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Edoxaban

Generic Name
Edoxaban
Brand Names
Lixiana, Savaysa, Roteas
Drug Type
Small Molecule
Chemical Formula
C24H30ClN7O4S
CAS Number
480449-70-5
Unique Ingredient Identifier
NDU3J18APO

Overview

Edoxaban is a member of the Novel Oral Anti-Coagulants (NOACs) class of drugs, and is a rapidly acting, oral, selective factor Xa inhibitor. By inhibiting factor Xa, a key protein in the coagulation cascade, edoxaban prevents the stepwise amplification of protein factors needed to form blood clots. It is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant. Traditionally, warfarin, a vitamin K antagonist, was used for stroke prevention in these individuals but effective use of this drug is limited by it's delayed onset, narrow therapeutic window, need for regular monitoring and INR testing, and numerous drug-drug and drug-food interactions. This has prompted enthusiasm for newer agents such as dabigatran, apixaban, and rivaroxaban for effective clot prevention. In addition to once daily dosing, the benefits over warfarin also include significant reductions in hemorrhagic stroke and GI bleeding, and improved compliance, which is beneficial as many patients will be on lifelong therapy.

Indication

Edoxaban is indicated for reducing the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). However, it should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg). It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.

Associated Conditions

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Stroke
  • Systemic Embolism

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2021/02/10
N/A
Completed
2021/01/29
Phase 3
Completed
2020/12/17
Phase 1
Completed
2020/12/10
N/A
Completed
Malmö University
2020/11/06
N/A
Active, not recruiting
2020/10/20
N/A
Completed
Daiichi Sankyo Turkey, a Daiichi Sankyo Company
2020/08/20
N/A
Completed
2020/08/18
Phase 3
Terminated
2020/07/20
N/A
Completed
Cardioangiologisches Centrum Bethanien
2020/03/05
N/A
Active, not recruiting
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Edoxaban Tosilate Tablets
国药准字H20223669
化学药品
片剂
9/14/2022
Edoxaban Tosilate Tablets
国药准字H20244387
化学药品
片剂
7/9/2024
Edoxaban Tosilate Tablets
国药准字H20249411
化学药品
片剂
11/15/2024

PPB Drug Approvals

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TGA Drug Approvals

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