Dabigatran - PharmaKB

Pradaxa(dabigatran)

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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Drug

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Variants

Financial

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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
cardiovascular diseases	D002318
operative surgical procedures	D013514

Trade Name

FDA

EMA

Pradaxa (generic drugs available since 2020-03-11)

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 etexilate	ANDA	2024-02-13
pradaxa	New Drug Application	2023-12-15

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

Patent Expiration

Patent	Expires	Flag	FDA Information
Dabigatran Etexilate Mesylate, Pradaxa, Boehringer Ingelheim
9034822	2031-01-20		U-1759
7866474	2027-08-31	DP
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

No data

Clinical

Clinical Trials

397 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	—	6	10	36	92	144
Venous thromboembolism	D054556	EFO_0004286	I74	—	7	6	4	17	34
Stroke	D020521	EFO_0000712	I63.9	—	1	4	5	12	22
Hemorrhage	D006470	MP_0001914	R58	1	1	7	3	9	21
Ischemic stroke	D000083242	—	—	1	—	2	1	11	15
Thromboembolism	D013923	HP_0001907	—	—	1	8	1	5	15
Thrombosis	D013927	—	—	1	2	—	3	4	10
Venous thrombosis	D020246	HP_0004936	I82.40	—	1	1	1	5	8
Coronary artery disease	D003324	—	I25.1	—	—	—	5	3	8
Pulmonary embolism	D011655	HP_0002204	I26	—	—	1	2	4	7

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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	—	—	—	71	1	1	—	—	72
Intracranial hemorrhages	D020300	EFO_0000551	I62	—	—	1	—	2	3
Replacement arthroplasty knee	D019645	—	—	—	1	2	—	—	3
Cerebral hemorrhage	D002543	—	—	—	1	1	—	—	2
Intracranial thrombosis	D020767	—	—	—	—	1	—	1	2
Periodontal diseases	D010510	—	K05.6	—	—	1	—	1	2
Subdural hematoma	D006408	HP_0100309	—	—	—	1	—	1	2
Patent foramen ovale	D054092	HP_0001655	Q21.12	—	—	2	—	—	2
Secondary prevention	D055502	—	—	—	—	2	—	—	2
Knee osteoarthritis	D020370	EFO_0004616	M17	—	—	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	—	—	1	3
Covid-19	D000086382	—	U07.1	—	1	—	—	1	2
Heart valve prosthesis	D006350	EFO_0003906	—	—	1	—	—	1	2
Cardiac catheterization	D006328	—	—	—	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
Drug interactions	D004347	—	—	5	—	—	—	—	5
Neoplasms	D009369	—	C80	1	—	—	—	3	4
Pharmacokinetics	D010599	—	—	2	—	—	—	1	3
Renal insufficiency	D051437	HP_0000083	N19	2	—	—	—	—	2
Blood coagulation disorders	D001778	EFO_0009314	D68.9	1	—	—	—	1	2
Interstitial lung diseases	D017563	HP_0006530	J84.89	1	—	—	—	1	2
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	1	—	—	—	—	1
Prostatic neoplasms	D011471	—	C61	1	—	—	—	—	1
Hiv	D006678	—	O98.7	1	—	—	—	—	1
Pancreatitis	D010195	HP_0001733	K85	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	2	2
Hip osteoarthritis	D015207	EFO_1000786	M16	—	—	—	—	2	2
Blood coagulation tests	D001780	—	—	—	—	—	—	2	2
Medication adherence	D055118	EFO_0006344	—	—	—	—	—	2	2
Oral surgery	D013515	—	—	—	—	—	—	1	1
Postoperative complications	D011183	—	—	—	—	—	—	1	1
Oral surgical procedures	D019647	—	—	—	—	—	—	1	1
Postoperative hemorrhage	D019106	—	—	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1
Uterine hemorrhage	D014592	—	—	—	—	—	—	1	1

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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