Drug

Finerenone

Finerenone is a non-steroidal mineralocorticoid receptor antagonist used in chronic kidney disease with type 2 diabetes and in heart failure.

Sources: FDA label · 13 registered trials

Finerenone at a glance

Mineralocorticoid Receptor Antagonists

Mechanism: non-steroidal mineralocorticoid receptor antagonist (nsMRA) · FDA label (DailyMed)

FDA-approved indications

To reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM).
To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.

Source: Kerendia label (DailyMed), label dated Aug 28, 2025

FDA actions

Overview

Unverified · drafted by AI from the sources cited below

Definition

Finerenone is a novel, non-steroidal mineralocorticoid receptor antagonist (MRA) that offers high selectivity and potent target-organ protection.1 It acts by selectively blocking the mineralocorticoid receptor (MR), thereby inhibiting aldosterone-mediated inflammatory and fibrotic pathways in the kidney and cardiovascular system.2 Through this mechanism, finerenone reduces renal inflammation, fibrosis, and the cardiovascular risk associated with chronic kidney disease (CKD) and type 2 diabetes mellitus.2

Treatment

Finerenone is primarily used to reduce the risk of kidney disease progression and cardiovascular events in patients with CKD associated with type 2 diabetes (T2D).12 It has also demonstrated benefit in heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).3 In a retrospective observational study of patients aged ≥18 years with T2D and CKD without prior heart failure (HF) or ischemic heart disease who initiated an MRA after first-line sodium-glucose co-transporter 2 (SGLT2) inhibitor therapy, finerenone initiation was associated with lower incidence rates of all-cause death over an 18-month follow-up compared to steroidal MRAs like spironolactone and eplerenone (N=3,680 total; 551 propensity-matched patients per group).5 41.7%; adjusted hazard ratio 0.72, 95% CI 0.64-0.82; P < 0.001).3 Regarding hemodynamic effects, a meta-analysis of 19,609 patients across randomized controlled trials showed that finerenone provides a modest, statistically significant reduction in office systolic blood pressure (LSM difference: −2.83 mmHg; 95% CI: −3.15 to −2.51; p < 0.001) and office diastolic blood pressure (LSM difference: −1.04 mmHg; 95% CI: −1.37 to −0.70; p < 0.001) compared with placebo.6

Open questions

Real-world evidence and direct head-to-head comparisons of finerenone against steroidal MRAs, such as spironolactone, remain limited in patients with CKD, T2D, and HFmrEF/HFpEF.12

Landmark trials

Primary results of 3 trials behind the evidence on finerenone, as each trial’s own publication reports them.

Left of the line at 1 favours the intervention; square size tracks trial size.Favours the interventionNo significant differenceFavours the comparator

0.512

FINEARTS-HF
finerenone vs placebo · 6,001 patients · N Engl J Med 2024
In patients with heart failure and a left ventricular ejection fraction of 40% or greater
Primary outcome: a composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes
Rate ratio 0.84 (0.74–0.95)
FIGARO-DKD
finerenone vs placebo · 7,437 patients · N Engl J Med 2021
In patients with CKD and type 2 diabetes
Primary outcome: a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure
HR 0.87 (0.76–0.98)
FIDELIO-DKD
finerenone vs placebo · 5,734 patients · N Engl J Med 2020
In patients with CKD and type 2 diabetes
Primary outcome: kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes
HR 0.82 (0.73–0.93)

Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention.

Trials by indication

Registered trials with finerenone in an arm, past phase 1 with at least 50 participants: the largest in each indication, newest first. Trials that give it only as the comparator are tagged; trials that give it in every arm are listed last.

Heart failure4 of 10

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial
NCT07575672 · Phase 3 · Not yet recruiting · 2,832 participants · started 2026
REDEFINE-HF
Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)
NCT06008197 · Phase 3 · Recruiting · 5,200 participants · started 2024
FINALITY-HF
A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)
NCT06033950 · Phase 3 · Recruiting · 2,600 participants · started 2024
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
NCT04435626 · Phase 3 · Completed · 6,016 participants · started 2020

Chronic kidney disease

FIGARO-DKD
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
NCT02545049 · Phase 3 · Completed · 7,352 participants · started 2015
FIDELIO-DKD
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
NCT02540993 · Phase 3 · Completed · 5,734 participants · started 2015

Other trials

The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
NCT06059664 · Phase 2 · Recruiting · 100 participants · started 2024

Source: ClinicalTrials.gov registry records.

How this page is built

A clinical question appears here only when its condition matches this topic, an outcome and a comparator were extracted from the studies, at least two studies and a patient count are on file, and the certainty is low or higher.

Supports benefit, no benefit shown, and mixed describe the direction of the measured effect. No benefit shown means the evidence does not support a benefit. It is not a finding of harm. Too little evidence means the question did not clear that bar.

Study count, RCT count, and patient count are separate. The patient total adds only studies that are linked into a study family and whose sample size is not flagged as implausible. A reversal is listed only when at least one randomized trial sits on each side of the change.

The overview is drafted from the guideline recommendations, trials, papers, and questions on this page, and every sentence has to cite one of them. It stays unverified until an NPI-verified clinician or a Synapse admin approves it. Approving records that person's name.