Apixaban
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Apixaban
- Molecular weight
- 459.51
- Structure (SMILES)
- COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
- apixaban accord
- Apixaban accord
- eliquis
- Eliquis
- 5 mg Apixaban Oral Tablet (EU product)
- 5 mg apixaban oral tablet eu product
- apixaban
- Apixaban
- Apixaban (ATC B01AF02)
- Apixaban (Eliquis)
- Apixaban [EMA EPAR]
- Apixaban [INN]
- Apixaban [JAN]
- Apixaban [MART.]
- Apixaban [MI]
- Apixaban [ORANGE BOOK]
- Apixaban [USAN]
- Apixaban [VANDF]
- Apixaban [WHO-DD]
- Apixaban 10 MG
- Apixaban 2.5 mg
- Apixaban 2.5 MG
- Apixaban 2.5 mg BID
- Apixaban 2.5 mg Oral Tablet
- Apixaban 2.5 MG Oral Tablet
- Apixaban 5 mg
- Apixaban 5 MG
- Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica)
- Apixaban 5 mg Oral Tablet
And 23 more, listed on the interactive page.
- ATC classification codes
- B01AF02
Sources for recorded values
- CAS registry numbers
- 503612-47-3
- ChEMBL ID
- CHEMBL231779
- InChIKey
- QNZCBYKSOIHPEH-UHFFFAOYSA-N
- PubChem compound IDs
- 10182969
- RxNorm IDs (RxCUI)
- 1364430
- FDA ingredient codes (UNII)
- 3Z9Y7UWC1J
- Applicant
- IMPAX
- Approval date
- 14 Feb 2025
- Application number
- ANDA209810
- Status
- Authorised
- Status date
- 18 May 2011
- Authorisation date
- 18 May 2011
- Approved indications
- Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.
- Product number
- EMEA/H/C/002148
- Authorisation holder
- Bristol-Myers Squibb / Pfizer EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 1
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthroplasty
- Venous Thromboembolism
European medicines record
- Patents
- 8
- Designations
- 2
- Earliest recorded loss of exclusivity
- 22 May 2041
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- apixaban
- Type
- Synthetic organic
- Drug name stem
- -xaban
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- coagulation factor X
- Gene symbol
- F10
- Protein identifier
- P00742
- Median affinity
- 10.1
- Affinity units
- pKi
- Primary target
- Yes
- Mechanism
- Coagulation factor X inhibitor
- Action type
- Inhibitor
- Target
- Coagulation factor X
- Protein identifier
- P00742
Open Targets mechanisms
- Mechanism
- Coagulation factor X inhibitor
- Action type
- Inhibitor
- Target
- Coagulation factor X
DrugCentral mechanisms
- Action type
- Inhibitor
- Gene symbol
- F10
- Protein identifier
- P00742
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Arthroplasty
- Highest recorded phase
- 4
- Subject identifier
- D001178
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Aortic Valve Stenosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000266
- Subject identifier
- D001024
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Ischemia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000556
- Subject identifier
- D007511
- Condition
- Stroke
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Embolism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003827
- Subject identifier
- D004617
- Condition
- Pulmonary Embolism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003827
- Subject identifier
- D011655
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Venous Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003907
- Subject identifier
- D020246
- Condition
- Atrial Flutter
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003911
- Subject identifier
- D001282
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Venous Thromboembolism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004286
- Subject identifier
- D054556
- Condition
- Acute Coronary Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005672
- Subject identifier
- D054058
- Condition
- Blood Coagulation Disorders
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009314
- Subject identifier
- D001778
- Condition
- Hematoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0010680
- Subject identifier
- D006406
- Condition
- Renal Insufficiency
- Highest recorded phase
- 3
- Condition identifier
- HP:0000083
- Subject identifier
- D051437
- Condition
- Foramen Ovale, Patent
- Highest recorded phase
- 2
- Condition identifier
- HP:0001655
- Subject identifier
- D054092
- Condition
- Thromboembolism
- Highest recorded phase
- 1
- Condition identifier
- HP:0001907
- Subject identifier
- D013923
- Condition
- Ischemic Stroke
- Highest recorded phase
- 1
- Condition identifier
- HP:0002140
- Subject identifier
- D000083242
- Condition
- Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- HP:0004419
- Subject identifier
- D013927
- Condition
- Venous Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- HP:0004936
- Subject identifier
- D020246
- Condition
- Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0000831
- Subject identifier
- D013927
And 4 more, listed on the interactive page.
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000275
- Condition identifier
- EFO_0000551
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000556
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0001074
- Condition identifier
- EFO_0001422
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003827
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003907
- Condition identifier
- EFO_0003907
- Highest recorded phase
- 4
- Condition identifier
- EFO_0003911
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004286
- Condition identifier
- EFO_0005672
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009909
- Condition identifier
- EFO_0010680
- Highest recorded phase
- 3
- Condition identifier
- HP_0001297
- Highest recorded phase
- 3
- Condition identifier
- HP_0001655
- Highest recorded phase
- 2
- Condition identifier
- HP_0001873
- Highest recorded phase
- 3
- Condition identifier
- HP_0001907
- Condition identifier
- HP_0001907
- Highest recorded phase
- 3
- Condition identifier
- HP_0002140
- Condition identifier
- HP_0002239
- Condition identifier
- HP_0004419
- Condition identifier
- HP_0004419
- Highest recorded phase
- 4
And 32 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- vascular toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Country
- United States
- Event
- anaemia
- Reports
- 1,317
- Reporting signal score
- 497.928
- Event
- atrial fibrillation
- Reports
- 896
- Reporting signal score
- 660.694
- Event
- cerebral haemorrhage
- Reports
- 714
- Reporting signal score
- 1,213.84
- Event
- cerebral infarction
- Reports
- 596
- Reporting signal score
- 793.816
- Event
- cerebrovascular accident
- Reports
- 1,442
- Reporting signal score
- 1,212.58
- Event
- deep vein thrombosis
- Reports
- 841
- Reporting signal score
- 652.083
- Event
- epistaxis
- Reports
- 797
- Reporting signal score
- 716.237
- Event
- fall
- Reports
- 1,514
- Reporting signal score
- 485.883
- Event
- gastrointestinal haemorrhage
- Reports
- 1,943
- Reporting signal score
- 2,801.79
- Event
- haematochezia
- Reports
- 497
- Reporting signal score
- 436.391
- Event
- haematoma
- Reports
- 653
- Reporting signal score
- 898.643
- Event
- haematuria
- Reports
- 602
- Reporting signal score
- 625.077
- Event
- haemorrhage
- Reports
- 1,358
- Reporting signal score
- 1,620.19
- Event
- haemorrhage intracranial
- Reports
- 510
- Reporting signal score
- 925.15
- Event
- ischaemic stroke
- Reports
- 373
- Reporting signal score
- 399.342
- Event
- melaena
- Reports
- 451
- Reporting signal score
- 496.579
- Event
- nausea
- Reports
- 479
- Reporting signal score
- 415.072
- Event
- renal impairment
- Reports
- 734
- Reporting signal score
- 467.97
- Event
- subdural haematoma
- Reports
- 430
- Reporting signal score
- 724.496
- Event
- thrombosis
- Reports
- 602
- Reporting signal score
- 407.193
- NCT00252005
- NCT00371683
- NCT03590743
- NCT04981327
- NCT00313300
- NCT00831441
- NCT00852397
- NCT02946944
- NCT00412984
- NCT00496769
- NCT00787150
- NCT01884350
- NCT02090075
- NCT02100228
- NCT02227550
- NCT02450682
- NCT02608099
- NCT02666157
- NCT02809469
- NCT03129490
- NCT03398434
- NCT03463317
- NCT03839355
- NCT04218266
- NCT04642430
And 58 more, listed on the interactive page.
- Dose
- 5 mg
- Route
- Oral
- How often
- Twice daily
- Hydrogen bond acceptors
- 6
- Hydrogen bond donors
- 1
- Polar surface area
- 110.76
- Calculated partition coefficient (ALogP)
- 2.7
- Calculated partition coefficient (XLogP)
- 2.2
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 5
- Heavy atoms
- 34
- Molecular formula
- C25H25N5O4
- Monoisotopic mass
- 459.19065430
- Natural product
- Yes
- 0115-1721
- 0115-1722
- 14445-149
- 14445-150
- 33342-337
- 33342-338
- 71610-662
- 71610-811
- 82804-085
- 50090-1436
- 50090-1437
- 50090-6451
- 50090-6454
- 55154-0612
- 55154-0613
- 70518-4462
- Recorded assays
- 567
- Active assays
- 78
- Confirmatory
- Other
- Factor Xa Inhibitors
These details could not be displayed.
Related records
Trials (289)
- A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
- A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa
- A Multi-center Study of Apixaban(APPROACH)
- A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.
- A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
- A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
- A Phase III Study of Apixaban in Patients With Atrial Fibrillation
- A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma
- A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
- A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE)
- A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism
- A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage
- A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE
- A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
- A Study of Direct Oral Anticoagulants in Patients with Painful Venous Malformations with Localized Intravascular Coagulation
- A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
- A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
- A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
- A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
- A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
Approved for (5)
In development for (16)
- Acute coronary syndrome Phase 3
- Acute lymphoblastic leukemia Phase 3
- Aortic valve stenosis Phase 3
- Atrial flutter Phase 3
- Blood coagulation disease Phase 1
- Cancer Phase 3
- Chronic kidney disease Phase 2
- Cirrhosis of liver Phase 2
- COVID-19 Phase 3
- Heart failure Phase 2
- Ischemic disease Phase 3
- Ischemic stroke Phase 1
- Kidney failure Phase 3
- Nephrotic syndrome Phase 1
- Patent foramen ovale Phase 2
- Sickle cell disease Phase 3
Other linked conditions (1)
- Morbid obesity
Targets (1)
- F10 Coagulation factor X inhibitor