Finerenone wins FDA clearance for type 1 diabetes–related CKD, lowering albuminuria in FINE-ONE and opening a long-awaited treatment path.
The FDA has approved finerenone (Kerendia) for adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), making it the first new FDA-approved treatment option for this population in more than 30 years, according to Bayer.¹
The 10-mg and 20-mg tablets are indicated to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease.¹ The wording is notable because the approval is based primarily on a surrogate marker of kidney injury rather than a completed trial demonstrating fewer kidney-failure events.
Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist that blocks mineralocorticoid receptor overactivation, a pathway involved in inflammation, fibrosis, and progressive kidney and cardiovascular damage.
Approximately 30% of people with T1D in the US develop CKD, placing them at increased risk for kidney failure and cardiovascular events. Despite glycemic management and treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, substantial residual risk of CKD progression remains.¹
The FDA decision was supported by findings from the phase 3 FINE-ONE trial, a global, randomized, double-blind, placebo-controlled study conducted at more than 80 sites across 9 countries. The trial included 242 adults with T1D and CKD who received once-daily finerenone or placebo in addition to standard care.¹˒²
At 6 months, finerenone produced a statistically significant 25% reduction in UACR relative to placebo, meeting the trial’s primary end point. Compared with placebo, UACR was reduced by 22% at month 3 and 28% at month 6.¹
At any postbaseline assessment, 68.1% of participants receiving finerenone achieved a UACR reduction of at least 30%, compared with 46.6% of those receiving placebo. A reduction of this magnitude has been associated with slower CKD progression in previous studies involving patients with CKD and type 2 diabetes.¹
However, FINE-ONE was not designed or powered to establish whether finerenone directly reduces kidney failure, sustained eGFR decline, cardiovascular events, or mortality in adults with T1D. The expectation of long-term kidney benefit was supported partly by evidence from the FIDELIO-DKD and FIGARO-DKD trials in patients with CKD associated with type 2 diabetes. According to Bayer, pooled analyses of those studies suggested that reductions in UACR explained more than 80% of finerenone’s observed kidney benefit.¹
The FINE-ONE findings were published in the New England Journal of Medicine in March 2026.²
Bayer reported that finerenone’s safety profile in FINE-ONE was largely consistent with the existing evidence from patients with CKD associated with type 2 diabetes.¹ The company’s announcement did not provide detailed treatment-emergent adverse-event rates from the T1D study.
Hyperkalemia is an established risk of finerenone, particularly among patients with lower kidney function, elevated baseline potassium, or concomitant medications that impair potassium excretion. Serum potassium and eGFR should be measured before treatment and monitored periodically thereafter. Finerenone should not be initiated when serum potassium exceeds 5 mEq/L.
The treatment is contraindicated in patients receiving strong CYP3A4 inhibitors, those with adrenal insufficiency, and patients with hypersensitivity to a component of the medication.
For primary care clinicians, the new indication reinforces the importance of routinely assessing both UACR and eGFR in adults with T1D. Because treatment decisions require consideration of kidney function, potassium concentrations, interacting medications, and background renin-angiotensin system therapy, coordination with endocrinology or nephrology may be appropriate for patients with advanced CKD or an elevated risk of hyperkalemia.
Finerenone was previously approved in the US for CKD associated with type 2 diabetes and for symptomatic chronic heart failure with a left ventricular ejection fraction of at least 40%. The new indication is its third FDA-approved use.¹
