Product
fezolinetant
Aliases
ESN364
Name
VEOZAH
INN Name
fezolinetant
FDA Approved
Yes
5 clinical trials
1 organization
5 indications
1 document
Indication
Vasomotor SymptomsIndication
Healthy Control ParticipantsIndication
Renal ImpairmentIndication
Liver ImpairmentIndication
Hot FlashesClinical trial
A Phase 1 Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Renal FunctionStatus: Completed, Estimated PCD: 2022-03-06
Clinical trial
A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement TherapyStatus: Completed, Estimated PCD: 2023-03-27
Clinical trial
A Phase 1 Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Hepatic FunctionStatus: Completed, Estimated PCD: 2021-03-22
Clinical trial
A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With MenopauseStatus: Completed, Estimated PCD: 2020-10-29
Clinical trial
A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With MenopauseStatus: Completed, Estimated PCD: 2022-01-04
Document
DailyMed Label: VEOZAHOrganization
Astellas Pharma US, Inc.