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May 24, 2026

Nonclinical Safety Assessment of Digadoglucitol, a Novel Magnetic Resonance Imaging Contrast Agent for the Central Nervous System.

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Authors

RBRoberta BonafèBracco (Italy)ACAlessandra CoppoLabCorp (United States)RQRoberta QuelitiLabCorp (United States)

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Implication

Randomized trial evaluates safety of digadoglucitol in the central nervous system, suggesting it is suitable for clinical use.

Key Points

  • The aim is to assess the safety profile of digadoglucitol, a new contrast agent, during nonclinical evaluations.
  • Conducted nonclinical safety pharmacology and toxicology studies according to Good Laboratory Practice principles.
  • Assessed various physiological systems including the central nervous, cardiovascular, and respiratory systems in multiple animal models.
  • Performed in vitro studies for blood compatibility and evaluated pharmacokinetics in rats.
  • Digadoglucitol was well tolerated in animals with no adverse effects noted on key physiological systems.
  • Demonstrated no mutagenic effects and showed favorable toxicity levels significantly higher than the anticipated clinical dose.
  • Rapidly eliminated from plasma with low plasma protein binding across species, indicating good safety margins.

Cite This Study

Bonafè et al. (2026) studied this question.

synapsesocial.com/papers/6a12959d48a0ea1665671cbehttps://doi.org/10.1097/rli.0000000000001296
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