RENAsym

RENAsym® is a quantitative systems toxicology (QST) software platform developed by Simulations Plus for predicting and understanding drug-induced kidney injury (DIKI). It is designed for pharmaceutical researchers and drug development teams who need to assess renal safety risks early in the development process, reduce the likelihood of late-stage failures, and support stronger regulatory submissions.

Using mechanistic, mathematical modeling, RENAsym simulates how drug candidates may impact the kidneys and predicts the likelihood of renal injury across a patient population under different dosing strategies. Beyond prediction, the platform provides deeper insight into the biological mechanisms underlying observed renal safety signals, enabling more informed drug design decisions.

Core Capabilities

• Mechanistic modeling of drug-induced kidney injury to simulate renal impact of drug candidates
• Prediction of renal injury likelihood across patient populations under varied dosing strategies
• Mechanistic insight into biological pathways contributing to observed renal safety signals
• Support for safer drug design and more robust regulatory submissions
• Reduction of patient risk and mitigation of drug development failures due to renal safety concerns

RENAsym Consortium

• RENAsym is developed and maintained through a pre-competitive partnership between Simulations Plus and the pharmaceutical industry, known as the RENAsym Consortium
• The Consortium's goals include improving patient safety, reducing the need for animal testing, and lowering the costs and time required for drug development
• A single membership fee provides access to both the RENAsym Consortium and the parallel DILI-sim Initiative, along with deliverables from both programs
• The Consortium is supported by a dedicated Scientific Advisory Board and led by expert scientists in quantitative systems pharmacology (QSP)

Learning and Onboarding

• RENAsym v2A includes a free introductory tutorial comprising 10 modules to help new users get started with the platform
• Peer-reviewed publications, presentations, and additional resources are available to support scientific understanding and application of the tool
• Demo scheduling is available for teams evaluating the platform for their drug development workflows

RENAsym is backed by Simulations Plus, a recognized leader in exposure and safety modeling solutions, and is actively presented at major scientific meetings and toxicology conferences. The platform is positioned as a key tool for pharmaceutical organizations seeking to integrate quantitative systems toxicology into their preclinical and clinical safety assessment processes.