Dabigatran 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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Events Timeline

YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
respiratory tract diseases	D012140
cardiovascular diseases	D002318
operative surgical procedures	D013514

Trade Name

FDA

EMA

Dabigatran etexilate, Pradaxa

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Dabigatran etexilate mesylate

Tradename	Company	Number	Date	Products
PRADAXA	Boehringer Ingelheim	N-022512 RX	2010-10-19	3 products, RLD, RS
PRADAXA	Boehringer Ingelheim	N-214358 RX	2021-06-21	6 products, RLD, RS

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

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

Patent Expiration

Patent	Expires	Flag	FDA Information
Dabigatran Etexilate Mesylate, Pradaxa, Boehringer Ingelheim
9034822	2031-01-20		U-1759
7932273	2025-09-07	DS, DP

ATC Codes

B: Blood and blood forming organ drugs

— B01: Antithrombotic agents

— B01A: Antithrombotic agents

— B01AE: Direct thrombin inhibitors

— B01AE07: Dabigatran etexilate

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

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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

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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

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Epidemiology

Epidemiological information for investigational and approved indications

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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