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Announcement

Latest Phoenix PK/PD analysis & modeling platform release prioritizes efficiency, power

June 16, 2025

RADNOR, PA – June 16, 2025 – Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of Phoenix™ version 8.6. Phoenix is the pharmaceutical industry’s gold standard in pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic (TK) analysis and modeling software. The Phoenix Platform is used by more than 75 of the top 100 pharmaceutical companies worldwide. Eleven regulatory agencies, including the U.S. FDA, Japan PMDA, and China NMPA, rely on Phoenix to evaluate drug candidates.

New enhancements address the growing need for both efficiency and precision in the generation of PK, PD, and TK profiles, which are regulatory gates between nonclinical, first-in-human, full clinical, and population-wide studies. While keeping its users at the helm of analysis, Phoenix equips clinical pharmacologists, formulation scientists, and pharmacometricians with tools to automate workflows and execute complex models. It enables scientists to rapidly determine PK parameters like absorption and metabolism, even for diverse subpopulations.

“We continue to invest in the Phoenix platform to support the complex modeling needs of PK/PD scientists who rely on Phoenix for decision making,” said Martin Snyder, President, Data Science Software. “From the first non-compartmental analysis to safety assessment for millions of patients, Phoenix is a critical system throughout drug development.”

Enhancements to the latest version of Phoenix:

  • Simplified NCA setup with new options, defaults, and flexible rules, reducing manual effort and improving analysis accuracy
  • Advanced data preparation and streamlined documentation options, accelerating analysis and increasing transparency to support better quality.
  • More efficient table creation, including the ability to add statistics with a click
  • Fast execution of non-linear mixed effects algorithms for population PK, which deliver best-fit models for predicting PK based on a range of variable patient characteristics

The new Phoenix release is available both as desktop software and as a remote hosted solution. Phoenix Cloud provides secure access from any device, lowers costs, and eliminates IT burden through Certara-managed validation and updates. A key benefit of Phoenix Cloud is rapid adoption with instant upgrades, including forthcoming cloud-based modules.

“Our Phoenix roadmap over the next year is groundbreaking,” said Snyder . “Our user community has asked for greater control to create, customize, and collaborate on the data visualizations that make up much of the Tables, Listings, and Figures section of submission documents. Later this year, they’ll have that ability with TFL Studio, the first module of the Phoenix Cloud.”

This release of Phoenix comes on the heels of a new release of Certara’s cloud-based and Phoenix-integrated data repository. The latest Integral release added a range of new endpoints to its REST API, increasing its flexibility and systems interoperability. Together, the two releases mark a major milestone on Phoenix’s road to a cloud-based ecosystem.

To learn more, visit https://www.certara.com/software/phoenix-pkpd/.

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 70 countries. Learn more at www.certara.com.

Certara contact:

Sheila Rocchio
[email protected]

Media contact:

Alyssa Horowitz
[email protected]

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