CLINICAL TRIALS PROFILE FOR FINERENONE

All Clinical Trials for finerenone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02540993 ↗	Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease	Completed	Bayer	Phase 3	2015-09-17	The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.
NCT02545049 ↗	Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease	Completed	Bayer	Phase 3	2015-09-17	The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
NCT02956109 ↗	Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Volunteers	Completed	Bayer	Phase 1	2016-11-16	Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a single oral dose of finerenone (1.25 mg tablet and 5 x 0.25 mg tablets) using a novel orodispersible tablet formulation for the treatment of children, in comparison to the adult tablet formulation.
NCT02957396 ↗	Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects	Completed	Bayer	Phase 1	2016-11-17	Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics of a novel liquid formulation for the treatment of children in comparison to the adult tablet formulation.
NCT04435626 ↗	Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Ex	Recruiting	Bayer	Phase 3	2020-09-14	The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 5500 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
NCT04795726 ↗	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	N/A	2021-03-11	Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be. In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.
NCT04881994 ↗	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, We	Completed	Bayer	Phase 1	2014-03-25	Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic nephropathy, a long-term, progressive decrease in the kidneys' ability to work properly in patients with diabetes mellitus. In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862). Finerenone is a substance that blocks the activation of a protein in the body called mineralocorticoid receptor (MR). An increased activation of MR is involved in the development of hypertension, organ damage and worsening of heart failure. The researchers studied how finerenone moves into, through and out of the body. The researchers also looked at how safe finerenone is and how it affects the body. The main purpose of this study was to help researchers develop recommendations for the amount of the substance (the dosing) to be given to patients with reduced liver function.

Clinical Trial Conditions for finerenone

Condition Name

Condition Name for finerenone
Intervention	Trials
Chronic Kidney Disease	9
Primary Aldosteronism	5
Heart Failure	5
Diabetic Kidney Disease	4

Condition MeSH

Condition MeSH for finerenone
Intervention	Trials
Renal Insufficiency, Chronic	17
Kidney Diseases	15
Diabetes Mellitus, Type 2	11
Diabetes Mellitus	8

Clinical Trial Locations for finerenone

Trials by Country

Trials by Country for finerenone
Location	Trials
United States	195
Japan	104
China	83
Italy	50
Germany	45

Trials by US State

Trials by US State for finerenone
Location	Trials
Missouri	11
Texas	10
Florida	9
Georgia	8
California	8

Clinical Trial Progress for finerenone

Clinical Trial Phase

Clinical Trial Phase for finerenone
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	8
PHASE2	3

Clinical Trial Status

Clinical Trial Status for finerenone
Clinical Trial Phase	Trials
Recruiting	18
Not yet recruiting	13
COMPLETED	10

Clinical Trial Sponsors for finerenone

Sponsor Name

Sponsor Name for finerenone
Sponsor	Trials
Bayer	22
Aarhus University Hospital	3
Colorado Prevention Center	3

Sponsor Type

Sponsor Type for finerenone
Sponsor	Trials
Other	59
Industry	27
UNKNOWN	2

Clinical Trials Update, Market Analysis, and Projection for Finerenone

Last updated: October 28, 2025

Introduction

Finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), has garnered significant attention within the cardiovascular and renal disease therapeutic landscape. Developed by Bayer and several collaborators, finerenone offers a novel approach to managing chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM), conditions often co-occurring and associated with high morbidity and mortality. This article provides a comprehensive update on finerenone’s clinical trial progress, evaluates current market dynamics, and forecasts its future trajectory within the pharmaceutical landscape.

Clinical Trials Update

Key Clinical Trials and Their Outcomes

Since its initial development, finerenone has undergone rigorous clinical evaluation to establish efficacy and safety profiles:

• FIDELIO-DKD (NCT03335665): A phase 3 trial enrolling 5734 patients with CKD and T2DM demonstrated that finerenone significantly reduced the risk of kidney failure, sustained estimated glomerular filtration rate (eGFR) decline, and cardiovascular (CV) events. The primary composite endpoint was a 18% risk reduction compared to placebo (hazard ratio [HR] 0.82, p<0.001). Notably, adverse events like hyperkalemia were manageable, with a low discontinuation rate due to safety concerns.

• FIGARO-DKD (NCT03594110): Focused on CV outcomes, this phase 3 trial involved 7439 patients and showed that finerenone reduced cardiovascular death, non-fatal myocardial infarction, stroke, or hospitalization for heart failure by 14% (HR 0.86, p=0.01). Both trials demonstrated consistent benefits across various subgroups.

• FUTURE Trials: Bayer has announced ongoing and planned larger-scale studies to explore finerenone’s potential in broader heart failure populations, including those without T2DM or CKD, reflecting an expanding clinical interest.

Regulatory Progress

• FDA Approval: In July 2021, the US Food and Drug Administration approved Kerendia® (finerenone) for reducing the risk of CKD progression and CV events in adult patients with T2DM and TNFR-enhanced CKD, positioning it as a key player in this therapeutic niche.

• European and Other Regulatory Bodies: The European Medicines Agency (EMA) granted marketing authorization in Europe in March 2022. Several other jurisdictions are evaluating registration submissions, indicating growing international acceptance.

Post-Marketing Surveillance and Real-World Evidence

Post-approval, Bayer and collaborators are conducting observational studies to monitor real-world safety, tolerability, and efficacy, particularly focusing on hyperkalemia management and long-term renal outcomes. Emerging data reinforce clinical trial findings, although hyperkalemia remains a notable safety concern requiring ongoing attention.

Market Analysis

Current Market Landscape

The global market for CKD and T2DM therapeutics is substantial, exceeding $50 billion annually (2022 estimates). Finerenone enters an ecosystem dominated by ACE inhibitors, angiotensin receptor blockers (ARBs), SGLT2 inhibitors, and mineralocorticoid receptor antagonists like spironolactone and eplerenone.

• Competitive Positioning: Unlike traditional MRAs, finerenone’s selectivity offers a superior safety profile, with less risk of hyperkalemia and gynecomastia, positioning it as a preferred agent for CKD patients with T2DM. Its unique mechanism and clinical benefits have fostered rapid adoption, particularly post-FIDELIO-DKD and FIGARO-DKD results.

• Market Penetration: Bayer reports increasing prescriptions, especially in North America and parts of Europe. Yet, penetration remains moderate relative to established therapies, with substantial potential for growth as awareness and clinician familiarity increase.

Key Market Drivers

• Increased CKD and T2DM Prevalence: Globally, CKD affects approximately 10% of the population, and T2DM prevalence is rising rapidly, expanding the patient pool requiring multi-faceted management [1].

• Clinical Evidence and Regulatory Endorsement: Robust trial data and regulatory approvals underpin clinician confidence, facilitating off-label and on-label applications.

• Unmet Medical Need: Existing treatments insufficiently address CV risk and CKD progression simultaneously, positioning finerenone as a differentiated therapy with added value.

Market Challenges

• Safety Concerns: Hyperkalemia, while less prevalent than with older MRAs, can limit usage, especially in polypharmacy or renal impairment.

• Cost and Reimbursement: Price points and reimbursement policies influence adoption, especially in emerging markets.

• Competition: SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin) also reduce CKD progression and CV events, potentially limiting finerenone’s market share initially.

Forecasting Market Growth

Given current trends, the finerenone market is expected to grow at a compound annual growth rate (CAGR) of approximately 20-25% over the next five years (2023–2028). Key factors influencing this projection include:

• Expanding indications into broader heart failure populations.

• Increased clinical adoption driven by ongoing large-scale trials confirming benefits beyond initial indications.

• Geographical expansion, particularly in emerging markets with rising CKD prevalence and improving healthcare infrastructure.

• Strategic collaborations and pipeline development may further boost market valuation.

By 2028, the global finerenone market could surpass $10 billion, based on current growth projections and expanding indications [2].

Future Outlook and Strategic Implications

Finerenone’s positioning as a differentiated, selective MRA with proven cardiovascular and renal benefits bodes well for sustained commercial success. Its integration into standard care protocols, combined with ongoing clinical trials exploring broader indications—including heart failure with preserved ejection fraction (HFpEF)—may unlock new revenue streams.

However, manufacturers must address safety management, educate clinicians on optimal dosing, and navigate reimbursement barriers. Emphasizing real-world evidence and expanding clinical applications will be critical to capitalize on the drug’s full market potential.

Key Takeaways

• Robust Clinical Evidence: Finerenone has demonstrated significant renal and cardiovascular benefits in large phase 3 trials, supporting its approval and growing use.

• Regulatory Endorsements: Approval in the US and Europe affirms its clinical value and paves the way for broader international adoption.

• Market Opportunity: The expanding CKD and T2DM patient population, coupled with distinct safety advantages over traditional MRAs, underpin substantial growth potential.

• Competitive Landscape: While SGLT2 inhibitors pose competition, finerenone’s unique mechanism and safety profile carve out a strategic niche.

• Future Prospects: Ongoing trials, broader indications, and real-world data will shape finerenone’s market trajectory, potentially positioning it as a cornerstone therapy for cardiorenal protection.

FAQs

1. What are the primary benefits of finerenone compared to traditional MRAs?
Finerenone offers higher selectivity for mineralocorticoid receptors, leading to fewer side effects such as gynecomastia and hyperkalemia, thereby permitting safer long-term use, especially in CKD and T2DM patients.

2. Are there significant safety concerns associated with finerenone?
Hyperkalemia remains the main safety concern, though its incidence is lower than with older MRAs. Proper patient selection and monitoring are critical to mitigate risk.

3. How does finerenone compare to SGLT2 inhibitors in CKD management?
While both agents provide renal and cardiovascular benefits, they have different mechanisms. Finerenone specifically targets mineralocorticoid receptor pathways, complementing SGLT2 inhibitors’ glycemic and natriuretic effects. Combination therapy may enhance patient outcomes.

4. What is the current market adoption rate of finerenone?
Adoption is growing, particularly in North America and Europe, but remains in early expansion phases due to ongoing clinician education and reimbursement considerations.

5. Are there ongoing trials exploring finerenone’s benefits beyond CKD and T2DM?
Yes. Bayer is investigating finerenone in broader heart failure populations, including HFpEF, and examining long-term outcomes, which could further enhance its market scope.

References

[1] International Diabetes Federation. Diabetes Facts & Figures. 2022.
[2] MarketWatch. "Global Finerenone Market Size, Share, Growth, and Forecast 2023–2028."