Certara Simcyp® Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib
MWN-AI** Summary
Certara, Inc. announced on March 3, 2026, that its Simcyp® Simulator's physiologically-based pharmacokinetic (PBPK) modeling had received approval from the U.S. FDA to support the new drug application (NDA) for asciminib (Scemblix®), a therapy for Chronic Myeloid Leukemia (CML). This innovative modeling approach predicts drug interactions in virtual biological systems, enhancing the drug development process and potentially replacing certain human clinical trials.
Asciminib, the first-in-class allosteric inhibitor targeting the BCR::ABL1 myristoyl pocket, is significant due to its effects on the approximately 15% of adults diagnosed with leukemia annually. In a landscape where CML had an incidence rate nearing one case per 100,000 in 2018, Certara's modeling optimized the understanding of asciminib’s pharmacokinetics, addressing its interaction complexities amidst diverse dosing regimens and patient populations.
The results, published in the study “Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib,” showcased the effectiveness of the Simcyp Simulator in accurately characterizing the drug’s behavior in both healthy volunteers and cancer patients, alongside predicting real-world drug interactions. Notably, this modeling allowed for the bridging of clinically tested and untested scenarios, ultimately replacing the need for at least ten dedicated clinical pharmacology studies.
Industry experts acknowledged the vital role that the Simcyp Simulator played in driving regulatory approval, enhancing the pharmacokinetic understanding of asciminib's optimal dosing and drug interaction profiles. Certara continues to support biopharmaceutical companies, regulatory agencies, and academic institutions globally with its biosimulation technologies, transforming the landscape of drug development.
MWN-AI** Analysis
Certara, Inc.'s recent announcement regarding the integration of its Simcyp® Simulator findings into the regulatory approval process for asciminib (Scemblix®) underscores a pivotal moment in pharmaceutical development and presents a compelling case for investors. As the FDA accepted PBPK modeling data that negated the need for certain human trials for chronic myeloid leukemia (CML) therapy, the efficiency of model-informed drug development is becoming increasingly apparent.
Investors should consider the implications of this regulatory shift, as it not only accelerates the development timelines for new therapies but also potentially reduces the overall costs associated with drug trials. Certara, with its innovative biosimulation technology, positions itself at the forefront of this evolution, driving demand for their software and services across a spectrum of pharmaceutical companies globally. As of now, the adoption of PBPK modeling could set a new standard for drug approval processes, making Certara an attractive prospect for long-term investment.
The relevance of asciminib, as a targeted allosteric inhibitor tailored for CML patients, also highlights the drug's significance in a market characterized by unmet medical needs. With CML representing a notable segment of leukemia cases, the long-term sales potential of Scemblix®, combined with decreased time to market due to these modeling advancements, boosts Certara's growth outlook.
That said, potential investors should remain vigilant about regulatory trends and competitive dynamics. As biotech firms increasingly adopt similar methodologies, monitoring Certara’s innovations and market positioning will be crucial. The successful navigation of these complexities could yield substantial returns as the company solidifies its leadership in the field of advanced drug development technologies.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
RADNOR, Pa., March 03, 2026 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced its Simcyp® Simulator enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix®). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in “Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib” (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making.
Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018,1 and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA.
“As a member of the Simcyp Consortium, we have firsthand experience with Simcyp’s capabilities and value its leading scientific rigor essential for enabling regulatory acceptance of PBPK models,” said Ioannis Loisios-Konstantinidis, Senior Principal Scientist, PK Sciences, Novartis Biomedical Research.
Key results from the PBPK modeling included:
- Bridging between clinically tested and untested scenarios
- Replacement of at least ten dedicated clinical pharmacology studies
- Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients
- Predicting how medicines work in real-life patients taking other medications
“This collaboration exemplifies the scientific partnership that the Simcyp Simulator enables,” said Rob Aspbury, President, Certara Predictive Technologies. “The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML.”
Learn more about the asciminib case study here.
About Certara
Certara accelerates medicines using biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Visit us at www.certara.com.
Certara contact:
Sheila Rocchio
Sheila.rocchio@certara.com
Media contact:
Alyssa Horowitz
certara@pancomm.com
1 https://ascopubs.org/doi/pdfdirect/10.1200/GO.21.00194
FAQ**
How has Certara Inc. CERT demonstrated the effectiveness of its Simcyp Simulator in influencing regulatory decisions like the FDA's acceptance of PBPK modeling for asciminib?
What role does Certara Inc. CERT play in the evolution of model-informed drug development, especially in the context of asciminib’s new drug application process?
Can you explain how the PBPK modeling by Certara Inc. CERT replaced clinical pharmacology studies in the NDA process for asciminib and its implications for future drug approvals?
In what ways has the collaboration between Novartis and Certara Inc. CERT showcased the benefits of PBPK modeling in personalized medicine, particularly for patients with Chronic Myeloid Leukemia?
**MWN-AI FAQ is based on asking OpenAI questions about Certara Inc. (NASDAQ: CERT).
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