Finerenone Receives FDA Approval for Treatment of Adults With CKD Associated With T1D

The FDA approved finerenone (Kerendia; Bayer HealthCare Pharmaceuticals) for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). The approval is supported by positive results from the phase 3 FINE-ONE clinical trial (NCT05901831).^1,2

Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of mineralocorticoid receptor (MR) overactivation. The overactivation of MR contributes to CKD progression and cardiovascular damage, which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.¹

The nsMRA received FDA approval in 2021 for the treatment of adult patients with CKD associated with type 2 diabetes (T2D), and in 2025 received approval for the treatment of adult patients with symptomatic chronic heart failure with left ventricular ejection fraction of 40% or greater.^3,4 In this newly approved indication, finerenone reduces urinary albumin-to-creatinine ratio (UACR), which is believed to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with T1D-associated CKD. The indication granted priority review by the FDA in May 2026.^1,5

“T1D care has become increasingly sophisticated in glucose management. This approval gives us another reason to bring kidney health to the center of the conversation,” Jennifer Goldman, PharmD, CDCES, BC-ADM, FCCP, professor of pharmacy practice at the Massachusetts College of Pharmacy and director of cardiometabolic services at Well Life Medical in Peabody, Massachusetts, explained to Pharmacy Times. “[Hemoglobin A1_C] (HbA1_C) and time in range matter, and so do albuminuria and kidney function.”

Finerenone Decreases UACR in FINE-ONE Trial

The FINE-ONE trial is a parallel-group, randomized, prospective, interventional, double-blind, multicenter global phase 3 trial that enrolled patients with T1D, CKD, and albuminuria. A total of 242 patients were randomly assigned to receive either 10 or 20 mg of finerenone per day (depending on eGFR) or matching placebo. The trial’s primary end point was the relative change in the UACR over a 6-month period, and secondary end points included the number of treatment-emergent adverse events (AEs) and serious AEs. Trial results were published in The New England Journal of Medicine.^1,2,6

According to the published findings, the median UACR decreased from about 574.6 at baseline to 373.5 at 6 months in finerenone-treated patients, and from 506.4 to 475.6 in those receiving placebo. Over a period of 6 months, the UACR decreased by approximately 34% with finerenone (geometric mean ratio to baseline, 0.66; 95% CI, 0.60-0.73) and 12% with placebo (geometric mean ratio to baseline, 0.88; 95% CI, 0.79- 0.98). This corresponded to an approximately 25% greater reduction with finerenone than with placebo (geometric mean ratio for finerenone vs. placebo, 0.75; 95% CI, 0.65-0.87; P < .001). At the 6-month period, the change in the eGFR was about –5.6 ml/min/1.73 m² with finerenone and –2.7 ml/min/1.73 m² with placebo (difference, –2.9 ml/minute/1.73 m²; 95% CI, –5.1 to –0.7). eGFR values approached baseline levels during the washout period, the investigators wrote.

Further, hyperkalemia was reported to be the most common AE; it occurred in 12 (10.1%) and 4 (3.3%) patients who received finerenone and placebo, respectively. Additionally, 2 participants (1.7%) discontinued finerenone because of hyperkalemia.⁶ Of note, finerenone’s safety profile in FINE-ONE was largely consistent with existing data in adults with CDK associated with T2D.¹

“FINE-ONE demonstrated an albuminuria benefit within just 6 months. Its size and duration limited what it could tell us about longer-term outcomes such as kidney failure or cardiovascular events. Those benefits might become apparent with longer follow-up and sufficient events, but that remains unproven in this population,” Goldman explained. “One of the most interesting findings is that the albuminuria response appeared consistent across the HbA1_C levels and diabetes durations examined. That supports evaluating kidney-directed treatment alongside glucose management, while recognizing that this was an exploratory analysis.”

According to the news release announcing the new FDA-approved indication, these findings are supported by pooled analyses from the phase 3 FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) studies in T2D-associated CKD, showing that more than 80% of finerenone’s kidney benefit was explained by reductions in UACR.¹

“An oral medication can still require a very deliberate safety plan. Before starting finerenone, clinicians need to assess potassium, kidney function, and drug interactions. The 4-week potassium check should be planned when the prescription is written,” Goldman said.

REFERENCES

1. U.S. FDA approves finerenone for new indication in patients with chronic kidney disease associated with type 1 diabetes. News release. Bayer. September 17, 2026. Accessed September 17, 2026. https://www.bayer.com/media/en-us/us-fda-approves-finerenone-for-new-indication-in-patients-with-chronic-kidney-disease-associated-with-type-1-diabetes/

2. 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 identifier: NCT05901831. Updated October 21, 2025. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05901831

3. Antrim A. Finerenone Granted FDA Approval to Reduce Risk of Kidney, Heart Complications in Adults with Chronic Kidney Disease, Type 2 Diabetes. Pharmacy Times. July 12, 2021. Accessed September 17, 2026. https://www.pharmacytimes.com/view/finerenone-granted-fda-approval-to-reduce-risk-of-kidney-heart-complications-in-adults-with-chronic-kidney-disease-type-2-diabetes

4. Halpern L. Finerenone Approved by FDA for Treatment of Adults With Heart Failure. Pharmacy Times. July 14, 2025. Accessed September 17, 2026. https://www.pharmacytimes.com/view/finerenone-approved-by-fda-for-treatment-of-adults-with-heart-failure

5. Halpern L. FDA Grants Priority Review to Finerenone for Chronic Kidney Disease in Adults With Type 1 Diabetes. Pharmacy Times. May 25, 2026. Accessed September 17, 2026. https://www.pharmacytimes.com/view/fda-grants-priority-review-to-finerenone-for-chronic-kidney-disease-in-adults-with-type-1-diabetes

6. 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