Simulations Plus, Inc. announced that the U.S. FDA has renewed its licenses to the DILIsym software platform. DILIsym is the industry gold standard for quantitative systems toxicology (QST) software designed for the prediction and investigation of drug-induced liver injury (DILI). The one-year renewal provides the FDA with continued access to the DILIsym platform for authorized employees across all FDA divisions.

DILIsym predicts the potential for DILI risk in new molecules and provides deeper insight into the mechanisms responsible for observed DILI responses at various stages of the development process. This allows pharmaceutical development teams to understand their compounds and tailor proposed dosing strategies for efficacy and safety. It also allows the FDA to evaluate the potential DILI risk across multiple populations, which supports informed decision-making regarding drug approvals.

For the last 14 years, Simulations Plus has coordinated the DILI-sim Initiative, which is a public-private partnership that guides the development of the DILIsym platform. DILI Sym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim initiative consortium and/or commercial licenses. Simulations Plus also routinely uses DILIsym for comprehensive consulting services on safety-related issues.