Pharmaceuticals

Bayer’s KERENDIA® (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes

United States of America

KERENDIA® (finerenone), a non-steroidal mineralocorticoid receptor antagonist (MRA), is the first new treatment in more than 30 years approved by the FDA for adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D).1,2  

Summary
Bayer today announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA® (finerenone) 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 in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), following the agency’s Priority Review of the supplemental New Drug Application (sNDA).1

 

Key Facts

  • The FDA approved KERENDIA to reduce UACR, which is expected to slow chronic kidney disease progression in adults with CKD associated with T1D.1 This approval is important for patients, as it is the first proven therapeutic advance in CKD associated with T1D in more than 30 years.1,2
  • Approval was supported by data from the Phase III FINE-ONE clinical trial in adult patients with CKD associated with T1D.1,2 It was also supported by Phase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD associated with type 2 diabetes (T2D).1 
  • Approximately 20-30% of people in the U.S. with T1D also have CKD4,5 which puts them at risk of kidney disease progression and kidney failure.5
  • KERENDIA is also approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.1 
  • In addition, KERENDIA is approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.1
     

Why This FDA Approval Matters for Patients and Physicians 


“For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression,"2 said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Executive Committee. "The approval of KERENDIA to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”1,2

 

KERENDIA, a once-daily, oral treatment option, is the only MRA indicated for adults with CKD associated with either T2D or T1D.1

 

“This approval builds on evidence linking reductions in UACR with improved kidney outcomes in KERENDIA’s clinical trial program in chronic kidney disease associated with type 2 diabetes,”1 said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “KERENDIA’s third indication validates the breadth of its clinical trial program across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved.”1,2

 

FINE-ONE Clinical Trial Results


FINE-ONE (NCT05901831) was a pivotal, global, randomized, prospective, double-blind, placebo-controlled, multicenter, Phase III study in adult patients with CKD associated with T1D. FINE-ONE enrolled 242 adult participants with the primary objective to demonstrate whether the addition of KERENDIA, 10 mg or 20 mg once daily, to standard of care was superior to placebo in reducing UACR over six months (averaged over months 3 and 6).1 UACR is an important marker of CKD progression.2

 

The results showed: 

  • KERENDIA significantly reduced UACR vs. placebo over 6 months (p=0.0001). Reductions in UACR were observed as early as Month 3 and were sustained through Month 6.1
    • At Month 3, KERENDIA reduced UACR compared to placebo by 22% (ratio of Least Square Geometric Mean Ratio [LSGMR] of 0.78; 95% CI: 0.68, 0.90). 
    • At Month 6, KERENDIA reduced UACR compared to placebo by 28% (ratio of LSGMR of 0.72; 95% CI: 0.60, 0.86). 
  • Safety and tolerability were consistent with the existing evidence for KERENDIA in adults with CKD associated with T2D.1
    • The rate of treatment-emergent adverse events was 47.1% for those treated with KERENDIA and 49.2% for placebo.2
    • The rate of treatment-emergent serious adverse events was 11.8% for KERENDIA and 11.5% for placebo.2
    • Hyperkalemia, an adverse event of special interest, was observed more frequently with KERENDIA (10.1%) compared to placebo (3.3%). The rate of treatment discontinuation due to hyperkalemia was 1.7% and 0%, respectively.2

 

Detailed FINE-ONE trial results were presented at the American Society of Nephrology (ASN) Kidney Week 2025 and published in the New England Journal of Medicine.

 

Why Managing UACR Matters
UACR is a modifiable risk factor associated with chronic kidney disease progression.2 In the FIDELIO-DKD and FIGARO-DKD trials, reductions in UACR with KERENDIA were shown to be associated with improved kidney outcomes in adults with CKD and T2D.1 Together with the FINE-ONE results, this evidence supported the use of UACR to bridge KERENDIA’s established kidney outcomes evidence from CKD associated with T2D to patients with CKD associated with T1D.1

 

KERENDIA’s Approved Indications1
Since 2021, KERENDIA has been approved by the FDA to reduce the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction, sustained eGFR decline and end-stage kidney disease in adult patients with CKD associated with T2D.

 

In July 2025, KERENDIA received FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with HF LVEF ≥40%.

 

Now, KERENDIA is also approved by the FDA to reduce UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with T1D.

 

About KERENDIA
KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.1

 

About KERENDIA’s Clinical Trial Program
KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 12 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL).

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Hypersensitivity to any component of this product
  • Concomitant use with strong CYP3A4 inhibitors 
  • Patients with adrenal insufficiency

 

WARNINGS AND PRECAUTIONS:
 

  • Hyperkalemia: KERENDIA can cause hyperkalemia. 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. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. 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.

 

  • 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.

     

    Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

 

MOST COMMON ADVERSE REACTIONS:

  • The adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%) in patients with HF LVEF ≥40%.

 

DRUG INTERACTIONS:

  • Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
  • Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
  • Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
  • Sensitive CYP2C8 Substrates at KERENDIA 40 mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40 mg is coadministered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

 

USE IN SPECIFIC POPULATIONS:

  • Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
  • Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

 

INDICATIONS:
KERENDIA (finerenone) 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 (T2D) (10 mg, 20 mg tablets)
  • 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 in adults with CKD associated with Type 1 diabetes (T1D) (10 mg, 20 mg tablets)
  • reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10 mg, 20 mg, 40 mg tablets)

 

Please see the full Prescribing Information for KERENDIA.


About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer’s legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys—two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs. With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose.

 

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros.

 

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

 

Media Contact: 
Joshua Mansbach
Bayer Media Relations 
joshua.mansbach@bayer.com
+ 1.201.626.8929
 

References

[1] KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc: September 2026

[2] Heerspink HJL, Birkenfeld AL, Cherney DZI, et al; FINE-ONE Investigators. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa2512854.

[3] Rossing P, Per-Henrik Groop, Singh R, Lawatscheck R, Tuttle KR. Prevalence of Chronic Kidney Disease in Type 1 Diabetes Among Adults in the U.S. Diabetes Care. Published online June 10, 2024. doi:https://doi.org/10.2337/dc24-0335

[4] Tuttle KR, Reynolds CL, Kornowske LM, et al. Prevalence and severity of chronic kidney disease in a population with type 1 diabetes from a United States health system: a real-world cohort study. The Lancet Regional Health - Americas. 2025;47:101130. doi:https://doi.org/10.1016/j.lana.2025.101130

[5] Heerspink H, et al. Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial Diabetes Research and Clinical Practice, 2023; 204

[6] Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/study/NCT04435626

[7] A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. https://www.clinicaltrials.gov/study/NCT06008197. 

[8] A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. https://www.clinicaltrials.gov/study/NCT06024746. 

[9] A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950.

[10] A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction (FIORE). Clinical trial registration No. NCT07188805. https://clinicaltrials.gov/study/NCT07188805.

[11] 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 (FIORELLO). Clinical trial registration No. NCT07192952. https://clinicaltrials.gov/study/NCT07192952.

[12] Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993. 

[13] Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) Clinical trial registration No. NCT02545049 https://clinicaltrials.gov/study/NCT02545049. 

[14] A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys’ Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). Clinical trial registration No. NCT05901831. https://www.clinicaltrials.gov/study/NCT05901831. 

[15] A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. https://www.clinicaltrials.gov/study/NCT05047263. 

[16] A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. https://www.clinicaltrials.gov/study/NCT05196035. 

[17] 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 (FIONA OLE). Clinical trial registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283.