Finerenone to Improve Acute Kidney Injury; a Multicenter, Randomized, Placebo-Controlled Study to Investigate the Feasibility of Finerenone in Treating Patients With Acute Kidney Injury (FiPAKI Pilot Trial)

This study is testing whether finerenone, when compared to placebo, is a tolerable and safe intervention when administered in patients with acute kidney injury (AKI). This study will explore whether finerenone can mitigate the risk of transitioning to chronic kidney disease following a moderate to severe AKI. Participants will be randomly assigned to receive either finerenone or a placebo, once daily for up to 45 days, in addition to their standard care. The study will monitor for side effects such as serum potassium levels and blood pressure, and will assess whether the drug helps prevent AKI from progressing to chronic kidney disease. This is a pilot feasibility study involving approximately 72 participants across 4-5 sites in Quebec and Ontario.

Start Date01 Jan 2027

Sponsor / Collaborator-

NCT07594145

/ Not yet recruitingPhase 2IIT

Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)

Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health & Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.

Start Date01 Nov 2026

Sponsor / Collaborator

Oregon Health & Science University

[+2]

NCT07155694

/ Not yet recruitingPhase 4IIT

Role of Finerenone in African American Veterans With Diabetic Kidney Disease

Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.
Secondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).

Start Date01 Oct 2026

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Finerenone

100 Translational Medicine associated with Finerenone

100 Patents (Medical) associated with Finerenone

915

Literatures (Medical) associated with Finerenone

31 Dec 2026·RENAL FAILURE

Finerenone attenuates chronic fibrotic remodeling during the AKI-CKD transition in an ischemia-reperfusion-induced acute kidney injury mouse model

Article

Author: Wan, Jianxin ; Zheng, Zongli ; Tang, Sha ; Chen, Yi ; Lian, Ruoshan ; Rao, Siyi

Objective: The transition from acute kidney injury (AKI) to chronic kidney disease (CKD) is a major cause of poor prognosis in renal injury, and preventing the progression from AKI to CKD has important clinical significance. Finerenone exerts renoprotective effects, however, its role in the AKI-CKD transition remains unclear.Methods: An ischemia-reperfusion (IR)-induced AKI mouse model was established in male C57BL/6 mice by unilateral renal artery clamping combined with contralateral nephrectomy. Finerenone was administered at doses of 10 mg/kg or 15 mg/kg, and renal function, aldosterone levels, podocyte injury, inflammatory responses, and renal fibrosis were evaluated at days 8 and 28 to investigate pathological mechanisms underlying the AKI-CKD transition.Result: Finerenone significantly attenuated IR-induced renal injury and improved renal function during the acute phase and throughout the subsequent AKI-CKD transition. Compared with 10 mg/kg, finerenone at 15 mg/kg more effectively reduced podocyte injury, dampened the inflammatory response, and attenuated renal fibrosis. Mechanistically, finerenone suppressed the p38 phosphorylation and reduced nuclear factor kappa-B (NF-κB) activation during the AKI-CKD transition.Conclusion: Finerenone exerts dose-dependent renoprotective effects during AKI progression and the subsequent AKI-CKD transition, potentially by suppressing podocyte mineralocorticoid receptor overactivation and concomitant reductions in renal inflammation and fibrosis, accompanied by attenuation of p38 phosphorylation and NF-κB activation during the AKI-CKD transition.

31 Dec 2026·RENAL FAILURE

Finerenone in IgA nephropathy: real-world 12-month propensity-matched cohort demonstrating proteinuria reduction, eGFR preservation, and safety profile

Article

Author: Shen, Xiaogang ; Zhu, Bin ; Yu, Jing-ting ; Zhang, Wei ; Zhuo, Cheng-cong ; Lin, Bo ; Jiang, Zhi-liang ; Zhang, Yu-jia ; Chen, Maosheng ; Zhou, Yi-dong

OBJECTIVE:

To evaluate the efficacy and safety of finerenone in patients with IgA nephropathy (IgAN).

METHODS:

This retrospective study included 105 patients with IgAN (35 in the finerenone group, 70 in the control group) from January 2022 to February 2025. The finerenone group received conventional therapy plus finerenone, while the controls received conventional therapy alone. Outcomes included 24-h urinary protein (UP24), estimated glomerular filtration rate (eGFR), and adverse events (AEs). Propensity score matching (PSM) was used to balance baseline characteristics (28 patients/group).

RESULTS:

After 1:1 PSM, the finerenone group demonstrated a sustained reduction in UP24, from 742 ± 519 mg at baseline to 380 ± 333 mg (p < 0.001), while the control group showed no significant improvement at 12 months (p = 0.402). A similar trend of proteinuria reduction was observed at 3 and 6 months in the finerenone group. The between-group difference in ΔUP24 was significant at 12 months (finerenone: -393 ± 506 mg vs. control: +235 ± 1114 mg, p = 0.027). Finerenone demonstrated better preservation of eGFR at 12 months compared to controls after matching (ΔeGFR: +3.43 ± 8.25 vs. -5.99 ± 7.31 mL/min/1.73 m², p < 0.001). Safety profiles, including the incidence of hyperkalemia, elevated ALT, hypotension, and overall AEs, were comparable between the groups.

CONCLUSIONS:

Finerenone significantly reduced proteinuria and preserved eGFR in patients with IgAN over 12 months, with a favorable safety profile, suggesting potential benefit as an adjunctive treatment, pending randomized controlled trial confirmation. This study provides real-world, hypothesis-generating evidence for finerenone in IgAN, which can inform future RCT design and meta-analyses.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

The interplay of bosentan and finerenone in amelioration of cardiac dysfunction within benign prostatic hyperplasia in rats

Article

Author: Refaie, Marwa Monier Mahmoud ; Alam-Eldin Ahmed, Amr ; Ibrahim, Randa Ahmed ; Hasan, Asmaa A ; Elsayed, Samar Hisham ; Sherkawy, Hoda S ; Ahmed, Ahmed ; Beshay, Olivia N ; Soliman, Aml Mohamed ; Fathy, Enas ; Muhammed, Asmaa A ; Habib, Heba A ; Hassan, Eman Abdel Naby

OBJECTIVES:

Benign prostatic hyperplasia (BPH) is a widespread urological clinical case in aged men associated with troublesome lower urinary tract symptoms and cardiac dysfunction, but its medical treatment is still insufficient. Thus, searching for more effective medical regimens is an essential target. We tried in current experiment to explore the role of bosentan (BOS) and/or finerenone (FIN) in this lesion.

METHODS:

BPH was adequately induced using testosterone propionate (TP) in a dose of (5 mg/kg/day) for 28 days of subcutaneous injection and an oral administration of BOS (50 mg/kg/day) and/or FIN (10 mg/kg/day) for 10 days.

RESULTS:

We found typical histopathological changes of BPH, increased serum dihydrotestosterone (DHT), prostatic specific antigen (PSA), cardiac enzymes, tissue malondialdehyde (MDA), aldosterone, endothelin-A, nuclear factor kappa b (NF-κB), and proliferating cell nuclear antigen (PCNA). However, significant decreases in total antioxidant capacity (TAC), reduced glutathione (GSH), and caspase-3. The histological findings were augmented by special staining techniques, immunohistochemical and morphometric studies. There are histopathological alternations as the hyperplastic nodules in the prostate's transition zone expand, and the prostatic urethra was compressed, lengthened and distorted. Interestingly the co-administration of BOS and/or FIN significantly improved BPH induced changes. This is mostly attributed to its ability in modulating endothelin receptors by BOS, aldosterone receptors by FIN, improved the histopathological changes with anti-oxidant, anti-inflammatory, anti-fibrotic, antiproliferative, and apoptotic properties.

CONCLUSIONS:

BOS and/or FIN showed a significant ameliorative effect in BPH.

133

News (Medical) associated with Finerenone

17 Sep 2026

·www.fiercepharma.com

Bayer’s Kerendia secures FDA nod as first drug in 30 years for Type 1 diabetes-associated kidney disease

Bayer just scored another label expansion for its blockbuster-in-waiting, Kerendia. The heart and kidney med earned the first FDA nod in three decades for adults with chronic kidney disease associated with type 1 diabetes. Kerendia, also known as finerenone, was approved to reduce urinary albumin-to-creatine ratio (UACR), a key risk factor of worsening CKD, in patients with type 1 diabetes associated CKD. According to Bayer, the drug stands to benefit 30% of the estimated 2 million U.S. type 1 diabetes patients who will develop CKD within their lifetime. UACR reduction with Kerendia is expected to reduce the risk of kidney disease progression in type 1 diabetes-associated CKD, including declining kidney filtration rates and end-stage kidney disease. The FDA decision was based on findings from Kerendia’s phase 3 Fine-one clinical trial in adult patients with CKD associated with type 1 diabetes. The 242-subject trial showed that Kerendia reduced UACR by more than 25% after 6 months, with benefits observed as early as 3 months. The data builds on Bayer’s clinical trial work in CKD associated with type 2 diabetes, which demonstrated that UACR is an important marker of CKD progression. In Bayer’s Fidelio-DKD and Figaro-DKD trials, UACR reduction with Kerendia was associated with improved kidney outcomes, including lower rates of kidney failure, sustained decrease in estimated glomerular filtration, and renal death. The approval “provides an important new treatment option for a population that has continued to face substantial unmet need,” said Janet McGill, M.D., from Washington University School of Medicine in St. Louis and co-chair of the Fine-one study’s executive committee. Kerendia is now the only non-steroidal mineralocorticoid receptor antagonist (MRA) indicated for adults with type 1 or type 2 diabetes-associated CKD. The label expansion marks the drug’s third indication since 2021, when it was first approved for type 2 diabetes-associated CKD. Then, last year, it picked up an approval for two types of heart failure: with preserved ejection fraction and mildly reduced ejection fraction. Bayer has more extensions up its sleeve after a phase 3 win in two of the most common forms of non-diabetic CKD earlier this spring. Continued regulatory and commercial momentum for Kerendia is critical to Bayer’s overall growth strategy. The drug is key to offsetting losses as older medications like Xarelto and Eylea face increasing generic and biosimilar competition. In the second quarter of 2026, the two older products saw sales decline 42.4% and 32.8%, respectively, for Bayer. While Bayer’s overall pharmaceutical sales were flat for Q2 , Kerendia’s sales proved to be a bright spot, demonstrating a better-than-expected 83% increase year-over-year. The company is now predicting peak annual sales for the drug will climb to $3 billion.

Drug ApprovalPhase 3Clinical Result

17 Sep 2026

·firstwordpharma.com

Bayer's Kerendia scores third FDA win, this time in type 1 diabetes-related CKD

Bayer said Thursday that the FDA approved a broader label for Kerendia (finerenone) to include the reduction of urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), marking the first new treatment option for this population in over 30 years.The regulator cleared the non-steroidal mineralocorticoid receptor antagonist in 2021 to lower the risk of kidney and cardiovascular events in adults with CKD linked to type 2 diabetes (T2D), followed by a second approval last year to treat adults with heart failure (HF) having left ventricular ejection fraction ≥40%."Kerendia's third indication validates the breadth of its clinical trial programme across cardiovascular and kidney diseases, helping a patient population that has historically been clinically underserved," said Carolina Aldworth, executive medical director at Bayer. The latest authorisation, granted under priority review, was supported by the Phase III FINE-ONE trial in adults with CKD associated with T1D, and additionally backed by earlier Phase III data from the FIDELIO-DKD and FIGARO-DKD studies in T2D populations. In FINE-ONE, Kerendia significantly reduced UACR versus placebo, with a 22% reduction observed as early as three months and sustained through six months at 28%.The FINEOVATE late-stage programme for Kerendia — one of Bayer's key growth products — comprises 12 studies across two domains: MOONRAKER in HF and THUNDERBALL in CKD. The drug’s recent pivotal success came in the latter, with the Phase III FIND-CKD trial showing that it slowed kidney function decline and reduced cardiorenal complications in patients with non-diabetic CKD.

Phase 3Drug ApprovalPriority ReviewClinical Result

17 Sep 2026

·www.biospace.com

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

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 WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer 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 CKD, 3,4 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 Indications 1 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). The MOONRAKER program includes FINEARTS-HF , 6 the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF , 7 CONFIRMATION-HF 8 and FINALITY-HF , 9 as well as the ongoing studies FIORE 10 and FIORELLO . 11 The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD , 12 FIGARO-DKD , 13 FINE-ONE 14 and FIND-CKD 15 as well as the ongoing investigational pediatric studies, FIONA 16 and FIONA-OLE . 17 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 . Find more information at Follow us on LinkedIn: Bayer | Pharmaceuticals: Overview | LinkedIn Follow us on Facebook: 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 . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. 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: 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: 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. 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. . 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. . 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. . 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. . 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. . 12 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration No. 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 . 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. . 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. . 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. . 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. . COR-KER-US-0224-1 9/26 Contacts Media Contact : Joshua Mansbach Bayer Media Relations joshua.mansbach@bayer.com +1.201.626.8929

100 Deals associated with Finerenone

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KEGG	Wiki	ATC	Drug Bank
D10633	Finerenone	-	DB16165

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Type 1 diabetes mellitus with established diabetic nephropathy	United States	Bayer AG	17 Sep 2026
Chronic heart failure	Japan	Bayer Yakuhin Ltd.	22 Dec 2025
Heart Failure	United States	Bayer AG	14 Jul 2025
Diabetes Mellitus, Type 2	Canada	Bayer, Inc.	14 Oct 2022
Chronic Kidney Diseases	South Korea	Bayer AG	10 May 2022
Type 2 diabetes mellitus with established diabetic nephropathy	United States	Bayer Healthcare LLC	09 Jul 2021
Type 2 diabetes mellitus with established diabetic nephropathy	United States	Bayer HealthCare Pharmaceuticals, Inc.	09 Jul 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-diabetic Chronic Kidney Disease	NDA/BLA	China	Bayer AG	30 Jul 2026
Heart failure with normal ejection fraction	Phase 3	Canada	Bayer AG	01 Dec 2025
Left ventricular systolic dysfunction	Phase 3	United States	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Argentina	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Austria	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Belgium	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Brazil	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Bulgaria	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Canada	Bayer AG	19 Nov 2025
Left ventricular systolic dysfunction	Phase 3	Czechia	Bayer AG	19 Nov 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05254002 (CONFIDENCE, Pubmed \| Hypertension)	Phase 2/3	-	800	Empagliflozin/Finerenone combination therapy	acjaivqcbl(lpxoxbyxza) = Combination therapy significantly reduced SBP versus monotherapies in the ≥130 mm Hg (P<0.0001) but not in the <130 mm Hg group. qbhabgjwcj (wuzgksrvmc ) View more	Positive	01 Sep 2026
				Finerenone
ESC2026	Not Applicable	Heart Failure	348	Finerenone 5-10 mg/day	ybgyjlgwkg(tehlhbxpqn) = elnbpobzxp ulronluvyu (jefezzukmf ) View more	Positive	31 Aug 2026
				Spironolactone 20 mg/day	ybgyjlgwkg(tehlhbxpqn) = ochneiynto ulronluvyu (jefezzukmf ) View more
CONFIDENCE (ESC2026)	Phase 3	Diabetes Mellitus, Type 2	1,399	Simultaneous initiation of finerenone and SGLT2i	uwoqihrirj(tcgxhvwbrq) = Rates of hyperkalemia were higher with finerenone nkqpcdwani (vahxyumsaw ) View more	Positive	30 Aug 2026
				Sequential initiation of finerenone and SGLT2i
ESC2026	Not Applicable	Heart failure with normal ejection fraction \| Chronic Kidney Diseases	888	Finerenone	uxjozyftiu(dxcckfprol) = kknjckdezu vnqgnrylxl (eqiamqbcjd ) View more	Positive	30 Aug 2026
				Spironolactone	uxjozyftiu(dxcckfprol) = zuhtskrwsx vnqgnrylxl (eqiamqbcjd ) View more
DIALY-MRA (ESC2026)	Phase 3	Cardiovascular Diseases \| Heart Failure	276	Finerenone 10 mg daily (titrated to 20 mg if tolerated)	dfcbdqgcyk(amjumuvaft) = ewxogvsuuf cwedzpmgbi (akfobrsgrl, -42 to -15) View more	Positive	28 Aug 2026
				Spironolactone 25 mg daily	dfcbdqgcyk(amjumuvaft) = ysfmxrhqvb cwedzpmgbi (akfobrsgrl, -32 to -8) View more
NCT05047263 (FIND-CKD, Pubmed \| N Engl J Med)	Phase 3	Chronic Kidney Diseases	1,584	Finerenone	nquqauyows(tumvdtvppv) = cqwkpkfvju kcggphvshd (ztpiciajuq, -3.6 to -3.1) View more	Positive	06 Aug 2026
				Placebo	nquqauyows(tumvdtvppv) = lelgyomtdd kcggphvshd (ztpiciajuq, -4.3 to -3.8) View more
NCT05047263 (Pubmed \| JAMA)	Phase 3	Glomerular disease	1,584	Finerenone 10 mg or 20 mg	qlamuhepgw(ufbiiswxuf): Difference = 0.73 (95.0% CI, 0.22 - 1.24) View more	Positive	21 Jul 2026
				Placebo
NCT02545049 \| NCT02540993 (FIDELITY, Pubmed \| JAMA Cardiol)	Phase 3	Metabolic Syndrome	12,990	Finerenone	mkwwtoborg(nrdazpaysl): HR = 1.96 (95.0% CI, 1.43 - 2.69) View more	Positive	01 Jul 2026
				Placebo
ADA2026	Not Applicable	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	6,537	Finerenone	gavjdveqmr(cewvauzaof) = hzcbvvqydx pmrmfwmaff (wakxpyxqda ) View more	Positive	20 Jun 2026
ADA2026	Not Applicable	Non-diabetic Chronic Kidney Disease	83	Finerenone	qmisztslhc(wzfnlljwow) = ujoopdulzf nukesznmfr (eixegqmctn ) View more	Positive	20 Jun 2026

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