Kerendia

(Finerenone)

ApprovedSmall molecule

Finerenone is used to treat kidney disease in patients with type 2 diabetes and to reduce the risk of heart and kidney problems in these patients.[2] Kerendia is currently approved and in use across 19 indications[4].[1]

Kerendia is one of 428 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

427

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

AlbuminuriaNot yet recruiting

GlomerulonephritisActive, not recruiting

IGA GlomerulonephritisApproved

Diabetic NephropathyApproved

Type 2 Diabetes MellitusActive, not recruiting

Primary AldosteronismActive, not recruiting

Kidney DiseaseActive, not recruiting

Kidney TransplantActive, not recruiting

Oxidative StressActive, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

AlbuminuriaApproved

Not yet recruiting

GlomerulonephritisPhase 2

Active, not recruiting

IGA GlomerulonephritisApproved

Approved

Diabetic NephropathyApproved

Approved

Type 2 Diabetes MellitusApproved

Active, not recruiting

Primary AldosteronismApproved

Active, not recruiting

Kidney DiseaseApproved

Active, not recruiting

Kidney TransplantPhase 2

Active, not recruiting

Oxidative StressPhase 3

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Kerendia

Bayer

Approved

3 2

NOVOLIN R

Novo Nordisk

Preclinical

5 3

Cysteine Hydrochloride

Novartis

Preclinical

1 4

Glargine

Eli Lilly

Preclinical

8 5

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

1 6

Forxiga

AstraZeneca

Preclinical

3 7

Sulfonylureas

Eli Lilly

Preclinical

1 8

Antiplatelet Drug

FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Preclinical

1 9

GLP-1

RRigshospitalet, Denmark

Preclinical

1 10

Blank Control

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Biomarkers

NCT05887817

Post-ApprovalNot yet recruiting

Heart Failure

NCT07351864

Phase 3Recruiting

Heart Failure

NCT06024746

Q4 2026

Phase 3Not yet recruiting

Iga Nephropathy

NCT06580288

Recruiting

Chronic Kidney Disease

NCT06838416

Post-ApprovalRecruiting

Chronic Kidney Disease

NCT06727409

Clinical

Trials by Indication[1]

Chronic Kidney Disease15 trials

The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Recruiting·TThe George Institute·Phase 3·NCT06058585·1,000 enrolled

A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease

Recruiting·PPeter Rossing·Phase 4·NCT07239570·125 enrolled

Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease

Recruiting·SSecond Affiliated Hospital of Soochow University··NCT06838416·300 enrolled

Show 12 more trials

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

Completed· Bayer logo

Bayer·Phase 3·NCT05901831·241 enrolled

An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice

Completed· Bayer logo

Bayer··NCT05526157·50,000 enrolled

An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results

Completed· Bayer logo

Bayer··NCT05640180·17,847 enrolled

An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice

Active, not recruiting· Bayer logo

Bayer··NCT06763146·1,200 enrolled

A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

Completed· Bayer logo

Bayer·Phase 3·NCT05047263·1,584 enrolled

FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

Not yet recruiting·UUniversity Medical Center Groningen·Phase 3·NCT07181135·180 enrolled

Retinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease

Not yet recruiting·—·Phase 4·NCT07235891·40 enrolled

Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i as Triple Therapy With Type 2 Diabetes and Chronic Kidney Disease

Recruiting·—·Phase 4·NCT06727409·82 enrolled

FIRST-2.5: Finerenone Research of Early Safety and Effectiveness, Part 2.5

Active, not recruiting· Bayer logo

Bayer··NCT06608212·150,000 enrolled

An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain

Recruiting· Bayer logo

Bayer··NCT07554469·500 enrolled

An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

Recruiting· Bayer logo

Bayer·Phase 3·NCT05457283·100 enrolled

A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria

Recruiting· Bayer logo

Bayer·Phase 3·NCT05196035·219 enrolled

Heart Failure9 trials

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

Recruiting·CColorado Prevention Center·Phase 3·NCT06024746·1,500 enrolled

Finerenone for Cardiorenal Protection in Diabetic CKD: Impact on Renal Function Decline and Heart Failure

Not yet recruiting·—·N/A·NCT07326631·120 enrolled

Finerenone Plus SGLT2 Inhibitors in Heart Failure

Not yet recruiting·MMansoura University·Phase 4·NCT07351864·60 enrolled

Show 6 more trials

A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction

Recruiting· Bayer logo

Bayer·Phase 3·NCT07188805·111 enrolled

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%

Completed· Bayer logo

Bayer·Phase 3·NCT04435626·6,016 enrolled

Efficacy and Safety With Early Treatment of Finerenone in Hospitalized Patients With Heart Failure

Recruiting·JJuntendo University·Phase 4·NCT07397650·550 enrolled

A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South Korea

Recruiting· Bayer logo

Bayer··NCT07379840·300 enrolled

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)

Recruiting·CColorado Prevention Center·Phase 3·NCT06033950·2,600 enrolled

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)

Recruiting·CColorado Prevention Center·Phase 3·NCT06008197·5,200 enrolled

Type 2 Diabetes Mellitus7 trials

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Completed· Bayer logo

Bayer·Phase 3·NCT02545049·7,352 enrolled

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· Bayer logo

Bayer··NCT05552339·5,000 enrolled

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

Completed· Bayer logo

Bayer·Phase 3·NCT02540993·5,734 enrolled

Show 4 more trials

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

Completed· Bayer logo

Bayer·Phase 4·NCT05705271·200 enrolled

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

Completed· Bayer logo

Bayer·Phase 2·NCT01807221·1,066 enrolled

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

Completed· Bayer logo

Bayer·Phase 2·NCT01874431·823 enrolled

A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

Completed· Bayer logo

Bayer·Phase 2·NCT05254002·1,664 enrolled

Primary Aldosteronism6 trials

Finerenone for Patients With Primary Aldosteronism (FAIRY)

Recruiting·QQifu Li·Phase 4·NCT06457074·306 enrolled

Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism

Completed·—·Phase 4·NCT05924620·60 enrolled

Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT06164379·150 enrolled

Show 3 more trials

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

Not yet recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 4·NCT05814770·96 enrolled

The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Completed·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 4·NCT06381323·55 enrolled

Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism

Recruiting·BBangladesh Medical University·Preclinical·NCT07688928·104 enrolled

Finerenone5 trials

Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers

Completed· Bayer logo

Bayer·Phase 1·NCT02956109·16 enrolled

A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants

Completed· Bayer logo

Bayer·Phase 1·NCT07116512·60 enrolled

A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution

Completed· Bayer logo

Bayer·Phase 1·NCT04881994·27 enrolled

Show 2 more trials

Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects

Completed· Bayer logo

Bayer·Phase 1·NCT02957396·16 enrolled

Finerenone and Cardiac Remodeling

Not yet recruiting·SSubodh Verma·Phase 3·NCT07270367·156 enrolled

16 more indications

Type 2 Diabetes3 trials

Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial

Completed·UUniversity Medical Center Groningen·Phase 4·NCT06094920·12 enrolled

Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.

Recruiting·UUniversity of Aarhus·Phase 4·NCT07026539·80 enrolled

Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study

Enrolling by invitation·SSteno Diabetes Center Copenhagen·Phase 4·NCT06954090·50 enrolled

Observational Study3 trials

An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Completed· Bayer logo

Bayer··NCT05703880·15,948 enrolled

An Observational Study Called FIRST-2.0 China to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions in a Chinese Population.

Active, not recruiting· Bayer logo

Bayer··NCT07124039·5,000 enrolled

An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

Recruiting· Bayer logo

Bayer··NCT06278207·50,000 enrolled

IgA Nephropathy2 trials

Effect of Finerenone in IgA Nephropathy

Not yet recruiting·ZZhejiang University·Phase 3·NCT06580288·120 enrolled

Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

Completed·TThe Fourth Affiliated Hospital of Zhejiang University School of Medicine··NCT06460987·245 enrolled

Biomarkers2 trials

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

Active, not recruiting·—·Phase 4·NCT05887817·100 enrolled

An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants

Completed· Bayer logo

Bayer·Phase 2·NCT05013008·951 enrolled

Kidney Disease2 trials

Investigation on the Impact of Finerenone on Myocardial Remodeling in Patients With Diabetic Kidney Disease and Heart Failure

Enrolling by invitation·—·Phase 4·NCT07442448·40 enrolled

Role of Finerenone in African American Veterans With Diabetic Kidney Disease

Not yet recruiting·WWashington D.C. Veterans Affairs Medical Center·Phase 4·NCT07155694·30 enrolled

Diabetic Retinopathy2 trials

A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR)

Completed· Bayer logo

Bayer··NCT04477707·206 enrolled

Completed· Bayer logo

Bayer·N/A·NCT04795726·70 enrolled

Glomerulonephritis1 trial

Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis

Recruiting·—·Phase 2·NCT06835322·100 enrolled

Cardiovascular Disease1 trial

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Recruiting·SSteno Diabetes Center Copenhagen·Phase 3·NCT06082063·2,000 enrolled

Oxidative Stress1 trial

Finerenone and Renal Oxidative Stress

Recruiting·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT06244758·75 enrolled

Tics1 trial

Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862

Completed· Bayer logo

Bayer·Phase 1·NCT01473108·67 enrolled

Kidney Transplant1 trial

The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study

Recruiting·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT06059664·150 enrolled

Function1 trial

A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced Kidney Function and in Healthy Participants With Similar Age, Weight and Gender Distribution

Completed· Bayer logo

Bayer·Phase 1·NCT04908436·33 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Finerenone and Empagliflozin in Delaying Renal Function Progression After Radical Nephrectomy in High-Risk CKD Patients: A Multicenter RCT

Terminated·JJinling Hospital, China·Phase 2·NCT06818305·10 enrolled

Nephropathy1 trial

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Recruiting·—·N/A·NCT07056595·30 enrolled

Left Ventricular Systolic Dysfunction1 trial

A Phase 3, Single-arm, Open-label Extension Study to Evaluate the Safety of Finerenone in Addition to Standard of Care, in Pediatric Heart Failure Patients, From Birth to 18 Years of Age, With Left Ventricular Systolic Dysfunction (LVSD)

Recruiting· Bayer logo

Bayer·Phase 3·NCT07192952·117 enrolled

Albuminuria1 trial

Efficacy and Safety of Finerenone for the Early Regression of Albuminuria in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Not yet recruiting·FFirst Affiliated Hospital of Zhejiang University·Approved·NCT07667517·148 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 9, 2021

KERENDIA

NDA NDA215341

Sources

References

[1]
ClinicalTrials.gov — 66 trial records for Finerenone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Kerendia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Finerenone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Finerenone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215341). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Kerendia. U.S. Food & Drug Administration.
[7]
PubMed — 2 publications indexed for Finerenone. U.S. National Library of Medicine.
[8]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Nonsteroidal MRA[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

Aug 26, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8436180Aug 26, 2033

RE49826Jul 29, 2035

Key Publications[7]

Cardiovascular and Renal Outcomes With Finerenone: FIGARO-DKD

N Engl J MedJun 24, 2022DOI: 10.1056/NEJMoa2204245

Finerenone in Chronic Kidney Disease and Type 2 Diabetes: FIDELIO-DKD Updated

N Engl J MedMay 19, 2022DOI: 10.1056/NEJMoa2204233

Kerendia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Chronic Kidney Disease15 trials

Heart Failure9 trials

Type 2 Diabetes Mellitus7 trials

Primary Aldosteronism6 trials

Finerenone5 trials

Type 2 Diabetes3 trials

Observational Study3 trials

IgA Nephropathy2 trials

Biomarkers2 trials

Kidney Disease2 trials

Diabetic Retinopathy2 trials

Glomerulonephritis1 trial

Cardiovascular Disease1 trial

Oxidative Stress1 trial

Tics1 trial

Kidney Transplant1 trial

Function1 trial

Efficacy and Safety1 trial

Nephropathy1 trial

Left Ventricular Systolic Dysfunction1 trial

Albuminuria1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

Related News