U.S. FDA Renews DILIsym® Software Licenses for 7th Year

Software: DILIsym®

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today 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.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, said, “It is now known what properties to avoid to minimize liver toxicity in a new drug candidate — but these same properties are often necessary to have therapeutic efficacy. By predicting safe dosing regimens of such drugs, DILIsym is now enabling successful development of important therapies that might otherwise be abandoned.”

“By incorporating disease pathophysiology, clinical presentation, and clinical outcomes into a unified framework, quantitative systems pharmacology (QSP) and toxicology (QST) models are powerful tools for evaluating therapies,” said Dr. Brett A. Howell, President of Quantitative Systems Pharmacology Solutions at Simulations Plus. “It’s exciting to see the FDA incorporate these methodologies and our software platform as part of their review process for submissions.”

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. DILIsym 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. Companies interested in a free trial version of the DILIsym software can request it here.