The US Food and Drug Administration has accepted a filing that could widen the reach of a kidney drug, and the KERENDIA CKD without diabetes application is the part that matters most to patients. Bayer announced on 8 October 2026 that the FDA has accepted its supplemental New Drug Application (sNDA) to extend KERENDIA (finerenone) to adults with chronic kidney disease (CKD) who do not have diabetes and are receiving standard care.
Acceptance means the FDA considers the application complete enough to review. It is not an approval. The release did not state whether the review is standard or priority, or give a decision date, so we cannot say when a decision could come. Below we set out the evidence behind the filing, the safety trade-offs and what it could mean.
The filing in brief
- Drug: KERENDIA (finerenone), a non-steroidal mineralocorticoid receptor antagonist.
- Proposed use: adults with CKD without diabetes, on top of standard of care.
- Basis: the Phase 3 FIND-CKD trial.
- FDA status: sNDA accepted for review; review type and action date not stated.
- Current US approvals: CKD with type 2 diabetes (2021), heart failure with an ejection fraction of 40% or more (July 2025), and CKD with type 1 diabetes (September 2026).
What the FIND-CKD trial showed
FIND-CKD was a randomised, double-blind, placebo-controlled Phase 3 trial of 1,584 adults with CKD without diabetes. Participants took KERENDIA or placebo on top of the maximum tolerated labelled dose of an ACE inhibitor or an angiotensin receptor blocker. Among those given KERENDIA, 56% had glomerular disease, including IgA nephropathy and focal segmental glomerulosclerosis, and 30% had hypertensive or ischaemic kidney disease.
- Primary endpoint (met): mean annual change in eGFR, a measure of kidney filtering, to month 32 was −3.3 with KERENDIA versus −4.0 mL/min/1.73 m² per year with placebo, a difference of 0.7 (95% CI 0.3 to 1.1; p below 0.001).
- Key secondary endpoint (met): a composite of kidney failure, a sustained eGFR fall of 57% or more, heart failure hospitalisation or cardiovascular death had a hazard ratio of 0.77 (95% CI 0.60 to 0.99; p = 0.04).
The results were published in the New England Journal of Medicine and presented at the 63rd ERA Congress. In our assessment, the headline effect is modest in absolute terms: 0.7 mL/min/1.73 m² per year is a slower decline, not a reversal, and the composite outcome result sits close to the edge of statistical significance (upper confidence limit 0.99). The company notes that eGFR slope is an increasingly accepted surrogate endpoint in CKD trials, which is relevant to how regulators weigh the result.
Safety: the potassium question
Hyperkalaemia, or raised blood potassium, is the best-known risk of this drug class. In FIND-CKD:
- Treatment-emergent adverse events occurred in 68.3% of KERENDIA patients and 65.4% of placebo patients.
- Serious adverse events were similar: 20.9% versus 21.2%.
- Hyperkalaemia occurred in 17.0% versus 13.3%. By our calculation, that is a 3.7 percentage-point difference.
- Serious hyperkalaemia was under 1%, and hyperkalaemia leading to hospitalisation or permanent discontinuation was under 2%.
The current label advises against starting treatment if serum potassium is above 5 mEq/L, and calls for monitoring of potassium and eGFR. It is contraindicated with strong CYP3A4 inhibitors and in adrenal insufficiency, and patients should avoid grapefruit and strong or moderate CYP3A4 inducers. Any expanded indication would keep these precautions.
Why this population matters
Bayer cites US data showing that more than 37 million American adults have CKD, that an estimated 50% to 70% of them do not have diabetes, and that 63% of US patients who progress to end-stage kidney disease do not have diabetes. If those figures hold, the current label, which is built around diabetic kidney disease, leaves a large group of patients outside its scope. That is the commercial and clinical logic of the filing. Note that these statistics are Bayer’s citation of public health data, not our own analysis.
One detail deserves attention. The trial population was mixed: more than half of treated patients had glomerular disease, which covers conditions such as IgA nephropathy, while others had hypertensive or ischaemic kidney disease. A label could be written broadly or narrowly depending on how the FDA reads results across these subgroups. The release does not report subgroup findings, so we cannot say whether benefit was consistent across them.
What FDA acceptance does and does not mean
- It means the application passed an initial completeness check and is under review.
- It does not mean the FDA agrees the data are sufficient.
- It does not set the outcome. Reviewers may ask for more data, restrict the population or require extra labelling.
- Approval, if it comes, would be a label expansion for an existing drug, not a new product.
Bayer’s Carolina Aldworth said that, if approved, KERENDIA has the potential to help physicians slow kidney function decline. The statement is conditional, as it should be at this stage.
What to watch next
- Whether the FDA grants standard or priority review, and the action date.
- Filings in other regions such as the EU, Japan and China; the release we reviewed did not state their status.
- Real-world potassium monitoring in non-diabetic patients, who may differ from diabetic patients in baseline risk.
- Further results from Bayer’s wider programme of Phase 3 studies in kidney and heart disease.
For more drug-regulatory news, browse our pharmaceutical coverage.
Frequently asked questions
Has the FDA approved KERENDIA for CKD without diabetes?
No. The FDA has accepted the application for review. It has not made a decision.
What is KERENDIA used for today?
In the US, for CKD with type 2 diabetes, CKD with type 1 diabetes, and heart failure with an ejection fraction of 40% or more, within the approved terms for each.
What did the FIND-CKD trial show?
A slower annual decline in eGFR (−3.3 versus −4.0) and a lower risk of the composite kidney and cardiovascular outcome (hazard ratio 0.77).
What is the main safety risk?
Raised potassium. Hyperkalaemia occurred in 17% of treated patients versus 13.3% on placebo, and potassium needs monitoring.
When will the FDA decide?
The release we reviewed did not give a decision date.
How we reported this: we relied on Bayer’s announcement of 8 October 2026 and the FIND-CKD trial registry. Efficacy and safety figures are the company’s reported trial results. Our commentary is labelled. Last updated: 9 October 2026. This article is news reporting and not medical advice.
