FDA Approves Kerendia (Finerenone) for CKD Associated with Type 1 Diabetes — First New Treatment in More Than 30 Years
On September 17, 2026, Bayer announced FDA approval of Kerendia (finerenone), a selective non-steroidal mineralocorticoid receptor antagonist (10/20 mg once daily), to reduce urinary albumin-to-creatinine ratio (UACR) — "expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease" — in adults with chronic kidney disease (CKD) associated with type 1 diabetes. Bayer called it "the first FDA-approved treatment option in more than 30 years for adults with chronic kidney disease (CKD) associated with type 1 diabetes1," in a population where approximately 30% of U.S. people with T1D develop CKD.
The approval rests on the Phase 3 FINE-ONE trial (NCT05901831, n=242): "finerenone in addition to standard of care significantly reduced the primary endpoint of relative change in urine albumin-to-creatinine ratio, or UACR, by 25% over six months2 compared with placebo." Per AJMC's readout of the data, least-squares geometric mean ratios were 0.78 at Month 3 (−22%) and 0.72 at Month 6 (−28%), p=.0001, with treatment-emergent adverse events broadly similar to placebo (47.1% vs 49.2%). FINE-ONE was published in the New England Journal of Medicine in March 2026 (Heerspink et al., N Engl J Med 2026;394:947-957) and presented as a "Featured High-Impact Clinical Trial" at ASN Kidney Week in November 2025.
This is finerenone's third U.S. indication — CKD with type 2 diabetes (2021), heart failure with LVEF ≥40% (2025), and now CKD with type 1 diabetes — making it the only MRA indicated for CKD associated with either diabetes type, and the U.S. the only country where Kerendia is approved for T1D-CKD. "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," said study Executive Committee co-chair Dr. Janet McGill of Washington University School of Medicine.
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An instance of First-in-history drug approvals now arrive in waves, not once per generation. — Another decades-long therapeutic vacuum closed within the same approval wave rather than once in a generation. ↩︎
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An instance of Slowing progressive chronic diseases requires substituting clinical endpoints with surrogate biomarkers. — The first T1D kidney therapy in three decades cleared on a six-month proteinuria surrogate rather than verified long-term renal outcomes — surrogate substitution applied to diabetic kidney disease. ↩︎