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Gaseous substances like general anesthetics are absorbed and excreted through the lungs via simple diffusion. This process depends on factors such as pulmonary blood flow, respiration rate, and the substance's solubility. Gaseous anesthetics like nitrous oxide with low blood solubility are excreted rapidly, while compounds like alcohol, with high blood and tissue solubility, are excreted slowly.
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Investigation of the Relevance of CYP3A4 Inhibition on the Pharmacokinetics of the Novel P2X3 Antagonist Filapixant: Results of In Vitro Explorations and a Fixed-Sequence Clinical Trial with Itraconazole in Healthy Volunteers.

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In Vitro and In Vivo Stability Assessment of the Novel, Macrocyclic Gadolinium-Based Contrast Agent Gadoquatrane.

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Pharmacokinetics, Excretion, and Organ Distribution of the Novel Gadolinium-Based MRI Contrast Agent Gadoquatrane in

Clemens Guenther1, Thomas Frenzel, Antje Rottmann

  • 1Bayer AG, Wuppertal, Germany (C.G., T.F., A.R., J.L., W.J.).

Investigative Radiology
|June 11, 2025
PubMed
Summary

Gadoquatrane, a novel MRI contrast agent, demonstrated rapid renal excretion and minimal tissue retention, similar to established agents. This suggests a favorable safety profile with no increased risk of prolonged gadolinium presence in tissues.

Keywords:
gadolinium tissue distributiongadolinium-based contrast agentgadoquatraneintraindividual comparisonmacrocyclic GBCAmass balancemonkeynonhuman primatepharmacokinetics

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Area of Science:

  • Pharmacology and Toxicology
  • Radiology and Medical Imaging

Background:

  • Gadoquatrane is a tetrameric, macrocyclic, extracellular gadolinium-based MRI contrast agent in Phase 3 development.
  • It exhibits high relaxivity and stability, necessitating pharmacokinetic characterization.

Purpose of the Study:

  • To characterize the pharmacokinetic profile of gadoquatrane in cynomolgus monkeys.
  • To compare gadoquatrane's profile with established gadolinium-based contrast agents (gadobutrol and gadoterate analogs).

Main Methods:

  • Single intravenous injection of gadoquatrane, Dy-butrol, and Tb-DOTA in cynomolgus monkeys.
  • Collection of blood, excreta, and tissue samples up to 58 days post-dose.
  • Quantification using inductively coupled plasma mass spectrometry and pharmacokinetic modeling.

Main Results:

  • Gadoquatrane exhibited a multi-phasic plasma concentration decrease with an effective half-life of approximately 1 hour.
  • Rapid and near-exclusive renal excretion (97% within 24 hours) was observed.
  • Minimal gadolinium tissue accumulation was detected, comparable to comparator agents, with rapid decline over time.

Conclusions:

  • Gadoquatrane displays a pharmacokinetic profile similar to macrocyclic comparator agents.
  • No evidence suggests an increased risk of prolonged gadolinium retention in tissues compared to established agents.
  • Metabolic profiling confirmed the metabolic stability of gadoquatrane.