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	8
Diabetic Kidney Disease	3
Chronic Kidney Diseases	3
Heart Failure	3

Condition MeSH

Condition MeSH for Finerenone
Intervention	Trials
Kidney Diseases	14
Renal Insufficiency, Chronic	12
Diabetes Mellitus, Type 2	8
Diabetes Mellitus	7

Clinical Trial Locations for Finerenone

Trials by Country

Trials by Country for Finerenone
Location	Trials
United States	156
Japan	104
China	79
Italy	40
Germany	39

Trials by US State

Trials by US State for Finerenone
Location	Trials
Florida	7
Missouri	7
California	6
Texas	6
North Carolina	6

Clinical Trial Progress for Finerenone

Clinical Trial Phase

Clinical Trial Phase for Finerenone
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	10
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Finerenone
Clinical Trial Phase	Trials
Not yet recruiting	13
Recruiting	7
Completed	7

Clinical Trial Sponsors for Finerenone

Sponsor Name

Sponsor Name for Finerenone
Sponsor	Trials
Bayer	17
Saint Luke's Hospital of Kansas City	1
Randers Regional Hospital	1

Sponsor Type

Sponsor Type for Finerenone
Sponsor	Trials
Other	31
Industry	19

Finerenone: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Finerenone

Finerenone, marketed as Kerendia by Bayer, is a non-steroidal, selective mineralocorticoid receptor antagonist that has been making significant waves in the medical and pharmaceutical industries. Initially approved by the FDA in 2021 for the treatment of chronic kidney disease associated with type 2 diabetes, finerenone is now being explored for its potential in treating heart failure.

Clinical Trials: FINEARTS-HF

One of the most pivotal clinical trials for finerenone is the FINEARTS-HF study. This Phase III trial was designed to evaluate the efficacy and safety of finerenone in patients with symptomatic heart failure with preserved or mildly reduced left ventricular ejection fraction (LVEF)[2][4].

Key Findings of FINEARTS-HF

• Primary Endpoint: The trial demonstrated that finerenone significantly reduced the composite of cardiovascular death and total heart failure events compared to placebo, thereby achieving its primary endpoint[2][4].
• Patient Enrollment: The study involved approximately 6,000 patients who were randomized to receive either finerenone or a placebo once a day for up to 42 months[2].
• Safety and Tolerability: Finerenone was well tolerated in the study, with a lower risk of elevated potassium levels compared to other mineralocorticoid receptor antagonists like spironolactone and eplerenone[2].

Mechanism of Action and Clinical Significance

Finerenone works by antagonizing the mineralocorticoid receptor, which plays a crucial role in the regulation of sodium and potassium balance in the body. This mechanism is particularly beneficial in patients with heart failure and chronic kidney disease, as it helps in reducing the progression of these conditions.

Comparison with Other Mineralocorticoid Receptor Antagonists

Unlike traditional mineralocorticoid receptor antagonists, finerenone has shown a more favorable safety profile, especially in terms of potassium levels. This is a significant advantage, as elevated potassium levels can be a critical concern in patients with heart failure and kidney disease[2].

Market Analysis and Projections

Current Market Position

Despite a slow start in the renal market, Bayer remains optimistic about the potential of finerenone. The company has retained its peak sales target of more than 3 billion euros ($3.3 billion), with a significant portion of this projection hinging on the drug's performance in the heart failure market[2].

Sales Projections

• Heart Failure Indication: Bayer is planning to discuss regulatory approval for finerenone in heart failure, which is central to its peak sales forecast. The positive results from the FINEARTS-HF trial have bolstered the company's confidence in achieving these sales targets[2].
• Chronic Kidney Disease: Although the renal market has not progressed as quickly as anticipated, the addition of heart failure as an indication is expected to significantly boost sales[2].

Cost-Effectiveness Analysis

A cost-effectiveness analysis of finerenone in the context of type 2 diabetes-related chronic kidney disease has shown promising results. Here are some key points:

Quality-Adjusted Life Years (QALYs)

• The treatment strategy of finerenone plus standard of care led to gains of 6.95 QALYs over a lifetime, with an added cost of $65,305.72 compared to standard of care alone[5].
• The incremental cost-effectiveness ratio (ICER) for finerenone was $135,257.06 per QALY, which is below the willingness-to-pay threshold in the United States ($150,000/QALY)[5].

Sensitivity Analysis

• Probabilistic sensitivity analyses indicated that the probability of finerenone plus standard of care being cost-effective was 57.6%[5].

Future Perspectives and Implications

Regulatory Approval

Bayer is set to engage with regulatory agencies to seek approval for finerenone in the heart failure indication. Given the positive outcomes from the FINEARTS-HF trial, there is a strong likelihood of approval, which would significantly expand the drug's market potential[2].

Clinical Impact

The success of finerenone in clinical trials could lead to a paradigm shift in the treatment of heart failure and chronic kidney disease. It offers a new therapeutic option with a favorable safety profile, which could improve patient outcomes and reduce the burden on healthcare systems.

Expert Insights

Stefan Oelrich, head of Bayer’s pharmaceuticals unit, has expressed optimism about the drug's potential, stating that the heart failure indication "will ultimately ... allow us to get to peak sales"[2].

Key Takeaways

• Clinical Trials: Finerenone has demonstrated efficacy and safety in the FINEARTS-HF trial for heart failure with preserved or mildly reduced LVEF.
• Market Projections: Bayer targets peak sales of over 3 billion euros, driven by the drug's performance in the heart failure market.
• Cost-Effectiveness: Finerenone is a cost-effective option for patients with type 2 diabetes-related chronic kidney disease.
• Regulatory Approval: Bayer is planning to seek regulatory approval for finerenone in heart failure based on positive trial results.

FAQs

What is finerenone and how does it work?

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist. It works by blocking the mineralocorticoid receptor, which helps in regulating sodium and potassium balance, thereby reducing the progression of heart failure and chronic kidney disease.

What are the key findings of the FINEARTS-HF trial?

The FINEARTS-HF trial showed that finerenone significantly reduced the composite of cardiovascular death and total heart failure events compared to placebo in patients with symptomatic heart failure with preserved or mildly reduced LVEF.

What is the current market position of finerenone?

Despite a slow start in the renal market, Bayer remains optimistic and has retained its peak sales target of over 3 billion euros, with a significant focus on the heart failure market.

Is finerenone cost-effective?

Yes, finerenone has been shown to be cost-effective in treating type 2 diabetes-related chronic kidney disease, with an ICER below the willingness-to-pay threshold in the United States.

What are the next steps for finerenone in terms of regulatory approval?

Bayer plans to discuss regulatory approval for finerenone in heart failure with regulatory agencies, based on the positive results from the FINEARTS-HF trial.

Sources

1. FINEARTS-HF Trial: Finerenone in Women and Men With Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JAMA Cardiology.
2. Bayer's Finerenone: Bayer's Finerenone Hits Primary Endpoint in Phase III Heart Failure Trial. BioSpace.
3. FIND-CKD Trial: Design and baseline characteristics of the Finerenone, in addition to standard of care, in patients with non-diabetic chronic kidney disease. Nephrology, Dialysis, Transplantation.
4. FINEARTS-HF Trial Update: Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure - FINEARTS-HF. American College of Cardiology.
5. Cost-Effectiveness Analysis: Cost-effectiveness of finerenone added to standard of care for treating type 2 diabetes mellitus-related chronic kidney disease in the United States. PubMed.