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
Trade Name
FDA
EMA
Tracleer (generic drugs available since 2019-04-26)
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tracleer | New Drug Application | 2021-01-25 |
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 | ||
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 hypertension | D000081029 | 2 | 2 | 7 | 8 | 4 | 22 | ||
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | 4 | 10 | 5 | 2 | 21 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 4 | 2 | 2 | 2 | 9 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | — | 1 | 1 | 5 |
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | — | 1 | 3 | 2 | — | 5 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 2 | — | 4 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | — | 1 | 1 | 1 | — | 2 |
| Eisenmenger complex | D004541 | I27.83 | — | — | 1 | 1 | — | 2 | |
| Tourniquets | D014111 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | 1 | — | 1 | 2 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 2 | 1 | — | — | 2 |
| Ischemic optic neuropathy | D018917 | EFO_1000809 | H47.01 | — | — | 1 | — | — | 1 |
| Atrial heart septal defects | D006344 | EFO_1000825 | Q21.1 | — | — | 1 | — | — | 1 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | 1 | — | — | 1 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | 1 | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | 1 | — | — | 1 |
| Pulmonary fibrosis | D011658 | J84.10 | — | 1 | 1 | — | — | 1 |
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 | — | 2 | — | — | 3 | 5 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
| Port-wine stain | D019339 | Q82.5 | — | 1 | — | — | — | 1 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
| Hepatopulmonary syndrome | D020065 | EFO_1001346 | K76.81 | — | 1 | — | — | — | 1 |
| Tricuspid atresia | D018785 | — | 1 | — | — | — | 1 | ||
| Hypoplastic left heart syndrome | D018636 | Q23.4 | — | 1 | — | — | — | 1 | |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | — | 1 |
| Mitral valve stenosis | D008946 | EFO_0007372 | 1 | 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 | — | — | — | 1 | 2 | ||
| Vasodilation | D014664 | 2 | — | — | — | — | 2 | ||
| Vasoconstriction | D014661 | 2 | — | — | — | — | 2 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | 1 | 1 | |
| Thromboangiitis obliterans | D013919 | EFO_1001211 | I73.1 | — | — | — | — | 1 | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | — | — | 1 | 1 |
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 |
Target
Agency Approved
EDNRB
EDNRB
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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