KERENDIA (finerenone)
** Kerendia (finerenone) is a nonsteroidal mineralocorticoid receptor antagonist (nsMRA). It is indicated in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM) to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure. Additionally, it is indicated for patients with heart failure and a left ventricular ejection fraction (LVEF) ≥ 40% to reduce the risk of cardiovascular death, heart failure hospitalization, and urgent heart failure visits. **IMPROVED_MOA:** Finerenone is a potent, selective nonsteroidal antagonist of the mineralocorticoid receptor (MR). It blocks MR-mediated sodium reabsorption and MR overactivation in both epithelial (kidney) and non-epithelial (heart and blood vessel) tissues. By inhibiting MR overactivation, which is triggered by aldosterone and cortisol, finerenone reduces the downstream processes of inflammation and fibrosis. Unlike steroidal MRAs, finerenone demonstrates high selectivity for the MR with no relevant affinity for androgen, progesterone, estrogen, or glucocorticoid receptors.
How KERENDIA Works
** Finerenone is a potent, selective nonsteroidal antagonist of the mineralocorticoid receptor (MR). It blocks MR-mediated sodium reabsorption and MR overactivation in both epithelial (kidney) and non-epithelial (heart and blood vessel) tissues. By inhibiting MR overactivation, which is triggered by aldosterone and cortisol, finerenone reduces the downstream processes of inflammation and fibrosis. Unlike steroidal MRAs, finerenone demonstrates high selectivity for the MR with no relevant affinity for androgen, progesterone, estrogen, or glucocorticoid receptors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-07-09
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
KERENDIA Approval History
What KERENDIA Treats
4 indicationsKERENDIA is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Kidney Disease
- Type 2 Diabetes
- Heart Failure
- Myocardial Infarction
KERENDIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KERENDIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KERENDIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KERENDIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 | recruiting | 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
KERENDIA FDA Label Details
Indications & Usage
FDA Label (PDF)KERENDIA is indicated for the treatment of Chronic Kidney Disease; Type 2 Diabetes; Heart Failure; Myocardial Infarction.
KERENDIA Patents & Exclusivity
Exclusivity
Pro Intelligence Preview
Deep insights for KERENDIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 18 active patents
Trial Analysis
- • 21 total trials
- • Stage: Expansion
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment