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2024/03/22 | Phase 1 | Withdrawn | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | ||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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