Pradaxa(dabigatran etexilate)
Pradaxa (dabigatran etexilate) is a small molecule pharmaceutical. Dabigatran etexilate was first approved as Pradaxa on 2008-03-17. It is used to treat pulmonary embolism in the USA. It has been approved in Europe to treat replacement arthroplasty and venous thromboembolism. It is known to target prothrombin.
Download report
Favorite
Top 200 Pharmaceuticals by Retail Sales
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
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pulmonary embolism | EFO_0003827 | D011655 | I26 |
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
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
Show 17 more
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 |
Show 5 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 | — | — | 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 |
Show 7 more
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 |
Show 2 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | DABIGATRAN ETEXILATE |
| INN | dabigatran etexilate |
| 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) | CCCCCCOC(=O)NC(=N)c1ccc(NCc2nc3cc(C(=O)N(CCC(=O)OCC)c4ccccn4)ccc3n2C)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 211914-51-1 |
| RxCUI | 1546356 |
| ChEMBL ID | CHEMBL539697 |
| ChEBI ID | 70746 |
| PubChem CID | 216210 |
| DrugBank | DB14726 |
| UNII ID | 2E18WX195X (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 3,058 documents
View more details
Safety
Black-box Warning
Black-box warning for: Dabigatran etexilate
, Pradaxa
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
39,092 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more