Finerenone (Kerendia) for T1D kidney disease
Bayer
Albuminuria fell; hard kidney outcomes remain unproven.
A nonsteroidal mineralocorticoid-receptor antagonist being reviewed by the FDA for adults with chronic kidney disease associated with type 1 diabetes. In the six-month FINE-ONE phase-3 trial it reduced albuminuria more than placebo, but the study was too short and was not designed to show fewer kidney failures or cardiovascular events. It is not yet approved for the T1D indication.
The scorecard
This is a kidney-protection programme, not a glucose-lowering one. FINE-ONE did not establish an HbA1c or time-in-range benefit and insulin remains essential.[1]
Hyperkalemia was the most common adverse event: 10.1% with finerenone versus 3.3% with placebo, and 1.7% stopped finerenone because of it. Potassium and kidney-function monitoring are therefore central to use.[1]
Urinary albumin-to-creatinine ratio fell 34% from baseline with finerenone and 12% with placebo, a 25% relative treatment effect. Albuminuria is a useful kidney-risk marker, but FINE-ONE did not measure a reduction in kidney failure, cardiovascular events, or death.[1]
A completed randomized phase-3 trial has been published in the New England Journal of Medicine, and the FDA accepted the supplemental application with Priority Review. That is late-stage evidence, not an approval.[3]
Finerenone is marketed for other heart and kidney indications, but chronic kidney disease associated with T1D is not an approved US indication as of 8 August 2026. Bayer still listed the submission as pending in its August pipeline update.[4]
These are scored as add-ons to insulin in Type 1 diabetes, never on their Type 2 diabetes evidence — a drug with a large Type 2 trial base but only small Type 1 studies scores low on maturity. Safety carries heavy weight here because the best-known adjunct risk, diabetic ketoacidosis at normal glucose levels, is potentially fatal and specific to Type 1. Most of this class is used off-label; that is reflected in access, not hidden.
Editor’s take
This is not another borrowed type-2 claim: FINE-ONE enrolled people with type 1 diabetes and albuminuric chronic kidney disease. The signal is meaningful, but its boundary matters. A six-month fall in albuminuria is not proof that fewer people will reach dialysis, have a cardiovascular event, or live longer. If approved, finerenone would fill a long-neglected complication gap; it would not improve glucose control and it would bring a real potassium-monitoring burden.
The full picture
Finerenone is a selective, nonsteroidal mineralocorticoid-receptor antagonist. It is already marketed as Kerendia for chronic kidney disease associated with type 2 diabetes and for some heart-failure indications, but that history cannot substitute for evidence in type 1 diabetes. FINE-ONE is the dedicated T1D study.
What FINE-ONE found
FINE-ONE randomized 242 adults with T1D and albuminuric chronic kidney disease to finerenone or placebo on top of standard care, including an ACE inhibitor or angiotensin-receptor blocker. Over six months, urinary albumin-to-creatinine ratio (UACR) fell 34% with finerenone and 12% with placebo. The between-group ratio was 0.75 (95% CI 0.65-0.87; P<0.001), equivalent to a 25% greater reduction with finerenone.1
That is a positive phase-3 result, but UACR is a surrogate marker. The trial was neither long enough nor designed to show fewer cases of kidney failure, dialysis, cardiovascular events, or death. Those benefits are plausible from other finerenone programmes, but those programmes were largely in type 2 diabetes; they are not direct T1D outcome evidence.
Safety and access
Hyperkalemia occurred in 10.1% of participants taking finerenone versus 3.3% on placebo, and 1.7% discontinued finerenone because of it.1 That makes potassium and kidney-function monitoring part of the treatment, not an optional extra.
The FDA accepted Bayer's supplemental application and granted Priority Review in May 2026.2 As of 8 August 2026 the T1D-associated CKD indication was still pending; Bayer's 4 August pipeline presentation continued to list a first approval as expected by the end of 2026.3 A company forecast is not an approval, and the marketed product's other indications do not make this T1D use on-label.
References
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Heerspink HJL, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med (2026). https://doi.org/10.1056/NEJMoa2512854 ↩ ↩2
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Bayer. U.S. FDA grants Priority Review for finerenone in chronic kidney disease associated with type 1 diabetes (21 May 2026). https://www.bayer.com/media/en-us/us-fda-grants-priority-review-for-finerenone-in-chronic-kidney-disease-associated-with-type-1-diabetes/ ↩
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Bayer. Q2 2026 investor call presentation (4 August 2026). https://www.bayer.com/sites/default/files/2026-08/q2-2026-investor-call-presentation.pdf ↩
Coming soon
ETA · Bayer anticipates a first T1D-CKD approval by the end of 2026. The company has not disclosed a binding FDA action date, and approval is not guaranteed.
- →FDA decision on the supplemental T1D-associated CKD indication · Bayer guidance says by end-2026
Sources
- [1]Finerenone in Type 1 Diabetes and Chronic Kidney Disease · peer-reviewed · 2026-03-04 — FINE-ONE randomized 242 adults. Over six months, UACR fell 34% with finerenone and 12% with placebo (between-group ratio 0.75, 95% CI 0.65-0.87; P<0.001). Hyperkalemia occurred in 10.1% versus 3.3%.
- [2]FINE-ONE: Finerenone in chronic kidney disease and type 1 diabetes · registry · 2025-10-21 — COMPLETED phase 3; actual start 26 February 2024, completion 15 September 2025. The registry lists actual enrollment as 241, while the publication reports 242 randomized participants; no registry results are posted.
- [3]U.S. FDA grants Priority Review for finerenone in chronic kidney disease associated with type 1 diabetes · manufacturer · 2026-05-21 — Bayer says the FDA accepted the supplemental application and granted Priority Review. Priority Review shortens the review goal; it does not mean the indication is approved.
- [4]Bayer Q2 2026 investor call presentation · manufacturer · 2026-08-04 — The 4 August pipeline still lists the US CKD/T1D submission as pending and anticipates a first approval by the end of 2026; this is company guidance, not an FDA decision date.