Simcyp Simulator streamlines regulatory submissions and increases efficiency

Version 25 builds on EMA qualification to advance regulatory-accepted PBPK modeling

RADNOR, PA – March 5th, 2026- Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in model-informed drug development, today announced the release of the Simcyp® Simulator Version 25, the latest update to its industry-leading physiologically-based pharmacokinetic (PBPK) modeling platform.

The Simcyp Simulator is the first and only EMA-qualified PBPK platform trusted globally to support critical research and development decisions and regulatory submissions involving drug-drug interaction (DDI) assessment, first-in-human dose prediction, special population modeling, and formulation and bioequivalence analysis. Version 25 includes new capabilities and enhancements designed to further streamline drug development across the pipeline.

“Building on last year’s Simcyp Simulator EMA Qualification milestone, Version 25 continues to advance regulatory-accepted PBPK approaches, helping streamline submissions and accelerate the delivery of better therapies to patients,” said Rob Aspbury, President, Certara Predictive Technologies at Certara. “We are proud of the unparalleled scientific rigor behind the Simcyp Simulator and the relationships we have built with regulators and industry partners.”

The Simcyp Simulator has been developed for over 25 years in collaboration with a consortium of more than 30 leading pharmaceutical companies worldwide. Version 25 reflects client demand to support faster, more confident decision-making and regulatory submissions, including expanded compound and population libraries. Some of the highlights in features and capabilities in Version 25 of the Simcyp Simulator are described below.

Transporter-Mediated DDI Expansion: An analysis of applications of PBPK models of novel drug approved by the FDA showed that assessing transporter-mediated DDIs was the second most popular application of this technology. Building on Simcyp’s existing EMA qualification for enzyme-mediated DDIs, additional compounds, case studies, model development and documentation continue to expand support for transporter-mediated DDI modeling and future qualification to enable better prediction and risk assessment.
Enhanced Biopharmaceutics Capabilities: Bioequivalence is a critical concept in the development of generic drugs. The traditional methods of assessing bioequivalence often involve extensive clinical trials, which can be time-consuming and costly. Furthering support for enabling formulations (e.g. Amorphous Solid Dispersion and lipid-based formulations) and expanding the virtual bioequivalence module will help accelerate this workflow.
Improved Usability and Efficiency: Streamlining PBPK model development and analysis through refined user interfaces, intuitive parameter sensitivity analysis to highlight which inputs matter most, integrated fitting and diagnostic tools, within tissues drug binding, and AI-enabled chat support will help modelers use the software quicker and more efficiently.

“We are excited to continue expanding Simcyp's adoption within the pharmaceutical industry and future scope of EMA qualification in response to feedback from our industry partners and evolving regulatory expectations,” said Masoud Jamei, Senior Vice President, Simcyp R&D. “Version 25 strengthens the Simcyp Simulator’s core features to advance PBPK modeling across key pre-clinical and clinical applications.”

The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs. It has also supported clinical trial waivers in many areas, including DDI and pediatric trials. Learn more about Simcyp Simulator Version 25 and its latest advancements in regulatory-accepted PBPK modeling in our recent webinar.

Certara（サターラ）について

サターラは、モデリング＆シミュレーション・ソフトウェアと技術を用いて、従来の創薬・開発を変革し、医薬品をよりスピーディーに患者さんに届けることをミッションとしています。製薬、教育機関、規制当局のお客様 2,600人以上、70ヵ国にてサターラの技術やサービスが活用されています。Learn more at certara.com

サターラの問い合わせ先：

Sheila Rocchio
[email protected]

報道機関の皆様：

赤津笑美 (emi.akatsu@certara.com)
[email protected]

アシミニブ ― PBPK モデリングが開発を効率化し、10件以上の臨床試験を回避

Asciminib (Scemblix®) is a novel drug with a unique mechanism of action for treating CML. Developing a new drug typically involves extensive clinical trials to determine safe and effective dosing regimens. A unique approach utilizing model-informed drug development (MIDD) was employed to bridge efficacy and safety data between dosing regimens. 

事例