Fezolinetant
Treatment for Menopause
Typical Dosage: 45mg orally once daily
Effectiveness
88%
Safety Score
65%
Clinical Trials
17
Participants
7K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
65
DangerousModerateSafe
Treatment Details
Dosage Range
45mg orally once daily
Time to Effect
1-4 weeks
Treatment Duration
Long-term, as needed
Evidence Quality
HIGHNumber Needed to Treat (NNT)
5(Treat 5 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
1000(Treat 1000 patients to see 1 additional serious adverse event)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$7,000
Monitoring:$200
Side Effect Mgmt:$100
Total Annual:$7,300
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$250,000/QALY
QALYs Gained
0.3
Outcome-Based Costs
Cost per Responder
$11,230.77
Cost per Remission
$20,857.14
Fezolinetant Outcomes
for Menopause
Efficacy Outcomes
Overall Effectiveness
+88%
Response Rate
+65%
Remission Rate
+35%
Common Side Effects
Abdominal pain
+7%
Diarrhea
+6%
Insomnia
+4%
Back pain
+4%
Liver enzyme elevations
+3%
Active Clinical Trials
4 active trials recruiting for Fezolinetant in Menopause
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
NCT06812754ACTIVE NOT RECRUITINGPHASE2
150 participants
INTERVENTIONAL
Beijing, China +26 more
Started: Mar 10, 2025
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
NCT06206421ACTIVE NOT RECRUITINGPHASE3
277 participants
INTERVENTIONAL
Nagoya, Japan +23 more
Started: Feb 22, 2024
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
NCT06975111NOT YET RECRUITINGPHASE2, PHASE3
200 participants
INTERVENTIONAL
Aurora, United States
Started: Oct 1, 2025
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
NCT06049797ACTIVE NOT RECRUITING
999 participants
OBSERVATIONAL
Birmingham, United States +47 more
Started: Nov 15, 2023
Completed Clinical Trials
12 completed trials for Fezolinetant in Menopause
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
NCT03192176COMPLETEDPHASE2
356 participants
INTERVENTIONAL
Anniston, United States +50 more
Started: Jul 19, 2017
A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause
NCT04451226COMPLETEDPHASE3
150 participants
INTERVENTIONAL
Beijing, China +28 more
Started: Jul 30, 2020
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
NCT05033886COMPLETEDPHASE3
453 participants
INTERVENTIONAL
Tienen, Belgium +68 more
Started: Nov 8, 2021
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause
NCT06206408COMPLETEDPHASE3
410 participants
INTERVENTIONAL
Chita-gun, Japan +63 more
Started: Feb 16, 2024
A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
NCT05034042COMPLETEDPHASE2
147 participants
INTERVENTIONAL
Matsudo-shi, Japan +39 more
Started: Nov 17, 2021
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause
NCT04234204COMPLETEDPHASE3
302 participants
INTERVENTIONAL
Beijing, China +47 more
Started: Mar 17, 2020
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
NCT04003155COMPLETEDPHASE3
527 participants
INTERVENTIONAL
Andalusia, United States +95 more
Started: Jul 11, 2019
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
NCT04003389COMPLETEDPHASE3
1.83K participants
INTERVENTIONAL
Andalusia, United States +181 more
Started: Jul 10, 2019
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
NCT04003142COMPLETEDPHASE3
501 participants
INTERVENTIONAL
Mesa, United States +92 more
Started: Jul 10, 2019
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
NCT04277624COMPLETEDPHASE1
22 participants
INTERVENTIONAL
Baltimore, United States
Started: Feb 20, 2020
Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
NCT05419908COMPLETEDPHASE2
87 participants
INTERVENTIONAL
Brussels, Belgium +7 more
Started: Sep 21, 2015
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
NCT03436849COMPLETEDPHASE1
44 participants
INTERVENTIONAL
Fukuoka, Japan
Started: Feb 22, 2018