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
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
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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