Bayer : finerenone significantly reduced kidney function decline and a composite of cardiovascular-kidney outcomes versus placebo in patients with non-diabetic chronic kidney disease

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Continue DocCheck-EN SPECIALIZED PRESS Export-LatestNews Export-PH Pharmaceuticals Research & Innovation Cardiovascular Diseases Bayer June 05 , 2026 | 12:36 PM Europe/Amsterdam Not intended for U.S. and UK Media - Late-Breaking FIND-CKD results presented at 63rd ERA Congress 2026: Bayer's finerenone significantly reduced kidney function decline and a composite of cardiovascular-kidney outcomes versus placebo in patients with non-diabetic chronic kidney disease Summary In the Phase III study FIND-CKD, presented at ERA and simultaneously published in the New England Journal of Medicine , finerenone showed a statistically significant and clinically meaningful improvement in total estimated glomerular filtration rate (eGFR) slope (0.7 ml/minute/1.73 m2/year 1 [95% CI, 0.3-1.1; p<0.001]) versus placebo in addition to standard of care / Finerenone also significantly reduced the key secondary endpoint, a composite of cardiovascular-kidney outcomes by 23% (HR 0.77 [95% CI, 0.60-0.99; p=0.04]) / A prespecified subgroup analysis of FIND-CKD showed that finerenone delayed progression of kidney disease versus placebo in patients with CKD caused by glomerular diseases, with similar effects across subtypes; results were simultaneously published in JAMA / FIND-CKD is the largest Phase III study to date focused on diverse etiologies of non-diabetic CKD, and the fifth completed Phase III study to report positive results with finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), which so far was studied in more than 20,000 patients across multiple patient populations with chronic kidney disease and/or heart failure Berlin, June 5, 2026 - Detailed results from the pivotal Phase III study FIND-CKD demonstrate that compared to placebo when added to standard of care, finerenone (Kerendia™/ Firialta™) showed a statistically significant and clinically meaningful improvement in total estimated glomerular filtration rate (eGFR) slope (0.7 ml/minute/1.73 m 2 /year [95% CI, 0.3-1.1; p<0.001]), defined as the mean annual rate of change in eGFR from baseline to Month 32, in adult patients with non-diabetic chronic kidney disease (CKD). Finerenone also significantly reduced the key secondary endpoint, a composite of cardiovascular-kidney outcomes, by 23% (HR 0.77 [95% CI, 0.60-0.99; p=0.04]). The FIND-CKD findings were presented today as a late-breaking clinical trial at the 63 rd European Renal Association (ERA) Congress 2026 and simultaneously published in the New England Journal of Medicine . "FIND-CKD is a large, rigorously conducted study in non-diabetic chronic kidney disease across multiple etiologies. The results show that finerenone significantly preserved kidney function and reduced the risk of cardiovascular-kidney outcomes with a consistent effect across prespecified subgroups, supporting a broad applicability in these patients," said Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Co-Chair of the study's Executive Committee. "These findings provide key insights into the benefits of finerenone in reducing cardiovascular and kidney complications in a broad, underserved patient population with non-diabetic CKD where only few guideline-directed options exist." Results from the FIND-CKD study The primary outcome of the FIND-CKD study was estimated glomerular filtration rate (eGFR) change over time (= total eGFR slope). The eGFR slope is a validated surrogate endpoint for clinical kidney outcomes. Finerenone showed a statistically significant and clinically meaningful improvement of kidney function compared with placebo: The mean annual decline in eGFR from baseline to 32 months (total slope) was −4.0 ml/minute/1.73 m 2 /year with placebo and −3.3 ml/minute/1.73 m 2 /year with finerenone, corresponding to a 0.7 ml/minute/1.73 m 2 /year slower decline with finerenone [95% CI, 0.3-1.1; p<0.001]). With regard to the exploratory outcome of chronic eGFR slope (from month 3 to the end of the treatment period), finerenone slowed kidney function decline compared to placebo by 1.24 ml/minute/1.73m 2 /year (95% CI, 0.86-1.61; p<0.0001). The results of finerenone versus placebo on the annual eGFR decline were consistent across all prespecified patient subgroups spanning diverse etiologies of non-diabetic chronic kidney disease populations. In addition to the reduction in eGFR decline, finerenone also significantly reduced the key secondary endpoint of a composite of cardiovascular-kidney outcomes of kidney failure, sustained ≥57% eGFR decline, heart failure hospitalization or CV death by 23% (HR 0.77 [95% CI, 0.60-0.99; p=0.04]). The result for the secondary endpoints of the composite of sustained ≥57% eGFR decline or kidney failure was HR 0.78 (95% CI, 0.60-1.01; p=0.06), and the composite of hospitalization for heart failure or cardiovascular death was HR 0.60 (95% CI, 0.27-1.33). Finerenone was well-tolerated in the FIND-CKD study, which is consistent with the well-established safety profile of finerenone. Results from a prespecified subgroup analysis from FIND-CKD in patients with CKD due to glomerular diseases: Among the non-diabetic CKD patients included in FIND-CKD, approximately 60% had an underlying glomerular disease, around half of them had immunoglobulin A nephropathy (IgAN) or focal segmental glomerularsclerosis (FSGS). A prespecified, exploratory subgroup analysis of FIND-CKD evaluating the efficacy and safety of finerenone in patients with CKD due to glomerular diseases was also presented as a late-breaker during the same session at ERA, and results were simultaneously published in JAMA . In this subgroup analysis, finerenone was shown to slow kidney function decline, reduce albuminuria, and lower the risk of kidney failure or sustained loss of kidney function, with consistent effects across subtypes of CKD due to glomerular disease. For details, see below in the respective section under "About FIND-CKD". "There is an urgent need for new treatments targeting shared disease mechanisms in non-diabetic CKD etiologies, to help improve the prognosis of these patients as they continue to experience progressive kidney function decline and cardiovascular risk despite currently available therapies. The FIND-CKD study delivers evidence that finerenone both improves kidney function and reduces cardiovascular-kidney risks, with consistent results across major underlying causes of non-diabetic CKD such as hypertension and glomerular disease," said Dr. Christian Rommel, Global Head of Research and Development at Bayer's Pharmaceuticals Division. "We are excited to share these data, which contribute to the breadth and consistency of findings with finerenone in chronic kidney disease." Approximately 850 million people worldwide are living with chronic kidney disease (CKD) and more than half of them have non-diabetic CKD. Worldwide, more than 3.5 million people with kidney failure are treated with dialysis, which is associated with a 5-year survival rate of about 40% after treatment initiation. Non-diabetic CKD can have a range of etiologies, of which the most common include kidney disease linked to hypertension and glomerulonephritis (including IgAN and FSGS). Despite standard of care, patients with non-diabetic CKD remain at risk for kidney failure and cardiovascular events. Chronic kidney disease linked to hypertension is the second most common cause of kidney failure. In addition, patients with advanced non-diabetic CKD face a significantly increased risk for a fatal cardiovascular event, about 2.6 times higher than that of the general population without CKD, which increases further as kidney function declines. Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that in five pivotal Phase III studies has demonstrated cardiovascular and/or kidney benefits, respectively, in patients with HF with left ventricular ejection fraction (LVEF) ≥40%, patients with CKD associated with type 2 diabetes, patients with CKD associated with type 1 diabetes, and patients with non-diabetic CKD. Bayer plans to provide the data to health authorities for regulatory assessment of finerenone for the treatment of non-diabetic CKD. About Kerendia ™ / Firialta ™ (finerenone) Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Since 2021, finerenone is marketed as Kerendia™ or, in selected countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan, and the U.S. Following priority review designation, finerenone has been approved for the treatment of heart failure with LVEF ≥ 40% in the U.S. since July 2025. In the EU, Japan, several other markets, and since recently in China, finerenone is also approved in heart failure with LVEF ≥ 40%. Applications for marketing authorization in HF with LVEF ≥ 40% have been filed in additional markets. The clinical study program with finerenone, FINEOVATE, currently comprises twelve Phase III studies with dedicated programs in CKD and HF respectively. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies in pediatric patient populations FIONA, and FIONA-OLE. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, the ongoing investigator-sponsored, collaborative studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF, as well as the ongoing Phase III studies in pediatric patient populations, FIORE and FIORELLO. About FIND-CKD FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD. The study investigated finerenone in a broad patient population spanning different etiologies of non-diabetic CKD, adding to the positive data and breadth of evidence of finerenone in CKD associated with diabetes. FIND-CKD ( FI nerenone, in addition to standard of care, on the progression of kidney disease in patients with N on- D iabetic C hronic K idney D isease) investigated the efficacy and safety of finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including kidney disease linked to hypertension and glomerular diseases. Patients were randomized to receive either finerenone 10mg or 20mg or placebo on top of maximum tolerated labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). The primary endpoint of FIND-CKD was estimated glomerular filtration rate (eGFR) change over time (=total eGFR slope), i.e. the mean annual rate of change in eGFR from baseline to Month 32. Finerenone showed a statistically significant and clinically meaningful improvement of kidney function compared with placebo: The mean annual decline in eGFR from baseline to 32 months (total slope) was −4.0 (95% CI, −4.3 to −3.8) ml/minute/1.73 m 2 /year with placebo and −3.3 (95% CI, −3.6 to −3.1) ml/minute/1.73 m 2 /year with finerenone, corresponding to a 0.7 ml/minute/1.73 m 2 /year slower decline with finerenone [95% CI, 0.3-1.1; p˂0.001]). The results of finerenone versus placebo on the annual eGFR decline were consistent across all prespecified patient subgroups spanning diverse etiologies of non-diabetic CKD populations. With regard to the exploratory outcome of chronic eGFR slope, measuring eGFR slope from month 3 to the end of the treatment period, finerenone slowed kidney function decline compared to placebo by 1.24 ml/minute/1.73m 2 /year (95% CI, 0.86-1.61). Finerenone also significantly reduced the key secondary endpoint, a composite of cardiovascular-kidney outcomes (consisting of kidney failure, sustained ≥57% eGFR decrease, hospitalization for heart failure or cardiovascular death), by 23% (HR 0.77 [95% CI, 0.60-0.99; p=0.04]). The result for the secondary endpoints of the composite of sustained ≥57% eGFR decline or kidney failure was HR 0.78 (95% CI, 0.60-1.01; p=0.06), and the composite of hospitalization for heart failure or cardiovascular death was HR 0.60 (95% CI, 0.27-1.33). In addition, finerenone achieved early and sustained reduction of the urine albumin-to-creatinine-ratio (UACR): At month 6, 56.0% of patients receiving finerenone and 24.4% of the placebo-treated patients achieved the exploratory endpoint of a ≥30% UACR reduction from baseline (odds ratio, 3.99; 95% CI, 3.22-4.95), with a maximum reduction of 39% seen at month 12. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs. Finerenone was well-tolerated in the FIND-CKD study, which is consistent with the well-established safety profile of finerenone. No new safety signals were identified. The overall incidence of treatment-emergent adverse events was comparable between finerenone and placebo groups (68.3% and 65.4%, respectively). Hyperkalemia-related adverse events occurred more frequently with finerenone than placebo (in 135 patients or 17% in the finerenone arm, versus in 105 patients or 13.3% in the placebo arm, respectively). There were no fatal adverse events of hyperkalemia in either treatment group, and the rate of serious hyperkalemia events and hyperkalemia leading to hospitalization or discontinuation of study drug was low in both groups (˂1% and ˂2%, respectively). Results of the prespecified subgroup analysis in patients with CKD due to glomerular diseases: Approximately 60% of the non-diabetic CKD patients included in FIND-CKD had an underlying glomerular disease. In a prespecified subgroup analysis, finerenone reduced the decline in kidney function in these patients, with a total eGFR slope difference (up to 32 months), of 0.73 (95% CI, 0.22-1.24) ml/minute/1.73 m 2 /year slower decline with finerenone versus placebo in addition to standard of care. Finerenone reduced albuminuria at month 12 by 42% (95% CI, 35%-48%) and lowered the risk of kidney failure or ≥40% eGFR decline (7.42 vs. 9.60 events per 100 patient-years; hazard ratio, 0.74; 95% CI, 0.57-0.97). The effects of finerenone were consistent across glomerular disease subtypes, by baseline sodium glucose cotransporter-2 inhibitor (SGLT2i) use, and in analyses restricted to biopsy-proven cases. Incidence of serious adverse events was similar with finerenone vs. placebo (19.5% vs. 21.4%), as was the incidence of serious hyperkalemia (0.9% vs. 0.9%). About Chronic Kidney Disease Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. Chronic Kidney Disease (CKD) represents a major global health challenge, affecting 850 million people worldwide - in fact, as the ninth leading cause of death, it results in 1.5 million fatalities each year, translating to one death every 20 seconds. In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. Healthy kidneys act as the body's filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure. As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain and confusion, trouble focusing, memory problems. Major underlying causes of CKD include diabetes, hypertension, and glomerular diseases such as immunoglobulin A nephropathy, focal segmental glomerulosclerosis and membranous nephropathy. About Bayer's Commitment in Cardiovascular and Kidney Diseases Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer's portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer's portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular and kidney diseases are treated. 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 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 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. Bayer AG is a holding company with operating subsidiaries worldwide. References to "Bayer" or "the company" herein may refer to one or more subsidiaries as context requires. 1 Milliliters per minute per 1.73 square meters per year is a measurement of kidney function showing how effectively the kidneys are filtering blood over time, adjusted for the size of the individual. Contact Dr. Daniela Esser Cardiology [email protected] +49 30 2215-41588 Downloads 2026-0090e.pdf 2026-0090e.rtf Newsroom Sign up for our Newsletter We will keep you informed about the latest news. Sign up

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