达瑞沙班(Darexaban Maleate) - 药物靶点：factor Xa_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Darexaban、Darexaban maleate (JAN)

+ [2]

靶点

factor Xa

作用机制

factor Xa抑制剂(激活型凝血因子X抑制剂)

治疗领域

心血管疾病神经系统疾病

在研适应症-

非在研适应症

急性冠状动脉综合征心房颤动脑卒中+ [3]

原研机构

Astellas Pharma, Inc.

在研机构-

非在研机构

Astellas Pharma Europe Ltd.

Astellas Pharma, Inc.Astellas Tokai KK

+ [2]

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)终止

特殊审评-

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结构

分子式C31H34N4O8

InChIKeyWHMPMUVISXATBH-BTJKTKAUSA-N

CAS号365462-24-4

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关联

27

项与达瑞沙班相关的临床试验

NCT01125657 / Completed临床1期

Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -

This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.

开始日期2010-02-01

申办/合作机构

Astellas Pharma, Inc.

NCT01125670 / Completed临床1期

Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet-

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.

开始日期2010-02-01

申办/合作机构

Astellas Pharma, Inc.

NCT01406002 / Completed临床1期

An Open-label, One-sequence Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Pharmacokinetics of YM150 (Darexaban) and Metabolites in Young Healthy Male Subjects

The primary objective of this study is to determine the effect of rifampicin on the way the body handles darexaban and its metabolites (drug degradation products). The secondary objective of the study is to evaluate the safety and tolerability of a single dose of darexaban alone and when administered together with rifampicin.

开始日期2010-01-01

申办/合作机构

Astellas Pharma, Inc.

100 项与达瑞沙班相关的临床结果

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100 项与达瑞沙班相关的转化医学

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100 项与达瑞沙班相关的专利（医药）

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72

项与达瑞沙班相关的文献（医药）

2023-01-13·Medicine

Efficacy of 11 anticoagulants for the prevention of venous thromboembolism after total hip or knee arthroplasty: A systematic review and network meta-analysis

Review

作者: Xu, Dan ; Zhao, Pengfei ; Huang, Zhihao ; Xu, Xinru ; Zou, Miao

Background:To systematically review the efficacy of 11 anticoagulants in the treatment of venous thromboembolism (VTE) after total hip or knee arthroplasty.Methods:PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang Data, VIP, and China Biology Medicine databases were electronically searched for studies assessing the efficacy of different anticoagulants for the prevention of VTE after total hip or knee arthroplasty from January 1, 2010, to January 27, 2022. Two reviewers independently screened the literature, extracted data, and graded the evidence using Confidence in Network Meta-Analysis. The network meta-analysis was then performed using Stata 16.0 software and R 4.1.0 software.Results:A total of 61 articles were included. The results of network meta-analysis showed that apixaban, edoxaban, fondaparinux, rivaroxaban, and darexaban were the most effective anticoagulants for the prevention of deep vein thrombosis in patients undergoing total hip or knee arthroplasty (P < .05), while there was no difference in the efficacy among the anticoagulants for the prevention of pulmonary embolism (P > .05).Conclusion:Apixaban, edoxaban, fondaparinux, rivaroxaban, and darexaban have the best efficacy for the prevention of VTE after total hip or knee arthroplasty.

2021-04-01·Pharmacological Research2区 · 医学

Ranking the efficacy of anticoagulants for the prevention of venous thromboembolism after total hip or knee arthroplasty: A systematic review and a network meta-analysis

2区 · 医学

Review

作者: Feng, Weili ; Huang, Daoqiang ; Wang, Xiaoping ; Lu, Anqi

BACKGROUNDAnticoagulants are essential in the prevention of venous thromboembolism. However, the effectiveness and safety of different anticoagulants have always been controversial. Therefore, we aimed to expand the sample of anticoagulant results and rank the efficacy and safety of 19 anticoagulants in the prevention of venous thromboembolism when total knee or total hip arthroplasty procedure is performed.METHODSA systematic review and network meta-analysis of randomized trials of adult patients undergoing total hip or knee arthroplasty were conducted. The trials were identified from PubMed, Web of Science, Cochrane Library, and Embase databases, in which anticoagulants were used as interventions randomized controlled trial. The incidence of venous embolism and bleeding are the key outcomes of assessing the efficacy of intervention drugs. We used the Physical Therapy Evidence Database (PEDro) to assess risk bias and used pairwise comparison and network meta-analysis with random effects to estimate the summary relative risk. The study has been registered with PROSPERO, number CRD42020200747.RESULTSFrom the 4083 identified manuscripts, 45,067 participants from 53 randomized trials were included in the analysis and randomly assigned to 19 anticoagulants. With Enoxaparin as a control, Rivaroxaban (risk difference 0.07, 95 % credible interval 0.06 to 0.08), Edoxaban (RD 0.09, 95 % CrI 0.08 to 0.11), and Apixaban (RD 0.05, 95 % CrI 0.04 to 0.06) had the best effect in preventing VTE. However, in terms of comprehensive bleeding rate, Apixaban, Edoxaban, and Darexaban were the most effective and stable. Although effective in preventing VTE, bleeding remains relatively high in Rivaroxaban. Enoxaparin is low-molecular-weight heparin that is widely used in clinics, and although its overall efficacy is not the best, its efficacy and safety are very stable.CONCLUSIONAccording to the available data, Apixaban, Edoxaban, and Darexaban are better than any anticoagulants in the prevention of VTE and bleeding during total knee or total hip arthroplasty. In our study, Fondaparinux, Eribaxaban, Dalteparin, Betrixaban, Bemiparin, Reviparin, Acenocoumarol, and Tinzaparin were scarce in the included studies, therefore, more evidence is needed to prove their efficacy and safety.

2021-01-01·Thrombosis Research3区 · 医学

Twice- or Once-Daily Dosing of Direct Oral Anticoagulants, a systematic review and meta-analysis

3区 · 医学

Review

作者: Nony, P ; Cucherat, M ; Durieu, I ; Laporte, S ; Mismetti, P ; Mainbourg, S ; Grange, C ; Bertoletti, L ; Lega, J-C ; Grenet, G ; Provencher, S ; Kilo, R ; Gueyffier, F

AIMThe direct oral anticoagulants (DOAC) have similar half-lives, but the dosing regimen varies between once daily (QD) or twice daily (BID). For some prescribers, the QD regimen improves compliance. Others prefer BID regimens to promote better stability of plasma concentrations, particularly in the event of missed doses. Limited level of evidence provides guidance about the best treatment strategy. The purpose of this study was to compare the treatment effect of QD vs. BID administration of DOACs in major orthopedic surgery (MOS), non-valvular atrial fibrillation (NVAF), venous thromboembolism (VTE), and acute coronary syndrome (ACS).METHODSWe conducted a systematic review up to April 2020. We included phase II clinical trials comparing DOAC QD vs BID with same daily dose. We extracted data for the occurrence of major thrombosis (proximal deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke) and major hemorrhage (ISTH criteria and recommendations of the European Medicines Agency for surgical patients). Relative risks (RR) were combined using a fixed and random effects weighted meta-analysis.RESULTSTwelve randomized, controlled, phase II trials were included (10,716 patients), representing 24 dosing regimen comparisons of apixaban, darexaban, edoxaban, rivaroxaban, letaxaban, and dabigatran. There was no difference for major thrombotic event (RR_BID/QD = 1.06, 95%IC 0.86-1.30) nor for major bleeding (RR_BID/QD = 1.02, 95%IC 0.84-1.23) between the BID vs QD regimens, without heterogeneity (I² = 0%).CONCLUSIONOur study does not support a global difference in term of efficacy and safety of the BID and QD regimens of DOAC in MOS, NVAF, VTE and ACS.

100 项与达瑞沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09817	达瑞沙班	-	DB12289

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
静脉血栓栓塞	临床3期	爱沙尼亚	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床3期	立陶宛	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床3期	德国	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床3期	美国	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床3期	巴西	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床3期	挪威	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床3期	奥地利	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床2期	芬兰	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床2期	丹麦	Astellas Pharma Europe Ltd.	2009-04-01
静脉血栓栓塞	临床2期	乌克兰	Astellas Pharma Europe Ltd.	2009-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00942435 (Pubmed \| J Heart Lung Transplant)	临床3期	-	156	Darexaban 15 mg bid	(構蓋製築築醖鬱艱築選) = 齋襯觸選簾醖夢鑰顧鹽餘糧構鏇廠構積遞膚獵 (壓願艱膚積蓋鏇積膚鬱 ) 更多	-	2012-09-01
				Darexaban (YM150) (Mechanical prophylaxis)	(構蓋製築築醖鬱艱築選) = 衊獵簾壓積淵鑰夢憲製餘糧構鏇廠構積遞膚獵 (壓願艱膚積蓋鏇積膚鬱 ) 更多
ONYX-2 (Pubmed \| J Thromb Haemost)	N/A	静脉血栓栓塞	1,017	YM150 5 mg	艱淵鬱築窪齋壓餘壓觸(糧積簾構壓憲願衊醖築) = 願鹹鑰齋襯積網壓顧鏇獵糧觸淵廠襯蓋鑰齋憲 (鹽積鑰窪憲鏇壓糧觸積 )	-	2010-04-01
				YM150 10 mg	艱淵鬱築窪齋壓餘壓觸(糧積簾構壓憲願衊醖築) = 壓夢窪築鬱製壓選獵簾獵糧觸淵廠襯蓋鑰齋憲 (鹽積鑰窪憲鏇壓糧觸積 )