N4S001

N4S001 is a novel biphasic release formulation of sildenafil developed by N4 Pharma for the treatment of erectile dysfunction. The formulation is designed with a unique two-stage release mechanism consisting of a 20 mg immediate-release layer intended for sublingual administration followed by an 80 mg sustained-release core for oral ingestion after swallowing. This biphasic design was intended to provide a faster onset of action compared to traditional oral sildenafil while extending the therapeutic window. Sildenafil is a small molecule phosphodiesterase type 5 (PDE5) inhibitor that works by inhibiting the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum, thereby enhancing penile blood flow during sexual stimulation. In 2018, N4 Pharma reported that a Phase 1 pharmacoscintigraphic clinical trial comparing N4S001 to Viagra did not meet its primary endpoints.

Other names

biphasic release sildenafil formulationsildenafil biphasic release