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Simcyp™-informed Drugs

120+ novel drugs approved by regulators using the Simcyp Simulator in lieu of clinical studies

Unlock Innovation with Simcyp

Imagine bringing over 120 novel drugs to market with precision, speed, and cost-efficiency—all without relying on lengthy clinical trials. That’s the transformative power of the Simcyp Simulator. By seamlessly integrating PBPK (physiologically based pharmacokinetic) modeling into the drug development process, Simcyp empowers sponsors to secure regulatory-approved label claims while saving both time and resources.

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Transforming drug development with Simcyp

Cost-efficient clinical trial waivers

What if you could reduce the financial burden of clinical trials without compromising patient safety or efficacy data? The Simcyp Simulator allows sponsors to skip traditional clinical studies for specific label claims. Together, the Simcyp-recommended approaches have saved organizations over $100 million and opened doors to broader patient populations by informing prescribing information.

Extrapolation to special populations

Simcyp goes beyond traditional modeling by answering critical R&D questions. From assessing new formulations and administration routes to predicting outcomes in special populations—like pediatric or diseased patients—our platform provides clarity where clinical studies fall short.

Whether it’s neonates, renal- or hepatic-impaired patients, or disease-specific populations, Simcyp’s PBPK modeling and simulation fill in the gaps, creating safer, more inclusive drug labels.

Optimizing clinical trials with smarter sampling

Even when in vivo studies are necessary, the Simcyp Simulator reduces the complexity and cost. By refining patient selection and justifying smaller sample sizes, Simcyp ensures your data is robust while minimizing participant numbers. This strategic approach leads to faster results and confident label claims, bringing your therapy to market sooner.

Meet the Simcyp 120+

The Simcyp Simulator has already helped sponsors achieve regulatory approval for more than 120 new drugs, resulting in over 400 label claims. These include critical prescribing details such as drug-drug interaction (DDI) predictions, dosing for untested populations (like pediatric and organ-impaired patients), and more—transforming the way we approach drug development. The Simcyp Simulator has been applied to both small and large molecule drugs in areas such as rare disease, CNS, gastroenterology, endocrine disorders, dermatology and infectious disease.

Regulatory success

When we say Simcyp capabilities align with global standards, we mean it. Regulatory bodies such as the US FDA, EMA, MHRA, and PMDA have widely adopted PBPK predictions, using guidance and draft positioning papers to formalize its applications. The result? Consistent approval of PBPK-driven analyses across diverse geographies and disease areas.

Global regulatory agencies that use the Simcyp Simulator

120+

FDA-approved novel drugs supported using the Simcyp Simulator in lieu of clinical studies

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Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

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Case Study

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

A vision for progress

We’re reimagining what’s possible in drug development. Every feature of the Simcyp Simulator is designed with innovation and empathy—to empower better therapeutics, faster approvals, and more inclusive patient outcomes. By removing barriers like time and cost, we’re providing unparalleled support to sponsors bringing life-saving drugs to market.

Join over 120 sponsors who are transforming their drug development strategies—and get your innovations into the hands of the patients who need them most.