A Phase 3, Single-arm, Open-label Extension Study to Evaluate the Safety of Finerenone in Addition to Standard of Care, in Pediatric Heart Failure Patients, From Birth to 18 Years of Age, With Left Ventricular Systolic Dysfunction (LVSD)

Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth.
The study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively.
The main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD.
To understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as "treatment emergent adverse events" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR).
In this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study.
The participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants <6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will:
* have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured
* have blood samples taken
* have physical examinations
* have their heart examined by an electrocardiogram and echocardiography
* answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer
* for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The doctors will check the participants' health a month after the participants take their last treatment.

Start Date01 Apr 2026

Sponsor / Collaborator

Bayer AG

NCT07442448

/ Enrolling by invitationPhase 4IIT

Investigation on the Impact of Finerenone on Myocardial Remodeling in Patients With Diabetic Kidney Disease and Heart Failure

The goal of this clinical trial is to evaluate the impact of Finerenone on myocardial remodeling in patients with diabetic kidney disease (DKD) and heart failure with a left ventricular ejection fraction (LVEF) ≥ 40%. The main questions it aims to answer are:
1. Does 6-month treatment with Finerenone significantly reduce myocardial fat infiltration (measured by MR Spectroscopy) and myocardial fibrosis (measured by extracellular volume fraction on CMR)?
2. Does Finerenone improve global left ventricular longitudinal systolic strain (GLS) and other structural remodeling indices in this patient population?
Researchers will compare cardiac imaging parameters after 6 months of treatment to baseline values to see if Finerenone effectively reverses or slows down pathological cardiac changes.
Participants will:
1. Take Finerenone (Kerendia) 10 mg or 20 mg orally once daily for a total of 6 months.
2. Undergo advanced cardiac imaging, including Cardiac Magnetic Resonance (CMR) and MR Spectroscopy (MRS), at the beginning of the study and after 6 months of treatment.
3. Receive regular clinical follow-up and blood tests to monitor safety (such as potassium levels and kidney function) and treatment efficacy.

Start Date01 Apr 2026

Sponsor / Collaborator

Cathay General Hospital

ChiCTR2600120637

/ Not yet recruitingNot ApplicableIIT

The efficacy and safety of finerenone versus placebo in peritoneal dialysis patients with residual renal function: A multicenter, randomized, double-blind trial (FINE-PD)

Start Date19 Mar 2026

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

[+1]

100 Clinical Results associated with Finerenone

100 Translational Medicine associated with Finerenone

100 Patents (Medical) associated with Finerenone

800

Literatures (Medical) associated with Finerenone

01 Jun 2026·METABOLISM-CLINICAL AND EXPERIMENTAL

From mechanism to clinic: A call for actionable strategies to optimize finerenone and SGLT2i complementary therapy in T2DM-related CKD

Letter

Author: Zhu, Junyuan ; Cui, Yangqing ; Liu, Yang

01 May 2026·JOURNAL OF ETHNOPHARMACOLOGY

Yitangkang decoction in the treatment of glomerular filtration barrier damage through AMPKα1/ZDHHC8/SLC7A11/GPX4 and TGF-β/Smad signaling pathways: A multi-omics analysis

Article

Author: Wu, Yi ; Zhang, Wenshun ; Dong, Baoqiang ; Dai, Jianyu ; Liu, Weinan ; Di, Zizhen ; Fan, Xu ; Shi, Yan ; Zhang, Hanwen ; Yu, Jiaxiang ; Chen, Yiran ; Wang, Zhimin

ETHNOPHARMACOLOGICAL RELEVANCE:

Diabetic kidney disease (DKD) is a prevalent microvascular complication of diabetes mellitus (DM) that significantly impairs patients' quality of life. Its early stage is characterized by glomerular filtration barrier damage and the occurrence of proteinuria. Without timely intervention, this condition progresses to renal fibrosis, and therapeutic options remain limited despite recent advances. Yitangkang decoction (YTK) has shown potential in ameliorating this barrier damage, thereby inhibiting proteinuria and ultimately preventing renal fibrosis; however, its precise mechanisms remain unclear.

AIM OF THE STUDY:

This study aimed to elucidate the therapeutic mechanism by which YTK ameliorates glomerular filtration barrier damage in DKD.

MATERIALS AND METHODS:

db/db mice were treated with high-, medium-, or low-dose YTK or with finerenone for 8 weeks. We employed a multi-omics approach-including data-independent acquisition (DIA) proteomics, transcriptomics, and palmitoyl-proteomics coupled with LC-MS/MS-to identify differentially expressed proteins, mRNAs, and palmitoylation sites related to YTK's renoprotective effects, as well as to characterize its absorbed serum components. In vitro validation was performed in D-glucose-injured MPC5 podocytes, mouse renal microvascular endothelial cells and mouse glomerular mesangial cells using YTK-medicated serum, finerenone-medicated serum, the active components puerarin and quercitrin, or pharmacological modulators of the AMPK and TGF-β1 pathways. YTK's efficacy was evaluated using biochemical, histopathological, and molecular biological indicators.

RESULTS:

YTK treatment dose-dependently reduced urinary albumin-to-creatinine ratio (UACR), serum creatinine (Scr), urea, uric acid (UA), and lipid peroxide (LPO) levels, while restoring glutathione (GSH) levels and alleviating renal pathology in db/db mice. Multi-omics integration revealed enrichment in pathways involving extracellular matrix (ECM)-receptor interaction, AMPK signaling, and glutathione metabolism. YTK attenuated glomerular filtration barrier damage through several coordinated mechanisms: (1) Inhibition of the TGF-β/Smad pathway, downregulating TMEM2, TGF-β1, Smad2/3/4, and MMP-9; (2) Enhancement of SLC7A11 palmitoylation via the AMPKα1/ZDHHC8 axis, which stabilized SLC7A11 protein and inhibited ferroptosis-a role confirmed by site-directed mutagenesis of the critical Cys327 site; (3) Direct modulation of macrophage polarization, suppressing pro-inflammatory M1 markers and promoting anti-inflammatory M2 markers; and (4) Multi-target cytoprotection against renal cell injury. Surface plasmon resonance (SPR) analysis confirmed the direct, concentration-dependent binding of puerarin and quercitrin to GPX4 and TGF-β1. In vitro, YTK-medicated serum, puerarin, and quercitrin restored viability in injured MPC5 podocytes, renal microvascular endothelial cells and glomerular mesangial cells, induced consistent mRNA expression changes of key targets across both cell types, and inhibited apoptosis via modulation of the TGF-β/Smad and AMPK/SLC7A11 pathways. Specificity validation of the palmitoylation detection method reinforced the reliability of the omics findings.

CONCLUSIONS:

This study comprehensively elucidates the multi-cellular protective mechanism of YTK on the glomerular filtration barrier. We demonstrate that YTK confers protection via a dual-pathway mechanism: (1) Suppression of the injury pathway by inhibiting TGF-β1/Smad overactivation via modulation of macrophage phenotype and ECM homeostasis, thereby mitigating inflammation and cellular damage; and (2) Activation of the protective pathway by enhancing SLC7A11 palmitoylation through the AMPKα1/ZDHHC8 axis, which stabilizes SLC7A11, restores glutathione metabolism, and inhibits ferroptosis. These two axes functionally interact to rebalance injury and protective signaling. Furthermore, puerarin and quercitrin were identified as key serum-absorbed constituents that directly bind to targets including TGF-β1 and GPX4, mediating the described dual-pathway regulation. In summary, YTK represents a promising multi-target therapeutic strategy that coordinately regulates injury and protective signaling networks to prevent and alleviate proteinuria in DKD.

01 Apr 2026·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Pharmacokinetic, tissue distribution, permeability, protein binding and stability studies of finerenone in SD rats using validated UPLC and LC-MS method

Article

Author: Rathaur, Shivam ; Gayen, Jiaur R ; Varshney, Parag ; Maity, Debalina

Finerenone (FNR) is a novel selective nonsteroidal mineralocorticoid receptor antagonist for the treatment of chronic kidney disease associated with diabetes. We aimed to develop a novel, reproducible and highly sensitive bioanalytical method in liquid chromatography coupled with mass spectrometry (LC-MS/MS) for FNR was validate in rat plasma for the first time and determining their pharmacokinetic (PK) and tissue distribution (TD) in SD rats. We have performed the in-vivo PK, TD and in-vitro solubility, Fasted/Feeded simulated intestinal (FaSSIF) and gastric fluid (FaSSGF) stability, plasma stability, microsomal stability, plasma protein binding (PPB), blood plasma partitioning, parallel artificial membrane permeability assay (PAMPA) and in-situ single pass intestinal permeability (SPIP) for FNR. FNR was more soluble in intestinal fluid and stable in FaSSIF, FeSSIF than FaSSGF. FNR was stable in plasma (91.98%) and metabolized in rat liver microsome (90.30%) at 5 μM concentration up to 3 and 1 h, respectively. PPB was found 94.11% and 96.97% at 5 and 10 μM concentration, respectively. The plasma partition coefficient results of FNR were found the fast equilibrium between blood and plasma. PAMPA and SPIP results demonstrate the passive permeability of FNR was high. Oral and intravenous (IV) administration of FNR, absolute bioavailability was observed 49.17%. The distribution of FNR was found the maximum concentration in following order: intestine> kidney> lungs> spleen> muscle> heart> brain> pancreas> liver. The all above in-vitro as well as in-vivo study are support the preclinical and clinical application of FNR.

113

News (Medical) associated with Finerenone

18 Mar 2026

·www.businesswire.com

KERENDIA ® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease

KERENDIA ® (finerenone) met its primary endpoint demonstrating a statistically significant improvement vs. placebo in the estimated glomerular filtration rate (eGFR) slope from baseline to Month 32 – a surrogate endpoint for slowing kidney disease progression 1 FIND-CKD is the fifth consecutive Phase III clinical trial where KERENDIA met its primary endpoint, adding to a clinical trial program of more than 20,000 patients across multiple patient populations with heart and kidney diseases FIND-CKD is the largest Phase III study to date focused on non-diabetic chronic kidney disease (CKD) and now expands KERENDIA’s clinical data in CKD to both diabetic and non-diabetic patients The clinical data from FIND-CKD will be presented at an upcoming scientific conference, and Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to this patient population KERENDIA is currently approved by the FDA for use in adults with CKD associated with type 2 diabetes (T2D) and heart failure with left ventricular ejection fraction (HF LVEF) ≥40% 2 The Phase III study FIND-CKD (NCT05047263) — investigating the efficacy and safety of KERENDIA® (finerenone) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD) — has met its primary endpoint.1 The results demonstrated a statistically significant improvement versus placebo in the primary efficacy outcome of estimated glomerular filtration rate (eGFR) slope, defined as the mean annual rate of change from baseline to Month 32,1 a validated surrogate endpoint for kidney disease progression.3 The safety profile of KERENDIA in the FIND-CKD study was consistent with its established safety profile.1 The FIND-CKD clinical trial data will be presented at an upcoming scientific conference. Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to non-diabetic CKD patients. “Patients with chronic kidney disease have substantial risk for cardiovascular events and kidney failure, so new treatments are needed to help slow kidney disease progression and improve outcomes,” said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine, clinical trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “The FIND-CKD topline results are encouraging because they now provide evidence for finerenone in a non-diabetic chronic kidney disease population, on top of its established evidence in diabetic chronic kidney disease.” Since 2021, KERENDIA has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received FDA approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.2 Approximately 850 million people worldwide are living with CKD, and those with non-diabetic CKD represent more than half of these cases.4,5,6 In the U.S., more than 35 million people are estimated to have CKD.7 In 2023, CKD accounted for over 1.4 million deaths, ranking as the ninth leading cause of death.8 “The FIND‑CKD findings mark the fifth consecutive Phase III trial in the KERENDIA clinical development program to meet its primary endpoint and represent a major milestone for people living with non-diabetic chronic kidney disease,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “When considered alongside the growing evidence base, this important trial adds to our understanding of KERENDIA across multiple patient populations with heart and kidney diseases.” KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.2 FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD and investigated KERENDIA in a population spanning different etiologies of non-diabetic CKD. The Phase III FIND-CKD9 study investigated finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic CKD etiologies, of which etiologies included hypertension and chronic glomerulonephritis (inflammation of the kidneys’ blood filters). Patients were randomized to receive either finerenone 10mg or 20mg, based on serum potassium levels and eGFR, or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). The primary endpoint was the mean annual rate of change in eGFR from baseline to 32 months. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs. KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF10 as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,11 CONFIRMATION-HF12 and FINALITY-HF.13 The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD,14 FIGARO-DKD,15 FINE-ONE16 and FIND-CKD17 as well as the ongoing investigational studies, FIONA18 and FIONA-OLE.19 CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD affects 850 million people worldwide. In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. Healthy kidneys act as the body’s filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure. As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain, confusion, trouble focusing and memory problems. Major underlying causes of CKD include diabetes, hypertension and glomerulonephritis such as immunoglobulin A nephropathy, focal segmental glomerulonephritis and membranous nephropathy. 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. 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. ___________________________ 1 Data on file. 2 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf. Accessed March 4, 2026 3 Research C for DE and. Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure. FDA. Published online August 20, 2020. https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure 4 Jager KJ, et al. Kidney Int. 2019;96(5):1048-1050. 5 GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. The Lancet. 2018;392(10159):1789-1858 6 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. 7 NIDDK. Kidney disease statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. Published 2023. Accessed March 4, 2026. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease 8 GBD 2023 Chronic Kidney Disease Collaborators. The Lancet. 2025;406(10518):2461-2482. 9 Heerspink HJL, Agarwal R, Bakris GL, et al. Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial. Nephrol Dial Transplant. 2025;40(2):308-319. doi:10.1093/ndt/gfae132 10 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 Accessed March 4, 2026 11 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. Accessed March 4, 2026. 12 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. Accessed March 4, 2026. 13 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. Accessed March 4, 2026. 14 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. Accessed March 4, 2026. 15 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. Accessed March 4, 2026. 16 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. Accessed March 4, 2026. 17 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. Accessed March 4, 2026. 18 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. Accessed March 4, 2026. 19 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. Accessed March 4, 2026. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug Approval

16 Mar 2026

·www.fiercepharma.com

Bayer heads to regulators with nondiabetic kidney disease trial win for Kerendia

Bayer did not divulge fine details around Kerendia’s performance but noted that it plans to present new data at an upcoming medical conference and submit them to regulators in hopes of expanding Kerendia into the nondiabetic chronic kidney disease population. With a fresh phase 3 win for Kerendia, Bayer is one step closer to pushing the ascendant drug into a much broader population of patients with chronic kidney disease (CKD). Kerendia, also known as finerenone, met the mark in Bayer’s late-stage Find-CKD study in adult patients with CKD who don’t have diabetes, allowing the study to hit its primary endpoint, the company said Monday. In the trial, Bayer’s drug helped patients chart a statistically significant and clinically meaningful reduction in kidney function decline compared to placebo, as measured by the estimated glomerular filtration rate (eGFR) slope, which is used as a surrogate endpoint for clinical kidney outcomes and a predictor for the risk of kidney failure. Patients in both trial arms received standard of care in addition to placebo or Kerendia.Bayer did not divulge fine details around Kerendia’s performance but noted that it plans to present the data at an upcoming medical conference and submit them to regulators in hopes of expanding Kerendia into the nondiabetic CKD population. Kerendia first emerged on the U.S. scene in 2021 with an FDA nod to curb the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks and hospitalization in patients with CKD associated with Type 2 diabetes. In addition, the mineralocorticoid receptor antagonist last year picked up a green light for two types of heart failure—either with preserved ejection fraction or mildly reduced ejection fraction—and has become, alongside Nubeqa, a key piece in Bayer’s strategy to navigate the decline of older products Xarelto and Eylea. Of the roughly 850 million people estimated to have CKD worldwide, “more than half” have nondiabetic CKD, according to Bayer. That version of the condition can stem from multiple sources, but the most common are hypertension and glomerulonephritis, with the latter referring to the inflammation of the tiny filters in the kidneys dubbed glomeruli, the company explained. Hypertension-linked CKD is the second most common cause of kidney failure, according to Bayer, which also noted that patients with the nondiabetic incarnation of the disease face a roughly 2.6 times higher risk of a fatal cardiovascular event than the general population without CKD. “The positive results of the Phase III FIND-CKD study represent an important advancement in the area of non-diabetic chronic kidney disease, regardless of the underlying cause,” Christian Rommel, global head of R&D at Bayer’s pharma division, said in a statement. Kerendia and its continued growth—both in terms of its sales and label—will be essential to Bayer’s execution in the coming months and years.The German conglomerate continues to grapple with generic competition against blood thinner Xarelto, which suffered (PDF) a 33% sales decline to 2.34 billion euros ($2.6 billion) last year, plus the recent entry of biosimilars to the Regeneron-partnered eye med Eylea, which experienced a 6% annual sales slide in 2025. The Eylea decline is expected to pick up pace in 2026, Bayer said in its earnings report earlier this month. Still, Kerendia and other newer drugs in Bayer’s roster are picking up steam. For all of last year, Kerendia’s sales soared a staggering 79%—and an even more impressive 93% in the fourth quarter specifically—to reach 829 million euros ($936 million) across 2025, coming close to but not quite breaching the blockbuster sales threshold. “We’re well set for our next wave of growth, right into the next decade, driven by significant, sustained Nubeqa and Kerendia sales,” Bayer’s pharma president Stefan Oelrich told analysts on a conference call in early March, highlighting the company’s fast-growing prostate cancer treatment alongside Kerendia.

Phase 3Clinical Result

16 Mar 2026

·endpoints.news

CytomX reports ADC data in late-line colorectal cancer; FDA OKs Cosentyx label expansion

Plus, news about Bayer’s Kerendia, Eli Lilly’s Ebglyss and Alto Neuroscience: 📈 CytomX’s colorectal cancer data: The biotech tested multiple doses of its antibody-drug conjugate varsetatug masetecan, or Varseta-M, in patients with late-line metastatic CRC. The low dose induced a response in one of 17 patients, the middle dose in four of 20, and the high dose in six of 19. CytomX will aim to meet with the FDA in the middle of the year to decide whether the mid- or high-dose will move forward into further trials. The company will also test Varseta-M in combination with Roche’s Avastin, along with an Avastin-chemotherapy combo. Separately, CytomX also reported that Astellas punted on the “remaining” preclinical programs from a 2020 partnership. CytomX’s stock $CTMX rose about 50% on Monday morning. — Max Gelman 🟢 FDA greenlights Cosentyx for children with inflammatory skin disease: Novartis’ medicine will now be available for patients aged 12 years and older with mild to moderate hidradenitis suppurativa. Cosentyx was originally approved for adults with the condition in October 2023. The drug pulled in about $6.7 billion in sales last year. — Ayisha Sharma 📊 Bayer’s Kerendia passes Phase 3 kidney disease test: The drug produced a significant improvement in estimated glomerular filtration rate at 32 months versus placebo in chronic kidney disease (CKD) patients who don’t have diabetes. Kerendia is approved for CKD patients who have type 2 diabetes. — Ayisha Sharma 📊 Eli Lilly’s Ebglyss succeeds in Phase 3 pediatric eczema trial: The company said Ebglyss reached its primary skin clearance endpoint after 16 weeks, with 63% of children achieving a response compared with 22% who took placebo. An investigator assessment also showed 44% of children reached clear or almost clear skin, compared with 15% on placebo. Lilly enrolled children as young as six months old and plans to submit the data for a label update. — Max Gelman 💰 Alto Neuroscience to raise $120M in private placement: The California biotech will use the funds to support its candidate, ALTO-207, through Phase 3 development for treatment-resistant depression. The program is set to enter a Phase 2b trial in the first half of the year, with a Phase 3 to follow in early 2027. — Ayisha Sharma Editor’s note: This article has been updated to include information about Astellas and CytomX’s now-terminated collaboration.

Phase 3Clinical ResultPhase 2Drug ApprovalADC

100 Deals associated with Finerenone

External Link

KEGG	Wiki	ATC	Drug Bank
D10633	Finerenone	-	DB16165

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
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 Pharmaceuticals, Inc.	09 Jul 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
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
Left ventricular systolic dysfunction	Phase 3	Finland	Bayer AG	19 Nov 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02545049 \| NCT02540993 (FIDELIO-DKD, Pubmed \| J Diabetes Complications)	Phase 3	Diabetes Mellitus, Type 2	8,370	Finerenone	tfgxixpixw(wktyntijlm): HR = 0.82 (95.0% CI, 0.68 - 0.99), P-Value = 0.043 View more	Positive	01 Apr 2026
				Placebo
NCT05901831 (FINE-ONE, Pubmed \| N Engl J Med)	Phase 3	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	242	Finerenone	jbgavnwzmv(hjtlrrfogd): GM ratio = 0.75 (95.0% CI, 0.65 - 0.87), P-Value = <0.001 View more	Positive	05 Mar 2026
				Placebo
NCT04435626 (FINEARTS-HF, Pubmed \| Eur Heart J Cardiovasc Pharmacother)	Phase 3	Heart failure with normal ejection fraction	6,001	Finerenone	lkhzvwnkbu(iunijfkwpk): HR = 0.94 (95.0% CI, 0.83 - 1.06) View more	Positive	16 Feb 2026
				Placebo
NCT04435626 (FINEARTS-HF, Pubmed \| Circ Heart Fail)	Phase 2	Heart Failure total bilirubin \| alkaline phosphatase \| alanine aminotransferase ... View more	6,001	Finerenone	pdmoqdjidy(fwduvdfnjc) = xvomhuhllt iglzvwvkjf (mwogqlmnll )	Positive	01 Feb 2026
NCT04435626 (FINEARTS-HF, Pubmed \| JACC Heart Fail)	Phase 3	Heart Failure	5,873	Finerenone	lzncymcpzi(ujnlbsxbcb): RR = 0.77 (95.0% CI, 0.63 - 0.94) View more	Positive	01 Feb 2026
				Placebo
NCT06381323 (Pubmed \| Hypertension)	Phase 4	Hyperaldosteronism	57	Finerenone 20-40 mg/d	uflvsxaktn(mitqioqvtn) = atwtdfuzel cxbzpzwplr (ujpyycncvm ) View more	Positive	22 Jan 2026
NCT02545049 \| NCT02540993 (FIDELIO-DKD, Pubmed \| Clin J Am Soc Nephrol)	Phase 3	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	-	Finerenone	qjswhhbqtv(rfyqiynrbs) = yzptszjfxq ehdukbhjrh (mvfmqjjqxc ) View more	Positive	14 Jan 2026
				Placebo	qjswhhbqtv(rfyqiynrbs) = wkasnctdjd ehdukbhjrh (mvfmqjjqxc ) View more
NCT05901831 (FINE-ONE, Company_Website \| ASN2025) Manual	Phase 3	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	242	Finerenone + SOC	pyagwlvvov(dmcnsouuob) = tertaereop hhyxokjyfj (ocyxqygsza ) Met View more	Positive	06 Nov 2025
				Placebo + SOC	nkbtbvwkob(lxqzwrzpcc) = yavjcjhnyk szxjgnxalp (jbeaevnzuz ) View more
ASN2025	Not Applicable	Type 2 diabetes mellitus with established diabetic nephropathy	22	Finerenone (Diabetic Nephropathy)	wcruqsdmby(duftykfxom) = cyjmuujtkw zgipbddrpe (ygkipmhflp ) View more	Positive	06 Nov 2025
				Finerenone (Non-Diabetic Renal Disease)	pxjnfetlno(efzkjvjzpq) = djjqcngmwt lrxrrihjtj (xakrbxcasm )
NCT05901831 (FINE-ONE, ASN2025)	Phase 3	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	242	Finerenone 20 mg	xffzcvcboa(mnjnptwgnc) = tzgkxywpxq cjwbxdufti (uwpdpohnps )	Positive	06 Nov 2025
				Placebo	tveekpcdjv(joxxslntos) = amlortkueo zzjlbvnoul (awevbfqaey )

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