Product Description
Ambrisentan is an oral medication classified as an endothelin receptor antagonist (ERA) which is approved for the treatment of pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Group 1 patients. (Sourced from: https://phassociation.org/patients/treatments/ambrisentan/)
Mechanisms of Action: ET Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Hypertension | Iris Diseases | Hypertension, Pulmonary
Known Adverse Events: Headache | Anemia | Bronchitis | Sinusitis | Dyspepsia | Edema | Flushing
Company: GlaxoSmithKline
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Canada, China, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan, Netherlands, Russia, Spain, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 2: Acute Kidney Injury|COVID-19|Diabetic Nephropathy|Hepatorenal Syndrome|Hypertension, Pulmonary|Liver Cirrhosis|Type 1 Diabetes
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| N-003-CRD005 | P2 |
Recruiting |
Hepatorenal Syndrome|Liver Cirrhosis|Acute Kidney Injury |
2025-03-01 |
24% |
| ASPIRE | P2 |
Not yet recruiting |
Diabetic Nephropathy|Type 1 Diabetes |
2025-03-01 |
|
| 2020-005104-20 | P2 |
Active, not recruiting |
COVID-19 |
2022-12-07 |
|
| NCT01342952 | P2 |
Completed |
Hypertension, Pulmonary |
2022-06-09 |