Active Ingredient: NIRAPARIB
Niraparib is an oral PARP inhibitor used in ovarian cancer maintenance therapy that demonstrates no clinically meaningful effect on cardiac repolarization or QTc intervals. In clinical evaluation across the NOVA trial substudies at the recommended dose of 300 mg daily, the upper bound of the two-sided 90% confidence interval for mean QTcF change remained strictly below 10 ms at all postdose timepoints (maximum 4.3 ms). Pharmacokinetic-pharmacodynamic modeling showed no statistically significant relationship between niraparib plasma concentrations and QTc changes (p = 0.164).
https://doi.org/10.1007/s00280-019-03774-w