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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.

Background

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

FDA Approved Products

Kerendia
Manufacturer:Bayer Healthcare Pharmaceuticals Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2021/07/09
NDC:50419-540
Kerendia
Manufacturer:Bayer Healthcare Pharmaceuticals Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2021/07/09
NDC:50419-541

Singapore Approved Products

KERENDIA FILM-COATED TABLET 10MG
Manufacturer:Bayer AG
Form:TABLET, FILM COATED
Strength:10mg
Online:Yes
Approved: 2021/11/25
Approval:SIN16387P
KERENDIA FILM-COATED TABLET 20MG
Manufacturer:Bayer AG
Form:TABLET, FILM COATED
Strength:20mg
Online:Yes
Approved: 2021/11/25
Approval:SIN16388P

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