FDA approves Kerendia as first new therapy in 30 years for CKD and T1D

On Septemeber 17, 2026, FDA approved Kerendia (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). Reduction in UACR is expected to reduce the risk of estimated glomerular filtration rate decline and end-stage kidney disease.

Finerenone was previously approved for CKD associated with type 2 diabetes (T2D) and, more recently, for certain patients with heart failure. This latest approval expands the drug's use to adults with CKD associated with T1D, a population that has historically lacked disease-specific treatment options.

Adults with T1D are at increased risk of developing CKD, with approximately 20% to 30% experiencing progressive kidney disease that can ultimately lead to kidney failure. Current standard of care consists largely of risk-factor management, including glycemic control, blood pressure management, and renin-angiotensin system blockade.

The approval was supported by results from the phase 3 FINE-ONE trial. Patients treated with finerenone experienced significant reductions in UACR compared with placebo, with benefits observed as early as three months and sustained through six months. UACR was reduced by 22% at three months and by 28% at six months. Because albuminuria is a key marker of CKD progression, these findings support the drug's expected ability to slow worsening kidney function and reduce the likelihood of future renal complications.

FDA's decision was also supported by evidence from the FIDELIO-DKD and FIGARO-DKD clinical programs in CKD associated with T2D, where reductions in albuminuria with finerenone were linked to improved kidney outcomes. Together with the FINE-ONE findings, these data helped support use of UACR reduction as a marker of anticipated long-term kidney benefit in adults with CKD associated with T1D.

The safety profile was consistent with previous experience with finerenone. Rates of treatment-emergent adverse events were similar between the finerenone and placebo groups (47.1% vs 49.2%), as were rates of serious adverse events (11.8% vs 11.5%). Hyperkalemia occurred more frequently with finerenone than placebo (10.1% vs 3.3%), although treatment discontinuation due to hyperkalemia was uncommon, occurring in 1.7% of treated patients.

“For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression,” said Janet McGill, MD, professor of medicine at Washington University School of Medicine in St. Louis and co-chair of the FINE-ONE executive committee. She noted that the approval provides “an important new treatment option for a population that has continued to face substantial unmet need."

Source: Bayer. (2026 Sep 17). 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