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Mutagenicity and teratogenicity studies of vitacoxib in rats and mice

Jianzhong Wang1,2, Feifei Sun1,2, Shusheng Tang1,2

  • 1Department of Veterinary Pharmacology and Toxicology, College of Veterinary Medicine, China Agricultural University, Beijing 100193, People's Republic of China.

Toxicology Reports
|August 22, 2018
PubMed

Insights

Vitacoxib, a selective cyclooxygenase-2 inhibitor, was evaluated for safety. Studies found no evidence of mutagenicity or teratogenicity in mice and rats at high doses, indicating a favorable safety profile for this anti-inflammatory drug candidate.

Area of Science:

  • Pharmacology
  • Toxicology
  • Drug Development

Background:

  • Selective cyclooxygenase-2 (COX-2) inhibitors are developed for treating inflammation, pain, and fever.
  • Vitacoxib is a novel drug candidate targeting the COX-2 pathway.

Purpose of the Study:

  • To assess the mutagenic and teratogenic potential of Vitacoxib.
  • To evaluate the safety profile of Vitacoxib in preclinical models.

Main Methods:

  • Mice sperm abnormality assay.
  • Mammalian erythrocyte micronucleus test.
  • In vivo chromosome aberration test.
  • Teratogenicity study in Sprague Dawley (SD) rats.

Main Results:

  • Vitacoxib did not increase structural chromosome aberrations in mice.
  • No increase in micronucleated polychromatic erythrocytes was observed in mice.
  • No toxicological signs were noted in SD rats during the teratogenicity testing.

Conclusions:

  • Vitacoxib demonstrated no mutagenicity in the conducted assays.
  • Vitacoxib exhibited no teratogenicity in Sprague Dawley rats.
  • These findings support Vitacoxib's potential as a safe therapeutic agent for inflammatory conditions.
Keywords:
CoxibMutagenicitySafety evaluationTeratogenicityToxicity studiesVitacoxib

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