FDA Expands Finerenone Approval to CKD Associated With Type 1 Diabetes

The FDA approved finerenone (Kerendia; Bayer) earlier this morning to treat adult patients with chronic kidney disease (CKD) associated with type 1 diabetes, making it the first new treatment in more than 30 years for this patient population.¹

Following its priority review of the supplemental New Drug Application, the agency approved finerenone, a non-steroidal mineralocorticoid receptor antagonist (MRA), to reduce the urinary albumin-to-creatinine ratio (UACR). Therefore, the treatment is expected to reduce the risk of sustained glomerular filtration rate decline and end-stage kidney disease in adults with CKD. The once-daily, oral treatment option is the only MRA indicated for adults associated with either type 1 or 2 diabetes.

Today’s decision marks finerenone’s third FDA approval. It was first approved in 2021 to reduce the risk of cardiovascular death and hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained estimated glomerular filtration rate decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes.² About 4 years later, finerenone received an expanded indication to reduce the risk of cardiovascular death and hospitalization for HF and urgent HF visits in adults with HF with a left ventricular ejection fraction of at least 40%.³

“…Kerendia’s third indication validates the breadth of its clinical trial program across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved,” Carolina Aldworth, MD, MSc, executive medical director at Bayer, said in a news release.¹

FINE-ONE Trial Supports Expanded Indication

The FINE-ONE trial (NCT05901831), a global, randomized, prospective, double-blind, placebo-controlled, multicenter, phase 3 study in adult patients with CKD associated with type 1 diabetes, supported the decision.⁴ It enrolled 242 participants, with the primary objective of demonstrating whether the addition of once-daily 10 or 20 mg finerenone to the standard of care was superior to placebo in reducing UACR over 6 months.

As presented at the American Society of Nephrology Kidney Week 2025 and published earlier this year in the New England Journal of Medicine, finerenone significantly reduced UACR vs placebo over 6 months (P = .0001), with reductions observed as early as Month 3 and sustained through Month 6.⁵ Specifically, finerenone reduced UACR vs placebo by 22% at Month 3 (ratio of Least Squares Geometric Mean Ratio [LSGMR], 0.78; 95% CI, 0.68-0.90) and 28% at Month 6 (ratio of LSGMR, 0.72; 95% CI, 0.60-0.86).

Safety and tolerability were consistent with existing evidence for finerenone in adults with CKD associated with type 2 diabetes.¹ The rate of treatment-emergent adverse events was 47.1% for patients treated with finerenone and 49.2% for those receiving placebo. The rate of treatment-emergent serious adverse events, however, was 11.8% for finerenone and 11.5% for placebo. Hyperkalemia, an adverse event of special interest to the investigators, was observed more frequently with finerenone (10.1%) than placebo (3.3%), with the rate of treatment discontinuation being 1.7% and 0%, respectively.

“For more than 3 decades, people with [CKD] 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 and co-chair of the study’s executive committee, said in a news release. "The approval of Kerendia to reduce UACR, which is expected to slow [CKD] progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

References

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. News release. Bayer. September 17, 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. Massaro L. FDA approves Kerendia for patients with CKD associated with T2D. AJMC^®. July 15, 2021. Accessed September 17, 2026. https://www.ajmc.com/view/fda-approves-kerendia-for-patients-with-ckd-associated-with-t2d
3. McNulty R. FDA approves finerenone for heart failure with mildly reduced or preserved LVEF. AJMC. July 14, 2025. Accessed September 17, 2026. https://www.ajmc.com/view/fda-approves-finerenone-for-heart-failure-with-mildly-reduced-or-preserved-lvef
4. A study to learn how well the study treatment finerenone works and how safe it is in people with long-term decrease in the kidneys’ ability to work properly (chronic kidney disease) together with type 1 diabetes (FINE-ONE). ClinicalTrials.gov. Updated October 21, 2025. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05901831
5. Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa2512854