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Related Experiment Videos

Toxicological evaluation of pidotimod

G Coppi1, M Amico-Roxas, F Bertè

  • 1Research Centre, Poli Industria Chimica S.p.A., Milan, Italy.

Arzneimittel-Forschung
|December 1, 1994
PubMed
Summary

Pidotimod, an immunomodulator, demonstrated very low acute toxicity across multiple species and administration routes. Repeated dose studies in rats and dogs revealed no toxic effects, even at doses significantly higher than anticipated clinical levels, indicating a high safety margin.

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Area of Science:

  • Pharmacology
  • Toxicology
  • Drug Safety Evaluation

Background:

  • Pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, CAS 121808-62-6) is an immunomodulatory agent.
  • Comprehensive toxicological assessment is crucial for understanding drug safety profiles.

Purpose of the Study:

  • To conduct a thorough toxicological evaluation of pidotimod in various animal models.
  • To determine the safety profile of pidotimod following acute and repeated dose administrations.
  • To assess potential effects on fertility, teratogenicity, and peri/postnatal development.

Main Methods:

  • Acute toxicity testing in mice, rats, and dogs via oral, intravenous (i.v.), intramuscular (i.m.), and intraperitoneal (i.p.) routes.
  • Repeated dose toxicity studies in rats (4 months i.p., 12 months oral) and dogs (26 weeks i.m., 52 weeks oral).

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  • Fertility, teratogenicity, and peri/postnatal development studies in rats and rabbits.

    • Main Results:

    • Pidotimod exhibited very low acute toxicity across all tested species and administration routes.
    • No toxic effects were observed in repeated dose studies in rats and dogs, even at doses substantially exceeding the maximum intended clinical dosage.
    • No adverse effects on fertility, embryonic development, teratogenicity, or peri/postnatal development were noted within the tested dose ranges.

    Conclusions:

    • Pidotimod possesses a high safety margin, characterized by minimal toxicity in preclinical evaluations.
    • The toxicological data support the safety of pidotimod for potential clinical use.
    • Local tolerability following intramuscular administration was also found to be very good.