Finerenone

Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues.

• Kerendia is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM). cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.ICD-10: E11.9, I21.9, I50.9, N18.9

• Kerendia is contraindicated in patients: Who are hypersensitive to any component of this product [see Adverse Reactions (6.2) ] . Who are receiving concomitant treatment with strong CYP3A4 inhibitors [see Drug Interactions (7.1) ].contraindicated

The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. ( 2.1 ) Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD and T2DM based on eGFR and serum potassium thresholds. ( 2.3 ) Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds. ( 2.3 ) Tablets may be taken with or without food ( 2.2 ) 2.1 Prior to Initiation of Kerendia Measure serum potassium levels and eGFR before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L [see Warnings and Precautions (5.1) ]. 2.2 Recommended Starting Dosage The recommended starting dose of Kerendia is based on eGFR and is presented in Table 1. Table 1: Recommended Starting Dosage eGFR (mL/min/1.73m 2 ) Starting Dose ≥ 60 20 mg orally once daily ≥ 25 to < 60 10 mg orally once daily < 25 Initiation is not recommended For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally [see Clinical Pharmacology (12.3) ] . 2.3 Monitoring and Dosage Adjustment CKD associated with T2DM The target daily dose of Kerendia is 20 mg orally.

Hyperkalemia. Patients with decreased kidney function and higher baseline potassium levels are at increased risk. Monitor serum potassium levels and adjust dose as needed. ( 2.1 , 2.2 , 2.3 , 5.1 ) Worsening of Renal Function in Patients with Heart Failure. Measure eGFR and adjust dose as needed. ( 2.1 , 2.3 , 6.1 ) 5.1 Hyperkalemia Kerendia can cause hyperkalemia [see Adverse Reactions (6.1) ] . The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with Kerendia and dose accordingly [see Dosage and Administration (2.1) ] . Do not initiate Kerendia if serum potassium is > 5.0 mEq/L. Measure serum potassium periodically during treatment with Kerendia and adjust dose accordingly [see Dosage and Administration (2.3) ] . More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium [see Drug Interactions (7.1 , 7.2) ] . 5.2 Worsening of Renal Function in Patients with Heart Failure Kerendia can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed [see Adverse Reactions (6.1) ] .

The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Adverse reactions occurring in ≥ 1% of patients on Kerendia and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. CKD associated with T2DM The safety of Kerendia in patients with CKD associated with T2DM was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKD, in which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively. Overall, serious adverse events occurred in 32% of patients receiving Kerendia and in 34% of patients receiving placebo in the FIDELIO-DKD study; the findings were similar in the FIGARO-DKD study. Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving Kerendia and in 5-6% of patients receiving placebo). The most frequently reported (≥ 10%) adverse reaction was hyperkalemia [see Warnings and Precautions (5.1) ].

Lactation: Breastfeeding not recommended ( 8.2 ) 8.1 Pregnancy Risk Summary There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 2 times those expected in humans (see Data ) . The clinical significance of these findings is unclear. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In the embryo-fetal toxicity study in rats, finerenone resulted in reduced placental weights and signs of fetal toxicity, including reduced fetal weights and retarded ossification at the maternal toxic dose of 10 mg/kg/day corresponding to an AUC unbound of at least 7 times that in humans.

Metabolism

Finerenone exposure increased proportionally over a dose range of 1.25 to 80 mg (0.06 to 4 times the maximum approved recommended dosage). Steady state of finerenone was achieved after 2 days of dosing.

In the event of suspected overdose, immediately interrupt Kerendia treatment. The most likely manifestation of overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated. Finerenone is unlikely to be efficiently removed by hemodialysis given its fraction bound to plasma proteins of about 90%.

• Jul 9, 2021NDANDA215341Bayer Hlthcare

1. 1Glomerular Filtration Rate Decreased28811%
2. 2Hyperkalaemia2379.0%
3. 3Blood Creatinine Increased2098.0%
4. 4Blood Potassium Increased1656.3%
5. 5Death1616.1%
6. 6Renal Impairment1244.7%
7. 7Dizziness1033.9%
8. 8Acute Kidney Injury903.4%
9. 9Nausea883.4%
10. 10Diarrhoea873.3%
11. 11Urine Albumin/creatinine Ratio Increased772.9%
12. 12Hypotension732.8%
13. 13Off Label Use732.8%
14. 14Fatigue672.6%
15. 15Headache582.2%

The 10 most recently updated of 93 ClinicalTrials.gov registrations naming Finerenone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
  Recruiting · Phase 3 · Interventional · 117 enrolled · Bayer
  NCT07192952updated 2026-06-05
• A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
  Recruiting · Phase 3 · Interventional · 100 enrolled · Bayer
  NCT05457283updated 2026-06-02
• A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting
  Active not recruiting · Observational · 4,613 enrolled · Bayer
  NCT05348733updated 2026-06-02
• Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis
  Completed · Phase 2 · Interventional · 100 enrolled · Alexandria University
  NCT06835322updated 2026-05-28
• An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score
  Not yet recruiting · Observational · 500 enrolled · Bayer
  NCT07554469updated 2026-05-26
• RAndomized EHR-based Prescribing to Improve Disease-modifying Therapies for Cardio-Kidney-Metabolic Care (RAPID-CKM)
  Not yet recruiting · Interventional · 600 enrolled · Baylor Research Institute
  NCT07605390updated 2026-05-26
• Precision T1D Platform - New Therapies for Cardio-Renal Complications
  Not yet recruiting · Phase 2 · Interventional · 57 enrolled · Oregon Health and Science University
  NCT07594145updated 2026-05-20
• "Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"
  Not yet recruiting · Phase 3 · Interventional · 88 enrolled · Chittagong Medical College
  NCT07598864updated 2026-05-20
• An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
  Active not recruiting · Observational · 1,200 enrolled · Bayer
  NCT06763146updated 2026-05-18
• An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea
  Recruiting · Observational · 500 enrolled · Bayer
  NCT07232537updated 2026-05-18

Frequently asked questions

How does Finerenone work?

Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues.

What is Finerenone used for?

According to FDA labeling, Finerenone carries indications including: Kerendia is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2DM). cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Finerenone?

Finerenone is classified as Aldosterone antagonists, Nonsteroidal Mineralocorticoid-Receptor Antagonist, Cytochrome P450 3A4 Inhibitors, Mineralocorticoid Receptor Antagonists.

What are the brand names for Finerenone?

Finerenone is marketed under brand names including Kerendia.

What are the contraindications for Finerenone?

Finerenone labeling lists contraindications including: Kerendia is contraindicated in patients: Who are hypersensitive to any component of this product [see Adverse Reactions (6.2) ] . Who are receiving concomitant treatment with strong CYP3A4 inhibitors [see Drug Interactions (7.1) ].. Always consult the full prescribing information and a clinician.