Yuekang Pharmaceutical's PED5 Inhibitor Adenafil Citrate Tablets Approved for Marketing

TextPharmaceutical Guanlan

Today (December 29), China's National Medical Products Administration (NMPA) announced that Yuekang Pharmaceutical's application for the marketing of idenafil citrate tablets has been approved

Screenshot source: NMPA official website

According to the public information of Yuekang Pharmaceutical, idenafil citrate is a new class 1 drug developed by the company, which is a PED5 inhibitor

In a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial, researchers evaluated the efficacy and safety of oral edenafil citrate tablets for the treatment of erectile dysfunction in men

The results of this phase 3 clinical trial study showed that idenafil was effective and safe in improving erectile function in patients with erectile dysfunction

The efficacy evaluation results of the two groups of subjects taking oral edenafil citrate or placebo for 4 weeks, 8 weeks and 12 weeks showed that in the comparison of the main efficacy indicators between the edenafil group and the placebo group, both Better than the placebo group, and the difference was statistically significant (P<0.

The safety evaluation results of the two groups of subjects taking oral idenafil citrate or placebo for 4 weeks, 8 weeks and 12 weeks showed that there was a statistically significant difference in the incidence of adverse events between the two groups (P<0.

No clinically significant changes were found in the ophthalmologic examination, electrocardiogram, blood pressure, and heart rate of the subjects in both groups

Erectile dysfunction (ED) is one of the most common male disorders

References:

[1] China State Food and Drug Administration’s December 29th Drug Approval Document Pending Information.