Clinical Skeletal Muscle Injury

FEASIBILITY1 SCOPING2 RESEARCH3 SUBMITTED4 QUALIFIED5

blue U.S. Food & Drug Administration (FDA)

green European Medicines Agency (EMA)

Overview

Drug-induced skeletal muscle injury is an undesirable side effect of some valuable medications, including cholesterol-lowering statins and fibrates. Serum ALT and creatinine kinase, as well as clinical outcomes reported by patients and physicians such as muscle pain and weakness, are imprecise and nonspecific. New biomarkers including skeletal troponin I (Tnni1, Tnni2), skeletal troponin T (Tnnt1, Tnnt3), creatinine kinase protein M (Ckm), parvalbumin (Pvalb), myosin light chain 3 (Myl3), fatty acid binding protein 3 (Fabp3), aldolase A (Aldoa), and myoglobinare are under investigation for their potential to more specifically and accurately detect and monitor drug-induced skeletal muscle injury.