Simulations Plus

Dr. Viera Lukacova serves as Chief Science Officer, a role highlighted when she was named an AAPS Fellow in August 2023 (per the firm, August 2023). She guides the development of the mechanistic modeling platforms, including GastroPlus and the DILIsym quantitative systems toxicology suite.

Revenue comes from three sources: licensing its biosimulation software to pharmaceutical and regulatory clients, providing consulting services for model-informed drug development, and conducting grant-funded research in partnership with institutions such as the FDA and NIH. The June 2024 acquisition of Pro-ficiency adds a learning-engine platform for clinical trial simulations.

The FDA is a repeat licensee of the firm's DILIsym software for drug-induced liver injury assessment, renewing annually for at least seven consecutive years. The agency also awards grants to Simulations Plus alongside academic partners to validate in vitro-in vivo extrapolation methods and expand mechanistic modeling for complex formulations.

Six platforms cover the drug lifecycle: GastroPlus (PBPK/PBBM absorption modeling), ADMET Predictor (machine learning for ADMET and AI-driven drug design), MonolixSuite (pharmacometrics and PK/PD), DILIsym (quantitative systems toxicology for liver injury), Thales (quantitative systems pharmacology), and Pro-ficiency (clinical trial simulation training). Each platform operates under its own release cycle.

It is a software and consulting firm, not a drug developer. Its platforms and scientists support preclinical and clinical-stage decision-making for external clients, including major pharmaceutical and biotech companies, rather than advancing an internal drug pipeline.

Yes. Simulations Plus has been listed on the Nasdaq under the ticker SLP since 1999 and was uplisted to the Nasdaq Global Select Market in 2021. It raised approximately $115 million in a 2020 public offering.

Founded in 1996 around a single gastrointestinal simulation tool, the firm expanded through targeted acquisitions: Cognigen (2014) for population PK/PD, DILIsym Services (2017) for liver-toxicity simulation, Lixoft (2020) for the MonolixSuite, Immunetrics (2023) for immunology and oncology, and Pro-ficiency (2024) for clinical trial simulation training.