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
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EMA
Bosentan, Tracleer (discontinued: Bosentan)
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
135 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 | — | — | 6 | 4 | 13 | 14 | 14 | 49 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | 5 | 14 | 7 | 8 | 34 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 3 | 2 | 8 | 10 | 24 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 5 | 4 | 3 | 4 | 14 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | 1 | 1 | 4 | 4 | 10 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 4 | 3 | 1 | 2 | 8 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 1 | 3 | 2 | — | 5 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 2 | 4 | 1 | — | 5 |
| Sclerosis | D012598 | — | — | — | — | — | 1 | 4 | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 2 | — | 4 |
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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 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 2 | 1 | — | — | 3 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | 3 | — | — | 3 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | 1 | — | 1 | 2 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | — | — | 1 | — | — | 1 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | — | 1 | — | — | 1 |
| Low vision | D015354 | — | — | — | — | 1 | — | — | 1 |
| Blindness | D001766 | — | H53.12 | — | — | 1 | — | — | 1 |
| Ischemic optic neuropathy | D018917 | EFO_1000809 | H47.01 | — | — | 1 | — | — | 1 |
| Atrial heart septal defects | D006344 | Orphanet_1478 | Q21.1 | — | — | 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 | — | Q24.9 | — | 2 | — | — | 3 | 5 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | 2 | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | — | — | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | 2 | 3 |
| Port-wine stain | D019339 | — | Q82.5 | — | 1 | — | — | 1 | 2 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | 1 | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 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 |
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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 | — | — | — | 5 | — | — | — | — | 5 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | 2 | 3 |
| Aneurysm | D000783 | — | I72.9 | 2 | — | — | — | — | 2 |
| Vasodilation | D014664 | — | — | 2 | — | — | — | — | 2 |
| Vasoconstriction | D014661 | — | — | 2 | — | — | — | — | 2 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Hyperemia | D006940 | EFO_0003822 | H34.82 | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcer | D014456 | MPATH_579 | — | — | — | — | — | 3 | 3 |
| 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 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 2 | 2 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 2 | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 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 |
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) |
Target
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Tracleer – Johnson & Johnson
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Trends
PubMed Central
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Additional graphs summarizing 7,782 documents
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Safety
Black-box Warning
Black-box warning for: Bosentan, Tracleer
Adverse Events
Top Adverse Reactions
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52,034 adverse events reported
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