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Finerenone

Generic Name
Finerenone
Brand Names
Kerendia
Drug Type
Small Molecule
Chemical Formula
C21H22N4O3
CAS Number
1050477-31-0
Unique Ingredient Identifier
DE2O63YV8R

Overview

Finerenone, or BAY 94-8862, is a mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus. Patients with kidney disease, would originally be given spironolactone or eplerenone to antagonize the mineraclocorticoid receptor. Spironolactone has low selectivity and affinity for the receptor; it dissociates quickly and can also have effects at the androgen, progesterone, and glucocorticoid receptors. Eplerenone is more selective and has longer lasting effects. More selective nonsteroidal mineralocorticoid antagonists such as apararenone, esaxerenone, and finerenone were later developed. So far, finerenone is the only nonsteroidal mineralocorticoid receptor antagonist to be FDA approved. Finerenone was granted FDA approval on 9 July 2021, followed by the EMA approval on 11 March 2022.

Indication

In the US, finerenone is indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus. In Europe, finerenone is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Associated Conditions

  • Cardiovascular Mortality
  • Chronic Kidney Disease, Stage 3 (Moderate)
  • End Stage Renal Disease (ESRD)
  • Hospitalizations
  • Nonfatal Myocardial Infarction
  • Stage 4 Chronic Kidney Disease
  • Sustained creatinine renal clearance decreased

Research Report

Published: Jun 11, 2025

Finerenone: A Novel Nonsteroidal Mineralocorticoid Receptor Antagonist for Cardiorenal Protection

Abstract

Finerenone (BAY 94-8862) is a novel, potent, selective, nonsteroidal mineralocorticoid receptor antagonist (MRA) developed to address the residual cardiorenal risk in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), and more recently, heart failure (HF) with preserved or mildly reduced ejection fraction. Unlike traditional steroidal MRAs such as spironolactone and eplerenone, finerenone possesses a unique chemical structure and pharmacological profile that allows for targeted MR blockade with minimal off-target hormonal effects, thereby reducing the incidence of side effects like gynecomastia. Its mechanism involves specific binding to the mineralocorticoid receptor (MR), preventing the recruitment of transcriptional coactivators and subsequently attenuating MR-mediated inflammation and fibrosis, key drivers of cardiorenal disease progression. Pivotal clinical trials, FIDELIO-DKD and FIGARO-DKD, and their pooled analysis, FIDELITY, have demonstrated finerenone's efficacy in significantly reducing the risk of both CKD progression and cardiovascular events in a broad spectrum of patients with T2D and CKD, largely independent of baseline SGLT2 inhibitor use. The FINEARTS-HF trial has further shown its potential in reducing cardiovascular death and heart failure events in patients with HF and a left ventricular ejection fraction $\ge$40%. While finerenone increases the risk of hyperkalemia, a manageable adverse event through established monitoring and dose-adjustment protocols, its overall safety profile is favorable. Finerenone has been incorporated into major international clinical practice guidelines (KDIGO, ADA, ESC) as a crucial component of comprehensive cardiorenal protective strategies. This report details the pharmacology, clinical evidence, safety profile, and therapeutic positioning of finerenone in contemporar

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/09
Not Applicable
Recruiting
Botkin Hospital
2025/06/18
Phase 4
Recruiting
2025/05/01
Phase 4
Not yet recruiting
2025/04/02
Phase 2
Recruiting
Peter Rossing
2025/03/25
Phase 2
Recruiting
2025/02/20
N/A
Recruiting
Second Affiliated Hospital of Soochow University
2025/02/10
Phase 2
Recruiting
Jinling Hospital, China
2025/01/08
N/A
Not yet recruiting
2024/12/10
Phase 4
Recruiting
2024/09/23
N/A
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bayer Healthcare Pharmaceuticals Inc.
50419-541
ORAL
20 mg in 1 1
7/9/2021
Bayer Healthcare Pharmaceuticals Inc.
50419-540
ORAL
10 mg in 1 1
7/9/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
2/16/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
KERENDIA FILM-COATED TABLET 10MG
SIN16387P
TABLET, FILM COATED
10mg
11/25/2021
KERENDIA FILM-COATED TABLET 20MG
SIN16388P
TABLET, FILM COATED
20mg
11/25/2021

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Finerenone Tablets
国药准字HJ20220057
化学药品
片剂
6/28/2022
Finerenone Tablets
国药准字HJ20220058
化学药品
片剂
6/28/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
KERENDIA finerenone 20 mg film-coated tablet blister pack
350773
Medicine
A
11/25/2021
KERENDIA finerenone 10 mg film-coated tablet blister pack
350772
Medicine
A
11/25/2021

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