Finerenone (Kerendia) for T1D kidney disease
Bayer
Albuminuria fell; hard kidney outcomes remain unproven.
What it is
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.
Editorial review: .
Most recent recorded citation date: 2026-08-04. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Glycemic benefit: This is a kidney-protection programme, not a glucose-lowering one. No HbA1c or time-in-range benefit was reported in the FINE-ONE abstract, and participants were insulin-treated.[1]
- Important harms and treatment burden
- Safety: 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]
- Approval and country access
- Kerendia is sold for other indications, but the T1D-associated CKD indication remained under FDA review at the 8 August 2026 cutoff.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 0 × 25 + 52 × 25 + 72 × 15 + 72 × 20 + 18 × 15 = 4090; divide by total weight 100. Unrounded weighted result: 40.9.
This is a kidney-protection programme, not a glucose-lowering one. No HbA1c or time-in-range benefit was reported in the FINE-ONE abstract, and participants were insulin-treated.[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 27 August 2026. Priority Review (accepted 21 May 2026) is not an approval; no FDA decision was found by this cutoff.[4]
These ratings concern add-on treatment alongside insulin in T1D. Maturity reflects the T1D evidence, and safety receives substantial editorial weight because risks differ by drug and population. For example, SGLT2 inhibitors can cause ketoacidosis even without markedly high glucose; this is not exclusive to T1D. Access reflects the stated indication and region, including whether a separate obesity indication applies.
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 2026.3 On 17 September 2026 Bayer announced FDA approval of Kerendia (finerenone) "for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D)"4; the new indication is "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". The marketed product's other indications do not make any other use on-label.
Coming soon
ETA · FDA-approved 17 September 2026: Kerendia (finerenone) "for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D)", indicated "to reduce urinary albumin-to-creatinine ratio (UACR)".
- →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 study · 2026-03-05 — 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%.
Heerspink HJL, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med (2026).
- [2]FINE-ONE: Finerenone in chronic kidney disease and type 1 diabetes · Trial 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.
Bayer. U.S. FDA grants Priority Review for finerenone in chronic kidney disease associated with type 1 diabetes (21 May 2026).
- [4]Bayer Q2 2026 investor call presentation · Manufacturer · 2026-08-04 — On 17 September 2026 Bayer announced that the FDA "has approved Kerendia (finerenone) for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D)", following the May 2026 Priority Review designation; finerenone "is now indicated to reduce urinary albumin-to-creatinine ratio (UACR)". This supersedes the 4 August pipeline guidance that anticipated a first approval by the end of 2026.
Bayer. Q2 2026 investor call presentation (4 August 2026).