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Pharmacomicrobiomics.

Naomi Gronich1,2,3, Naama Geva-Zatorsky3,4,5, Rachel Herren4

  • 1Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Clalit Health Services, Haifa, Israel.

Clinical Pharmacology and Therapeutics
|September 29, 2025
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Summary
This summary is machine-generated.

Gut microbes significantly impact drug effectiveness and toxicity by altering pharmacokinetics and immune responses. Pharmacomicrobiomics research, though challenging, holds potential for personalized medicine by leveraging microbiome data.

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Area of Science:

  • Microbiology
  • Pharmacology
  • Immunology

Background:

  • Gut commensal microbes influence oral drug pharmacokinetics and efficacy through metabolism and immune modulation.
  • Variability in drug response, including cancer immunotherapy, is linked to gut microbiome composition and function.

Purpose of the Study:

  • To advocate for clinical studies in pharmacomicrobiomics, the study of how microbiome differences affect drug response.
  • To highlight the potential of modeling, simulation, and real-world data for advancing pharmacomicrobiomics research.

Main Methods:

  • Review of existing literature and methodologies in pharmacomicrobiomics.
  • Proposal for integrated approaches using modeling, simulation, and within-subject comparisons with real-world data.

Main Results:

  • Clinical pharmacomicrobiomic studies face challenges including microbiome variability, confounding factors, and methodological standardization.
  • Modeling and simulation can provide a quantitative framework for data integration and prediction.

Conclusions:

  • Despite challenges, pharmacomicrobiomics offers significant potential to improve pharmaceutical product development and utilization.
  • An integrated approach is crucial to overcome inter-individual microbiome variability and harness its therapeutic potential.