Tier IPCSK9 monoclonal220 trials

PCSK9 mAb (alirocumab) — The LDL-C Lowering Antibody

Alirocumab is a monoclonal antibody that profoundly lowers LDL cholesterol by inhibiting the PCSK9 protein. By drastically reducing atherogenic lipoproteins, it directly targets cardiovascular disease, which is the leading cause of age-related mortality globally.

Mechanism of Action

Alirocumab is a fully human monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9). By inhibiting PCSK9, it prevents the degradation of low-density lipoprotein receptors (LDLRs) on the surface of hepatocytes. This leads to an increased number of LDLRs available to clear circulating LDL-C, resulting in profoundly lowered plasma LDL-C levels. Lowering LDL-C is a primary strategy for reducing atherosclerotic cardiovascular disease risk, a major driver of age-related mortality.

Human Trial Evidence

The ODYSSEY OUTCOMES trial (2018) demonstrated that alirocumab significantly reduced the risk of major adverse cardiovascular events (MACE) and all-cause mortality in patients with a recent acute coronary syndrome. It is highly effective at lowering LDL-C levels in humans.

Dosing Protocol

75 mg or 150 mg administered subcutaneously once every 2 weeks, or 300 mg once every 4 weeks. Prescription required.

Safety & Contraindications

Common adverse effects include injection site reactions, nasopharyngitis, and influenza. Rare but serious risks include hypersensitivity reactions. Prescription required. Long-term safety is generally well-established, though very low LDL-C levels require monitoring.

Key Papers

Quick Stats
Evidence TierTier I
Clinical Trials220
Typical Dose75 mg q2w
Est. Cost/Day$18.40
Purity99.0%
Synergistic Compounds
StatinsEzetimibeBempedoic acid
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