Updates strengthen Certara’s position as a leader of PBPK modeling in drug development to advance regulatory decision-making

RADNOR, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has released a new version of the Simcyp™ Simulator for physiologically-based pharmacokinetic (PBPK) modeling. Simcyp PBPK models describe and predict the behavior of drugs in different body tissues. The latest version includes numerous advancements to further support data-driven decision-making at every stage of development.  

“We’re advancing the Simcyp Simulator to address the evolving needs of our pharmaceutical collaborators and regulators,”  Rob Aspbury, President, Certara Predictive Technologies said. “Simcyp Version 24 supports the growing adoption of PBPK in drug development and regulatory decision-making, as well as the broader applications of PBPK from discovery through clinical development.”

A consortium of more than 30 leading pharmaceutical companies guides the development of the Simcyp Simulator. Version 24 incorporates their feedback, which enhances and expands existing capabilities and databases.  Masoud Jamei, Ph.D., Senior Vice President of Simcyp R&D at Certara added, “We’re proud of the Simulator’s continuous advancement of innovative technology. Currently, 4 out of 5 drugs leveraging PBPK for FDA approval in recent years used the Simcyp Simulator.”

Simcyp Simulator V24 features numerous updates, including:

• Biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module now include features for predicting food effects that improve the simulation of drug absorption under various meal conditions.
• Expanded library for drug-drug interactions (DDI): New and upgraded compound files for enzymes and transporters cover a broader range of DDI capabilities. These capabilities provide qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney.

• More precise characterization of the behavior of membrane-bound targets across various tissues and plasma in biologics models. These include soluble target movement and drug-target complex dynamics throughout the body, and refinements to the target shedding model. Further, nonlinear protein and plasma binding, and target-mediated drug disposition are incorporated for small molecules.
• Expanded Trial Design support: Enhanced speed and ease of use for designing and simulating clinical trials.
• Special Populations modeling: Enhanced and expanded capabilities for pediatric, pregnancy, and lactation populations.
• Performance and Usability: Modernized UI, cloud computing add-on, ‘Ask Simcyp’ AI-enabled help chat, and chemical structure-based parameter predictors.
• Routes of Administration: Improved functionality for long-acting injectables, inhalation, and ocular routes.
  

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. 

For more insights on the latest developments, register for the Simcyp V24 release webinar.

About Certara

Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.

Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com  

Media Contact:
Alyssa Horowitz
certara@pancomm.com