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 | 2024-11-27 |
| dabigatran etexilate | ANDA | 2025-02-11 |
| 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 | ||
HCPCS
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Clinical
Clinical Trials
416 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 | 1 | 7 | 11 | 41 | 106 | 165 |
| Thromboembolism | D013923 | — | — | — | 9 | 15 | 9 | 26 | 59 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 8 | 10 | 6 | 20 | 44 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 3 | 7 | 8 | 23 | 41 |
| Thrombosis | D013927 | — | — | 1 | 4 | 7 | 8 | 20 | 39 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | 2 | 11 | 4 | 19 | 37 |
| Ischemic stroke | D000083242 | — | — | 1 | 2 | 3 | 3 | 17 | 26 |
| Venous thrombosis | D020246 | — | I82.40 | — | 2 | 5 | 2 | 9 | 17 |
| Embolism | D004617 | — | — | — | — | 1 | 7 | 7 | 15 |
| Ischemia | D007511 | EFO_0000556 | — | — | 2 | — | 4 | 7 | 13 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 77 | 1 | 1 | — | — | 78 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | 3 | — | 2 | 5 |
| Cerebral hemorrhage | D002543 | — | — | — | 1 | 1 | — | 1 | 3 |
| Intracranial thrombosis | D020767 | — | — | — | — | 1 | — | 2 | 3 |
| Hematoma | D006406 | EFO_0010680 | — | — | — | 2 | — | 1 | 3 |
| Recurrence | D012008 | — | — | — | — | 1 | — | 2 | 3 |
| Replacement arthroplasty knee | D019645 | — | — | — | 1 | 2 | — | — | 3 |
| Fibrosis | D005355 | — | — | — | 1 | 1 | — | 2 | 3 |
| Intracranial sinus thrombosis | D012851 | — | — | — | — | 3 | — | — | 3 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | 1 | — | 1 | 2 |
Show 21 more
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 | — | — | 2 | 4 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | — | — | 1 | 3 |
| Heart valve prosthesis | D006350 | EFO_0003906 | — | — | 1 | — | — | 1 | 2 |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | 1 | — | — | — | 1 |
| Cardiac catheterization | D006328 | — | — | — | 1 | — | — | — | 1 |
| Cadasil | D046589 | Orphanet_136 | I67.850 | — | 1 | — | — | — | 1 |
| Multi-infarct dementia | D015161 | — | F01 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | 5 | 6 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 1 | — | — | — | 4 | 5 |
| Hemostatic disorders | D020141 | — | — | 1 | — | — | — | 4 | 5 |
| Drug interactions | D004347 | — | — | 5 | — | — | — | — | 5 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | 1 | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | 1 | 2 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | 1 | — | — | — | 1 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | 1 | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
Show 22 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative complications | D011183 | — | — | — | — | — | — | 3 | 3 |
| Postoperative hemorrhage | D019106 | — | — | — | — | — | — | 3 | 3 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | — | — | — | — | 2 | 2 |
| Therapeutic chemoembolization | D016461 | — | — | — | — | — | — | 2 | 2 |
| Postphlebitic syndrome | D011186 | — | I87.0 | — | — | — | — | 2 | 2 |
| Postthrombotic syndrome | D054070 | EFO_0007452 | I87.0 | — | — | — | — | 2 | 2 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 2 | 2 |
| Blood coagulation tests | D001780 | — | — | — | — | — | — | 2 | 2 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 2 | 2 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
Show 27 more
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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Financial
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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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78,813 adverse events reported
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