Data updated: Jun 28, 2026
FINERENONE
Approved 2021-07-09
Details
- Status
- Prescription
- First Approved
- 2021-07-09
- Routes
- FILM COATED
- Dosage Forms
- TABLET
FINERENONE Approval History
No approval records found
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Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07523867 SAFE-K | HM-IC-SAFEK | Ph 4 | not yet recruiting | Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study |
| NCT07575672 FINE-VALUE | 2026-0377 | Ph 3 | not yet recruiting | Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure |
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT06008197 REDEFINE-HF | 202301CPC | Ph 3 | recruiting | A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients |
| NCT07537088 | 2026-ethics-58 | Ph 4 | not yet recruiting | Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease |
| NCT06058585 CAPTIVATE | P01351 U1111-1324-3113 | Ph 3 | recruiting | The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect |
| NCT07442448 FINE-REMODEL | CGH-P114066 202511026MINE | Ph 4 | enrolling by invitation | Investigation on the Impact of Finerenone on Myocardial Remodeling in Patients With Diabetic Kidney Disease and Heart Failure |
| NCT06094920 Optimize@Home | 18253 | Ph 4 | completed | Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial |
| NCT07351864 FIN-SGLT2-HF | MDP.25.08.190 | Ph 4 | not yet recruiting | Finerenone Plus SGLT2 Inhibitors in Heart Failure |
| NCT07270367 FINE-MECH | CL-0011 | Ph 3 | not yet recruiting | Finerenone and Cardiac Remodeling |
| NCT07239570 CKD-bioMatch | 2023-507449-27 | Ph 4 | recruiting | A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease |
| NCT07235891 | 0202162 | Ph 4 | not yet recruiting | Retinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease |
| NCT05901831 FINE-ONE | 22267 2022-503024-27-00 | Ph 3 | completed | 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 |
| NCT06381323 | PA2024 | Ph 4 | completed | The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism |
| NCT06835322 | Finerenone and GN | Ph 2 | completed | Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis |
| NCT06033950 FINALITY-HF | 202304CPC | Ph 3 | recruiting | 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 |
| NCT06024746 CONFIRMATION | 202303CPC | Ph 3 | recruiting | A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) |
| NCT06727409 RAiSiN | RAiSiN CREC number: 2023.615-T | Ph 4 | recruiting | 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 |
| NCT06082063 Steno1 | NNF 22OC0077730 | Ph 3 | recruiting | Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes |
| NCT06580288 FIGHT | IIT20240069C-R1 | Ph 3 | not yet recruiting | Effect of Finerenone in IgA Nephropathy |
| NCT05924620 | Finerenone study | Ph 4 | completed | Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism |
| NCT05887817 FIVE-STAR | 00002 | Ph 4 | active not recruiting | Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) |
| NCT07594145 | 30027 | Ph 2 | not yet recruiting | Precision T1D Platform - New Therapies for Cardio-Renal Complications |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FINERENONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.