Fezolinetant for hot flashes associated with menopause: SKYLIGHT 1 and SKYLIGHT 2

The SKYLIGHT 1 and SKYLIGHT 2 studies took place in Europe and North America between 2019 and 2021. The studies looked at the effect of fezolinetant treatment on hot flashes/flushes and night sweats (also known as vasomotor symptoms) associated with menopause. Hot flashes are common, bothersome, and often continue for many years during menopause. All study participants took either a fezolinetant pill or a placebo pill. Researchers wanted to find out how many hot flashes were reported, and how severe the hot flashes were. They also looked at side effects, sleep problems, and quality of life.

The results of the SKYLIGHT 1 and SKYLIGHT 2 studies showed that fezolinetant reduced the number and severity of hot flashes associated with menopause. Fezolinetant is now approved as a treatment option for moderate to severe vasomotor symptoms associated with menopause in multiple regions worldwide, including North America, Europe, Asia, and Australia, at a dose of 45 mg once daily.

Original Article:

Lederman S, Johnson K, Ottery FD et al. Fezolinetant treatment for hot flashes associated with menopause: a plain language summary of the SKYLIGHT 1 and SKYLIGHT 2 studies. Future Endocrinology & Metabolism. 2025;12(1): 2493610. DOI: 10.1080/29968879.2025.2493610

Meet the Lead Author: 

Dr. Samuel Lederman grew up in South Florida and started practicing Obstetrics and Gynecology in Palm Beach County in 1991. He graduated from Duke University with a degree in Computer Science. He received his medical degree from the University of Miami Medical School in 1987, and completed his residency training at the University of Colorado.

Dr. Lederman is board-certified by the American College of Obstetrics and Gynecology. He is an active member of the Florida Medical Association, the Palm Beach County Medical Society, and past president of the Palm Beach County Ob/Gyn Society. He is the founding member and Managing Partner of a private practice with four physicians, two nurse practitioners and two nurse midwifes. He is currently Chief of Staff at JFK Medical Center.

Dr. Lederman is also founder and Medical Director of Altus Research, and for the past 27 years has served as principal investigator in clinical trials in the areas of women’s health, obesity treatment, osteoporosis, menopause symptoms, family planning, urinary incontinence, and many more. His participation was pivotal in improving the quality of cervical cytology specimens and changing the current recommendations for cervical cancer screening. In addition, he participated in many vaccine trials during the Covid pandemic which resulted in approval of several products. Dr. Lederman has participated as a member of numerous scientific and academic and industry advisory boards and expert panels, and serves as a frequent speaker in the field of women’s health.

Under the direction of Dr. Lederman, the practice pioneered the transition to electronic health records in 2006. The practice was the recipient of the 2008 Davies Award honoring excellence in the implementation of electronic health records. The award is sponsored by the Healthcare Information and Management Systems Society.