Pradaxa(dabigatran)
Pradaxa (dabigatran) is a small molecule pharmaceutical. Dabigatran was first approved as Pradaxa on 2008-03-17. It has been approved in Europe to treat replacement arthroplasty and venous thromboembolism. The pharmaceutical is active against prothrombin.
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Commercial
Trade Name
FDA
EMA
Pradaxa (generic drugs available since 2020-03-11)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dabigatran etexilate | ANDA | 2023-04-15 |
| pradaxa | New Drug Application | 2022-08-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DABIGATRAN ETEXILATE MESYLATE, PRADAXA, BOEHRINGER INGELHEIM | |||
| 2024-12-21 | PED | ||
| 2024-06-21 | I-862, NP | ||
HCPCS
No data
Clinical
Clinical Trials
241 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 4 | 7 | 27 | 35 | 73 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 7 | 6 | 4 | 8 | 25 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 2 | 1 | 4 | 8 |
| Thrombosis | D013927 | 1 | 2 | — | 3 | 1 | 7 | ||
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | 2 | 3 | 6 |
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | — | 1 | 1 | 1 | 3 | 6 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | 1 | 2 | 2 | 5 |
| Coronary disease | D003327 | — | 1 | — | 3 | — | 4 | ||
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 3 | — | 3 | |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 2 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thromboembolism | D013923 | HP_0001907 | — | 1 | 8 | — | — | 9 | |
| Ischemic stroke | D000083242 | 1 | — | 2 | — | 3 | 6 | ||
| Replacement arthroplasty knee | D019645 | — | 1 | 2 | — | — | 3 | ||
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | 1 | — | 1 | 2 |
| Secondary prevention | D055502 | — | — | 2 | — | — | 2 | ||
| Cerebral hemorrhage | D002543 | — | — | 1 | — | — | 1 | ||
| Hypertensive intracranial hemorrhage | D020299 | — | — | 1 | — | — | 1 | ||
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | 1 | — | — | 1 |
| Subdural hematoma | D006408 | HP_0100309 | — | — | 1 | — | — | 1 | |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | 2 | — | — | 1 | 3 |
| Cardiac catheterization | D006328 | — | 1 | — | — | — | 1 | ||
| Heart valve prosthesis | D006350 | EFO_0003906 | — | 1 | — | — | — | 1 | |
| Cadasil | D046589 | Orphanet_136 | I67.850 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 70 | — | — | — | — | 70 | ||
| Neoplasms | D009369 | C80 | 1 | — | — | — | 2 | 3 | |
| Drug interactions | D004347 | 2 | — | — | — | — | 2 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | — | — | — | 2 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | 1 | — | — | — | 1 | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Pancreatitis | D010195 | EFO_0000278 | K85 | 1 | — | — | — | — | 1 |
| Cognitive dysfunction | D060825 | G31.84 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral surgery | D013515 | — | — | — | — | 1 | 1 | ||
| Postoperative complications | D011183 | — | — | — | — | 1 | 1 | ||
| Oral surgical procedures | D019647 | — | — | — | — | 1 | 1 | ||
| Embolism | D004617 | — | — | — | — | 1 | 1 | ||
| Menorrhagia | D008595 | N92.0 | — | — | — | — | 1 | 1 | |
| Periodontal diseases | D010510 | K05.6 | — | — | — | — | 1 | 1 | |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Thrombotic stroke | D000083244 | — | — | — | — | 1 | 1 | ||
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DABIGATRAN |
| INN | dabigatran |
| Description | Dabigatran is an aromatic amide obtained by formal condensation of the carboxy group of 2-{[(4-carbamimidoylphenyl)amino]methyl}-1-methyl-1H-benzimidazole-5-carboxylic acid with the secondary amoino group of N-pyridin-2-yl-beta-alanine. The active metabolite of the prodrug dabigatran etexilate, it acts as an anticoagulant which is used for the prevention of stroke and systemic embolism. It has a role as an anticoagulant, an EC 3.4.21.5 (thrombin) inhibitor and an EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitor. It is an aromatic amide, a member of benzimidazoles, a carboxamidine, a member of pyridines and a beta-alanine derivative. |
| Classification | Small molecule |
| Drug class | thrombin inhibitors (argatroban type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cn1c(CNc2ccc(C(=N)N)cc2)nc2cc(C(=O)N(CCC(=O)O)c3ccccn3)ccc21 |
Identifiers
| PDB | — |
| CAS-ID | 211914-51-1 |
| RxCUI | 1546356 |
| ChEMBL ID | CHEMBL48361 |
| ChEBI ID | 70752 |
| PubChem CID | 216210 |
| DrugBank | DB14726 |
| UNII ID | I0VM4M70GC (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Dabigatran etexilate
, Pradaxa
Adverse Events
Top Adverse Reactions
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669 adverse events reported
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