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
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
No data
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 | — | — | — | 2 | 9 | 7 | 2 | 19 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | 2 | 8 | 4 | 2 | 17 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 3 | 4 | 2 | 1 | 8 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 2 | — | 3 | 1 | 6 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 1 | 3 | 2 | — | 5 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 2 | 4 | 1 | — | 5 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 3 | 3 | 1 | — | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 1 | — | 3 |
| Familial primary pulmonary hypertension | D065627 | — | I27.0 | — | 1 | — | 1 | — | 2 |
| Sclerosis | D012598 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | 3 | — | — | 3 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | 1 | — | — | 1 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | 1 | — | — | 1 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Tricuspid atresia | D018785 | — | — | — | 1 | — | — | — | 1 |
| Hypoplastic left heart syndrome | D018636 | — | Q23.4 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | — | — | — | — | 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 |
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
No data
Variants
No data
Financial
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Tracleer – Johnson & Johnson
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,698 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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