Thirteen-week oral toxicity study of the new cognition-enhancing agent nefiracetam in dogs

The 13-week oral toxicity of nefiracetam (N-(2,6-dimethylphenyl)-2-(2-oxo- 1-pyrrolidinyl) acetamide, DM-9384, CAS 77191-36-7), a new cognition-enhancing agent, was investigated in Beagle dogs of both sexes. No change was observed in the 20 mg/kg group. Hypospermatogenesis and slightly increased deposition of hemosiderin in the spleen were seen in male dogs treated with 60 mg/kg or more. Dosing at 180 mg/kg induced a decrease in food consumption, increases in urinary volume and urinary protein, and renal papillary necrosis in both male and female dogs. The non-toxic dose was 20 mg/kg under these experimental conditions.