MedPath

Finerenone

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

A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists

Phase 3
Not yet recruiting
Conditions
Heart Failure
Interventions
Drug: Placebo
Drug: Finerenone
First Posted Date
2023-09-13
Last Posted Date
2024-04-17
Lead Sponsor
Colorado Prevention Center
Target Recruit Count
2600
Registration Number
NCT06033950

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Phase 3
Recruiting
Conditions
Heart Failure
Interventions
First Posted Date
2023-09-06
Last Posted Date
2024-07-22
Lead Sponsor
Colorado Prevention Center
Target Recruit Count
1500
Registration Number
NCT06024746
Locations
🇺🇸

Kansas City, MO Investigative Site, Kansas City, Missouri, United States

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Phase 3
Recruiting
Conditions
Heart Failure
Acute Heart Failure
Interventions
Drug: Finerenone
Drug: Placebo
First Posted Date
2023-08-23
Last Posted Date
2024-03-01
Lead Sponsor
Colorado Prevention Center
Target Recruit Count
5200
Registration Number
NCT06008197
Locations
🇺🇸

Aurora, CO Investigative Site, Aurora, Colorado, United States

🇺🇸

Denver, CO Investigative Site, Denver, Colorado, United States

🇺🇸

Boca Raton, FL Investigative Site, Boca Raton, Florida, United States

and more 1 locations

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Phase 4
Completed
Conditions
Primary Aldosteronism
Interventions
First Posted Date
2023-06-29
Last Posted Date
2024-06-18
Lead Sponsor
Chongqing Medical University
Target Recruit Count
60
Registration Number
NCT05924620
Locations
🇨🇳

The First Affilated Hospital of Chongqing Medical University, Chongqing, Chongqing, China

A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes

Phase 3
Recruiting
Conditions
Chronic Kidney Disease
Type 1 Diabetes Mellitus
Interventions
Drug: Finerenone
Other: Placebo
First Posted Date
2023-06-13
Last Posted Date
2024-12-17
Lead Sponsor
Bayer
Target Recruit Count
220
Registration Number
NCT05901831
Locations
🇬🇧

Cardiff and Vale University Health Board - University Hospital of Wales (UHW), Cardiff, United Kingdom

🇺🇸

Stanford University | Endocrinology Department - Diabetes Research, Stanford, California, United States

🇺🇸

Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California, Vallejo, California, United States

and more 82 locations

Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)

Phase 4
Active, not recruiting
Conditions
Chronic Kidney Diseases
Type 2 Diabetes
Interventions
Drug: Placebo
Drug: Finerenone
First Posted Date
2023-06-05
Last Posted Date
2024-02-07
Lead Sponsor
Saga University
Target Recruit Count
100
Registration Number
NCT05887817
Locations
🇯🇵

Saga University Hospital, Saga, Japan

Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

Phase 4
Not yet recruiting
Conditions
Primary Aldosteronism
Hypertension
Interventions
First Posted Date
2023-04-18
Last Posted Date
2023-04-18
Lead Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Target Recruit Count
96
Registration Number
NCT05814770

A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus

Phase 4
Active, not recruiting
Conditions
Type 2 Diabetes Mellitus
Chronic Kidney Disease
Interventions
First Posted Date
2023-01-30
Last Posted Date
2025-01-10
Lead Sponsor
Bayer
Target Recruit Count
200
Registration Number
NCT05705271
Locations
🇮🇳

Dr Balabhai Nanavati Hospital, Mumbai, Maharashtra,, Maharashtra, India

🇮🇳

Bhate Hospital, Karnataka, Belagavi, India

🇮🇳

Kempegowda Institute of Medical Sciences Hospital & R C, Bangalore, Karnataka, India

and more 14 locations

A Study Called SMART-Finder to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients

Recruiting
Conditions
Type 2 Diabetes Mellitus
Chronic Kidney Disease
Interventions
First Posted Date
2022-09-23
Last Posted Date
2025-01-10
Lead Sponsor
Bayer
Target Recruit Count
5000
Registration Number
NCT05552339
Locations
🇩🇪

Many locations, Multiple Locations, Germany

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

Phase 3
Recruiting
Conditions
Proteinuria
Chronic Kidney Disease
Children
Interventions
First Posted Date
2022-07-13
Last Posted Date
2025-01-10
Lead Sponsor
Bayer
Target Recruit Count
100
Registration Number
NCT05457283
Locations
🇺🇸

Phoenix Children's Hospital | Main - Transplant Department, Phoenix, Arizona, United States

🇺🇸

University of California San Diego (UCSD), La Jolla, California, United States

🇺🇸

Stanford Medicine, Palo Alto, California, United States

and more 122 locations
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