Product Description
Alirocumab injection is used along with diet, alone or in combination with other cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins] or ezetimibe [Zetia, in Liptruzet, in Vytorin]), in adults who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally) to decrease the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood. Alirocumab injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibodies. It works by blocking the production of LDL cholesterol in the body therefore decreasing the amount of cholesterol that may build up on the walls of the arteries. (Sourced from: https://medlineplus.gov/druginfo/meds/a615035.html)
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 | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: Myocardial Infarction | Hyperlipidemia | Stroke | Angina, Stable | Angina, Unstable | Hypercholesterolemia
Known Adverse Events: Hyperlipidemia | Chest Pain | Pain Unspecified | Nasopharyngitis | Pharyngitis | Myalgia | Influenza, Human
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: France, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 3: Hypercholesterolemia|Hyperlipidemia|Type 2 Diabetes
Phase 2: Non-Small-Cell Lung Cancer
Phase 1: Sepsis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TOP2201 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2027-01-01 |
|
| TOP 2301 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2026-08-30 |
|
| PALMS | P1 |
Recruiting |
Sepsis |
2025-02-01 |
|
| 2017-001903-60 | P3 |
Completed |
Hypercholesterolemia |
2022-08-05 |