Astellas Launches Phase 3 Trials for Nonhormonal Menopause VMS Treatment in Japan

Astellas Pharma has initiated the STARLIGHT 2 Phase 3 study, which involves the dosing of fezolinetant, an oral nonhormonal drug candidate, for treating vasomotor symptoms (VMS) in Japanese women experiencing menopause. The STARLIGHT 2 study is a 12-week trial that will assess the drug's efficacy and safety. Additionally, the STARLIGHT 3 study, which is a 52-week trial, will focus on the safety and tolerability of the drug.

Vice President of BioPharma Development at Astellas, Marci English, stated that VMS, which includes hot flashes and night sweats, affects millions of women in Japan. The Phase 3 studies are a significant step towards offering a novel nonhormonal treatment option for these women.

The dosing strategy for the STARLIGHT trials was informed by global data, including the Phase 2b study that concluded in 2022. The Phase 2b study's primary results were presented at the Japan Society for Menopause and Women's Health's Annual Meeting.

Fezolinetant operates by inhibiting the neurokinin B (NKB) binding on the KNDy neuron, which aids in restoring balance in the hypothalamus, the brain's temperature regulation center. This mechanism aims to decrease the frequency and severity of hot flashes and night sweats.

Astellas Pharma is a global pharmaceutical company that adopts a Focus Area Approach to develop new drugs for diseases with significant unmet needs. They are also developing Rx+® healthcare solutions by integrating their expertise with advanced technology from external partners.

VMS significantly impact the daily activities and quality of life of women, with more than half of women aged 40 to 64 worldwide experiencing these symptoms. In Japan, the prevalence is estimated to be between 25% to 37%.

It is important to note that while the studies are underway, there is no assurance that fezolinetant will receive regulatory approval or become commercially available for the treatment of VMS associated with menopause.