Active Ingredient: APREMILAST
Apremilast is an oral small-molecule phosphodiesterase 4 (PDE4) inhibitor that demonstrates no clinically meaningful prolongation of cardiac repolarization or QTc intervals. In a randomized crossover thorough QT study using continuous 24-hour Holter ECG monitoring with moxifloxacin positive control, therapeutic (30 mg bid) and supratherapeutic (50 mg bid) exposures demonstrated mean placebo-corrected baseline-adjusted QTcI changes below 1 ms, with upper 90% confidence bounds remaining strictly below 10 ms across all time points.
https://doi.org/10.5414/cp202555