FDA accepts Bayer application for Kerendia in non-diabetic CKD

Bayer announced on October 8, 2026, that the U.S. Food and Drug Administration accepted its supplemental New Drug Application for Kerendia (finerenone). The application seeks approval to treat adults with chronic kidney disease (CKD) who do not have diabetes and are receiving standard care.

The regulatory filing is based on data from the Phase III FIND-CKD trial, which evaluated 1,584 adults. In the trial, the mean annual decline in estimated glomerular filtration rate was -3.3 mL/min/1.73 m² with Kerendia compared with -4.0 mL/min/1.73 m² with placebo, resulting in a statistically significant difference of 0.7 mL/min/1.73 m² per year.

Kerendia also met its secondary composite kidney-cardiovascular endpoint, reducing risk by 23% compared with placebo (hazard ratio 0.77; p=0.04). Serious adverse events occurred in 20.9% of Kerendia patients and 21.2% of the placebo group, while hyperkalemia was observed in 17% of patients on Kerendia compared to 13.3% on placebo.

Kerendia is already approved in the United States for patients with CKD associated with type 2 diabetes, heart failure with left ventricular ejection fraction of 40% or higher, and CKD associated with type 1 diabetes.