FDA Accepts Bayer sNDA for Kerendia in Non-Diabetic Kidney Disease

Bayer announced on 8. oktober 2026 that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for finerenone, marketed as Kerendia, supporting a potential new indication in adults with chronic kidney disease (CKD) without diabetes. The application is based on results from the pivotal Phase III FIND-CKD study, in which, according to the company, finerenone significantly delayed kidney disease progression and reduced cardiovascular-kidney events versus placebo when added to standard of care in a broad population of adults with CKD without diabetes.

“For many people living with CKD without diabetes, kidney function can decline silently for years before symptoms become apparent, while the risk of kidney failure and cardiovascular complications continues to rise,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division. Rommel said the FDA’s acceptance of the application marks an important step toward potentially expanding the use of finerenone, a non-steroidal mineralocorticoid receptor antagonist, to a broader group of patients who still have few treatment options and may benefit from the cardio-kidney protective effects of finerenone. By targeting mineralocorticoid receptor overactivation, he said, finerenone addresses a pathway implicated in kidney disease progression and cardiovascular damage.

FIND-CKD Study Design and Results

FIND-CKD is the largest Phase III study to date focused on CKD without diabetes, according to Bayer. The study investigated the efficacy and safety of finerenone compared with placebo, in addition to standard of care, in more than 1,500 patients whose disease spanned different etiologies, including kidney disease linked to hypertension and glomerular diseases. Patients were randomized to receive finerenone 10 mg or 20 mg, or placebo, on top of maximum tolerated labeled doses of a renin-angiotensin system blocking therapy such as an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker. The primary endpoint was the mean annual rate of change in estimated glomerular filtration rate, or eGFR, from baseline to Month 32. Bayer describes the eGFR slope as a validated surrogate endpoint for clinical kidney outcomes and a predictive metric for the risk of kidney failure.

Over 32 months, patients treated with finerenone experienced a statistically significant 0.7 ml/minute/1.73 m2/year slower annual decline in eGFR than those receiving placebo, the company reported. Finerenone also significantly reduced the risk of the key secondary composite cardiovascular-kidney outcome by 23% compared with placebo. Additional secondary endpoints, including composites of sustained ≥57% eGFR decline or kidney failure and of hospitalization for heart failure or cardiovascular death, showed results consistent with the overall positive profile, according to Bayer. The study’s safety endpoints were the occurrence of treatment-emergent adverse events, treatment-emergent serious adverse events, and hyperkalemia adverse events. Bayer said finerenone was well-tolerated in the study, consistent with its established safety profile.

Approximately 850 million people worldwide, and more than 35 million adults in the U.S., have CKD, and an estimated 50% to 70% of these patients have CKD without diabetes, according to the company. More than 3.5 million people with kidney failure are treated with dialysis, which is associated with a five-year survival rate of about 40% after treatment initiation. The most common etiologies of CKD without diabetes include kidney disease linked to hypertension and glomerulonephritis, including immunoglobulin A nephropathy and focal segmental glomerulosclerosis, and CKD linked to hypertension is the second most common cause of kidney failure. Patients with advanced CKD without diabetes face a risk of fatal cardiovascular events about 2.6 times that of the general population without CKD, a risk that increases further as kidney function declines. In 2023, CKD accounted for over 1.4 million deaths, ranking as the ninth leading cause of death. Bayer characterizes patients with CKD without diabetes as underserved, with few guideline-directed treatment options and a significantly increased risk of cardiovascular complications, kidney disease progression, and kidney failure.

Bayer first reported on 16. marts 2026 that FIND-CKD had met its primary endpoint, with finerenone achieving a statistically significant and clinically meaningful improvement versus placebo, in addition to standard of care, in eGFR slope from baseline to Month 32. The company said at the time that the FIND-CKD clinical data would be presented at an upcoming scientific conference and that it planned to submit the data to health authorities to extend the Kerendia indication to this patient population. Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen and Co-Chair of the study’s Executive Committee, said in the March announcement that patients with non-diabetic CKD experience a progressive loss of kidney function and are at high risk of kidney failure and cardiovascular disease. “The FIND-CKD results are encouraging because they show the benefits of finerenone in preserving kidney function in a dedicated study across several etiologies of non-diabetic chronic kidney disease,” he said. FIND-CKD was the fifth completed Phase III study to report positive results with finerenone, which had been studied in more than 20,000 patients across multiple patient populations with chronic kidney disease and heart failure as of that announcement.

Kerendia Approval History and FINEOVATE Program

Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist that, according to Bayer, has been shown to block harmful effects of mineralocorticoid receptor overactivation, which contributes to CKD progression and cardiovascular damage that can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Kerendia and Firialta are globally protected trademarks for finerenone. Since 2021, finerenone has been marketed as Kerendia or, in selected countries, as Firialta, and it is approved for the treatment of adult patients with CKD associated with type 2 diabetes in more than 100 countries, including China, Europe, Japan, and the U.S. Finerenone is also approved for the treatment of heart failure with left ventricular ejection fraction of 40% or greater in the U.S., the EU, Japan, and China, among other health authorities, with additional applications under regulatory review. Finerenone is currently not approved for the treatment of CKD without diabetes.

Bayer describes finerenone as the first drug targeting the mineralocorticoid receptor pathway that, in five pivotal Phase III studies, has demonstrated cardiovascular or kidney benefits across patient populations including heart failure with left ventricular ejection fraction of 40% or greater, CKD associated with type 2 diabetes, CKD associated with type 1 diabetes, and CKD without diabetes.

The clinical study program with finerenone, known as FINEOVATE, currently comprises twelve Phase III studies with dedicated programs in CKD and heart failure. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, the Phase II study CONFIDENCE, and the ongoing Phase III studies in pediatric patient populations FIONA and FIONA-OLE. The MOONRAKER heart failure program includes the completed pivotal Phase III study FINEARTS-HF; the ongoing investigator-sponsored, collaborative studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF; and the ongoing Phase III studies in pediatric patient populations FIORE and FIORELLO.