FDA Approves Kerendia for Kidney Disease in Type 1 Diabetes
FDA Approves Kerendia for Kidney Disease in Type 1 Diabetes
Bayer’s finerenone is now approved for adults with chronic kidney disease tied to type 1 diabetes. The approval rests on one six-month trial that measured a lab marker, not kidney failure.
On September 16, 2026, the FDA approved Kerendia (finerenone), a once-daily pill from Bayer, for adults with chronic kidney disease associated with type 1 diabetes. Bayer calls it the first new treatment for this group in more than 30 years.
The approval rests on one randomized trial, FINE-ONE, published in the New England Journal of Medicine in March 2026. That trial did not count kidney failure. It measured albumin in the urine, a lab marker of kidney damage. The label, as quoted by Bayer, says the drug reduces that marker, which is expected to lower the risk of kidney decline and end-stage kidney disease.
The drug itself isn’t new. According to Bayer, it has been approved since 2021 for kidney disease in type 2 diabetes, and since 2025 for a type of heart failure. What changed is who it’s approved for.
What FINE-ONE found
FINE-ONE enrolled 242 adults with type 1 diabetes, reduced kidney function (eGFR 25 to under 90), and elevated urine albumin (a urine albumin-to-creatinine ratio, or UACR, of 200 to under 5,000 mg/g). Everyone was already taking an ACE inhibitor or an ARB. Participants were randomized to finerenone, 10 or 20 mg a day depending on kidney function, or placebo.
Worth naming plainly: Bayer funded the trial and makes the drug, and several of the paper’s authors are Bayer employees.
The result: over six months, urine albumin fell 25% more with finerenone than with placebo (95% CI for the ratio, 0.65 to 0.87). Bayer’s release quotes the same comparison at single time points instead, 22% at month 3 and 28% at month 6. The trial tracked three things worth knowing. Tap each.
What nobody knows yet
FINE-ONE shows finerenone lowers albumin in people with type 1 diabetes. On its own, it does not show fewer cases of kidney failure. That link is borrowed from the type 2 trials. There are two fair ways to read that.
VIEW 1 The bridge is reasonable
In type 2 diabetes, FIDELIO-DKD (5,734 people, also Bayer-funded) found fewer combined kidney events with finerenone over a median 2.6 years: 17.8% versus 21.1% on placebo. The FINE-ONE design paper says regulators agreed urine albumin could bridge that evidence to type 1, as long as set criteria were met.
VIEW 2 A stand-in is still a stand-in
Six months and 242 people is too short and too small to count kidney failure, dialysis, or deaths. What is known about safety in type 1 also comes from those six months. No long-term outcome trial of finerenone in type 1 diabetes has reported.
Both can be true at once. The approval follows a logic regulators agreed to in advance, and the long-term answer in type 1 is still open.
The approval rests on a lab value moving in the right direction. That is a reasonable bet, and it is still a bet.
An editorial observationWhat this means for people with type 1
Kidney disease is a common complication. Bayer’s release puts it at roughly 20 to 30% of people in the U.S. with type 1 diabetes, and the FINE-ONE design paper says up to 40% develop it despite guideline-recommended treatment.
Kerendia is not an insulin and is not a blood sugar medication. The approval covers adults who already have kidney disease tied to type 1. The trial tested it on top of an ACE inhibitor or ARB, not in place of one, and it enrolled adults only.
Dr. Janet McGill of Washington University School of Medicine, the final author on the FINE-ONE paper, said in Bayer’s release that this group has had “limited options to address the risk of kidney disease progression.”
For anyone following their kidney health, the two lab numbers in this story are urine albumin (UACR) and eGFR. Whether any medication makes sense for a specific person, and how potassium would be watched, is a conversation to have with a doctor.
FINE-ONE results. Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med 394(10):947–957, March 2026. Randomized, double-blind, placebo-controlled phase 3 trial, n=242. Funded by Bayer. NCT05901831.
FINE-ONE design. Heerspink HJL, et al. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease. Diabetes Res Clin Pract 204:110908, October 2023. Several authors are Bayer employees.
Type 2 outcomes. Bakris GL, Agarwal R, Anker SD, et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes (FIDELIO-DKD). N Engl J Med 383:2219–2229, 2020. Randomized trial, n=5,734. Funded by Bayer.
1993 captopril trial. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med 329:1456–1462, 1993. Randomized trial, n=409.
Press release. Bayer, via Business Wire, September 16, 2026. Company statement, not peer reviewed.
How to read this evidence. FINE-ONE is a randomized trial, the strongest study design, but it is one trial, industry-funded, six months long, and its main endpoint is a lab marker rather than kidney failure. The kidney-outcome evidence for finerenone comes from people with type 2 diabetes. The approval covers adults with chronic kidney disease associated with type 1 diabetes; it does not cover children, and finerenone is not a treatment for blood sugar.
This post is for educational purposes only and is not medical advice. Nothing here is a recommendation to start, stop, or change any medication. Talk with your doctor before making any changes to your care.
Kerendia approved for kidney disease in type 1 diabetes
On September 16, 2026, the FDA approved Bayer’s finerenone (Kerendia) for adults with chronic kidney disease associated with type 1 diabetes. It is not a blood sugar drug, and the approval rests on a lab marker, not on kidney-failure outcomes.
What the research shows
- FINE-ONE (NEJM, 2026; 242 adults; Bayer-funded): urine albumin fell 25% more with finerenone than with placebo over six months.
- Everyone in FINE-ONE was already on an ACE inhibitor or ARB; finerenone was added on top.
- High potassium was the most common adverse event in FINE-ONE: 10.1% on finerenone vs. 3.3% on placebo; 1.7% stopped the drug for it.
- In type 2 diabetes, FIDELIO-DKD (NEJM, 2020; 5,734 people; Bayer-funded) found fewer combined kidney events with finerenone: 17.8% vs. 21.1% on placebo.
What it does not show
- Six months and 242 people: too short and too small to count kidney failure in type 1.
- The approval treats urine albumin as a stand-in for kidney outcomes, a link borrowed from the type 2 trials.
- In FINE-ONE, eGFR dropped more with finerenone at six months (a difference of 2.9 mL/min/1.73 m²); the paper reports values approached baseline after the drug was stopped.
For people with type 1
- The approval covers adults with kidney disease tied to type 1. FINE-ONE enrolled adults only, and the drug does not treat blood sugar.
- Bayer’s release estimates 20 to 30% of people in the U.S. with type 1 have chronic kidney disease.
- The two lab numbers in this story are urine albumin (UACR) and eGFR.
- Whether any medication fits a specific person is a conversation to have with a doctor.
Sources: Heerspink et al., N Engl J Med 2026, doi:10.1056/NEJMoa2512854 · Heerspink et al., Diabetes Res Clin Pract 2023, doi:10.1016/j.diabres.2023.110908 · Bakris et al., N Engl J Med 2020, doi:10.1056/NEJMoa2025845 · Bayer press release, Sept. 16, 2026.
Educational only. Not medical advice. · juiceboxpodcast.com
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