Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan [Yahoo! Finance]
ASTELLAS PHARMA UNSP/ADR (ALPMY)
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Source: Yahoo! Finance
first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause in Japanese women. In Japan , two Phase 3 clinical studies are underway. STARLIGHT 2 is evaluating the efficacy and safety of fezolinetant once-daily through 12 weeks. STARLIGHT 3 is evaluating the safety and tolerability of fezolinetant once-daily through 52 weeks. Marci English , Vice President, Head of BioPharma Development, Astellas "VMS associated with menopause affects millions of women in Japan . We are excited the STARLIGHT Phase 3 clinical studies are underway, bringing us one step closer to making this novel, nonhormonal treatment option available in Japan for women experiencing VMS associated with menopause." Dosing for the STARLIGHT Phase 3 clinical studies was determined based on available global data, including the STARLIGHT Phase 2b study ( NCT05034042 ) that en
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