Fezolinetant demonstrates topline results in long-term phase 3 study for VMS


Astellas announced positive data from its study investigating the long-term safety of fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Astellas Pharma announced positive results from its SKYLIGHT 4 clinical trial evaluating the long-term safety of fezolinetant, and oral, nonhormonal, selective neurokinin-3 (NK3) receptor antagonist, for the treatment moderate to severe vasomotor symptoms associated with menopause (VMS).1

“Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area,” said Genevieve Neal-Perry, MD, PhD, chair of the Department of Obstetrics and Gynecology at the University of North Carolina School of Medicine. “I am excited by the potential of a new nonhormonal treatment option for women experiencing moderate to severe VMS associated with menopause.”

SKYLIGHT 4 (NCT04003389) is a phase 3, randomized, placebo-controlled, double-blind clinical trial evaluating the safety of fezolinetant in 1,800 women with VMS associated with menopause over 52 weeks.

The study’s goals were to evaluate the effect of fezolinetant on endometrial health, as well as the long-term safety and tolerability of fezolinetant. Also, the study achieved its primary endpoint of assessing endometrial health. Common treatment emergent adverse events (TEAE) included headache and COVID-19 and were consistent with placebo.

Astellas plans to present more details of the topline data at upcoming medical meetings and will use these data to support future regulatory submissions in the United States and Europe, according to a company press release.1

If approved, fezolinetant would be a first-in-class, nonhormonal treatment option to help reduce the severity and frequency of VMS associated with menopause.1

“Based on our initial assessment, we are pleased with the outcome of the SKYLIGHT 4 study, which further characterizes the long-term safety of fezolinetant,” said Nancy Martin, MD, PharmD, vice president and global medical head of medical specialties at Astellas. “With these fezolinetant data, we are hopeful that we will have the opportunity to deliver a first-in-class, nonhormonal treatment option for moderate to severe VMS associated with menopause.”


1. Astellas announces topline results from long-term phase 3 safety study of fezolinetant which inform future regulatory filings for the treatment of vasomotor symptoms associated with menopause. Astellas Pharma US, Inc. | News Room. Accessed March 11, 2022. https://newsroom.astellas.us/2022-03-07-Astellas-Announces-Topline-Results-from-Long-Term-Phase-3-Safety-Study-of-Fezolinetant-which-Inform-Future-Regulatory-Filings-for-the-Treatment-of-Vasomotor-Symptoms-Associated-with-Menopause

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