Product Description
Bosentan is used to treat the symptoms of pulmonary arterial hypertension (PAH) in adults or in children 3 years of age or older. It improves the ability to exercise and slows down the worsening of the patient's physical condition. (Sourced from: https://www.mayoclinic.org/drugs-supplements/bosentan-oral-route/precautions/drg-20068086?p=1)
Mechanisms of Action: ET Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Pulmonary Heart Disease | Hypertension | Resistant Hypertension | Hypertension, Pulmonary
Known Adverse Events: Anemia | Respiratory Tract Infections
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Germany, Jordan, Spain
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Giant Cell Arteritis
Phase 2: Multiple Sclerosis
Phase 1: Diabetic Retinopathy|Healthy Volunteers|Hypertension, Pulmonary
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT06484673 | P1 |
Completed |
Hypertension, Pulmonary |
2024-05-22 |
|
| NCT05723874 | P1 |
Completed |
Healthy Volunteers |
2023-05-26 |
70% |
| BOSRET | P1 |
Completed |
Diabetic Retinopathy |
2022-05-20 |
43% |
| CECIBO | P3 |
Active, not recruiting |
Giant Cell Arteritis |
2021-05-13 |