FDA Approves Bayer's Kerendia (finerenone) for CKD Associated With Type 1 Diabetes, First New Option in Over 30 Years
核心洞察
The FDA approved Bayer (搜索)'s Kerendia (finerenone) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease (搜索) associated with type 1 diabetes (搜索).
The approval, granted after Priority Review of a supplemental New Drug Application, marks the first new FDA-approved treatment for this population in more than 30 years.
The Phase III FINE-ONE trial showed finerenone reduced UACR versus placebo by 25% over six months, with reductions of 22% at Month 3 and 28% at Month 6.
Bayer (搜索) announced on September 17, 2026 that the U.S. Food and Drug Administration (搜索) has approved Kerendia (finerenone), a selective, non-steroidal mineralocorticoid receptor (搜索) antagonist (nsMRA), for the treatment of adult patients with chronic kidney disease (搜索) (CKD) associated with type 1 diabetes (搜索) (T1D). The approval, granted following the agency's Priority Review of Bayer's supplemental New Drug Application, makes finerenone the first new FDA-approved treatment option in more than 30 years for this patient population.
Finerenone (10 mg, 20 mg) is now 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 in adults with CKD associated with T1D. The drug is administered once daily by the oral route.
A Population With Longstanding Unmet Need
Approximately 30% of people with type 1 diabetes (搜索) in the U.S. develop chronic kidney disease (搜索), increasing their risk of kidney failure and cardiovascular events. Even with recommended treatments for blood glucose and blood pressure management, many patients remain at risk of kidney disease progression and cardiovascular complications.
"For more than three decades, people with chronic kidney disease (搜索) and type 1 diabetes (搜索) have had limited options to address the risk of kidney disease progression," said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study's Executive Committee. "The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need."
CKD is a common and potentially deadly condition that is widely underrecognized, progressing silently and unpredictably with many symptoms not appearing until the disease is well-advanced. It is one of the most frequent complications arising from diabetes and an independent risk factor for cardiovascular disease. The 2017 global prevalence of CKD due to T1D was an estimated 32.5 per 100,000 individuals. Despite guideline-recommended treatment with ACE inhibitors and ARBs, residual risk remains high in people with CKD and T1D, with up to a quarter progressing to end-stage kidney disease.
"This approval builds on evidence linking reductions in UACR with improved kidney outcomes in Kerendia's clinical trial program in chronic kidney disease (搜索) associated with type 2 diabetes (搜索)," said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer (搜索). "Kerendia's third indication validates the breadth of its clinical trial program across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved."
FINE-ONE Trial Results
The approval is based on the positive results of the Phase III FINE-ONE study, which were published in the New England Journal of Medicine in March 2026 and presented in November 2025 as a "Featured High-Impact Clinical Trial" during the Opening Plenary session of the American Society of Nephrology's Kidney Week.
FINE-ONE (NCT05901831) was a pivotal, global, randomized, prospective, double-blind, placebo-controlled, multicenter Phase III study in adult patients with CKD associated with T1D. The trial enrolled 242 adult participants randomized from more than 80 sites across 9 countries to receive either finerenone or placebo once daily, in addition to usual therapy to treat symptoms and comorbidities. The primary objective was to demonstrate whether the addition of finerenone, 10 mg or 20 mg once daily, to standard of care was superior to placebo in reducing UACR over six months, averaged over months 3 and 6.
Finerenone significantly reduced UACR versus placebo over six months (p=0.0001), with reductions observed as early as Month 3 and sustained through Month 6. At Month 3, finerenone reduced UACR compared with placebo by 22% (ratio of Least Square Geometric Mean Ratio [LSGMR] of 0.78; 95% CI: 0.68, 0.90). At Month 6, the reduction was 28% (ratio of LSGMR of 0.72; 95% CI: 0.60, 0.86). Overall, finerenone reduced the primary endpoint of relative change in UACR by 25% over six months compared with placebo.
At any time following baseline, 68.1% of participants receiving finerenone achieved a reduction in UACR of at least 30%, compared with 46.6% receiving placebo. A reduction in UACR of 30% is a threshold established by the American Diabetes Association as being associated with slower CKD progression in patients with CKD associated with type 2 diabetes (搜索). Reductions of this magnitude have been shown in prior Phase III studies in adults with CKD and T2D to be associated with a delay in kidney disease progression and a reduction in cardiovascular events.
Safety Profile
The safety profile of finerenone in FINE-ONE was largely consistent with the existing body of evidence in adults with chronic kidney disease (搜索) associated with type 2 diabetes (搜索). The rate of treatment-emergent adverse events was 47.1% for those treated with finerenone and 49.2% for placebo, while the rate of treatment-emergent serious adverse events was 11.8% and 11.5%, respectively. Hyperkalemia (搜索), an adverse event of special interest, was observed more frequently with finerenone (10.1%) compared with placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% for finerenone and 0% for placebo.
Per the prescribing information, Kerendia can cause hyperkalemia (搜索), and serum potassium and eGFR should be measured in all patients before initiation of treatment and dosed accordingly; treatment should not be initiated if serum potassium is greater than 5 mEq/L. Kerendia is contraindicated in patients with hypersensitivity to any component of the product, in those taking strong CYP3A4 inhibitors, and in patients with adrenal insufficiency.
UACR as a Bridge Between Indications
UACR is a modifiable risk factor associated with chronic kidney disease (搜索) progression. In the FIDELIO-DKD and FIGARO-DKD trials, reductions in UACR with finerenone were shown to be associated with improved kidney outcomes in adults with CKD and T2D. Pooled analyses from those Phase III studies showed that more than 80% of finerenone's kidney benefit was explained by reductions in UACR. Together with the FINE-ONE results, this evidence supported the use of UACR to bridge finerenone's established kidney outcomes evidence from CKD associated with T2D to patients with CKD associated with T1D.
An Expanding Indication Set
In the U.S., Kerendia has been approved since 2021 for the treatment of adult patients with CKD associated with type 2 diabetes (搜索), where it is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure (搜索). In July 2025, the FDA approved the drug to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%. With the new approval, Kerendia becomes the only MRA indicated for adults with CKD associated with either T2D or T1D.
Finerenone is a selective, non-steroidal mineralocorticoid receptor (搜索) antagonist that blocks harmful effects of MR overactivation, which contributes to CKD progression and cardiovascular damage driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. The compound has so far been studied in more than 20,000 patients across multiple populations with chronic kidney disease (搜索) and/or heart failure (搜索), and is the first drug targeting the MR pathway to demonstrate clinically proven heart and/or kidney benefits in five pivotal Phase III studies across patients with HF LVEF ≥ 40%, CKD associated with T2D, CKD associated with T1D, and CKD without diabetes.
Since 2021, finerenone has been marketed as Kerendia or, in selected countries, as Firialta (搜索), and is approved for the treatment of adult patients with CKD associated with T2D in more than 100 countries worldwide, including China, Europe, Japan, and the U.S. It is also approved for the treatment of heart failure (搜索) with LVEF ≥ 40% in the U.S., Europe, Japan, China, and several other markets. Applications for marketing authorization in non-diabetic CKD have been filed in China and Japan, but finerenone is not yet approved in non-diabetic CKD in any country worldwide. With the new approval, the U.S. is the only country where Kerendia is approved for the treatment of adult patients with CKD associated with type 1 diabetes (搜索).
Kerendia's clinical trial program, called FINEOVATE, currently comprises 12 Phase III studies with dedicated programs in heart failure (搜索) (MOONRAKER) and CKD (THUNDERBALL). The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD, FIGARO-DKD, FINE-ONE, and FIND-CKD, as well as the ongoing investigational pediatric studies FIONA and FIONA-OLE.