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    Home > Medical News > Latest Medical News > Yuekang Pharmaceutical's PED5 Inhibitor Adenafil Citrate Tablets Approved for Marketing

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

    • Last Update: 2022-02-23
    • Source: Internet
    • Author: User
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    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.


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