Business Wire·Sep 17, 2026, 2:30 AM ET

Bayer’s KERENDIA® (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes

BAYRY BAYZF

The FDA approved KERENDIA (finerenone) for adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), marking the first new treatment in over 30 years for this population.
The approval is based on the Phase III FINE-ONE clinical trial, which demonstrated that KERENDIA significantly reduced urinary albumin-to-creatinine ratio (UACR) by 22% at Month 3 and 28% at Month 6 compared to placebo.
Reducing UACR with KERENDIA is expected to slow CKD progression, reduce the risk of sustained eGFR decline, and lower the risk of end-stage kidney disease in adults with T1D.
KERENDIA is also approved to reduce risks of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with type 2 diabetes (T2D).
The drug received an additional approval to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure and left ventricular ejection fraction (HF LVEF) ≥40%.
KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) administered as a once-daily oral treatment.
Safety data from the FINE-ONE trial showed hyperkalemia occurred in 10.1% of patients taking KERENDIA compared to 3.3% on placebo, with a 1.7% discontinuation rate due to hyperkalemia.
Treatment-emergent adverse events were reported in 47.1% of the KERENDIA group versus 49.2% in the placebo group, with serious adverse events occurring in 11.8% and 11.5% respectively.
Contraindications for KERENDIA include hypersensitivity to product components, concomitant use with strong CYP3A4 inhibitors, and patients with adrenal insufficiency.
Warnings include the risk of hyperkalemia, which requires monitoring of serum potassium before initiation and periodically during treatment, and worsening renal function in patients with heart failure.
The FINE-ONE trial results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine in September 2026.
Approximately 20-30% of U.S. adults with type 1 diabetes have CKD, placing them at high risk for kidney disease progression and kidney failure.
KERENDIA is part of Bayer's FINEOVATE clinical trial program, which includes 12 Phase III studies focused on heart failure and chronic kidney disease.