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    Home > Medical News > Latest Medical News > Two key Phase 3 clinical trials of Astellas fezolinetant reach the primary endpoint

    Two key Phase 3 clinical trials of Astellas fezolinetant reach the primary endpoint

    • Last Update: 2021-03-25
    • Source: Internet
    • Author: User
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    CompilationFan Dongdong

    A few days ago, Japanese pharmaceutical company Astellas Pharma announced that its oral non-hormonal treatment of moderate to severe menopausal vasomotor symptoms (VMS) fezolinetant has achieved positive results in two phase 3 phases.


    SKYLIGHT 1 and SKYLIGHT 2 are double-blind and placebo-controlled studies.


    The results of the trial showed that the two key trials reached 4 main co-endpoints.


    In the trial, no more than 2% of the subjects had a serious treatment emergency adverse event (TEAE), and the most common side effect was headache.


    Non-hormonal therapy fezolinetant is an oral non-hormonal selective neurokinin 3 receptor (NK3R) antagonist.


    This transaction was driven by the results of a phase IIa clinical study of the drug.


    Vasomotor symptoms, hot flashes and night sweats related to menopause, are common symptoms of menopausal women.


    Hormone therapy is currently the first-line drug choice for women with vasomotor symptoms without contraindications.


    In addition to the above two trials, Astellas is also conducting another SKYLIGHT 4 (NCT04003389) trial, which is a 52-week double-blind and placebo-controlled study to study the long-term safety of fezolinetant.


    It is worth mentioning that in January last year, Astellas fezolinetant received clinical approval in China for the treatment of moderate to severe vasomotor disease (VMS).


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