MedPath

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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/28
Phase 2
Not yet recruiting
2024/10/21
Phase 4
Not yet recruiting
Emily McDonald
2024/06/10
Not Applicable
Active, not recruiting
2024/04/18
Phase 1
Active, not recruiting
VarmX B.V.
2024/03/22
Phase 1
Withdrawn
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
2024/02/29
Not Applicable
Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carita
2023/11/29
Phase 3
Not yet recruiting
2023/05/22
Phase 2
Recruiting
2023/04/07
N/A
Recruiting
2023/02/17
N/A
Completed
Galaxia Empírica

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Daiichi Sankyo Inc.
65597-203
ORAL
60 mg in 1 1
2/6/2024
Daiichi Sankyo Inc.
65597-202
ORAL
30 mg in 1 1
2/6/2024
Daiichi Sankyo Inc.
65597-201
ORAL
15 mg in 1 1
2/6/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
6/19/2015
Authorised
4/19/2017

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
LIXIANA FILM-COATED TABLET 30 MG
SIN16060P
TABLET, FILM COATED
30 mg
12/18/2020
LIXIANA FILM-COATED TABLET 60 MG
SIN16059P
TABLET, FILM COATED
60 mg
12/18/2020
LIXIANA FILM-COATED TABLET 15 MG
SIN16061P
TABLET, FILM COATED
15 mg
12/18/2020

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
LIXIANA TABLETS 15MG
N/A
N/A
N/A
5/31/2016
LIXIANA TABLETS 60MG
N/A
N/A
N/A
5/31/2016
LIXIANA TABLETS 30MG
N/A
N/A
N/A
5/31/2016

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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