FDA Grants Priority Review to Finerenone for Type 1 Diabetes and CKD

On May 21, 2026, Bayer announced that the US Food and Drug Administration (FDA) had accepted a supplemental New Drug Application (sNDA) and granted Priority Review for finerenone (Kerendia) for adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), which is supported by the phase 3 FINE-ONE trial.1

The regulatory submission is based primarily on albuminuria reduction data rather than kidney failure or cardiovascular outcomes in this population.1

“The FDA’s acceptance of this application underscores the clinical importance of our ongoing program for Kerendia, and growing evidence base, across broad patient populations in cardiovascular and kidney diseases,” Carolina Aldworth, MD, MSc, executive medical director at Bayer, said in a statement. “With 5 Phase 3 trials now having achieved their primary endpoints - including FINE-ONE, which forms the basis of this submission - we’re proud that this milestone brings us one step closer to potentially addressing unmet needs among people living with type 1 diabetes and chronic kidney disease.”1

FDA Priority Review for Finerenone in T1D and CKD

The proposed indication would expand finerenone beyond its current US approvals. Finerenone is already indicated to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with T2D. It is also approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure and left ventricular ejection fraction of ≥40%.2

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist. The drug blocks mineralocorticoid receptor overactivation, a pathway implicated in inflammatory and fibrotic processes in the heart and kidneys. In the T1D setting, the sNDA remains under FDA review, and the currently approved label does not include CKD associated with T1D.2

FINE-ONE Phase 3 Trial Results

FINE-ONE was a pivotal, global, randomized, prospective, double-blind, multicenter phase 3 trial enrolling 242 adults with T1D and CKD. Participants received finerenone 10 mg or 20 mg, or placebo once daily, added to standard of care. The trial’s primary objective was to determine whether finerenone was superior to placebo for reducing urine albumin-to-creatinine ratio (UACR) over 6 months.1,3

According to Bayer, finerenone significantly reduced UACR compared with placebo over the 6-month study period, with a least-squares mean change of 0.75 (95% CI, 0.65-0.87; P < .001). Detailed trial results were presented at the American Society of Nephrology Kidney Week 2025 and published in the New England Journal of Medicine.1,3

UACR is commonly used as a marker of kidney disease progression and cardiovascular risk, but the reported FINE-ONE data are not a direct demonstration of reduced kidney failure, cardiovascular events, or mortality in adults with T1D and CKD. The sNDA was also supported by pooled phase 3 data from FIDELIO-DKD and FIGARO-DKD, which studied adults with CKD associated with type 2 diabetes (T2D), according to the company.1

Safety Findings and Remaining Questions for Clinicians

Safety findings in FINE-ONE were generally consistent with the established safety profile of finerenone in CKD associated with T2D, according to Bayer. Treatment-emergent adverse events occurred in 47.1% of participants receiving finerenone and 49.2% receiving placebo. Treatment-emergent serious adverse events were reported in 11.8% and 11.5%, respectively.1

Hyperkalemia, a known adverse event of interest with mineralocorticoid receptor antagonism, was more frequent with finerenone than placebo in FINE-ONE, occurring in 10.1% vs 3.3% of participants. Discontinuation due to hyperkalemia occurred in 1.7% of finerenone-treated participants and 0% of placebo-treated participants.1

The current prescribing information lists contraindications including hypersensitivity to any product component, concomitant use with strong CYP3A4 inhibitors, and adrenal insufficiency. It also recommends potassium and eGFR assessment before initiation and periodic monitoring during treatment because hyperkalemia risk increases with lower kidney function and higher baseline potassium levels.2

The regulatory decision, if favorable, would address a population with fewer disease-modifying kidney therapies than patients with T2D and CKD. However, the available announcement centers on 6-month UACR reduction and safety, leaving longer-term clinical outcomes in T1D and CKD as an important area for continued evaluation.

Key Facts

• Finerenone: nonsteroidal MRA
• Use: T1D + CKD under FDA review
• Evidence: FINE-ONE phase 3
• UACR reduced vs placebo
• Hyperkalemia: 10.1% vs 3.3%

References

1. Bayer. Bayer’s KERENDIA® (finerenone) granted Priority Review of supplemental New Drug Application by U.S. FDA for treatment of adults with type 1 diabetes and chronic kidney disease. Published May 21, 2026. Accessed May 21, 2026. https://www.bayer.com/en/us/news-stories/kerendiar-granted-priority-review

2. KERENDIA (finerenone) [prescribing information]. Bayer HealthCare Pharmaceuticals Inc. August 2025. Accessed May 21, 2026. https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf

3. 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:https://doi.org/10.1056/NEJMoa2512854