Antigenicity study of the new cognition-enhancing agent nefiracetam.
The potential antigenicity of the new cognition-enhancing agent nefiracetam (N-(2,6-dimethylphenyl)-2-(2-oxo-1-pyrrolidinyl)acetamide, DM-9384, CAS 77191-36-7) was investigated by tests for passive cutaneous anaphylaxis (PCA), systemic anaphylaxis (SA) and skin reaction in mice and guinea pigs. Mice were sensitized with nefiracetam (10-100 micrograms/animal) or nefiracetam-egg albumin (OA) mixture (10 micrograms/animal). No IgE antibodies to nefiracetam were detected in plasmas obtained from nefiracetam and nefiracetam-OA sensitized mice, indicating that nefiracetam has no immunogenicity or antigenicity eliciting potential. Guinea pigs were sensitized with nefiracetam (20-100 or 20 mg/kg) or nefiracetam-OA (2 mg/kg). No antibodies to nefiracetam were detected in the sera obtained from sensitized guinea pigs by PCA. Neither SA nor skin reaction was observed in the sensitized guinea pigs after the injection of challenge. These results suggest that nefiracetam possesses no antigenicity in mice and guinea pigs.
Drug Safety Research Center, Developmental Research Laboratories, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
N
N
Wagai
F
F
Yamaguchi
T
T
Hasegawa
S
S
Takayama
D000707:Anaphylaxis / Q000276:immunology; D000818:Animals; D000941:Antigens / Q000276:immunology; D005260:Female; D006168:Guinea Pigs; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C / Q000276:immunology; D008809:Mice, Inbred C3H / Q000276:immunology; D010047:Ovalbumin / Q000276:immunology; D010323:Passive Cutaneous Anaphylaxis / Q000187:drug effects; D011619:Psychotropic Drugs / Q000276:immunology*; D011760:Pyrrolidinones / Q000276:immunology*; D051381:Rats; D017207:Rats, Sprague-Dawley; D012882:Skin Tests
D000941:Antigens; D011619:Psychotropic Drugs; D011760:Pyrrolidinones; C058876:nefiracetam; D010047:Ovalbumin