.Pharmacolibrary.Drugs.ATC.C.C10AX14 .Pharmacolibrary.Drugs.ATC.C.C10AX14| name: | Alirocumab |
| ATC code: | C10AX14 | route: | subcutaneous |
| n-compartments | 2 |
Alirocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It is used as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol. Alirocumab is approved and in current clinical use.
Pharmacokinetic parameters reported for healthy adult subjects after single subcutaneous dose administration.
Martinez, JM, et al., & Fabre, D (2019). Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis-Menten Approximation of a Target-Mediated Drug Disposition Model-Support for a Biologics License Application Submission: Part I. Clinical pharmacokinetics 58(1) 101–113. DOI:10.1007/s40262-018-0669-y PUBMED:https://pubmed.ncbi.nlm.nih.gov/29725996
Li, H, et al., & Li, J (2020). Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study. American journal of cardiovascular drugs : drugs, devices, and other interventions 20(5) 489–503. DOI:10.1007/s40256-020-00394-1 PUBMED:https://pubmed.ncbi.nlm.nih.gov/32080823
Kovalenko, P, et al., & DiCioccio, AT (2025). Target-Mediated Modeling of Alirocumab in Adolescents and Children ≥8 to <12 Years of Age Using Phase II and III Data. Clinical pharmacology in drug development 14(5) 347–359. DOI:10.1002/cpdd.1523 PUBMED:https://pubmed.ncbi.nlm.nih.gov/40136083