Product Description
Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. (Sourced from: https://www.nejm.org/doi/full/10.1056/nejmoa1615664)
Mechanisms of Action: PCSK9 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Korea, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 17
Highest Development Phases
Phase 3: Calcinosis|Coronary Artery Disease|Dyslipidemia|Hypercholesterolemia|Hyperlipidemia|Myocardial Infarction|Myocardial Ischemia|ST Elevation Myocardial Infarction|Stroke
Phase 2: Acute Coronary Syndrome|Heart Failure, Chronic|Heart Failure, Systolic|Heart Transplant|Non-Small-Cell Lung Cancer|Prostate Cancer|Renal Cell Carcinoma
Phase 1: Aortic Aneurysm, Abdominal|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| R01HL166991 | P1 |
Not yet recruiting |
Aortic Aneurysm, Abdominal |
2028-01-31 |
|
| BOOST-RCC | P2 |
Active, not recruiting |
Renal Cell Carcinoma |
2026-10-01 |
|
| EVO-STEMI_version 4.1 | P3 |
Recruiting |
ST Elevation Myocardial Infarction |
2025-12-31 |
|
| PSM1A | P1 |
Not yet recruiting |
Healthy Volunteers |
2025-12-01 |