KERENDIA (finerenone) - (FIND-CKD)

October 7, 2026: Bayer announced that the FDA accepted its supplemental NDA for KERENDIA (finerenone) in adults with chronic kidney disease without diabetes receiving background standard of care.

The filing is supported by the Phase III FIND-CKD trial (NCT05047263), a randomized, double-blind, placebo-controlled study in 1,584 adults. KERENDIA met the primary endpoint, significantly slowing kidney function decline versus placebo based on eGFR slope through month 32: mean annual decline was -3.3 vs -4.0 mL/min/1.73 m²/year, for a between-group difference of 0.7 mL/min/1.73 m²/year (95% CI 0.3 to 1.1; p<0.001).

For a key secondary endpoint, KERENDIA significantly reduced the risk of a composite kidney-cardiovascular outcome versus placebo (HR 0.77; 95% CI 0.60 to 0.99; p=0.04), including kidney failure, sustained eGFR decrease of at least 57%, hospitalization for heart failure, or cardiovascular death.

Safety was described as consistent with prior Phase III studies. Treatment-emergent serious adverse events were 20.9% with KERENDIA and 21.2% with placebo. Hyperkalemia occurred more often with KERENDIA (17.0% vs 13.3%), while serious hyperkalemia and hyperkalemia leading to hospitalization or permanent discontinuation were each under 1% and under 2%, respectively. Detailed FIND-CKD results were published in NEJM and presented at the 63rd ERA Congress.