Astellas doses first patient in phase 3 VMS trial of fezolinetant

Japanese pharma company Astellas Pharma has dosed the first patient in the SKYLIGHT 1 phase 3 trial for fezolinetant, an investigational oral, non-hormonal compound for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

Vasomotor symptoms are hot flashes and night sweats which occur in nearly 57% on women, aged 40-64 years as per Makara-Studzińśka MT, Kryś-Noszczyk KM, Jakiel G. Epidemiology of the symptoms of menopause – an intercontinental review.

Fezolinetant has been designed to be a selective neurokinin-3 (NK3) receptor antagonist. The non-hormonal compound functions by preventing neurokinin B (NKB) signaling and normalizing KNDy (kisspeptin/NKB/dynorphin) neuron activity, which regulates the temperature control center and lowers the frequency and severity of hot flashes.

SKYLIGHT 1 marks the first trial of the BRIGHT SKY clinical development program that will assess the efficacy and safety of 30 and 45 mg once-daily (QD) fezolinetant in reducing the frequency and severity of vasomotor symptoms.

Salim Mujais – Senior Vice President and Therapeutic Area Head, Medical Specialties of Astellas Pharma said: “There are currently limited non-hormonal options for managing vasomotor symptoms, which can be quite disruptive and often interfere with daily life.

“With the initiation of our Phase 3 fezolinetant program, we move further towards our goal of providing women with a non-hormonal treatment for moderate-to-severe hot flashes.”

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