Bosentan - PharmaKB

Tracleer(bosentan)

Bosentan, Stayveer, Tracleer (bosentan) is a small molecule pharmaceutical. Bosentan was first approved as Tracleer on 2001-11-20. It is used to treat pulmonary hypertension in the USA. It has been approved in Europe to treat pulmonary hypertension and systemic scleroderma. The pharmaceutical is active against endothelin receptor type B. In addition, it is known to target endothelin-1 receptor.

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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
respiratory tract diseases	D012140
cardiovascular diseases	D002318
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Bosentan, Tracleer (discontinued: Bosentan)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Bosentan

Tradename	Company	Number	Date	Products
TRACLEER	Actelion	N-209279 RX	2017-09-05	1 products, RLD, RS
TRACLEER	Actelion	N-021290 RX	2001-11-20	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
bosentan	ANDA	2024-10-15
tracleer	New Drug Application	2024-02-21

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
pulmonary hypertension	EFO_0001361	D006976	I27.20

Agency Specific

FDA

EMA

Expiration	Code
BOSENTAN, TRACLEER, ACTELION
2024-09-05	ODE*, ODE-161

Patent Expiration

Patent	Expires	Flag
Bosentan, Tracleer, Actelion
7959945	2027-12-28	DP
8309126	2026-05-15	DP

ATC Codes

C: Cardiovascular system drugs

— C02: Antihypertensives

— C02K: Other antihypertensives in atc

— C02KX: Antihypertensives for pulmonary arterial hypertension

— C02KX01: Bosentan

HCPCS

No data

Clinical

Clinical Trials

131 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	3	8	22	20	16	67
Pulmonary arterial hypertension	D000081029	—	—	6	5	16	14	14	53
Pulmonary hypertension	D006976	EFO_0001361	I27.20	2	7	16	6	9	37
Familial primary pulmonary hypertension	D065627	—	I27.0	—	2	8	12	6	28
Systemic scleroderma	D012595	EFO_0000717	M34.0	1	6	3	3	4	14
Diffuse scleroderma	D045743	EFO_0000404	—	1	6	3	3	3	13
Sclerosis	D012598	—	—	1	2	1	2	4	9
Fibrosis	D005355	—	—	—	4	4	2	—	8
Pulmonary fibrosis	D011658	—	—	—	2	4	2	—	6
Idiopathic pulmonary fibrosis	D054990	—	J84.112	—	1	3	2	—	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ulcer	D014456	MPATH_579	—	—	—	2	—	3	5
Heart failure	D006333	HP_0001635	I50	1	1	1	—	2	4
Skin ulcer	D012883	HP_0200042	L98.4	—	—	2	—	2	4
Sarcoidosis	D012507	EFO_0000690	D80-D89	—	2	1	—	1	3
Sickle cell anemia	D000755	EFO_0000697	D57	—	—	3	—	—	3
Persistent fetal circulation syndrome	D010547	EFO_1001103	P29.3	—	—	1	—	1	2
Muscle cramp	D009120	HP_0003394	—	—	1	1	—	1	2
Spasm	D013035	—	M62.83	—	1	1	—	1	2
Diabetic nephropathies	D003928	EFO_0000401	—	—	—	1	—	—	1
Arteritis	D001167	EFO_0009011	I77.6	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Congenital heart defects	D006330	HP_0001627	Q24.9	—	3	—	—	3	6
Heart diseases	D006331	EFO_0003777	I51.9	—	1	—	—	3	4
Asthma	D001249	EFO_0000270	J45	—	2	—	—	1	3
Port-wine stain	D019339	—	Q82.5	—	1	—	—	1	2
Capillary hemangioma	D018324	—	Q82.5	—	1	—	—	1	2
Univentricular heart	D000080039	—	Q20.4	—	1	—	—	1	2
Localized scleroderma	D012594	EFO_1001361	L94.0	—	2	—	—	—	2
Insulin resistance	D007333	HP_0000855	—	1	1	—	—	—	2
Sleep apnea syndromes	D012891	HP_0010535	G47.3	1	1	—	—	—	2
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	4	—	—	—	—	4
Drug interactions	D004347	—	—	1	—	—	—	2	3
Vasodilation	D014664	—	—	2	—	—	—	—	2
Vasoconstriction	D014661	—	—	2	—	—	—	—	2
Pure autonomic failure	D054970	—	—	1	—	—	—	—	1
Pancreatic neoplasms	D010190	EFO_0003860	C25	1	—	—	—	—	1
Therapeutic equivalency	D013810	—	—	1	—	—	—	—	1
Glaucoma	D005901	EFO_0000516	H40	1	—	—	—	—	1
Blood flow velocity	D001783	—	—	1	—	—	—	—	1
Altitude	D000531	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	2	2
Infections	D007239	EFO_0000544	—	—	—	—	—	2	2
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	2	2
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	2	2
Pain	D010146	EFO_0003843	R52	—	—	—	—	2	2
Down syndrome	D004314	EFO_0001064	Q90	—	—	—	—	2	2
Hyperaldosteronism	D006929	HP_0011736	E26	—	—	—	—	2	2
Urinary tract infections	D014552	EFO_0003103	N39.0	—	—	—	—	2	2
Hypokalemia	D007008	HP_0002900	E87.6	—	—	—	—	2	2
Sleep initiation and maintenance disorders	D007319	—	F51.01	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Bosentan
INN	bosentan
Description	Bosentan is a sulfonamide, a member of pyrimidines and a primary alcohol. It has a role as an antihypertensive agent and an endothelin receptor antagonist.
Classification	Small molecule
Drug class	endothelin receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccccc1Oc1c(NS(=O)(=O)c2ccc(C(C)(C)C)cc2)nc(-c2ncccn2)nc1OCCO