FDA Approves Finerenone for Chronic Kidney Disease With Type 1 Diabetes

The FDA approved finerenone (Kerendia) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D).¹

The agency granted priority review to the supplemental new drug application, and the reduction in UACR is expected to lower the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in this population. The approval marks the first new treatment advance for CKD associated with T1D in more than 30 years.¹

FINE-ONE Trial Supported the Approval

The approval was based on data from FINE-ONE (NCT05901831), a phase 3, international, randomized, double-blind, placebo-controlled trial in adults with T1D, CKD, and albuminuria who were also taking an angiotensin-converting–enzyme (ACE) inhibitor or an angiotensin-receptor blocker. Investigators enrolled 242 participants with an eGFR of 25 to less than 90 mL/min/1.73 m² and a UACR of 200 to less than 5000, randomly assigning 120 to finerenone, 10 mg or 20 mg once daily depending on eGFR, and 122 to placebo.²

Over 6 months, the median UACR fell from 574.6 to 373.5 in the finerenone group and from 506.4 to 475.6 in the placebo group. The least-squares geometric mean ratio to baseline was 0.75 for finerenone compared with placebo (95% CI, 0.65-0.87; P < .001), a 25% greater reduction with finerenone than with placebo.²

Furthermore, investigators noted a 22% reduction at month 3 (least-squares geometric mean ratio, 0.78; 95% CI, 0.68-0.90) and a 28% reduction at month 6 (least-squares geometric mean ratio, 0.72; 95% CI, 0.60-0.86; P = .0001).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," Janet B. McGill, MD, professor of medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, said in a news release.¹ "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."

Finerenone's kidney-function effects followed a hemodynamic pattern reported in earlier finerenone trials of type 2 diabetes (T2D). The least-squares mean change in eGFR at 6 months was −5.6 mL/min/1.73 m² with finerenone compared with −2.7 mL/min/1.73 m² with placebo (difference, −2.9 mL/min/1.73 m²; 95% CI, −5.1 to −0.7), and eGFR values moved back toward baseline during a 30-day washout period after the last dose.²

Safety Signals Centered on Hyperkalemia

Adverse events occurred in 47.1% of participants who received finerenone and 49.2% of those who received placebo, and serious adverse events occurred in 11.8% and 11.5%, respectively. Hyperkalemia was the most common adverse event, reported in 12 participants (10.1%) in the finerenone group and 4 participants (3.3%) in the placebo group; 2 participants (1.7%) discontinued finerenone because of hyperkalemia.²

Carolina Aldworth, MD, MSc, executive medical director at Bayer, tied the approval to that broader trial program. "This approval builds on evidence linking reductions in UACR with improved kidney outcomes in Kerendia's clinical trial program in chronic kidney disease associated with type 2 diabetes," she said in the news release.¹ "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."

Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, is now approved for 3 separate indications: CKD associated with T2D since 2021, heart failure with left ventricular ejection fraction of 40% or higher since July 2025, and now CKD associated with T1D.¹

What Pharmacists Should Know

Finerenone is dosed at 10 mg or 20 mg once daily based on kidney function, and patients may take it with or without food; those unable to swallow the tablet can crush it and mix it with water or a soft food such as applesauce. Patients should avoid grapefruit and grapefruit juice during treatment.³

Because hyperkalemia is finerenone's principal safety concern, pharmacists should reinforce potassium monitoring and counsel patients to seek care promptly for confusion, irregular heartbeat, nausea or vomiting, numbness or tingling, or unusual weakness.³

Finerenone is contraindicated with strong CYP3A4 inhibitors, including itraconazole, ketoconazole, clarithromycin, and ritonavir, and interactions are also possible with moderate and weak CYP3A4 inhibitors and with CYP3A4 inducers.³ That interaction profile gives pharmacists a concrete checkpoint during medication reconciliation for patients with CKD and T1D who are prescribed finerenone alongside a new antifungal or macrolide.

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 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. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa2512854

3. Finerenone (oral route). Mayo Clinic. Updated September 1, 2026. Accessed September 17, 2026. https://www.mayoclinic.org/drugs-supplements/finerenone-oral-route/description/drg-20518736