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Drug

Finerenone

Approved · EMA
ClassMineralocorticoid receptor antagonistEmerging researchLate-stage development

Also known as Kerendia.

RxNorm2562811ChEMBLCHEMBL2181927ATCC03DA05UNIIDE2O63YV8R
3
Research papers
36
Active clinical trials
Mineralocorticoid receptor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-07Results expected Q1 2027 · ClinicalTrials.gov

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)

Clinical trial2026-07-06Results expected Q4 2027 · ClinicalTrials.gov

Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

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)

Clinical trial2026-06-29Results expected Q4 2030 · ClinicalTrials.gov

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

Clinical trial2026-06-26Results expected Q4 2028 · ClinicalTrials.gov

Updated evidence on cardiovascular and renal effects of GLP-1 receptor agonists and combination therapy with SGLT2 inhibitors and finerenone: a narrative review and perspectives.

Research2024-11-15Cardiovascular diabetology

Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes.

Research2024-09-01Nature medicine

Approval: Kerendia (EMA)

Regulatory2022-02-16EMA

Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.

Research2022-02-01European heart journal

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Finerenone
Aliases & brands
Kerendia
RxNorm CUI
2562811
ChEMBL ID
CHEMBL2181927
ATC codes
C03DA05
UNII
DE2O63YV8R
Primary mechanism
Mineralocorticoid receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Mineralocorticoid receptor
NR3C2 · P08235
ANTAGONISTMineralocorticoid receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-02-16
Latest approval
2022-02-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-02-16Approval
Approval: Kerendia (EMA)
Indication: Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and… Show full indication

Kerendia is indicated for the treatment of chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. For study results with respect to renal and cardiovascular events, see section 5.1. Kerendia is indicated for the treatment of symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

57 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
57
registered trials across all phases
LATEST COMPLETION 2026
36
Active studies
35
Recruiting
46
Late-stage (III+)
18
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 57
Phase 12Phase 29Phase 319Phase 422Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Enrolling by invitationPH IVCathay General Hospitaln=402029

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Not yet recruitingPH IVBaylor Research Instituten=642029

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

RecruitingPH IVJuntendo Universityn=5502028

A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease: A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study

RecruitingPH IVPeter Rossingn=1252028

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

RecruitingPH IVUniversity of Aarhusn=802028

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effect of Finerenone on Proteinuria and GFR Progression in Patients With Non Diabetic Glomerulonephritis: A Randomized Clinical Trial

CompletedPH IIAlexandria Universityn=1002026

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients With Non-Diabetic Chronic Kidney Disease

CompletedPH IIIKey trialBayern=1,5842026

Effects of Finerenone on Renal Hemodynamics and Oxidative Stress

CompletedPH IIIUniversity of Erlangen-Nürnberg Medical Schooln=912025

Optimization of Albuminuria-Lowering Therapies for Individual Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Pilot Remote Clinical Trial.

CompletedPH IVUniversity Medical Center Groningenn=122025

A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Addition to Standard of Care, in Participants With Chronic Kidney Disease and Type 1 Diabetes

CompletedPH IIIBayern=2412025

A Prospective, Interventional, Multicenter, Phase IV, Open-label, Single Arm Study to Assess the Safety and Effectiveness of Finerenone in Participants From India With Chronic Kidney Disease Associated With Type 2 Diabetes.

CompletedPH IVBayern=2002025

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20222024
Major research themes8
Diabetes Mellitus, Type 23Cardiovascular Diseases2Renal Insufficiency, Chronic2Drug Therapy, Combination1Glucagon-Like Peptide-1 Receptor1Glucagon-Like Peptide-1 Receptor Agonists1Heart Failure1Kidney1
Journals, researchers & institutions
Top journals
  • Cardiovascular diabetology1
  • European heart journal1
  • Nature medicine1
Leading researchers
  • Agarwal R2
  • Anker SD2
  • Filippatos G2
  • Kolkhof P2
  • Pitt B2
  • Rossing P2
  • Ruilope LM2
  • Bakris GL1
Leading institutions
free-text, unnormalised
  • Attikon University Hospital1
  • Brigham and Women's Hospital1
  • Cardiology and Nephrology Clinical Development1
  • Cardiorenal Translational Laboratory and Hypertension Unit1
  • Charité University1
  • Clinical Development Operations1

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.