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Drug ReportsDabigatran etexilate
Pradaxa(dabigatran etexilate)
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.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
operative surgical proceduresD013514
Trade Name
FDA
EMA
Dabigatran etexilate, Pradaxa (discontinued: Dabigatran etexilate)
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
dabigatranANDA2025-07-11
dabigatran etexilateANDA2025-09-22
pradaxaNew Drug Application2025-06-27
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
79322732025-09-07DS, DP
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
422 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 fibrillationD001281EFO_0000275I48.0271141107167
ThromboembolismD01392391582355
Venous thromboembolismD054556EFO_0004286I7481062044
StrokeD020521EFO_0000712I63.913882242
ThrombosisD01392714772038
HemorrhageD006470MP_0001914R58111141936
Ischemic strokeD00008324212331827
Venous thrombosisD020246I82.402521018
EmbolismD00461726715
IschemiaD007511EFO_000055623611
Show 43 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients771178
Intracranial hemorrhagesD020300EFO_0000551I62325
Intracranial thrombosisD020767134
Cerebral hemorrhageD0025431113
HematomaD006406EFO_0010680213
RecurrenceD012008123
Patent foramen ovaleD054092Q21.12213
Replacement arthroplasty kneeD019645123
FibrosisD0053551123
Intracranial sinus thrombosisD01285133
Show 21 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.12114
Transient ischemic attackD002546EFO_0003764G45.9224
Heart valve prosthesisD006350EFO_0003906112
Staphylococcus aureusD013211NCBITaxon_128011
Cardiac catheterizationD00632811
CadasilD046589Orphanet_136I67.85011
Multi-infarct dementiaD015161F0111
Indications Without Phase
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)
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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 IDI0VM4M70GC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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76,240 adverse events reported
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