Agency will use the software platform to support modern cosmetic safety assessment through integrated exposure and toxicity modeling.

Simulations Plus, Inc. (NASDAQ:SLP) ("Simulations Plus" or the "Company"), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced that the U.S. Food and Drug Administration’s (FDA) Cosmetics Regulatory Science Branch has licensed ADMET Predictor® to support its computational research for modern cosmetic safety assessment. The contract expands the use of Simulations Plus technology within the FDA, underscoring the growing importance of predictive modeling and mechanistic science in advancing regulatory research.

The ADMET Predictor platform provides researchers with advanced artificial intelligence and machine learning (AI/ML) technology, novel descriptors, premium data, and predictive models to rapidly predict endpoint properties and systemic exposure in animals and humans.

By coupling high-throughput pharmacokinetic (HTPK) modeling with predictive ADMET and toxicity assessments, ADMET Predictor provides FDA researchers in the Cosmetic Regulatory Science Branch with tools to evaluate both potential exposure and intrinsic hazard within a unified computational framework. The development of modern, science-based approaches to cosmetic safety assessment supports the FDA's ongoing research into New Approach Methodologies (NAMs).

The announcement builds on Simulations Plus’ work in computational safety assessment beyond pharmaceuticals. In 2024, the Company announced a research collaboration with the International Collaboration on Cosmetics Safety (ICCS) to evaluate physiologically based kinetic (PBK) modeling approaches that support animal-free safety assessment of cosmetics and other non-pharmaceutical ingredients. Together, these initiatives help to reinforce the expanding role of Simulations Plus technologies in advancing predictive science across regulated industries.