Finerenone

The medicine inside Kerendia. It is a pill that blocks the mineralocorticoid receptor and is not a steroid. In the FIDELIO-DKD trial it lowered the risk of kidney disease getting worse in people with chronic kidney disease and type 2 diabetes, and it caused more stopping of the medicine because of high potassium. In the FINEARTS-HF trial in people with heart failure and an ejection fraction of 40% or more, it lowered the rate of a combined outcome of worsening heart failure events and cardiovascular death, with more high potassium; cardiovascular death alone did not clearly differ.

Also called Finerenone

Drug
In this atlas

Overview

Technical summary

RxNorm ingredient 2562811. A nonsteroidal, selective mineralocorticoid receptor antagonist. In FIDELIO-DKD the primary kidney outcome hazard ratio was 0.82 (95% CI 0.73 to 0.93). Hyperkalemia-related discontinuation was 2.3% on finerenone and 0.9% on placebo. RxClass lists finerenone under the mineralocorticoid receptor antagonist class, which this record links to. The heart-failure trial FINEARTS-HF is in a separate claim: the rate ratio for total worsening heart failure events and cardiovascular death was 0.84 (95% CI 0.74 to 0.95), with more hyperkalemia.

About this drug

Level: Substance
Mechanism: A nonsteroidal, selective mineralocorticoid receptor antagonist.

Claims and evidence

Context Adults with chronic kidney disease and type 2 diabetes (FIDELIO-DKD)

Recipient: Adult
Population: Patients with chronic kidney disease and type 2 diabetes who had a urinary albumin-to-creatinine ratio of 30 to below 300, an eGFR of 25 to below 60 and diabetic retinopathy, or a ratio of 300 to 5000 and an eGFR of 25 to below 75. All were treated with renin-angiotensin system blockade adjusted to the maximum label dose they tolerated.
Care setting: Multicenter trial. The care setting is not described further in the sources read.
Geography: Multinational. The registry lists the sites by country on the study page.
Life stage: Adults aged 18 years or older (registry minimum age 18 years)
Follow-up: Median follow-up 2.6 years.

Eligibility: 3 inclusion criteria; exclusion criteria not stated

Included: Chronic kidney disease and type 2 diabetes
Albumin-to-creatinine ratio 30 to below 300, eGFR 25 to below 60 and diabetic retinopathy; or ratio 300 to 5000 and eGFR 25 to below 75
Renin-angiotensin system blockade at the maximum tolerated label dose
Excluded: None stated

Effect Interventional Certainty not assessed

In FIDELIO-DKD, 5734 patients with chronic kidney disease and type 2 diabetes, all on maximum tolerated renin-angiotensin system blockade, were randomly assigned to finerenone or placebo. During a median follow-up of 2.6 years, the primary outcome (kidney failure, a sustained decrease of at least 40% in eGFR from baseline, or death from renal causes) occurred in 504 of 2833 patients (17.8%) on finerenone and 600 of 2841 (21.1%) on placebo (hazard ratio 0.82; 95% CI 0.73 to 0.93; P=0.001). The key secondary outcome (death from cardiovascular causes, nonfatal heart attack, nonfatal stroke or hospitalization for heart failure) occurred in 367 patients (13.0%) and 420 (14.8%) (hazard ratio 0.86; 95% CI 0.75 to 0.99; P=0.03). Overall adverse events were similar in the two groups, but stopping the trial regimen because of high potassium (hyperkalemia) was more frequent on finerenone, 2.3% against 0.9%.
Applies to Adult
- Patients with chronic kidney disease and type 2 diabetes who had a urinary albumin-to-creatinine ratio of 30 to below 300, an eGFR of 25 to below 60 and diabetic retinopathy, or a ratio of 300 to 5000 and an eGFR of 25 to below 75. All were treated with renin-angiotensin system blockade adjusted to the maximum label dose they tolerated.
- Multicenter trial. The care setting is not described further in the sources read.
- Multinational. The registry lists the sites by country on the study page.
- Adults aged 18 years or older (registry minimum age 18 years)
Follow-up Median follow-up 2.6 years.
Certainty method
Not assessed

Limitations
Participants had to be on renin-angiotensin system blockade and had diabetic kidney disease, so the result does not cover people without diabetes or without that blockade. Funded by Bayer (named in the abstract). Only the PubMed abstract was read.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (6)
1. Supports Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2020-12-03 · DOI: 10.1056/NEJMoa2025845 · PMID: 33264825
  
  Locator
  Abstract, RESULTS, sentence 1
  
  How it applies
  Primary outcome events by arm, hazard ratio and p-value.
  
  Retrieved
  2026-10-14T18:18:49Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  aa1851e07117283e5bda4286fa413399c6767f2e4854a017e0ea917d59982a1d
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Supports Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2020-12-03 · DOI: 10.1056/NEJMoa2025845 · PMID: 33264825
  
  Locator
  Abstract, RESULTS, sentence 2
  
  How it applies
  Key secondary outcome.
  
  Retrieved
  2026-10-14T18:18:49Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  aa1851e07117283e5bda4286fa413399c6767f2e4854a017e0ea917d59982a1d
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
3. Supports Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2020-12-03 · DOI: 10.1056/NEJMoa2025845 · PMID: 33264825
  
  Locator
  Abstract, RESULTS, sentence 3; Abstract, RESULTS, sentence 4
  
  How it applies
  Adverse events overall and hyperkalemia-related discontinuation.
  
  Retrieved
  2026-10-14T18:18:49Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  aa1851e07117283e5bda4286fa413399c6767f2e4854a017e0ea917d59982a1d
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
4. Supports Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2020-12-03 · DOI: 10.1056/NEJMoa2025845 · PMID: 33264825
  
  Locator
  Abstract, CONCLUSIONS, sentence 1
  
  How it applies
  The authors conclusion.
  
  Retrieved
  2026-10-14T18:18:49Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  aa1851e07117283e5bda4286fa413399c6767f2e4854a017e0ea917d59982a1d
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
5. Background Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2020-12-03 · DOI: 10.1056/NEJMoa2025845 · PMID: 33264825
  
  Locator
  Abstract, BACKGROUND, sentence 1; Abstract, METHODS, sentence 4; Abstract, METHODS, sentence 5
  
  How it applies
  What finerenone is, and the primary and key secondary outcome definitions.
  
  Retrieved
  2026-10-14T18:18:49Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  aa1851e07117283e5bda4286fa413399c6767f2e4854a017e0ea917d59982a1d
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
6. Background Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2020-12-03 · DOI: 10.1056/NEJMoa2025845 · PMID: 33264825
  
  Locator
  Abstract, CONCLUSIONS, sentence 2
  
  How it applies
  Funding line.
  
  Retrieved
  2026-10-14T18:18:49Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  aa1851e07117283e5bda4286fa413399c6767f2e4854a017e0ea917d59982a1d
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Context Patients with heart failure and an ejection fraction of 40% or greater (FINEARTS-HF)

Recipient: Recipient not specified
Population: Patients with heart failure and a left ventricular ejection fraction of 40% or greater, which covers mildly reduced and preserved ejection fraction.
Care setting: International, double-blind, randomized trial; the abstract does not describe the care setting further.
Geography: International, according to the abstract. The countries were not read.
Life stage: Not stated in the abstract.
Gestational age: Not reported
Postnatal age: Not reported
Follow-up: Median follow-up 32 months.

Eligibility: 2 inclusion criteria; exclusion criteria not stated

Included: Heart failure
Left ventricular ejection fraction of 40% or greater
Excluded: None stated

Effect Interventional Certainty not assessed

In FINEARTS-HF, patients with heart failure and a left ventricular ejection fraction of 40% or greater were randomly assigned, in a 1:1 ratio, to finerenone or matching placebo, each on top of usual therapy; the finerenone dose was titrated to a maximum of 20 mg or 40 mg once daily. The primary outcome counted two things together: total worsening heart failure events (first or repeat unplanned hospitalizations or urgent visits for heart failure) and death from cardiovascular causes. Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients on finerenone and 1283 events in 719 of 2998 patients on placebo (rate ratio 0.84; 95% CI 0.74 to 0.95; P=0.007). Worsening heart failure events alone numbered 842 on finerenone and 1024 on placebo (rate ratio 0.82; 95% CI 0.71 to 0.94; P=0.006). Death from cardiovascular causes occurred in 8.1% and 8.7% of patients (hazard ratio 0.93; 95% CI 0.78 to 1.11), an interval that includes 1. Finerenone was associated with more hyperkalemia and less hypokalemia.
Applies to Recipient not specified
- Patients with heart failure and a left ventricular ejection fraction of 40% or greater, which covers mildly reduced and preserved ejection fraction.
- International, double-blind, randomized trial; the abstract does not describe the care setting further.
- International, according to the abstract. The countries were not read.
- Not stated in the abstract.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Median follow-up 32 months.
Certainty method
Not assessed

Limitations
One double-blind trial, funded by Bayer (named in the abstract). Only the PubMed abstract was read, not the full paper, and the registry record the abstract names (NCT04435626) was not read. The abstract gives no age limits and no certainty grade. The primary outcome is a composite. Total worsening heart failure events alone were also lower, while for cardiovascular death alone the confidence interval included 1. The abstract gives no size for the hyperkalemia and hypokalemia findings. The ejection fraction band of 40% or greater covers the mildly reduced and the preserved range, and it includes 40% itself, which NHLBI counts in the reduced range, so the result is not specific to the mildly reduced or the preserved type.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (6)
1. Supports Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists commentary on the paper and no correction. · Published 2024-10-24 · DOI: 10.1056/NEJMoa2407107 · PMID: 39225278
  
  Locator
  Abstract, RESULTS, sentence 1
  
  How it applies
  Primary-outcome events and patients by arm, rate ratio and p-value.
  
  Retrieved
  2026-10-14T18:18:51Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  a5952811b7ff90f593b834a08399a1df3ec77ced0ca460a95a593c31d9a9922b
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Supports Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists commentary on the paper and no correction. · Published 2024-10-24 · DOI: 10.1056/NEJMoa2407107 · PMID: 39225278
  
  Locator
  Abstract, RESULTS, sentence 2
  
  How it applies
  Total worsening heart failure events.
  
  Retrieved
  2026-10-14T18:18:51Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  a5952811b7ff90f593b834a08399a1df3ec77ced0ca460a95a593c31d9a9922b
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
3. Supports Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists commentary on the paper and no correction. · Published 2024-10-24 · DOI: 10.1056/NEJMoa2407107 · PMID: 39225278
  
  Locator
  Abstract, RESULTS, sentence 3; Abstract, RESULTS, sentence 4
  
  How it applies
  Cardiovascular death and potassium findings.
  
  Retrieved
  2026-10-14T18:18:51Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  a5952811b7ff90f593b834a08399a1df3ec77ced0ca460a95a593c31d9a9922b
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
4. Supports Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists commentary on the paper and no correction. · Published 2024-10-24 · DOI: 10.1056/NEJMoa2407107 · PMID: 39225278
  
  Locator
  Abstract, CONCLUSIONS, sentence 1
  
  How it applies
  The authors conclusion.
  
  Retrieved
  2026-10-14T18:18:51Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  a5952811b7ff90f593b834a08399a1df3ec77ced0ca460a95a593c31d9a9922b
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
5. Background Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists commentary on the paper and no correction. · Published 2024-10-24 · DOI: 10.1056/NEJMoa2407107 · PMID: 39225278
  
  Locator
  Abstract, METHODS, sentence 1; Abstract, METHODS, sentence 2
  
  How it applies
  Population, doses and the primary outcome definition.
  
  Retrieved
  2026-10-14T18:18:51Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  a5952811b7ff90f593b834a08399a1df3ec77ced0ca460a95a593c31d9a9922b
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
6. Background Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. PubMed lists commentary on the paper and no correction. · Published 2024-10-24 · DOI: 10.1056/NEJMoa2407107 · PMID: 39225278
  
  Locator
  Abstract, CONCLUSIONS, sentence 2
  
  How it applies
  Funding line.
  
  Retrieved
  2026-10-14T18:18:51Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  a5952811b7ff90f593b834a08399a1df3ec77ced0ca460a95a593c31d9a9922b
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact FIDELIO-DKD looked at kidney failure, eGFR decline and renal death in people with type 2 diabetes: Chronic kidney disease (CKD) (Evaluated for)
Applies to Adult
- Patients with chronic kidney disease and type 2 diabetes who had a urinary albumin-to-creatinine ratio of 30 to below 300, an eGFR of 25 to below 60 and diabetic retinopathy, or a ratio of 300 to 5000 and an eGFR of 25 to below 75. All were treated with renin-angiotensin system blockade adjusted to the maximum label dose they tolerated.
- Multicenter trial. The care setting is not described further in the sources read.
- Multinational. The registry lists the sites by country on the study page.
- Adults aged 18 years or older (registry minimum age 18 years)
Follow-up Median follow-up 2.6 years.
In FIDELIO-DKD, 5734 patients with chronic kidney disease and type 2 diabetes, all on maximum tolerated renin-angiotensin system blockade, were randomly assigned to finerenone or placebo. During a median follow-up of 2.6 years, the primary outcome (kidney failure, a sustained decrease of at least 40% in eGFR from baseline, or death from renal causes) occurred in 504 of 2833 patients (17.8%) on finerenone and 600 of 2841 (21.1%) on placebo (hazard ratio 0.82; 95% CI 0.73 to 0.93; P=0.001). The key secondary outcome (death from cardiovascular causes, nonfatal heart attack, nonfatal stroke or hospitalization for heart failure) occurred in 367 patients (13.0%) and 420 (14.8%) (hazard ratio 0.86; 95% CI 0.75 to 0.99; P=0.03). Overall adverse events were similar in the two groups, but stopping the trial regimen because of high potassium (hyperkalemia) was more frequent on finerenone, 2.3% against 0.9%.
Limitations. Participants had to be on renin-angiotensin system blockade and had diabetic kidney disease, so the result does not cover people without diabetes or without that blockade. Funded by Bayer (named in the abstract). Only the PubMed abstract was read.
Claim, not a settled fact FINEARTS-HF: lower rate of the combined outcome of worsening heart failure events and cardiovascular death than placebo, with more hyperkalemia: Heart failure with mildly reduced or preserved ejection fraction (Evaluated for)
Applies to Recipient not specified
- Patients with heart failure and a left ventricular ejection fraction of 40% or greater, which covers mildly reduced and preserved ejection fraction.
- International, double-blind, randomized trial; the abstract does not describe the care setting further.
- International, according to the abstract. The countries were not read.
- Not stated in the abstract.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Median follow-up 32 months.
In FINEARTS-HF, patients with heart failure and a left ventricular ejection fraction of 40% or greater were randomly assigned, in a 1:1 ratio, to finerenone or matching placebo, each on top of usual therapy; the finerenone dose was titrated to a maximum of 20 mg or 40 mg once daily. The primary outcome counted two things together: total worsening heart failure events (first or repeat unplanned hospitalizations or urgent visits for heart failure) and death from cardiovascular causes. Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients on finerenone and 1283 events in 719 of 2998 patients on placebo (rate ratio 0.84; 95% CI 0.74 to 0.95; P=0.007). Worsening heart failure events alone numbered 842 on finerenone and 1024 on placebo (rate ratio 0.82; 95% CI 0.71 to 0.94; P=0.006). Death from cardiovascular causes occurred in 8.1% and 8.7% of patients (hazard ratio 0.93; 95% CI 0.78 to 1.11), an interval that includes 1. Finerenone was associated with more hyperkalemia and less hypokalemia.
Limitations. One double-blind trial, funded by Bayer (named in the abstract). Only the PubMed abstract was read, not the full paper, and the registry record the abstract names (NCT04435626) was not read. The abstract gives no age limits and no certainty grade. The primary outcome is a composite. Total worsening heart failure events alone were also lower, while for cardiovascular death alone the confidence interval included 1. The abstract gives no size for the hyperkalemia and hypokalemia findings. The ejection fraction band of 40% or greater covers the mildly reduced and the preserved range, and it includes 40% itself, which NHLBI counts in the reduced range, so the result is not specific to the mildly reduced or the preserved type.

Record details

Record id: cardio:finerenone
Content hash: 561f3a3bc4ec30cd46fda8fcf3f3648add29c4f7e330c070505f20d35eb7feac