Dabigatran
Dabigatran Etexilate, 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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| operative surgical procedures | D013514 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dabigatran | ANDA | 2025-04-09 |
| dabigatran etexilate | ANDA | 2025-05-15 |
| pradaxa | New Drug Application | 2024-04-03 |
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 | ||
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Clinical
Clinical Trials
420 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 | 3 | 13 | 27 | 47 |
| Thromboembolism | D013923 | — | — | — | 9 | 11 | 3 | 8 | 31 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 8 | 8 | 1 | 5 | 22 |
| Thrombosis | D013927 | — | — | — | 2 | 1 | 2 | 1 | 6 |
| Renal insufficiency | D051437 | — | N19 | 3 | — | — | 2 | — | 5 |
| Replacement arthroplasty | D019643 | — | — | — | — | — | 1 | 3 | 4 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | — | — | 2 | — | 3 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 1 | — | 1 | — | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | 1 | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | 4 | — | 3 | 8 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 2 | — | 2 | 5 |
| Replacement arthroplasty knee | D019645 | — | — | — | 1 | 2 | — | — | 3 |
| Secondary prevention | D055502 | — | — | — | — | 2 | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 2 | — | — | 2 |
| Replacement arthroplasty hip | D019644 | — | — | — | — | 1 | — | 1 | 2 |
| Hematoma | D006406 | EFO_0010680 | — | — | — | 1 | — | — | 1 |
| Embolic stroke | D000083262 | — | — | — | — | 1 | — | — | 1 |
| Percutaneous coronary intervention | D062645 | — | — | — | — | 1 | — | — | 1 |
| Intracranial sinus thrombosis | D012851 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary disease | D003327 | — | — | — | 1 | — | — | 1 | 2 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | — | — | 1 |
| Cardiac catheterization | D006328 | — | — | — | 1 | — | — | — | 1 |
| Heart valve prosthesis | D006350 | EFO_0003906 | — | — | 1 | — | — | — | 1 |
| Venous thrombosis | D020246 | — | I82.40 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 53 | — | — | — | — | 53 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | — | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood coagulation tests | D001780 | — | — | — | — | — | — | 1 | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Recreational drug use | D000084783 | — | — | — | — | — | — | 1 | 1 |
| Drug tolerance | D004361 | — | — | — | — | — | — | 1 | 1 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | — | — | — | 1 | 1 |
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 | — |
| ChEMBL ID | CHEMBL48361 |
| ChEBI ID | 70752 |
| PubChem CID | 216210 |
| DrugBank | DB14726 |
| UNII ID | I0VM4M70GC (ChemIDplus, GSRS) |
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Dabigatran
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Trends
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Safety
Black-box Warning
Black-box warning for: Dabigatran, Dabigatran etexilate, Pradaxa
Adverse Events
Top Adverse Reactions
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78,971 adverse events reported
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