Active Ingredient: FILGOTINIB
Filgotinib is a selective Janus kinase 1 (JAK1) inhibitor used in chronic inflammatory diseases that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In an ICH E14 thorough QT study of 52 healthy volunteers with moxifloxacin positive control, therapeutic (200 mg daily) and supratherapeutic (450 mg daily) doses showed that the upper bound of the two-sided 90% confidence interval for ddQTc remained strictly below 10 ms at all postdose timepoints. Pharmacokinetic-pharmacodynamic modeling confirmed no concentration-dependent repolarization delay for either filgotinib or its primary active metabolite.
https://doi.org/10.1002/cpdd.755