Certara Launches DIDB® Concomitant Meds Navigator, Extending Leadership in Drug Interaction Science

RADNOR, PA – 2025 年 9 月 22 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today announced the availability of DIDB® Concomitant Meds Navigator, a new capability built on the Drug Interaction Database (DIDB). This software enables research teams to rapidly identify concomitant medications that are contraindicated, require dose adjustments, or need monitoring during a study—especially in early development when guidance is often incomplete.

Widespread concomitant medication use – particularly among older or chronically ill patients – increases DDI risk. While certain protections exist for licensed medications, safeguards for investigational products remain inconsistent. These knowledge gaps leave participants vulnerable to avoidable adverse events.

The new Navigator builds on Certara’s long-standing leadership in drug-interaction science. DIDB is the pharmaceutical industry’s largest scientist-curated collection of human in vitro and clinical data used to assess DDIs and safety. DIDB includes tens of thousands of citations and hundreds of NDA/BLA packages.

In addition, Certara’s Simcyp® PBPK Simulator has helped sponsors secure regulatory-approved label claims for more than 120 novel drugs in lieu of clinical studies. It has helped generate 400+ label claims and advance dosing recommendations for untested patient populations – evidence of its impact on safety and, more inclusive labels. In 2025, Simcyp became the first and only PBPK platform to receive an EMA Qualification Opinion for defined DDI contexts of use.

Certara also brings a globally recognized team of clinical pharmacologists and DDI specialists who partner with sponsors to minimize risk from pre-IND through labeling via in-vitro strategy, clinical pharmacology consulting, PBPK, and regulatory strategy.

• Search a comprehensive, scientist-curated list of drug characteristics—including substrates, inhibitors, and inducers for enzymes and transporters—anchored to marker studies to quickly assess DDI risk and inform clinical strategy for new molecular entities (NMEs).
• Align with FDA-recommended classifications for substrate sensitivity and precipitant potency to standardize trial guidance.
• Go beyond marketed products to include investigational drugs, natural/herbal/food products, excipients, and endogenous biomarkers for broader real-world coverage.
• See the context behind each classification (e.g., exposure changes, supporting DDI and pharmacogenetic data, PK details) to enable nuanced decisions.
• Access the most complete, interactive list of drug- interaction characteristics available today—with 5–6X more compounds and characteristics than publicly available FDA/ICH resources—curated and updated daily from DIDB.

The launch coincides with Certara’s exhibition at the 2025 ISSX International Meeting (Chicago, Sept 21-24). Visit booth #315 for live product demos of Concomitant Meds Navigator and to meet DIDB and Simcyp experts.