Finerenone is the First Therapy Approved in 30 Years for Kidney Disease and T1D
Today, the U.S. Food and Drug Administration (FDA) approved finerenone (brand name Kerendia) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). UACR is a measure of kidney damage, and reducing it is expected to slow kidney disease progression in adults with CKD and T1D. This is a major win for the T1D community—finerenone is the first therapeutic advance in 30 years for people living with the burden of T1D and kidney disease.
Finerenone
Finerenone is a once-daily pill that has been approved since 2021 for the treatment of CKD in type 2 diabetes and, since July 2025, for certain adults with heart failure. In CKD, the hormone aldolsterone is overactive, leading to kidney damage. Finerenone blocks this hormone’s activity to protect the kidneys from further damage.
Data from the FINE-ONE Study that Led to this Approval
Bayer’s global, phase 3 FINE-ONE clinical trial investigated the use of finerenone in people with CKD associated with T1D. This trial achieved its primary outcome: finerenone significantly reduced UACR—a measure of kidney damage—compared to placebo.
So, what does this mean? Previous clinical trials with people who have type 2 diabetes and CKD have shown that reductions in UACR from finerenone are associated with positive long-term health outcomes. In people with T1D, reductions in UACR caused by finerenone are likely indicative of lower risk of kidney disease progression, kidney failure, and cardiovascular events. These data were published in The New England Journal of Medicine.
Finerenone was well-tolerated, with no new safety issues reported and few serious adverse events. Based on these results, Bayer submitted the data for regulatory review, with the goal of expanding finerenone’s indication to include treatment of CKD in people living with T1D. Finerenone’s approval represents an incredible step forward for people living with the burden of both kidney disease and T1D.
A Win for T1D and Kidney Disease
CKD is one of the most common complications of T1D. Nearly a third of people living with T1D will develop CKD, increasing the risk of both kidney failure and cardiovascular disease. Right now, the treatment options for people with T1D and CKD are limited—and there is a major need for therapies that can address this.
Finerenone is the first therapy in three decades to achieve positive outcomes for CKD in people with T1D. This is a huge step forward in the right direction, and this exciting data has the potential to transform the lives of people living with T1D with CKD now that finerenone is approved for this population.
The Bigger Picture
Breakthrough T1D strategically collaborated with Bayer to support the FINE-ONE clinical trial, and we are committed to further collaboration with Bayer to advance therapies for people with T1D. Working together with Bayer and other companies will allow us to deliver more treatments to people with T1D to address complications like kidney disease.
“Today, there are few treatments available for chronic kidney disease, a common complication of type 1 diabetes. The approval of finerenone (brand name Kerendia) is a huge win for the T1D community. Breakthrough T1D thanks the FDA for its review and approval and Bayer for their commitment to giving people with T1D a new therapeutic option for chronic kidney disease.”
Jonathan Rosen, Ph.D., Research Director at Breakthrough T1D
As a part of our Improving Lives portfolio, we aim to identify and support treatments and therapies that can address complications that arise from T1D, like CKD. The approval of finerenone opens the door for more treatments to come that could transform the landscape of available therapies for people with T1D, and industry investment in this space helps drive progress forward faster than ever. The T1D community needs more options, and our strategic industry partnerships will help make this possible.
Breakthrough T1D thanks the FDA for approving finerenone and Bayer for their commitment to improving the lives of people living with CKD associated with T1D.
