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)

Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth.
The study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively.
The main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD.
To understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as "treatment emergent adverse events" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR).
In this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study.
The participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants <6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will:
* have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured
* have blood samples taken
* have physical examinations
* have their heart examined by an electrocardiogram and echocardiography
* answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer
* for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The doctors will check the participants' health a month after the participants take their last treatment.

Start Date05 Jan 2026

Sponsor / Collaborator

Bayer AG

NCT07223502

/ RecruitingPhase 3

Sarfez Pharmaceuticals Inc. - A Randomized, Parallel, TwoArm Study Comparing the Net Clinical Benefit of Finerenone Versus a FixedDose Combination of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and PRoteinuric ChrOnic KidNey Disease

A study Comparing the Clinical Benefit of Finerenone Versus a Fixed-Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients with Hypertension and Chronic Kidney Disease.

Start Date01 Dec 2025

Sponsor / Collaborator

Sarfez Pharmaceuticals, Inc.

NCT07181135

/ Not yet recruitingPhase 3IIT

A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Participants With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

Study to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.

Start Date01 Dec 2025

Sponsor / Collaborator

University Medical Center Groningen

100 Clinical Results associated with Finerenone

100 Translational Medicine associated with Finerenone

100 Patents (Medical) associated with Finerenone

757

Literatures (Medical) associated with Finerenone

01 Jan 2026·AMERICAN JOURNAL OF CARDIOLOGY

Coronary Artery Disease in Heart Failure With Preserved Ejection Fraction

Review

Author: Falcão, Luiz Menezes ; Ono, Ryohei

Coronary artery disease (CAD), including both obstructive epicardial coronary artery disease and coronary microvascular dysfunction (CMD), is a common and impactful contributor to heart failure with preserved ejection fraction (HFpEF). CAD is associated with worse outcomes, progressive myocardial remodeling, and transition to reduced ejection fraction. CMD, which is particularly prevalent in women, impairs myocardial perfusion and energetics. This leads to exercise intolerance and elevated filling pressures. Emerging treatments such as sodium-glucose co-transporter 2 (SGLT2) inhibitors and finerenone offer benefit across HFpEF phenotypes, including those with ischemia. Multimodal diagnostic approaches, such as positron emission tomography, cardiovascular magnetic resonance, Doppler echocardiography, and invasive coronary physiology, are essential to identify CMD and subclinical CAD in appropriate patients. In conclusion, recognizing ischemic phenotypes within HFpEF is critical for risk stratification and therapeutic decision-making. Future studies should focus on phenotype-specific strategies to improve outcomes in this heterogeneous syndrome.

31 Dec 2025·RENAL FAILURE

Observation of the therapeutic effect of finerenone, a novel non-steroidal mineralocorticoid receptor antagonist, in patients with non-diabetic CKD

Article

Author: Jin, Li ; Li, Huixian ; Lv, Jia ; Lu, Wanhong ; Han, Jing ; Zhang, Wenjing ; Li, Fang ; Feng, Jie ; Wang, Zhigang ; Sun, Jiping

Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, exhibits anti-fibrotic and anti-inflammatory properties. While numerous studies have demonstrated its efficacy in reducing kidney and cardiovascular events in diabetic kidney disease, data on non-diabetic chronic kidney disease (CKD) remain limited. This retrospective study evaluated the safety and efficacy of finerenone in adult patients with non-diabetic CKD. The primary study parameters included estimated glomerular filtration rate (eGFR), 24-h proteinuria, serum potassium (sK+), and serum albumin. A total of 78 patients met the eligibility criteria. Following finerenone treatment, the overall efficacy rate was 61.5% (n = 48). Among responders, 24-h proteinuria significantly decreased (1.71 ± 0.32 g/d at baseline, 0.64 ± 0.14 g/d at 3 months, and 0.55 ± 0.14 g/d at 6 months), while eGFR showed a transient decline (88.34 ± 4.48 mL/min/1.73 m² at baseline, 82.09 ± 4.69 mL/min/1.73 m² at 3 months, and 87.05 ± 6.21 mL/min/1.73 m² at 6 months). Serum potassium fluctuated slightly (4.23 ± 0.07 mmol/L at baseline, 4.46 ± 0.07 mmol/L at 3 months, and 4.41 ± 0.08 mmol/L at 6 months), whereas serum albumin progressively increased (39.17 ± 0.93 g/L at baseline, 41.80 ± 0.70 g/L at 3 months, and 42.24 ± 0.70 g/L at 6 months). Among patients with IgA nephropathy (IgAN), 50% (n = 20) achieved proteinuria reduction. Adverse effects were minimal. Finerenone effectively reduced proteinuria in non-diabetic CKD patients with minimal impact on eGFR and sK+, supporting its efficacy and safety in real-world clinical practice in China.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of finerenone therapy for patients with chronic kidney disease and type 2 diabetes in England & Wales: results of the FINE-CKD model

Article

Author: Folkerts, Kerstin ; Roy-Chaudhury, Prabir ; Mernagh, Paul ; Levy, Pierre ; Pochopień, Michał ; Drzewiecka, Aleksandra ; Sullivan, Sean D. ; Cherney, David ; Millier, Aurélie ; Morris, Stephen

OBJECTIVE:

Chronic kidney disease (CKD) is the leading cause of kidney failure, end-stage kidney disease (ESKD), and cardiovascular (CV) events in patients with type 2 diabetes (T2D). The FIDELIO-DKD trial demonstrated that finerenone lowered the risk of renal and CV events in patients with CKD and T2D, regardless of cardiovascular disease history. This study evaluated the cost-effectiveness of finerenone added to background treatment (finerenone + BT) versus background treatment (BT) alone in patients with CKD and T2D from the perspective of the National Health Service in England and Wales.

METHODS:

A lifetime Markov model assessed the indicated usage of finerenone for the treatment of stage 3 or 4 CKD with albuminuria associated with T2D in adults, as per the relevant marketing authorization. The model structure considered kidney disease progression and CV risk, with health states encompassing patients' kidney disease stage and CV event profiles, using patient-level data from the FIDELIO-DKD trial. Model outcomes were life years, quality-adjusted life years (QALYs), per-patient costs, incremental costs, and incremental cost-effectiveness ratio (ICER). Sensitivity and scenario analysis were performed, including an analysis exploring the impact of real-world data which suggests more frequent sodium-glucose co-transporter-2 (SGLT2) inhibitor use in the United Kingdom since FIDELIO-DKD.

RESULTS:

Patients receiving finerenone experienced kidney and CV benefits, including reduced rates of nonfatal CV events and CV deaths, translating to improvements in survival and quality-adjusted life years (QALYs) of 6.11 and 5.97 per patient for finerenone + BT versus BT, respectively. Total discounted per-patient costs were £48,940 for finerenone + BT and £47,716 for BT alone, resulting in an incremental cost-effectiveness ratio of £8,808 per QALY gained for finerenone + BT versus BT.

CONCLUSION:

Sensitivity and scenario analyses, including more frequent SGLT2 inhibitor use consistent with real-world data, indicate a robust ICER that remains within the bounds of what is typically considered cost-effective.

104

News (Medical) associated with Finerenone

06 Nov 2025

·pharma.economictimes.indiatimes.com

Bayer secures expanded approval for Kerendia in India for heart failure treatment

New Delhi: German pharmaceutical giant Bayer has secured expanded approval for its innovative therapy Kerendia for treating adult patients with heart failure. Kerendia , developed from the active ingredient Finerenone , is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) that blocks MR overactivation--- a key driver of inflammation and fibrosis in both the heart and the kidney. By selectively inhibiting MR activity, it helps lower the risk of kidney failure and reduces events such as heart failure and myocardial infarction. Given its non-steroidal base, the drug holds a safety edge against conventional therapies like Spironolactone and has a better targeted delivery design. Previously, the therapy is approved to treat patients with chronic kidney disease ( CKD ) linked to type 2 diabetes and the latest approval expands its label to treat heart failure with preserved and mildly reduced ejection fraction—HFpEF and HFmrEF. According to Bayer , the approval in India is based on data from the FINEARTS-HF Phase III trial, where the oral therapy demonstrated a 16 per ent reduction in the composite risk of cardiovascular death and total heart failure events, along with improvements in patient-reported health status. Besides India, the innovator has also secured expanded approval in the US for the same indications. In India, the therapy was approved in 2022, and last year the company inked a distribution agreement with Sun Pharma, granting non-exclusive rights to market the drug under a second brand name. The innovator is banking on Kerendia as its potential blockbuster brand and in the last clander year (2024) it clocked net sales of €463 million (~over Rs 4,600 crore). Commenting on the approval, Shweta Rai, MD - India and Country Division Head - South Asia, Bayer’s Pharmaceutical Division, said, “With the expansion of Finerenone ’s indication, we are addressing types of heart failure that account for nearly half of all heart failure cases but have had limited proven treatment options.” In 2023, Danish drug giant Novo Nordisk attempted to challenge Kerendia with a $1.3 billion buyout. However, a year later, Novo discontinued its development plans as the bet failed to meet the primary endpoint of a Phase 3 study for the CKD indication. By Online Bureau ,

Drug ApprovalPhase 3Clinical ResultAHA

06 Nov 2025

·www.prnewswire.com

Breakthrough T1D Encouraged by Promising Results of FINE-ONE Phase 3 Clinical Trial Evaluating Finerenone for Chronic Kidney Disease Associated with Type 1 Diabetes

NEW YORK, Nov. 6, 2025 /PRNewswire/ -- Results of the Bayer-led Phase 3 FINE-ONE clinical trial, presented at the American Society of Nephrology Kidney Week in Houston, demonstrate that finerenone significantly reduced the urine albumin-to-creatine ratio (UACR) from baseline over six months in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). A reduction in UACR has been shown to indicate a delay in CKD progression, improved kidney health, and decreased cardiovascular complication risks. Chronic kidney disease remains a significant risk for those living with T1D, with nearly one in three individuals with T1D developing kidney disease in their lifetime. Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that is approved for treatment of adults with CKD associated with type 2 diabetes. The results of the FINE-ONE trial, which Bayer plans to provide to health authorities for regulatory assessment of finerenone in CKD associated with T1D, are evidence that it is effective for CKD associated with T1D as well. "We are thrilled to see the results from FINE-ONE showing that finerenone improved kidney health in people with type 1 diabetes and chronic kidney disease," said Jonathan Rosen, Ph.D., Research Director at Breakthrough T1D. "Few kidney therapies are currently available for people with type 1 diabetes, and FINE-ONE is a landmark achievement. Breakthrough T1D applauds Bayer for addressing the huge unmet need by conducting this pivotal phase 3 program and is grateful for the collaboration on this effort." Breakthrough T1D was a strategic collaborator on the FINE-ONE trial and is committed to further collaboration with Bayer to support therapy development and improved treatment of CKD and other chronic conditions for people with T1D. About Breakthrough T1D, Formerly JDRF As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. About Type 1 Diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts approximately 9.5 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. Contact: Casey Fielder 509-651-0087 [email protected] SOURCE Breakthrough T1D, Formerly JDRF 21% more press release views with Request a Demo

Phase 3Clinical ResultDrug Approval

06 Nov 2025

·www.businesswire.com

KERENDIA ® (finerenone) Meets Primary Endpoint in Phase III Clinical Trial for Adults with Type 1 Diabetes and Chronic Kidney Disease

The investigational FINE-ONE trial met its primary endpoint, demonstrating that finerenone led to a significant reduction in urine albumin-to-creatinine ratio (UACR), an important marker of cardiovascular risk and kidney disease progression, from start of trial through six months, for people living with type 1 diabetes (T1D) and chronic kidney disease (CKD) versus those receiving standard of care plus placebo 1 These data were presented as a late-breaker at the opening plenary session at the American Society of Nephrology (ASN) Kidney Week 2025 Additionally, three presentations from the CONFIDENCE trial in patients with type 2 diabetes (T2D) and CKD, which investigated simultaneous administration of finerenone and a sodium-glucose transport protein 2 inhibitor (SGLT2i), 2 will also be presented as two late-breaking analyses and featured independently as part of the “Best of the Journal of the American Medical Association and the New England Journal of Medicine ” session WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced new Phase III investigational data from the pivotal FINE-ONE trial showing that KERENDIA® (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87]; p=0.0001).1 These late-breaking data were presented today at the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 in Houston by Dr. Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Chair of the study’s Steering Committee. “We are excited to announce the results of the FINE-ONE trial, which represents the first positive Phase III study in 30 years dedicated to patients with type 1 diabetes and chronic kidney disease3—a research advancement underscored by the trial’s inclusion in the opening plenary session,” said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Steering Committee. “By significantly reducing UACR—a key marker of cardiovascular risk and kidney damage4—finerenone has the potential to become an important addition to the treatment landscape for patients with type 1 diabetes and chronic kidney disease.” Up to 30% of Americans living with T1D are affected by CKD.5,6 Since July 2021, KERENDIA has been approved to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure, non-fatal myocardial infarction (MI), sustained estimated glomerular filtration rate (eGFR) decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received U.S. Food and Drug Administration (FDA) approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) of ≥40%.7 FINE-ONE (FINErenone efficacy and safety in chronic kidney disease and type ONE diabetes; NCT05901831) is a pivotal, global, randomized, prospective, double-blind, multicenter, Phase III study in people with T1D and CKD. It enrolled 242 adult participants with the primary objective to demonstrate whether the addition of finerenone, 10 or 20 mg once daily, to standard of care is superior to placebo in reducing UACR over six months. The primary endpoint was the relative change in UACR from baseline over six months. UACR is being investigated as a bridging biomarker to demonstrate delayed kidney disease progression.1 Elevated UACR is strongly associated with CV risk and kidney disease progression in multiple patient populations, including T1D and T2D.8,9,10 Safety of finerenone was also assessed in the study. Finerenone is the first investigational treatment, since the 1990s, to show positive results in a Phase III study dedicated to people living with T1D and CKD1 and works by selectively and potently blocking mineralocorticoid receptor overactivation in the heart and kidneys.7 In FINE-ONE, safety and tolerability with finerenone were largely consistent with the existing evidence for people with T2D and CKD. The rate of treatment-emergent adverse events (TEAEs) was 47.1% for those treated with finerenone and 49.2% for placebo. The rate of treatment-emergent serious adverse events (TESAEs) was 11.8% and 11.5%, respectively. Hyperkalemia, an adverse event of special interest (AESI), was observed more frequently with finerenone (10.1%) compared to placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively.1 “FINE-ONE is the fourth positive consecutive pivotal Phase III clinical trial for KERENDIA,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “The findings represent another important milestone reinforcing the evidence for KERENDIA across cardiovascular and kidney care in multiple patient populations.” Bayer plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA based on the results of FINE-ONE in 2026. Additional Data to be Presented at ASN 2025 Data from the Phase II CONFIDENCE (COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint; NCT05254002) trial in patients with T2D and CKD, which investigated simultaneous administration of finerenone and a sodium-glucose transport protein 2 inhibitor (SGLT2i),2 will be presented as two late-breaking analyses. Previously announced results from CONFIDENCE will also be featured independently in the “Best of the Journal of the American Medical Association and the New England Journal of Medicine” session taking place on November 7, highlighting the most impactful kidney research articles recently published in these prestigious journals. “The findings from the CONFIDENCE study add to the robust body of evidence reinforcing UACR as a critical marker of risk for cardiovascular events and kidney failure,” said Dr. Rajiv Agarwal, Professor Emeritus of Medicine, Indiana University School of Medicine and VA Medical Center, Indianapolis, and Chair of the CONFIDENCE study’s Steering Committee. “I am proud to be sharing the CONFIDENCE study during the ‘Best of the Journal of the American Medical Association and the New England Journal of Medicine’ session because it reflects the importance of these findings for patients with type 2 diabetes and chronic kidney disease and their physicians.” About KERENDIA’s Clinical Trial Program KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,11 CONFIRMATION-HF12 and FINALITY-HF.13 The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD, FIGARO-DKD, and FINE-ONE14 as well as the ongoing investigational studies FIND-CKD,15 FIONA,16 and FIONA-OLE.17 About KERENDIA® (finerenone)7 INDICATIONS: KERENDIA (finerenone) is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets) cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any component of this product Concomitant use with strong CYP3A4 inhibitors Patients with adrenal insufficiency WARNINGS AND PRECAUTIONS: Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly . Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m 2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function. MOST COMMON ADVERSE REACTIONS: CKD associated with T2D : From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). HF LVEF ≥40% : From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). 18 Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%). DRUG INTERACTIONS: Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice. Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate. Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers. Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions. USE IN SPECIFIC POPULATIONS: Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment. Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B). Please see the Prescribing Information for KERENDIA. About Bayer’s Commitment in Cardiovascular and Kidney Diseases Bayer’s legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys—two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs. With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on X: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 1 Heerspink HJL, Cherney D, Rossing P, Lawatscheck R, McGill JB. Finerenone in chronic kidney disease and type 1 diabetes [abstract]. Presented at: American Society of Nephrology Kidney Week; November 6, 2023; Houston, TX. 2 Agarwal R, Green JB, Heerspink HJL, et al. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. New England Journal of Medicine. 2025;393(6). doi:https://doi-org.libproxy1.nus.edu.sg/10.1056/nejmoa2410659 3 Heerspink, Hiddo J L et al. “Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial.” Diabetes research and clinical practice vol. 204 (2023): 110908. doi:10.1016/j.diabres.2023.110908 4 Barzilay JI, Youssef M.K. Farag, Durthaler JM. Albuminuria: An Underappreciated Risk Factor for Cardiovascular Disease. Journal of the American Heart Association. 2024;13(2). doi:https://doi-org.libproxy1.nus.edu.sg/10.1161/jaha.123.030131 5 Tuttle KR, Reynolds CL, Kornowske LM, et al. Prevalence and severity of chronic kidney disease in a population with type 1 diabetes from a United States health system: a real-world cohort study. The Lancet Regional Health - Americas. 2025;47:101130. doi:https://doi-org.libproxy1.nus.edu.sg/10.1016/j.lana.2025.101130 6 Rossing P, Per-Henrik Groop, Singh R, Lawatscheck R, Tuttle KR. Prevalence of Chronic Kidney Disease in Type 1 Diabetes Among Adults in the U.S. Diabetes Care. Published online June 10, 2024. doi:https://doi-org.libproxy1.nus.edu.sg/10.2337/dc24-0335 7 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215341s009lbl.pdf. Accessed October 1, 2025. 8 Coresh, Josef et al. “Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies.” The lancet. Diabetes & endocrinology vol. 7,2 (2019): 115-127. doi:10.1016/S2213-8587(18)30313-9 9 Heerspink, Hiddo J L et al. “Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials.” The Lancet. Diabetes & endocrinology vol. 7,2 (2019): 128-139. doi:10.1016/S2213-8587(18)30314-0 10 de Boer, Ian H et al. “Albuminuria Changes and Cardiovascular and Renal Outcomes in Type 1 Diabetes: The DCCT/EDIC Study.” Clinical journal of the American Society of Nephrology: CJASN vol. 11,11 (2016): 1969-1977. doi:10.2215/CJN.02870316 11 A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. https://www.clinicaltrials.gov/study/NCT06008197. Accessed March 10, 2025. 12 A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. https://www.clinicaltrials.gov/study/NCT06024746. Accessed March 10, 2025. 13 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 (FINALITY-HF). Clinical trial registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950. Accessed March 10, 2025. 14 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 (FINE-ONE). Clinical trial registration No. NCT05901831. https://www.clinicaltrials.gov/study/NCT05901831. Accessed March 10, 2025. 15 A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. https://www.clinicaltrials.gov/study/NCT05047263. Accessed March 10, 2025. 16 A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. https://www.clinicaltrials.gov/study/NCT05196035. Accessed March 10, 2025. 17 A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283. Accessed March 10, 2025. 18 Data on file. COR-KER-US-0173-1 11/25

Clinical ResultPhase 3Drug ApprovalPhase 2

100 Deals associated with Finerenone

External Link

KEGG	Wiki	ATC	Drug Bank
D10633	Finerenone	-	DB16165

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	United States	Bayer AG	14 Jul 2025
Diabetes Mellitus, Type 2	Canada	Bayer, Inc.	14 Oct 2022
Chronic Kidney Diseases	South Korea	Bayer AG	10 May 2022
Type 2 diabetes mellitus with established diabetic nephropathy	United States	Bayer HealthCare Pharmaceuticals, Inc.	09 Jul 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Left ventricular systolic dysfunction	Phase 3	United States	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Argentina	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Austria	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Belgium	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Brazil	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Bulgaria	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Canada	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Czechia	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Finland	Bayer AG	28 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Germany	Bayer AG	28 Nov 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05901831 (FINE-ONE, Company_Website \| ASN2025) Manual	Phase 3	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	242	Finerenone + SOC	jhqlfzlwzg(iypqugfbsl) = zbekeizstt uahnptwrhd (bsudmlnzrm ) Met View more	Positive	06 Nov 2025
				Placebo + SOC	boyueimqhs(hcqbscaxig) = hxpxcvlhuf fhtytnhytw (oetdjaufxy ) View more
NCT01807221 \| NCT01345656 \| NCT01874431 \| NCT05047263 (FIDELIO-DKD, Pubmed \| J Am Soc Nephrol)	Not Applicable	Chronic Kidney Diseases	14,180	Finerenone	eoqbdvcirh(mrhcgyndnf) = zjadgicuwi hzlzeeecav (fwuwjkaicy ) View more	Positive	12 Sep 2025
				Placebo	eoqbdvcirh(mrhcgyndnf) = wcalrbrjeg hzlzeeecav (fwuwjkaicy ) View more
NCT05254002 (CONFIDENCE, Pubmed \| Nephrol Dial Transplant)	Phase 3	-	818	Finerenone plus empagliflozin	epupjwunha(cavqjwdrpq) = zoxdpjvmvx uzbrwguvoi (heurimuerb ) View more	Positive	31 Aug 2025
NCT04435626 (FINEARTS-HF, CTgov)	Phase 3	Stroke \| Heart Failure	6,016	BAY94-8862 (Finerenone (BAY94-8862))	qwznyqobxz = sielyzqzhn qanvkkzchz (whtwtzvtqh, ztaxyglzye - ewojoxbjod) View more	-	26 Aug 2025
				placebo (Placebo)	qwznyqobxz = kiewxvnbol qanvkkzchz (whtwtzvtqh, kfchgbabxa - zjlmvkoemi) View more
Pubmed Manual	Not Applicable	Diabetes Mellitus, Type 2 \| Diabetic Nephropathies	48	finerenone	jfppwtfzby(dvyqhcefxz) = jvikswybff kzvacauzcw (huqwaesget, 51.14 - 288.77) View more	Positive	18 Aug 2025
				finerenone (Microalbuminuria)	jfppwtfzby(dvyqhcefxz) = ngxovmppfj kzvacauzcw (huqwaesget, 32.10 - 94.34) View more
NCT05254002 (CONFIDENCE, Pubmed \| Nephrol Dial Transplant)	Phase 2	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases eGFR \| UACR \| HbA1c ... View more	818	Finerenone plus Empagliflozin	fmhlqzzozb(kjlqyaqcde) = xovlkhuweg divvirflgh (dozpzchobk, 292 - 1140) View more	Positive	01 Aug 2025
NCT04435626 (FINEARTS-HF, Pubmed \| Eur J Heart Fail)	Phase 3	Heart failure with normal ejection fraction	6,001	Finerenone	pcgxdwrofr(xnenposfnt) = rmcuvzqnhv jqlmfkrlyk (fsklfggigm, 449 - 1946) View more	Positive	01 Aug 2025
				Placebo	vjxqdlrkmu(jehiuceoop) = gqouhgzxkq nwylattwwl (mdhdcbmbun, 8.1 - 16.7)
NCT04435626 (FINEARTS-HF, FDA_CDER) Manual	Phase 3	Heart Failure	-	Kerendia 10 or 20 or 40 mg OD	avurroppuq(qnwdenfrmd) = bkqeffgpby ihepgbeaqq (ispqjwhlyc ) View more	Positive	11 Jul 2025
				Placebo	avurroppuq(qnwdenfrmd) = ouhrffctam ihepgbeaqq (ispqjwhlyc ) View more
NCT04435626 (Pubmed \| JAMA Cardiol)	Phase 3	Heart failure with reduced ejection fraction left ventricular ejection fraction (LVEF)	6,001	Finerenone 20 mg	oalpslynvs(xpwqlhfuhb) = mzhkpocgev tkuklfjnsj (lmolrwobhy ) View more	Positive	01 Jul 2025
NCT04435626 (FINEARTS-HF, Pubmed \| JAMA Cardiol)	Phase 3	Atrial Fibrillation AF \| paroxysmal AF \| persistent or permanent AF	5,984	Finerenone 20 mg	xwmgviagsp(nflkjnbekp) = kgqgkzzkix vtntxswhlg (hwejlittaq )	Positive	01 Jul 2025
				Finerenone 40 mg	xwmgviagsp(nflkjnbekp) = ampdfymqep vtntxswhlg (hwejlittaq )

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