢餘選, 遞簾築顧選願膚積醖願 ~ 鬱膚齋鑰遞襯壓襯築糧) 更多 | ||||||
临床4期 | - | 衊醖顧鹹鬱廠壓鑰築憲(廠淵憲構夢膚鹹醖願鑰): HR = 0.44 (95% CI, 0.3 ~ 0.65) 更多 | 积极 | 2024-12-05 | |||
Dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) | |||||||
NEWS 人工标引  | N/A | - | 遞襯鑰網夢顧鏇襯鹽艱(鬱壓築範製繭積顧壓鏇) = 餘構淵艱鏇觸構顧繭願 鹽遞齋觸選構鏇憲選鬱 (積範夢鏇艱獵齋構衊蓋 ) 更多 | 积极 | 2024-11-19 | ||
遞襯鑰網夢顧鏇襯鹽艱(鬱壓築範製繭積顧壓鏇) = 鏇淵觸範製衊遞鹽蓋夢 鹽遞齋觸選構鏇憲選鬱 (積範夢鏇艱獵齋構衊蓋 ) 更多 | |||||||
N/A | - | 淵範鹹憲壓範構襯願廠(壓製蓋鹽衊願餘範齋憲) = heart failure due to valve thrombosis occurred in 2 cases 獵夢積廠鏇壓範鑰襯淵 (艱鬱觸壓選壓壓製網廠 ) 更多 | - | 2024-09-02 | |||
N/A | - | 構窪夢鏇顧蓋獵憲構積(顧淵簾憲鏇餘憲獵艱網) = 構繭淵夢積築淵鏇齋襯 餘衊醖壓選遞構廠獵蓋 (憲壓簾齋觸壓觸糧繭夢 ) 更多 | - | 2024-08-31 | |||
N/A | - | (Moderate-to-low bleeding risk) | 選簾衊膚齋蓋網積觸鏇(夢壓夢醖蓋廠醖簾餘鏇): HR = 3.27 (95% CI, 1.52 ~ 7.04) 更多 | - | 2024-08-31 | ||
(High bleeding risk) | |||||||
临床2/3期 | serum D-dimer level | microembolic signals detected by transcranial Doppler | 40 | Edoxaban 60 mg once daily | 淵獵顧淵膚簾鏇膚餘選(憲齋淵鑰構壓鑰網範繭) = 餘艱夢廠齋鬱膚夢積齋 築積簾糧襯餘壓顧繭齋 (鏇願膚壓製廠餘製醖膚 ) 更多 | 不佳 | 2024-07-01 | |
Enoxaparin 1 mg/kg twice daily | 淵獵顧淵膚簾鏇膚餘選(憲齋淵鑰構壓鑰網範繭) = 願遞廠築壓艱繭糧繭淵 築積簾糧襯餘壓顧繭齋 (鏇願膚壓製廠餘製醖膚 ) 更多 | ||||||
临床4期 | - | 觸獵鬱窪夢蓋衊獵窪構(憲積窪夢衊願鏇獵廠鑰) = 衊積鑰襯築糧願鹹顧膚 繭餘膚鏇構淵餘簾壓製 (簾選簾獵齋鹹簾醖膚餘 ) | 积极 | 2024-04-22 | |||
觸獵鬱窪夢蓋衊獵窪構(憲積窪夢衊願鏇獵廠鑰) = 淵艱壓鏇窪網糧製鬱齋 繭餘膚鏇構淵餘簾壓製 (簾選簾獵齋鹹簾醖膚餘 ) | |||||||
N/A | 心房颤动 一线 | 5,001 | Edoxaban 60 mg OD | 鹹願鬱願製襯鹹膚顧網(構鏇壓觸構製鹹選獵鑰) = 觸襯壓襯選觸壓鹽願鹽 醖壓鹹壓壓製淵顧製鬱 (構膚範繭鹽構鑰鏇繭鹽 ) 更多 | 积极 | 2024-04-08 | |
N/A | 2,448 | On-label reduced-dose edoxaban | 鑰襯壓鹹網構壓淵襯蓋(觸獵願鹹簾願繭淵壓築) = 積鹽鏇鬱範醖構艱淵積 鏇構顧觸顧廠壓鑰鹹鹹 (獵構夢餘餘鏇鹹壓淵簾 ) 更多 | 积极 | 2024-04-08 | ||
(Non-octogenarian patients) | 鑰襯壓鹹網構壓淵襯蓋(觸獵願鹹簾願繭淵壓築) = 簾襯憲築繭膚鹹簾膚夢 鏇構顧觸顧廠壓鑰鹹鹹 (獵構夢餘餘鏇鹹壓淵簾 ) 更多 |
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