Overview
Apixaban is an oral, direct, and highly selective factor Xa (FXa) inhibitor of both free and bound FXa, as well as prothrombinase, independent of antithrombin III for the prevention and treatment of thromboembolic diseases. It is marketed under the name Eliquis. Apixaban was approved by the FDA on December 28, 2012.
Indication
Apixaban is indicated for reducing the risk of stroke and systemic embolism in patients who have nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis(DVT) leading to pulmonary embolism(PE) in patients after a hip or knee replacement surgery, and treatment of DVT and PE to reduce the risk of recurrence.
Associated Conditions
- Deep Vein Thrombosis
- Deep vein thrombosis recurrent
- Pulmonary Embolism
- Recurrent Pulmonary Embolism (Disorder)
- Stroke
- Systemic Embolism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 3 | Recruiting | |||
2025/05/01 | Phase 4 | Not yet recruiting | |||
2025/03/20 | Early Phase 1 | Recruiting | Rushad Patell | ||
2024/12/19 | Phase 3 | Recruiting | |||
2024/12/11 | Phase 2 | Not yet recruiting | Oslo University Hospital | ||
2024/10/21 | Phase 4 | Not yet recruiting | Emily McDonald | ||
2024/09/20 | N/A | Completed | Abu Dhabi Health Services Company | ||
2024/09/19 | Phase 4 | Recruiting | |||
2024/08/13 | Phase 3 | Recruiting | |||
2024/07/31 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| E.R. Squibb & Sons, L.L.C. | 0003-0894 | ORAL | 5 mg in 1 1 | 3/2/2018 | |
| Bryant Ranch Prepack | 63629-7747 | ORAL | 5 mg in 1 1 | 1/17/2022 | |
| A-S Medication Solutions | 50090-6454 | ORAL | 5 mg in 1 1 | 3/2/2018 | |
| N/A | 82982-054 | ORAL | 5 mg in 1 1 | 2/21/2023 | |
| E.R. Squibb & Sons, L.L.C. | 0003-0893 | ORAL | 2.5 mg in 1 1 | 3/2/2018 | |
| Indoco Remedies Limited | 14445-149 | ORAL | 2.5 mg in 1 1 | 6/15/2021 | |
| A-S Medication Solutions | 50090-1436 | ORAL | 2.5 mg in 1 1 | 3/2/2018 | |
| Cardinal Health 107, LLC | 55154-0612 | ORAL | 2.5 mg in 1 1 | 11/8/2018 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-662 | ORAL | 5 mg in 1 1 | 2/1/2023 | |
| Indoco Remedies Limited | 14445-150 | ORAL | 5 mg in 1 1 | 6/15/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 7/23/2020 | ||
Authorised | 5/18/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DCLOT 2.5 FILM COATED TABLETS 2.5 MG | SIN16675P | TABLET, FILM COATED | 2.5mg | 1/11/2023 | |
| Eliquis Tablet 2.5mg | SIN14279P | TABLET, FILM COATED | 2.5mg | 12/24/2012 | |
| DCLOT 5 FILM COATED TABLETS 5 MG | SIN16674P | TABLET, FILM COATED | 5mg | 1/11/2023 | |
| ELIQUIS TABLET 5MG | SIN14407P | TABLET, FILM COATED | 5mg | 9/11/2013 |
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 |
|---|---|---|---|---|---|
| APO-APIXABAN TABLETS 2.5MG | N/A | N/A | N/A | 11/21/2024 | |
| APO-APIXABAN TABLETS 5MG | N/A | N/A | N/A | 11/21/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APIBIC apixaban 5 mg film coated tablet blister pack | 444073 | Medicine | A | 2/11/2025 | |
| APIXIBIC apixaban 5 mg film coated tablet blister pack | 444083 | Medicine | A | 2/11/2025 | |
| APIXABAN APPL apixaban 2.5 mg film coated tablet blister pack | 444076 | Medicine | A | 2/11/2025 | |
| ELAPEX apixaban 5 mg tablet blister pack | 428663 | Medicine | A | 12/3/2024 | |
| ELIQUIS apixaban 5 mg film-coated tablet blister pack | 193474 | Medicine | A | 5/2/2013 | |
| APIXABAN LAPL apixaban 5 mg tablet blister pack | 392234 | Medicine | A | 5/23/2025 | |
| APIBIC apixaban 2.5 mg film coated tablet blister pack | 444072 | Medicine | A | 2/11/2025 | |
| APIXABAN APL apixaban 5 mg film coated tablet blister pack | 444081 | Medicine | A | 2/11/2025 | |
| AXIBIC apixaban 5 mg film coated tablet blister pack | 444089 | Medicine | A | 2/11/2025 | |
| ELIBIC apixaban 2.5 mg film coated tablet blister pack | 444086 | Medicine | A | 2/11/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APIXABAN | sanis health inc | 02548887 | Tablet - Oral | 5 MG | 11/6/2024 |
| PRO-APIXABAN | PRO DOC LIMITEE | 02530732 | Tablet - Oral | 5 MG | 9/26/2022 |
| AG-APIXABAN | angita pharma inc. | 02529920 | Tablet - Oral | 5 MG | 10/28/2022 |
| SANDOZ APIXABAN SDZ | 02489236 | Tablet - Oral | 5 MG | 9/22/2022 | |
| MINT-APIXABAN | mint pharmaceuticals inc | 02495449 | Tablet - Oral | 5 MG | 10/28/2022 |
| NRA-APIXABAN | nora pharma inc | 02526050 | Tablet - Oral | 2.5 MG | 10/5/2022 |
| M-APIXABAN | mantra pharma inc | 02529017 | Tablet - Oral | 5 MG | 9/21/2022 |
| AURO-APIXABAN | auro pharma inc | 02486814 | Tablet - Oral | 5 MG | 11/28/2022 |
| APO-APIXABAN | 02487403 | Tablet - Oral | 5 MG | 6/20/2022 | |
| BIO-APIXABAN | biomed pharma | 02527979 | Tablet - Oral | 2.5 MG | 9/21/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| APIXABAN ALTER GENERICOS 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Alter S.A. | 90390 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| APIXABAN NORMOGEN 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Laboratorios Normon S.A. | 88701 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| SEWAB 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Adalvo Limited | 90109 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| APIXABAN FARMAPROJECTS 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Farmaprojects S.A.U. | 89469 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| APIXABAN ZENTIVA 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 89960 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| ELIQUIS 5 MG COMPRIMIDO RECUBIERTO CON PELICULA | 111691010 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| APIXABAN KERN PHARMA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 89975 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| APIXABAN TEVA 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 85788 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| APIXABAN TEVA 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 85787 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| APIXABAN TARBIS 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 89724 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
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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