FDA Qualifies Glutamate Dehydrogenase (GLDH) Biomarker to Enhance Liver Safety Monitoring in Clinical Trials

The U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research has qualified glutamate dehydrogenase (GLDH) as a safety biomarker to detect possible drug-induced liver injury (DILI) in conjunction with alanine aminotransferase (ALT) and other standard liver injury markers in clinical trials, particularly in participants with elevated transaminases due to muscle injury. For example, patients with Duchenne muscular dystrophy can have elevated ALT due to muscle degeneration, which can confound a DILI signal. In these situations, GLDH can provide additional information to help make a DILI determination.