No antigenicity: no anaphylaxis (ASA/PCA) reactions or drug-specific antibodies
“Neither ASA nor PCA reactions were found and no specific antibodies to KW-6002 were detected. Under the conditions of this study, no antigenicity was determined with KW-6002.”
✓ VerifiedFDA pharmacology/toxicology review, p. 134Source ↗
Biodistribution & persistence
Placental and milk transfer; radioactivity higher and more persistent in fetuses and neonates than in dams
“In two studies of radiolabeled istradefylline in pregnant or nursing rats, the radioactivity persisted for a longer time and at higher levels in both fetuses and neonates than in dams.”
✓ VerifiedFDA pharmacology/toxicology review, p. 21Source ↗
Modality-specific risk
Brain vascular mineralization in rats; human relevance unclear without a known mechanism
“Overall, the available data demonstrate an increase in incidence and severity of brain mineralization only in rat. However, whether this finding is species-specific or not of relevance to humans is unclear, particularly without an identified mechanism of action.”
✓ VerifiedFDA pharmacology/toxicology review, p. 4Source ↗