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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.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
operative surgical proceduresD013514
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)
Dabigatran etexilate mesylate
Tradename
Company
Number
Date
Products
PRADAXABoehringer IngelheimN-022512 RX2010-10-19
3 products, RLD, RS
PRADAXABoehringer IngelheimN-214358 RX2021-06-21
6 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dabigatran etexilate ANDA2023-04-15
pradaxaNew Drug Application2022-08-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary embolismEFO_0003827D011655I26
Agency Specific
FDA
EMA
Expiration
Code
DABIGATRAN ETEXILATE MESYLATE, PRADAXA, BOEHRINGER INGELHEIM
2024-12-21PED
2024-06-21I-862, NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Dabigatran Etexilate Mesylate, Pradaxa, Boehringer Ingelheim
90348222031-01-20U-1759
78664742027-08-31DP
79322732025-09-07DS, DP
99251742023-06-14DP
ATC Codes
B: Blood and blood forming organ drugs
B01: Antithrombotic agents
B01A: Antithrombotic agents
B01AE: Direct thrombin inhibitors
B01AE07: Dabigatran etexilate
HCPCS
No data
Clinical
Clinical Trials
241 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.047273573
Venous thromboembolismD054556EFO_0004286I74764825
StrokeD020521EFO_0000712I63.912148
ThrombosisD01392712317
HemorrhageD006470MP_0001914R581236
Venous thrombosisD020246HP_0004936I82.4011136
Pulmonary embolismD011655EFO_0003827I261225
Coronary diseaseD003327134
Acute coronary syndromeD054058EFO_000567233
Coronary artery diseaseD003324I25.1213
Show 17 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThromboembolismD013923HP_0001907189
Ischemic strokeD0000832421236
Replacement arthroplasty kneeD019645123
Intracranial hemorrhagesD020300EFO_0000551I62112
Secondary preventionD05550222
Cerebral hemorrhageD00254311
Hypertensive intracranial hemorrhageD02029911
Subarachnoid hemorrhageD013345EFO_0000713I6011
Subdural hematomaD006408HP_010030911
Cerebral intraventricular hemorrhageD00007404211
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Transient ischemic attackD002546EFO_0003764G45.9213
Cardiac catheterizationD00632811
Heart valve prosthesisD006350EFO_000390611
CadasilD046589Orphanet_136I67.85011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients7070
NeoplasmsD009369C80123
Drug interactionsD00434722
Renal insufficiencyD051437HP_0000083N1922
Interstitial lung diseasesD017563EFO_0004244J84.89112
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.8111
Prostatic neoplasmsD011471C6111
PharmacokineticsD01059911
PancreatitisD010195EFO_0000278K8511
Cognitive dysfunctionD060825G31.8411
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Oral surgeryD01351511
Postoperative complicationsD01118311
Oral surgical proceduresD01964711
EmbolismD00461711
MenorrhagiaD008595N92.011
Periodontal diseasesD010510K05.611
Hip osteoarthritisD015207EFO_1000786M1611
Liver cirrhosisD008103EFO_0001422K74.011
Thrombotic strokeD00008324411
Idiopathic pulmonary fibrosisD054990J84.11211
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDABIGATRAN ETEXILATE
INNdabigatran 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 classthrombin 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-ID211914-51-1
RxCUI1546356
ChEMBL IDCHEMBL539697
ChEBI ID70746
PubChem CID216210
DrugBankDB14726
UNII ID2E18WX195X (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
F2
F2
Organism
Homo sapiens
Gene name
F2
Gene synonyms
NCBI Gene ID
Protein name
prothrombin
Protein synonyms
Coagulation factor II, prepro-coagulation factor II, prothrombin B-chain, thrombin factor II
Uniprot ID
Mouse ortholog
F2 (14061)
prothrombin (P19221)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,058 documents
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Safety
Black-box Warning
Black-box warning for: Dabigatran etexilate , Pradaxa
Adverse Events
Top Adverse Reactions
Mock data
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39,092 adverse events reported
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