Finerenone: The Kidney-and-Heart Drug for Diabetic Kidney Disease

Finerenone is a once-a-day prescription tablet that blocks a hormone switch in the kidneys, heart and blood vessels called the mineralocorticoid receptor. It was first approved in the United States in 2021 for people whose kidneys are being damaged by type 2 diabetes, and its label has since grown to include heart failure in which the heart still pumps reasonably well, and kidney disease in type 1 diabetes. This page explains what the hormone switch does when it is overactive, how finerenone differs from the two older medicines that block the same switch, what the United States Food and Drug Administration (FDA) has approved and when, what each of the large trials found in numbers, how often blood potassium rose too high, the label’s rules for potassium checks and for other medicines that change finerenone levels, and what is still not known.

The Diabetic Nephropathy page gives the headline results of the three main kidney trials. This page goes further: the early trials, the pooled analyses, the heart failure trial, the newest trials in type 1 diabetes and in kidney disease without diabetes, and the detail on high potassium.

Table of Contents

  1. What Finerenone Is
  2. What the Mineralocorticoid Receptor Does
  3. How It Differs From Spironolactone and Eplerenone
  4. What the FDA Has Approved
  5. The Early Trials
  6. FIDELIO-DKD: Kidney Outcomes
  7. FIGARO-DKD: Heart Outcomes in Earlier Kidney Disease
  8. FIDELITY and FINE-HEART: The Pooled Analyses
  9. FINEARTS-HF: Heart Failure With a Pumping Fraction of 40% or More
  10. Type 1 Diabetes and Kidney Disease Without Diabetes
  11. Starting Together With Empagliflozin
  12. High Potassium: How Often It Happened
  13. What the Label States About Potassium and Dosing
  14. Medicines and Foods That Change Finerenone Levels
  15. Other Hazards on the Label
  16. What Is Not Known
  17. Key Research Papers
  18. Connections
  19. Featured Videos

What Finerenone Is

Finerenone is a small-molecule tablet. The label calls it a non-steroidal mineralocorticoid receptor antagonist (MRA): a medicine that sits in the docking site of the mineralocorticoid receptor so that the body’s own hormones cannot switch it on, and whose chemical shape is not built on the steroid ring found in the two older drugs of the same family. It comes as 10 mg, 20 mg and 40 mg tablets, taken once a day with or without food.

The label gives these basic facts about how the body handles it:

What the Mineralocorticoid Receptor Does

The mineralocorticoid receptor is a protein inside cells that, once switched on, changes which genes the cell reads. The label states that it is switched on by two hormones from the adrenal glands: aldosterone, the salt-keeping hormone, and cortisol, the stress hormone.

Its best-known job is in the kidney. There, aldosterone acting on this receptor makes the kidney hold on to sodium (and water with it) and let go of potassium. That is the reason every medicine that blocks this receptor tends to raise blood potassium: the kidney is told to keep more of it.

A 2021 review in the European Heart Journal describes how the picture has widened over 80 years of research. The receptor is found not only in kidney tubules but in the heart, blood vessels, immune cells and fibroblasts (the cells that lay down scar tissue). The review states that “pathophysiological overactivation of the MR leads to inflammation and fibrosis in cardiorenal disease”. A 2022 review by the drug’s developers lists the parts of that harm studied in animals: extra reactive oxygen molecules (oxidative stress), inflammation, scarring (fibrosis) and thickening of heart muscle (hypertrophy).

In plain terms, the researchers’ model is this. In long-standing diabetes and in heart failure, the receptor is switched on more than it ought to be. In the kidney this is linked to scarring of the filters and the tissue around them, which shows up as protein (albumin) leaking into the urine and a slow fall in filtering power. In the heart and vessels it is linked to stiffening and scarring. Blocking the receptor is meant to slow both. The label puts it more cautiously: overactivation “is thought to contribute to fibrosis and inflammation”.

How It Differs From Spironolactone and Eplerenone

Two older medicines block the same receptor: spironolactone and eplerenone. Both are steroids in chemical shape. The sources describe four differences.

Hormone side effects

Spironolactone is known for hormone-type side effects. In the 1999 RALES heart failure trial, breast enlargement or breast pain was reported in 10% of men taking spironolactone compared with 1% of men on placebo. The finerenone label states that it has “no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.”

Where the drug goes in the body

The 2021 review reports that finerenone has “a balanced distribution between the heart and kidney compared with spironolactone, which is preferentially concentrated in the kidneys.” The same review reports that, in rodents, finerenone at doses that caused the same salt loss as eplerenone showed stronger anti-inflammatory and anti-scarring effects on the kidney. These are animal findings.

How it binds

The review describes non-steroidal blockers as differing in their “binding mode to the MR and subsequent gene expression”, meaning they sit in the receptor in a different way and change a different set of genes.

Potassium in a head-to-head trial

Only one randomised trial has compared finerenone with spironolactone directly, and it measured blood tests, not outcomes. The ARTS trial, published in 2013 under finerenone’s laboratory code name BAY 94-8862, gave 392 people with heart failure with reduced pumping and moderate kidney disease finerenone at 2.5 to 10 mg a day, placebo, or open-label spironolactone at 25 or 50 mg a day. Average blood potassium rose by 0.04 to 0.30 mmol/L on finerenone and by 0.45 mmol/L on spironolactone. High potassium occurred in 5.3% on finerenone and 12.7% on spironolactone. Finerenone lowered markers of heart strain (B-type natriuretic peptide) and urine albumin “at least as much as spironolactone”.

The 2021 review sums up the developers’ reading: non-steroidal blockers “appear to demonstrate a better benefit-risk ratio than steroidal MRAs, where risk is measured as the propensity for hyperkalaemia.” No trial has compared finerenone with spironolactone or eplerenone on kidney failure, heart attacks, hospital stays or death.

What the FDA Has Approved

The Drugs@FDA record for finerenone lists the original approval on 9 July 2021, as a new molecular entity, followed by efficacy supplements approved on 1 September 2022, on 11 July 2025 (classed as a new indication) and on 16 September 2026. The label on DailyMed, revised September 2026, lists three uses, given here in the label’s own terms:

The label lists no use in children, in heart failure with an ejection fraction below 40%, or in kidney disease without diabetes.

The Early Trials

Before the large outcome trials, a dose-finding trial called ARTS-DN, published in 2015, gave 821 people with diabetic kidney disease, most already taking an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, one of several finerenone doses or placebo for 90 days. The fall in urine albumin rose with the dose. The label reports the placebo-corrected falls at day 90 as 25% at 10 mg and 38% at 20 mg. In the trial report, high potassium leading to stopping the drug did not occur in the placebo or 10 mg groups, and occurred in 1.7% to 3.2% of the higher-dose groups. There was no difference in the share of people whose filtering rate fell by 30% or more.

These short trials measured urine albumin and blood tests, not kidney failure or heart events. That question went to two large trials that together enrolled over 13,000 people.

FIDELIO-DKD: Kidney Outcomes

FIDELIO-DKD, published in 2020, randomly assigned 5,734 adults with type 2 diabetes and chronic kidney disease to finerenone or placebo. Everyone was already taking an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker at the highest dose they could tolerate. To enter, people needed either a moderately raised urine albumin with a filtering rate of 25 to under 60 plus diabetic eye disease, or a heavily raised urine albumin with a filtering rate of 25 to under 75. The label describes the group: average age 66, 70% men, average filtering rate 44, median urine albumin-to-creatinine ratio 852 mg/g, and blood potassium no higher than 4.8 at screening. Only 5% were taking a sodium-glucose cotransporter-2 inhibitor, the newer kidney-protecting diabetes drug family.

The trials gave 10 mg a day to people with a filtering rate under 60 and 20 mg to those at 60 or above, aiming for 20 mg.

Over a median of 2.6 years:

FIGARO-DKD: Heart Outcomes in Earlier Kidney Disease

FIGARO-DKD, published in 2021, asked whether the drug helped people at an earlier stage of kidney disease. It enrolled 7,437 people with type 2 diabetes and either a moderately raised urine albumin with a filtering rate of 25 to 90, or a heavily raised urine albumin with a filtering rate of 60 or more. In the label’s description, the average filtering rate was 68 and the median urine albumin-to-creatinine ratio 308 mg/g, so these kidneys were in better shape than in FIDELIO-DKD. Its main outcome was the heart outcome.

Over a median of 3.4 years:

FIDELITY and FINE-HEART: The Pooled Analyses

FIDELITY: both kidney trials together

Because FIDELIO-DKD and FIGARO-DKD used the same drug, dose and design in overlapping groups, the investigators planned in advance to pool every patient. The FIDELITY analysis, published in 2022, covered 13,026 people followed for a median of 3.0 years. It used a stricter kidney outcome: a lasting fall in filtering rate of 57% or more (roughly a doubling of blood creatinine) instead of 40%.

The authors pointed out that 40% of these patients had a filtering rate above 60, which many people would read as normal kidney function. They were in the trials only because a urine albumin test had been done. The authors drew from this a case for screening urine albumin in type 2 diabetes.

FINE-HEART: all three large trials together

A 2024 pooled analysis called FINE-HEART added the heart failure trial FINEARTS-HF to the two kidney trials, for 18,991 people followed for a median of 2.9 years. Its main question was death from heart and vessel causes:

So the pooled analysis did not meet its own main goal, while the lower death rate from any cause reached significance only when all three trials were added together. None of the three trials alone showed a clear fall in deaths from heart and vessel causes.

FINEARTS-HF: Heart Failure With a Pumping Fraction of 40% or More

The FINEARTS-HF report opens by noting that the steroidal blockers reduce illness and death in heart failure with reduced pumping. In RALES, 35% of patients on spironolactone died against 46% on placebo. Heart failure in which the heart still pumps reasonably well was a different story. The TOPCAT trial of spironolactone in 3,445 people with an ejection fraction of 45% or more, published in 2014, did not find a significant effect on its main outcome (18.6% versus 20.4%, hazard ratio 0.89), though hospital stays for heart failure were lower (12.0% versus 14.2%), and high potassium doubled (18.7% versus 9.1%).

FINEARTS-HF, published in 2024, tested finerenone in 6,001 people with heart failure and an ejection fraction of 40% or more, on top of their usual treatment. The trial gave up to 20 mg a day to people with a filtering rate under 60 and up to 40 mg to those at 60 or above. The label describes the group: average age 72, 46% women, average ejection fraction 53%, 41% with diabetes, 87% on a water tablet (loop diuretic), and 14% on a sodium-glucose cotransporter-2 inhibitor. About a fifth were enrolled in hospital or within a week of a heart failure flare.

Over a median of 32 months:

The label reports that the effect on the main outcome was consistent across the subgroups it names, including people with and without diabetes and with and without a sodium-glucose cotransporter-2 inhibitor. A 2025 analysis grouped patients by blood potassium (above or below 4.5) and filtering rate (above or below 60) at the start. People with a filtering rate under 60 had a 1.5- to 2-fold higher risk of events whatever they were taking. The analysis found no significant difference in the drug’s effect between the four groups, but side effects and stopping the drug were more common among those with weaker kidneys or higher potassium.

The label also reports what FINEARTS-HF showed about the kidneys in heart failure: adverse reactions related to worsening kidney function were reported in 18% on finerenone versus 12% on placebo, and hospital stays for these events in 2.0% versus 1.3%. Most were mild to moderate.

Type 1 Diabetes and Kidney Disease Without Diabetes

FINE-ONE: type 1 diabetes

FINE-ONE, published in 2026, is the first finerenone trial in type 1 diabetes. It randomly assigned 242 adults with type 1 diabetes, a filtering rate of 25 to under 90 and a urine albumin-to-creatinine ratio of 200 to under 5,000, all taking an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, to finerenone (10 or 20 mg a day, depending on filtering rate) or placebo for 6 months.

This trial lasted 6 months and measured urine albumin, not kidney failure. The type 1 use on the label rests on the inference described under What the FDA Has Approved.

FIND-CKD: kidney disease without diabetes

FIND-CKD, also published in 2026, tested finerenone in 1,584 adults with chronic kidney disease and raised urine albumin who did not have diabetes. Over 32 months, the filtering rate fell by 3.3 a year on finerenone and by 4.0 a year on placebo, a difference of 0.7 a year. A combined outcome of kidney and heart events was lower on finerenone (hazard ratio 0.77, confidence interval 0.60 to 0.99). The kidney events alone (0.78, interval 0.60 to 1.01) and heart events alone (0.60, interval 0.27 to 1.33) were not statistically clear on their own. High potassium occurred in 17.0% versus 13.3%, led to stopping in 1.5% versus 0.1%, and to hospital stays in 0.9% versus 0.6%. Kidney disease without diabetes is not a use on the September 2026 label.

Starting Together With Empagliflozin

By the time finerenone was approved, the sodium-glucose cotransporter-2 inhibitors had their own kidney trials, and the trial’s authors noted that there was limited evidence on starting the two at the same time. The CONFIDENCE trial, published in 2025, randomly assigned about 800 people with type 2 diabetes and chronic kidney disease (filtering rate 30 to 90, urine albumin-to-creatinine ratio 100 to 5,000, median 579), all already on a renin-angiotensin system blocker, to finerenone alone, empagliflozin alone, or both together from day one. The trial gave finerenone at 10 or 20 mg a day and empagliflozin at 10 mg a day.

At 180 days, the fall in urine albumin with both drugs together was 29% greater than with finerenone alone and 32% greater than with empagliflozin alone. The trial measured urine albumin only, over six months, not kidney failure.

A 2026 secondary analysis looked at potassium. Its authors noted that sodium-glucose cotransporter-2 inhibitors might lower the potassium risk of other kidney-protecting drugs. Over 180 days, high potassium occurred in 15.1% on both drugs, 18.8% on finerenone alone and 9.7% on empagliflozin alone. The authors reported no significant difference between the combination and finerenone alone in the average potassium change or in the odds of high potassium, and concluded that the combination “did not significantly mitigate the risk of hyperkalemia.” Few people stopped treatment, and the fall in urine albumin held whether or not high potassium developed.

High Potassium: How Often It Happened

High blood potassium (hyperkalaemia) is the main hazard of every drug in this family, because blocking the receptor tells the kidney to hold on to potassium. Very high potassium can disturb the heart’s rhythm; the Hyperkalemia page covers the signs and causes. The trials reported it this way:

Every one of these trials ran a strict potassium plan. In FIDELIO-DKD, the drug was paused whenever potassium went above 5.5 and restarted at 10 mg once it fell to 5.0 or less. The authors wrote that “routine potassium monitoring and hyperkalemia management strategies employed in FIDELIO-DKD minimized the impact of hyperkalemia.” How closely ordinary care matches that monitoring is a separate question.

What the Label States About Potassium and Dosing

The label builds the trial potassium plan into its dosing rules. (Potassium in mEq/L, the label’s unit, is the same number as mmol/L.)

In the trials, the label reports that about 65% of FINEARTS-HF patients had reached their target dose by month 6.

Medicines and Foods That Change Finerenone Levels

Because 90% of finerenone is broken down by the CYP3A4 liver enzyme, anything that blocks that enzyme raises finerenone levels, and anything that speeds it up lowers them. The label’s measured and modelled examples show how large the effect is:

Other Hazards on the Label

What Is Not Known

Decisions about kidney and heart medicines belong with the clinician who knows a person’s blood results and other medicines.

Key Research Papers

  1. Agarwal R, Kolkhof P, Bakris G, Bauersachs J, Haller H, Wada T, et al. Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine. Eur Heart J. 2021;42(2):152-161. PubMed PMID: 33099609
  2. Kolkhof P, Lawatscheck R, Filippatos G, Bakris GL. Nonsteroidal Mineralocorticoid Receptor Antagonism by Finerenone-Translational Aspects and Clinical Perspectives across Multiple Organ Systems. Int J Mol Sci. 2022;23(16):9243. PubMed PMID: 36012508
  3. Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341(10):709-17. PubMed PMID: 10471456
  4. Pitt B, Kober L, Ponikowski P, Gheorghiade M, Filippatos G, Krum H, et al. Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial. Eur Heart J. 2013;34(31):2453-63. PubMed PMID: 23713082
  5. Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, et al. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015;314(9):884-94. PubMed PMID: 26325557
  6. Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020;383(23):2219-2229. PubMed PMID: 33264825
  7. Agarwal R, Joseph A, Anker SD, Filippatos G, Rossing P, Ruilope LM, et al. Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial. J Am Soc Nephrol. 2022;33(1):225-237. PubMed PMID: 34732509
  8. Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, et al. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021;385(24):2252-2263. PubMed PMID: 34449181
  9. Agarwal R, Filippatos G, Pitt B, Anker SD, Rossing P, Joseph A, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474-484. PubMed PMID: 35023547
  10. Vaduganathan M, Filippatos G, Claggett BL, Desai AS, Jhund PS, Henderson A, et al. Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes. Nat Med. 2024;30(12):3758-3764. PubMed PMID: 39218030
  11. Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014;370(15):1383-92. PubMed PMID: 24716680
  12. Solomon SD, McMurray JJV, Vaduganathan M, Claggett B, Jhund PS, Desai AS, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024;391(16):1475-1485. PubMed PMID: 39225278
  13. Vardeny O, Vaduganathan M, Claggett BL, Desai AS, Jhund PS, Lam CSP, et al. Finerenone, Serum Potassium, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JAMA Cardiol. 2025;10(1):42-48. PubMed PMID: 39550716
  14. Ferreira JP, Vaduganathan M, Claggett BL, Kulac I, Ostrominski JW, Desai AS, et al. Interplay of serum potassium and kidney function with finerenone in heart failure with mildly reduced or preserved ejection fraction: Findings from FINEARTS-HF. Eur J Heart Fail. 2025;27(11):2422-2432. PubMed PMID: 41039732
  15. Heerspink HJL, Birkenfeld AL, Cherney DZI, Colhoun HM, Groop PH, Ji L, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. N Engl J Med. 2026;394(10):947-957. PubMed PMID: 41780000
  16. Heerspink HJL, Neuen BL, Agarwal R, Cherney DZI, Lam CSP, Tuttle KR, et al. Finerenone in Persons with Chronic Kidney Disease without Diabetes. N Engl J Med. 2026;395(6):533-545. PubMed PMID: 42246672
  17. Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, et al. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025;393(6):533-543. PubMed PMID: 40470996
  18. Agarwal R, Green JB, Heerspink HJL, McGill JB, Mottl A, Nangaku M, et al. Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial. J Am Coll Cardiol. 2026;87(7):772-784. PubMed PMID: 41493296

Other Sources

  1. DailyMed, National Library of Medicine. Finerenone tablets: prescribing information, including indications, dosage and potassium monitoring, contraindications, warnings, drug interactions, pregnancy, clinical pharmacology and clinical studies (revised September 2026). DailyMed setid fc726765-5d5a-4d6e-b037-b847bda9fb7c
  2. Drugs@FDA, U.S. Food and Drug Administration. Finerenone, NDA 215341: original approval 9 July 2021 and efficacy supplements of 1 September 2022, 11 July 2025 and 16 September 2026. Drugs@FDA NDA 215341

PubMed Topic Searches

  1. finerenone randomized controlled trial
  2. finerenone hyperkalemia
  3. finerenone heart failure preserved ejection fraction
  4. finerenone type 1 diabetes
  5. nonsteroidal mineralocorticoid receptor antagonist
  6. finerenone SGLT2 inhibitor combination

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