Introduction: Inosine pranobex (Methisoprinol, ISO, Isoprinosine) is an immuno-modulatory antiviral drug that has been licensed since 1971 in several countries worldwide. In humans, the drug is approved for the treatment of viral infections, and it might also have therapeutic use in animals. The aims of the presented work were to investigate the genotoxicity of inosine pranobex on BALB/3T3 clone A1 and HepG2 cell lines and to elucidate its mutagenicity using the Ames test.
Material and methods: The BALB/3T3 clone A1 and HepG2 cells were incubated with inosine pranobex at concentrations from 0.1 to 1,000 μg/mL. The genotoxicity was determined by comet and micronucleus assays, and the mutagenicity was determined by Ames assay.
Results: Inosine pranobex did not induce a significant dose-related increase in the number of comets or micronuclei in BALB/3T3 clone A1 and HepG2 cells. Moreover, based on the results of the Ames test, it was concluded that inosine pranobex is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Conclusion: Based on the results of a comet assay, micronucleus assay, and Ames test, it was concluded that inosine pranobex is neither genotoxic nor mutagenic.
Keywords: Inosine pranobex; Methisoprinol; genotoxicity; mutagenicity.