Last reviewed 2026-04-20 · How we verify

Praluent (ALIROCUMAB)

Praluent blocks the PCSK9 protein, which helps remove LDL cholesterol from the bloodstream, thereby reducing cholesterol levels.

Praluent (Alirocumab) is a PCSK9 inhibitor, a small molecule drug developed by Sanofi Aventis, targeting proprotein convertase subtilisin/kexin type 9. It is used to treat atherosclerosis, complex dyslipidemia, familial hypercholesterolemia, and hypercholesterolemia. Praluent was FDA-approved in 2015 and remains a patented product. Key safety considerations include injection site reactions and increased risk of neuroendocrine tumors. Praluent works by blocking PCSK9, a protein that helps remove LDL cholesterol from the bloodstream, thereby reducing cholesterol levels.

At a glance

Mechanism of action

Alirocumab is human monoclonal antibody that binds to proprotein convertase subtilisin kexin type (PCSK9). PCSK9 binds to the low-density lipoprotein (LDL) receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

Approved indications

• Atherosclerosis
• Complex dyslipidemia
• Familial hypercholesterolemia - heterozygous
• Hypercholesterolemia

Common side effects

• Non-cardiac chest pain
• Nasopharyngitis
• Myalgia
• Local injection site reactions
• Liver-related disorders
• Increases in serum transaminases
• Hypersensitivity reactions
• Pruritus
• Elevated liver enzymes
• Allergic reactions
• Hypersensitivity vasculitis
• Nummular eczema

Key clinical trials

• Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma (EARLY_PHASE1)
• A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia (PHASE2)
• Cardiac Allograft Vasculopathy Inhibition With Alirocumab (PHASE2)
• TOP 2301: Neoadjuvant Chemo for NSCLC (PHASE2)
• Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy
• Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction (PHASE4)
• PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung (PHASE2)
• Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Primary sources

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