Finerenone

The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA ® (finerenone) in adults with chronic kidney disease (CKD) without diabetes who were also receiving background standard of care. More than 37 million adults in the U.S. have CKD, a progressive condition that can lead to cardiovascular complications and kidney failure. i An estimated 50% to 70% of people with CKD do not have diabetes, ii and among those who progress to end-stage kidney disease in the U.S., 63% do not have diabetes. i WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer Summary Bayer announced today that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for KERENDIA® (finerenone), which is being investigated for the treatment of adults with chronic kidney disease (CKD) without diabetes who are receiving background standard of care. Key Facts The sNDA was supported by results from the Phase III FIND-CKD trial investigating KERENDIA in adults with CKD without diabetes who were also receiving background standard of care. iii KERENDIA met the primary endpoint, showing a significant reduction in the rate of kidney function decline, as measured by estimated glomerular filtration rate (eGFR) slope (mean annual change from baseline to month 32), compared with placebo. KERENDIA also showed a statistically significant reduction versus placebo in the risk of a secondary composite kidney-cardiovascular endpoint, which included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure or cardiovascular death. KERENDIA met the primary endpoint, showing a significant reduction in the rate of kidney function decline, as measured by estimated glomerular filtration rate (eGFR) slope (mean annual change from baseline to month 32), compared with placebo. KERENDIA also showed a statistically significant reduction versus placebo in the risk of a secondary composite kidney-cardiovascular endpoint, which included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure or cardiovascular death. The safety profile of KERENDIA was consistent with prior Phase III studies. The incidence of serious adverse events was similar between the KERENDIA and placebo groups (20.9% and 21.2%, respectively). KERENDIA is approved by the FDA 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 type 2 diabetes (T2D). iv KERENDIA is also approved by the FDA to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with type 1 diabetes (T1D). iv In addition, KERENDIA is approved by the FDA 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%. iv What the sNDA Acceptance Means for Adults with CKD Without Diabetes “As many as 70% of people with chronic kidney disease do not have diabetes, and even though this population is at high risk for progressive loss of kidney function and adverse cardiovascular outcomes, treatment advances have disproportionately centered on those people with chronic kidney disease and type 2 diabetes,”ii,iii,v said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “If approved for this new indication, KERENDIA has the potential to help physicians slow kidney function decline and reduce the risk of kidney and cardiovascular complications.” FIND-CKD Clinical Trial Designiii FIND-CKD (NCT05047263) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III trial that investigated KERENDIA versus placebo in 1,584 adults with CKD without diabetes. Reflecting the diverse etiologies of CKD without diabetes, 56% of patients in the FIND-CKD trial who received KERENDIA had underlying glomerular disease, such as IgA nephropathy and focal segmental glomerulosclerosis, while 30% had hypertensive/ischemic nephropathy. Excluding type 2 diabetes, these are the two most common etiologies of CKD.vi Participants were randomized to receive either KERENDIA or placebo in addition to standard of care, which included maximally tolerated labeled doses of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB). FIND-CKD Clinical Trial Resultsiii KERENDIA met the primary efficacy endpoint by showing a statistically significant improvement in eGFR slope compared with placebo. The mean annual rate of eGFR decline from baseline to month 32 was −3.3 mL/min/1.73 m²/year with KERENDIA and −4.0 mL/min/1.73 m²/year with placebo, corresponding to a between-group difference of 0.7 mL/min/1.73 m²/year (95% CI, 0.3 to 1.1; p<0.001). eGFR slope is a surrogate endpoint increasingly used to assess drug efficacy in CKD trials. The mean annual rate of eGFR decline from baseline to month 32 was −3.3 mL/min/1.73 m²/year with KERENDIA and −4.0 mL/min/1.73 m²/year with placebo, corresponding to a between-group difference of 0.7 mL/min/1.73 m²/year (95% CI, 0.3 to 1.1; p<0.001). eGFR slope is a surrogate endpoint increasingly used to assess drug efficacy in CKD trials. As a key secondary endpoint, KERENDIA showed a statistically significant reduction in the risk of a prespecified composite kidney-cardiovascular outcome compared with placebo (hazard ratio 0.77; 95% CI, 0.60 to 0.99; p=0.04). The composite outcome included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure, or cardiovascular death. The composite outcome included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure, or cardiovascular death. 56% of patients in FIND-CKD who received KERENDIA had underlying glomerular disease, including IgAN and FSGS. The incidence rate of treatment-emergent adverse events (TEAEs) was 68.3% with KERENDIA and 65.4% with placebo. The rate of treatment-emergent serious adverse events (TESAEs) was 20.9% with KERENDIA and 21.2% with placebo. Hyperkalemia, an adverse event of special interest (AESI), was observed more frequently with KERENDIA (17%) compared to placebo (13.3%). The rate of serious hyperkalemia events and hyperkalemia leading to hospitalization or permanent discontinuation was ˂1% and ˂2%, respectively. Detailed FIND-CKD trial results were published in the New England Journal of Medicine and presented at the 63rd European Renal Association (ERA) Congress. KERENDIA’s Approved Indicationsiv Since 2021, KERENDIA has been 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. 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 heart failure with left ventricular ejection fraction (HF LVEF) ≥40%. In September 2026, KERENDIA was 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 KERENDIAiv KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys. 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). The MOONRAKER program includes FINEARTS-HF , vii the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF , viii CONFIRMATION-HF ix and FINALITY-HF , x as well as the ongoing studies FIORE xi and FIORELLO . xii The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD , xiii FIGARO-DKD , xiv FINE-ONE xv and FIND-CKD xvi as well as the ongoing investigational pediatric studies, FIONA xvii and FIONA-OLE . xviii 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 m 2 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. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on LinkedIn: Bayer | Pharmaceuticals: Overview | LinkedIn Follow us on Facebook: http://www.facebook.com/bayer Follow us on X: @BayerUS 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. i Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2026. ii Wanner C, et al. BMC Nephrol. 2025;26:1–11. / Webster AC, Nagler EV, Morton RL, Masson P. Chronic kidney disease. Lancet. 2017;389:1238–52. iii Heerspink HJL, et al. N Eng J Med. 2026; doi: 10.1056/NEJMoa2604625 iv KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc: September 2026 v Tuttle KR, Ji L, Mathieu C, Rosen J. Addressing unmet needs for chronic kidney disease treatment in type 1 diabetes: A review. Diabetes Obes Metab. 2026 Jan;28(1):16-26. doi: 10.1111/dom.70180. Epub 2025 Oct 6. PMID: 41054018; PMCID: PMC12673433. vi Ying M, Shao X, Qin H, et al. Disease burden and epidemiological trends of chronic kidney disease at the global, regional, national levels from 1990 to 2019. Nephron 2024;148:113-23. vii 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 viii 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. ix 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. x 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. xi 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. xiii 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. xiv 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. xv 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. xvi 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. xvii 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. xviii 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.