Drug-induced-liver-injury, or DILI, is a rare, but serious and often fatal, form of liver toxicity caused by the administration of a drug

​

+Idiosynchratic DILI (Type B toxicity) generally occurs with a typical frequency of anywhere from 1:1000 to 1: 10,000

​

+DILI is the No 1 cause of newly approved drugs being withdrawn for safety-related reasons from the market (>50 drugs withdrawn)

 

+DILI is the major cause of liver transplant in humans

 

+Drug withdrawal after market approval can be catastrophic for the drug company, not only in terms of financial consequences but also in terms of public image and perception

​

+Although dose and lipophilicity seem to be important factors, exact mechanism(s) of DILI are still not fully understood but we now have available a range of in vitro assays that can help identify DILI-positive compounds early, before major investment decisions are made and so DILI assessment should now form part of the early de-risking strategy.

​