FDA Approves Finerenone (Kerendia) for CKD and Type 1 Diabetes

The US Food and Drug Administration (FDA) has approved finerenone (Kerendia) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), Bayer announced.¹

The approval, granted through Priority Review of a supplemental New Drug Application, is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in this population.¹ It marks the first new treatment option for CKD associated with T1D in more than 30 years.^1,2

“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," Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Executive Committee, said in a statement.¹ "The approval of [finerenone] to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

Finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), was first approved in 2021 to reduce cardiovascular and kidney risk in adults with CKD associated with type 2 diabetes (T2D).¹ The agent gained a second indication in July 2025 for heart failure with left ventricular ejection fraction (LVEF) of 40% or higher.¹ With this latest approval, finerenone becomes the only MRA indicated for CKD associated with either T1D or T2D.¹

Finerenone Efficacy and UACR Reduction in the FINE-ONE Trial

Approval was supported by data from FINE-ONE, a global, randomized, double-blind, placebo-controlled, multicenter phase 3 trial in adults with CKD associated with T1D. The study enrolled 242 participants who received finerenone at 10 mg or 20 mg once daily, added to standard of care, or placebo. The primary objective was to demonstrate superiority over placebo in reducing UACR over six months, averaged across months 3 and 6.^1,2

Finerenone significantly reduced UACR compared with placebo over the six-month period (P = .0001), with reductions apparent as early as month 3 and sustained through month 6. At month 3, finerenone reduced UACR by 22% relative to placebo (least squares geometric mean ratio [LSGMR], 0.78; 95% CI, 0.68-0.90). At month 6, the reduction reached 28% (LSGMR, 0.72; 95% CI, 0.60-0.86).¹

Detailed FINE-ONE results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.²

Finerenone Safety Profile and Secondary Endpoints in FINE-ONE

Safety and tolerability in FINE-ONE were consistent with existing evidence for finerenone in adults with CKD associated with T2D, according to Bayer.¹ Treatment-emergent adverse events occurred in 47.1% of patients on finerenone compared with 49.2% on placebo, and treatment-emergent serious adverse events occurred in 11.8% and 11.5%, respectively.²

Hyperkalemia, an adverse event of special interest for MRAs, occurred more frequently with finerenone (10.1%) than with placebo (3.3%). Discontinuation due to hyperkalemia occurred in 1.7% of finerenone-treated patients and none of the placebo group.² No new safety signals were identified in the T1D population.¹

The FINE-ONE data build on findings from FIDELIO-DKD and FIGARO-DKD, in which UACR reductions with finerenone were associated with improved kidney outcomes in adults with CKD associated with T2D. Together, this evidence supported use of UACR as a bridge from finerenone's established kidney-outcomes data in T2D to the T1D population.¹

Finerenone's clinical trial program, FINEOVATE, includes 12 phase 3 studies across dedicated heart failure and CKD programs, including ongoing pediatric studies in CKD. Roughly 20% to 30% of people in the US with T1D also have CKD, putting them at risk for disease progression and kidney failure.¹

References

1. Bayer. 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. Published September 16, 2026. Accessed September 17, 2026. https://www.businesswire.com/news/home/20260916814212/en/Bayers-KERENDIA-finerenone-Receives-FDA-Approval-as-the-First-New-Treatment-in-30-Years-for-Adults-with-Chronic-Kidney-Disease-CKD-and-Type-1-Diabetes

2. Heerspink HJL, Birkenfeld AL, Cherney DZI, et al; FINE-ONE Investigators. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa2512854.