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

The approval follows the agency's Priority Review of the supplemental New Drug Application and marks the first new treatment in more than 30 years for adult patients with CKD associated with T1D. FDA’s approval also establishes Kerendia as the only non-steroidal mineralocorticoid receptor antagonist (MRA) indicated for adults with CKD associated with either type 2 diabetes (T2D) or T1D.¹

Approximately 20-30% of people in the U.S. with T1D also have CKD, putting them at elevated risk of kidney disease progression and kidney failure.¹ Until now, that population has had limited treatment options specifically studied and approved for their condition, making this approval significant both for the size of the patient group it addresses and for the length of time since the last therapeutic advance in this specific disease combination.

What was the approval based on?

Data from the Phase III Fine-One clinical trial (NCT05901831), a pivotal, global, randomized, prospective, double-blind, placebo-controlled, multicenter study in adult patients with CKD associated with T1D² supported the approval. Fine-One enrolled 242 adult participants, with the primary objective of demonstrating whether adding Kerendia, at 10 mg or 20 mg once daily, to standard of care was superior to placebo in reducing UACR over six months, averaged across months three and six.²

In the trials, Kerendia significantly reduced UACR compared with placebo over six months, with reductions observed as early as month three and sustained through month six. At month three, Kerendia reduced UACR relative to placebo by 22%, and at month six, reduction reached 28%.²

Safety and tolerability were consistent with existing evidence for Kerendia in adults with CKD associated with T2D. The rate of treatment-emergent adverse events was 47.1% for patients treated with Kerendia versus 49.2% for placebo, while treatment-emergent serious adverse events occurred in 11.8% of the Kerendia group versus 11.5% of the placebo group.²

Hyperkalemia, an adverse event of special interest, was observed more frequently with Kerendia (10.1%) than placebo (3.3%), with treatment discontinuation due to hyperkalemia occurring in 1.7% of Kerendia patients and none of the placebo group.² Detailed Fine-One results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.

Approval was also supported by Phase III data from the Fidelio-Dkd and Figaro-Dkd trials in adults with CKD associated with T2D.¹ In those trials, reductions in UACR with Kerendia were associated with improved kidney outcomes, and together with the Fine-One results, the evidence supports using UACR to bridge Kerendia's established kidney outcomes data from CKD associated with T2D to patients with CKD associated with T1D.¹

"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 Dr. 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. "The approval of Kerendia 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."

How does this fit into Kerendia's broader label?

In July 2025, Kerendia received FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%. This latest approval extends that label further, making Kerendia approved to reduce UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease, in adults with CKD associated with T1D.¹

Sources

1. 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 Bayer 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. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The Fine-One trial PubMed October 5, 2023, https://pubmed.ncbi.nlm.nih.gov/37805000/