Simulations Plus, Inc. (SLP) is a worldwide developer of sophisticated software and services aimed at enhancing drug discovery and development processes. The company employs artificial intelligence and machine learning technologies to create tools for modeling, simulation, and predicting molecular characteristics. Its operations are divided into four main business units: Simulations Plus, Cognigen, DILIsym, and Lixoft. Among its diverse software offerings are GastroPlus, which models the absorption and drug interactions of compounds in both human and animal subjects, as well as DDDPlus and MembranePlus for various simulations. The company also provides a range of products built on mechanistic and mathematical models, such as its quantitative systems pharmacology software like DILIsym, NAFLDsym, IPFsym, RENAsym, and MITOsym. Furthermore, Simulations Plus offers the ADMET Predictor, a chemistry-focused computer program that forecasts molecular properties from structural inputs, alongside MedChem Designer, MonolixSuite, and PKPlus for additional modeling and simulation needs. Beyond software, the company extends its expertise through various services, including contract research for population modeling and simulation, specialized training and consultation to advance pharmacometrics studies, and clinical-pharmacology consulting to aid in regulatory submissions. Simulations Plus serves a broad spectrum of clients globally, including pharmaceutical, biotechnology, agrochemical, cosmetic, and food companies, as well as academic institutions and regulatory bodies. The company was founded in 1996 and maintains its headquarters in Lancaster, California.
Simulations Plus Expands FDA Adoption of ADMET Predictor® with New Licenses for the Cosmetics Regulatory Science Branch
The FDA's Cosmetics Regulatory Science Branch has licensed ADMET Predictor, Simulations Plus' AI/ML-driven predictive modeling platform, to support computational research for modern cosmetic safety assessment.
The contract expands the company's use of its technology within the FDA, pairing high-throughput pharmacokinetic modeling with predictive ADMET and toxicity tools to support the agency's New Approach Methodologies (NAMs) research.
It builds on a 2024 research collaboration with the International Collaboration on Cosmetics Safety evaluating PBK modeling for animal-free safety assessment. No financial terms of the new license were disclosed.
CEO Shawn O'Connor framed the deal as evidence of the platform's versatility beyond pharmaceutical research, though the release notes no regulatory authority has endorsed or validated the company's products.