Astellas Pharma Inc. announced dosing of the first patient in the SKYLIGHT 1™ Phase 3 pivotal trial for fezolinetant, an investigational oral, non-hormonal compound being studied for the treatment of moderate-to-severe vasomotor symptoms (VMS) – i.e., hot flashes and night sweats associated with menopause.
Fezolinetant is a selective neurokinin-3 (NK3) receptor antagonist. The first trials of the BRIGHT SKY™ clinical development program will evaluate the efficacy and safety of 30 and 45 mg once-daily (QD) fezolinetant in reducing VMS frequency and severity.
“There are currently limited non-hormonal options for managing vasomotor symptoms, which can be quite disruptive and often interfere with daily life,”
said Salim Mujais, M.D., Senior Vice President and Therapeutic Area Head, Medical Specialties, Astellas.
“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.”
Results of a Phase 2b fezolinetant study were presented at The Endocrine Society’s annual meeting in March 2019. Additional information on the Phase 2b study results can be found here.