KERENDIA (finerenone) - (FINE-ONE)

September 16, 2026: Bayer announced FDA approval of KERENDIA (finerenone) for adults with chronic kidney disease associated with type 1 diabetes (T1D), following Priority Review of a supplemental NDA. The new indication is to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease.

The approval was supported by the Phase III FINE-ONE trial (NCT05901831), a randomized, double-blind, placebo-controlled study in 242 adults with CKD and T1D. Over 6 months, KERENDIA significantly reduced UACR versus placebo (p=0.0001), with a 22% reduction at Month 3 (LSGMR 0.78; 95% CI 0.68-0.90) and a 28% reduction at Month 6 (LSGMR 0.72; 95% CI 0.60-0.86). Safety was consistent with prior experience: treatment-emergent adverse events were 47.1% with KERENDIA vs 49.2% with placebo; serious adverse events were 11.8% vs 11.5%. Hyperkalemia occurred more often with KERENDIA (10.1% vs 3.3%), with discontinuation due to hyperkalemia in 1.7% vs 0%.

The release says detailed FINE-ONE results were presented at ASN Kidney Week 2025 and published in the New England Journal of Medicine. KERENDIA already had FDA approvals in CKD associated with type 2 diabetes and, as of July 2025, in heart failure with LVEF ≥40%.