BACKGROUND AND OBJECTIVES: Finerenone (BAY 94-8862) is a selective, nonsteroidal 
mineralocorticoid receptor antagonist. The aim of this study was to assess the 
effect of mild or moderate hepatic impairment on the pharmacokinetics, safety 
and tolerability of finerenone.
METHODS: The study was conducted in a single-center, nonrandomized, 
noncontrolled, nonblinded observational design with group stratification. A 
single oral 5-mg dose of finerenone was administered as a tablet to participants 
with mild or moderate hepatic impairment (Child-Pugh A, score 5-6 [n = 9], or 
Child-Pugh B, score 7-9 [n = 9], respectively) and to age-, weight- and 
sex-matched healthy participants (n = 9). The pharmacokinetics of finerenone and 
its metabolites were assessed in plasma and urine, and safety and tolerability 
were monitored.
RESULTS: Finerenone area under the plasma concentration-time curve (AUC) and 
unbound AUC were 38% and 55% greater, respectively, in participants with 
moderate hepatic impairment than in healthy participants, whereas maximum plasma 
concentration (Cmax) was unchanged. No clear effects on AUC or Cmax were seen in 
participants with mild hepatic impairment. Finerenone was safe and well 
tolerated in all participants.
CONCLUSION: The effects of mild or moderate hepatic impairment on systemic 
exposure of finerenone are small, consistent with its low hepatic extraction and 
preponderance of gastrointestinal over hepatic first-pass clearance. Considering 
the small increases in AUC and the absence of changes in Cmax, a dose adaptation 
does not appear to be warranted in patients with mild or moderate hepatic 
impairment.