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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tracleer (generic drugs available since 2019-04-26)
Drug Products
FDA
EMA
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
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Clinical
Clinical Trials
129 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 | — | — | 3 | 3 | 8 | 11 | 10 | 34 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | 5 | 13 | 5 | 6 | 29 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 4 | 2 | 2 | 3 | 10 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | — | 2 | 3 | 8 |
| 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 | HP_0006530 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 2 | 1 | — | 1 | 3 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | 1 | — | 1 | 2 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | — | 1 | — | — | 1 |
| Low vision | D015354 | — | — | — | — | 1 | — | — | 1 |
| Ischemic optic neuropathy | D018917 | EFO_1000809 | H47.01 | — | — | 1 | — | — | 1 |
| Atrial heart septal defects | D006344 | Orphanet_1478 | 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 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | 1 | — | — | 2 | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | — | — | 1 | 3 |
| 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 |
| 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 | — | — | — | 2 | 3 |
| Vasodilation | D014664 | — | — | 2 | — | — | — | — | 2 |
| Vasoconstriction | D014661 | — | — | 2 | — | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 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 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 2 | 2 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | — | — | — | — | 2 | 2 |
Show 49 more
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 |
Identifiers
| PDB | — |
| CAS-ID | 147536-97-8 |
| RxCUI | 1468845 |
| ChEMBL ID | CHEMBL957 |
| ChEBI ID | 51450 |
| PubChem CID | 104865 |
| DrugBank | DB00559 |
| UNII ID | XUL93R30K2 (ChemIDplus, GSRS) |
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Tracleer – Johnson & Johnson
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Trends
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Additional graphs summarizing 6,751 documents
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Safety
Black-box Warning
Black-box warning for: Bosentan, Tracleer
Adverse Events
Top Adverse Reactions
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46,762 adverse events reported
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