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Tracleer(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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Tracleer (generic drugs available since 2019-04-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bosentan
Tradename
Company
Number
Date
Products
TRACLEERActelionN-021290 RX2001-11-20
2 products, RLD, RS
TRACLEERActelionN-209279 RX2017-09-05
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tracleerNew Drug Application2021-01-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary hypertensionEFO_0001361D006976I27.20
Agency Specific
FDA
EMA
Expiration
Code
BOSENTAN, TRACLEER, ACTELION
2024-09-05ODE*, ODE-161
Patent Expiration
Patent
Expires
Flag
FDA Information
Bosentan, Tracleer, Actelion
79599452027-12-28DP
83091262026-05-15DP
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
99 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary arterial hypertensionD0000810292278422
Pulmonary hypertensionD006976EFO_0001361I27.2014105221
Systemic sclerodermaD012595EFO_0000717M34142229
HypertensionD006973EFO_0000537I1012—115
Idiopathic pulmonary fibrosisD054990J84.112—132—5
Type 2 diabetes mellitusD003924EFO_0001360E11—112—4
Interstitial lung diseasesD017563EFO_0004244J84.89—111—2
Eisenmenger complexD004541I27.83——11—2
TourniquetsD014111———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Persistent fetal circulation syndromeD010547EFO_1001103P29.3——1—12
SarcoidosisD012507EFO_0000690D80-D89—21——2
Ischemic optic neuropathyD018917EFO_1000809H47.01——1——1
Atrial heart septal defectsD006344EFO_1000825Q21.1——1——1
Connective tissue diseasesD003240EFO_1001986M35——1——1
Diastolic heart failureD054144EFO_1000899I50.30——1——1
Sickle cell anemiaD000755EFO_0000697D57——1——1
Pulmonary fibrosisD011658J84.10—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital heart defectsD006330HP_0001627Q24.9—2——35
AsthmaD001249EFO_0000270J45—2———2
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9—1———1
Port-wine stainD019339Q82.5—1———1
Liver cirrhosisD008103EFO_0001422K74.0—1———1
Hepatopulmonary syndromeD020065EFO_1001346K76.81—1———1
Tricuspid atresiaD018785—1———1
Hypoplastic left heart syndromeD018636Q23.4—1———1
Heart failureD006333EFO_0003144I5011———1
Mitral valve stenosisD008946EFO_000737211———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 interactionsD0043471———12
VasodilationD0146642————2
VasoconstrictionD0146612————2
Pancreatic neoplasmsD010190EFO_0003860C251————1
Therapeutic equivalencyD0138101————1
Diabetes mellitusD003920EFO_0000400E08-E131————1
GlaucomaD005901EFO_0000516H401————1
Blood flow velocityD0017831————1
AltitudeD0005311————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35————11
Peripheral arterial diseaseD058729EFO_0004265————11
Thromboangiitis obliteransD013919EFO_1001211I73.1————11
Raynaud diseaseD011928EFO_1001145I73.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBOSENTAN
INNbosentan
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 classendothelin 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
Identifiers
PDB5XPR
CAS-ID147536-97-8
RxCUI1468845
ChEMBL IDCHEMBL957
ChEBI ID51450
PubChem CID104865
DrugBankDB00559
UNII IDXUL93R30K2 (ChemIDplus, GSRS)
Target
Agency Approved
EDNRB
EDNRB
Organism
Homo sapiens
Gene name
EDNRB
Gene synonyms
ETRB
NCBI Gene ID
Protein name
endothelin receptor type B
Protein synonyms
Endothelin receptor non-selective type, endothelin receptor subtype B1, Hirschsprung disease 2
Uniprot ID
Mouse ortholog
Ednrb (13618)
endothelin receptor type B (Q542M3)
Alternate
EDNRA
EDNRA
Organism
Homo sapiens
Gene name
EDNRA
Gene synonyms
ETA, ETRA
NCBI Gene ID
Protein name
endothelin-1 receptor
Protein synonyms
endothelin receptor subtype A, Endothelin receptor type A, endothelin-1-specific receptor, ET-A, ETA-R, G protein-coupled receptor, hET-AR
Uniprot ID
Mouse ortholog
Ednra (13617)
endothelin-1 receptor (Q91VV2)
Variants
Clinical Variant
No data
Financial
Tracleer - Johnson & Johnson
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,209 documents
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Safety
Black-box Warning
Black-box warning for: Tracleer
Adverse Events
Top Adverse Reactions
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20,039 adverse events reported
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