Drug-Induced Liver Injury Indicator Seen: FDA

Researchers at FDA’s National Center for Toxicological Research (NCTR) have found that drug interactions with UDP-glucuronosyltransferase (UGT) enzymes are a strong predictor of drug-induced liver injury (DILI) across different drug types. An agency statement says NCTR conducted the study with scientists from Elsevier’s Life Sciences.

“This insight adds to current DILI prediction methods,” the notice says, “offering a valuable tool for drug development.”

The research is part of the Liver Toxicity Knowledge Base Project, an NCTR initiative to identify DILI risk factors and develop models to predict DILI accurately.

The results were published 7/17 in Hepatology and reported that drugs acting as pure inhibitors of a UGT enzyme are three times more likely to have high DILI risk than non-inhibitors. Drugs that are both substrates and inhibitors of a UGT enzyme are 13 times more likely to raise DILI concerns, the authors said.