Pharmacokinetics and Safety of Fezolinetant in Women with Hepatic or Renal Impairment.

ABSTRACT: The neurokinin 3 receptor antagonist fezolinetant is an approved treatment for vasomotor symptoms due to menopause. The impacts of hepatic and renal impairment on the pharmacokinetics and safety of a single oral dose of fezolinetant 30 mg were investigated in two independent studies. The studies enrolled healthy women and women with mild or moderate hepatic impairment (defined by Child-Pugh classification) or mild to severe renal impairment (categorized by estimated glomerular filtration rate). Blood samples for fezolinetant and its metabolite, ES259564, were collected predose and up to 96 h postdose. Safety was assessed using treatment-emergent adverse events (TEAEs). Overall, 26 and 27 women were enrolled in the hepatic and renal studies. Fezolinetant exposure (area under the concentrati

SUBMITTER: Iwai M 

PROVIDER: S-EPMC12555095 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature