Randomized Controlled Trial Evaluating the Impact of Mineralocorticoid Receptor Blockade by Eplerenone on Echocardiographic Abnormalities Among Kidney Graft Recipient Under Calcineurin Inhibitors. KT-CANOPY: Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.

The main objective of this research is to evaluate the effect, for 36 weeks, of eplerenone on abnormalities observed on cardiac ultrasound in patients with kidney transplantation for at least one year, under cyclosporine or tacrolimus. The intervention group will receive the usual standard treatment coupled with eplerenone for 36 weeks from randomization, while the control group will only receive the standard treatment. The main hypothesis is that anticalcineurins (cyclosporin or tacrolimus) lead to activation of the MR of vascular smooth muscle cells, vasoconstriction and vascular inflammation, which contributes to the persistence or recurrence of heart abnormalities in these patients after the initial post-transplant phase. The administration of eplerenone could antagonize this hyperactivation, reduce the cardiovascular effects of anticalcineurins and thus ultimately improve the cardiovascular prognosis of transplant patients.

Start Date01 Feb 2027

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nancy

NCT07539259

/ Not yet recruitingPhase 2IIT

Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial

This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.
Even after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure.
This study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS.
There will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months.
Participants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit.
These medicines might help patients after AVR by reducing heart muscle thickness and scarring.

Start Date01 Dec 2026

Sponsor / Collaborator

University College London

NCT07795762

/ Not yet recruitingPhase 1IIT

Effect of Short-Term Oral Eplerenone on Intraocular Pressure in Healthy Adult Volunteers: A Randomized, Double-Masked, Placebo-Controlled Crossover Study

The goal of this clinical trial is to determine whether eplerenone lowers eye pressure in healthy adults. Eplerenone is a medication approved by the U.S. Food and Drug Administration for other medical conditions. Researchers will compare eplerenone with placebo (a substance containing no active drug) to determine whether eplerenone affects intraocular pressure (IOP). Participants will receive both eplerenone and placebo during different study periods and will have their eye pressure measured throughout the study. Blood pressure, kidney function, and potassium levels will also be monitored for safety.

Start Date01 Oct 2026

Sponsor / Collaborator

University of Florida

100 Clinical Results associated with Eplerenone

100 Translational Medicine associated with Eplerenone

100 Patents (Medical) associated with Eplerenone

1,584

Literatures (Medical) associated with Eplerenone

01 Dec 2026·RENAL FAILURE

Mineralocorticoid receptor antagonists in dialysis patients after ACHIEVE and ALCHEMIST: updated systematic review and meta-analysis of 14 randomized trials.

Review

Author: Qiu, Fengping ; Li, Juan ; Huang, Zhongping ; Zhu, Yifan

End-stage kidney disease (ESKD) patients receiving dialysis bear a heavy burden of cardiovascular disease (CVD), the leading cause of mortality. Mineralocorticoid receptor antagonists (MRAs) have cardiovascular protective effects in non-dialysis patients, but their efficacy and safety in dialysis-dependent individuals remain controversial. This study aimed to clarify their clinical value via an updated systematic review and meta-analysis. Following preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, we systematically searched PubMed, EMBASE, and The Cochrane Library up to 25 August 2025. Eligible studies were parallel-design randomized controlled trials (RCTs) enrolling adults (≥18 years) on maintenance dialysis, comparing MRAs with placebo or no intervention. Two reviewers independently screened studies, extracted data, and assessed quality using the Cochrane Risk of Bias Tool 2.0. Meta-analysis was performed with Cochrane Review Manager 5.4. The results showed that a total of 14 RCTs involving 4,525 patients were included (13 used spironolactone, one used eplerenone; follow-up: 3-40.8 months). MRAs significantly reduced nonfatal CVD events (RR 0.68, p = 0.04) but had no significant effect on cardiovascular mortality (RR 0.75, p = 0.14) or all-cause mortality (RR 0.76, p = 0.05). They significantly elevated risks of severe hyperkalemia (RR 1.35, p = 0.009) and gynecomastia and breast pain (RR 4.23, p < 0.001). In conclusion, MRAs can reduce the incidence of nonfatal cardiovascular events in dialysis patients; however, clinicians also need to be mindful of the risks of severe hyperkalemia as well as gynecomastia and breast pain in men when prescribing them.

01 Dec 2026·Dialogues in health

Early mineralocorticoid receptor antagonism for end-organ protection in hypertension: Implications for disparities and rethinking the timing paradigm

Review

Author: Ezeugwu, Camellus O

Purpose:

Hypertension-related end-organ damage disproportionately affects Black populations, with earlier onset, greater severity, and higher rates of heart failure and chronic kidney disease despite treatment. Because structural injury may persist even when blood-pressure (BP) targets are met, this review examines aldosterone-mineralocorticoid receptor (MR) signaling as a driver of residual tissue injury and develops a hypothesis-generating framework for earlier, risk-stratified MR antagonism.

Methods:

This is a narrative review. We searched PubMed/MEDLINE and the Cochrane Library (inception-July 2026) using terms including mineralocorticoid receptor antagonist, aldosterone, spironolactone, eplerenone, finerenone, hypertension, resistant hypertension, end-organ damage, fibrosis, hyperkalemia, chronic kidney disease, heart failure, and health disparities. We prioritized randomized controlled trials, prespecified pooled analyses, mechanistic studies, and current guidelines, and hand-searched reference lists. No quantitative synthesis was performed.

Findings:

Aldosterone-MR signaling promotes fibrosis, inflammation, oxidative stress, and adverse remodeling across cardiovascular and renal tissues, and may be particularly relevant in low-renin, salt-sensitive phenotypes observed more frequently, on average, among Black patients. Randomized trials support MR antagonists (MRAs) in resistant hypertension, heart failure, and diabetic CKD; however, MRAs are often introduced late, when reduced renal function raises hyperkalemia risk and limits preventive benefit.

Conclusion:

In selected higher-risk patients with preserved renal function and controlled potassium, earlier MR antagonism may warrant prospective evaluation as a tissue-protective, disparity-reducing strategy. This framework is hypothesis-generating and is intended to stimulate research, not to alter current guideline-directed therapy.

01 Nov 2026·AMERICAN HEART JOURNAL

Stratified medicine with eplerenone for myocardial infarction or injury and no obstructive coronary arteries: A registry-based basket trial

Article

Author: Kamdar, Anna L ; Brogan, Richard A ; McFarlane, Richard ; Tan, Dylan ; Ghattas, Angie ; Rocchiccioli, Paul J ; Gohar, Aisha ; Collison, Damien G ; McKinley, Gemma ; Reynolds, Harmony ; Orchard, Vanessa ; Hanna, Rebecca ; Vicere, Andrea ; Eteiba, Hany ; Sykes, Robert ; Joshi, Francis R ; McCartney, Peter J ; Lindsay, Mitchell M ; Good, Richard I S ; McConnachie, Alex ; Apps, Andrew P ; Jamieson, Louise ; Ang, Daniel ; Carrick, David ; Tzolos, Evangelos ; McMenamin, Marianne ; Robertson, Keith E ; Watkins, Stuart ; Gildea, Pamela ; Morrow, Andrew J ; Shaukat, Aadil ; Galbraith, Mary ; Berry, Colin ; Carberry, Jaclyn ; Bradley, Conor

BACKGROUND:

Myocardial Infarction with No Obstructive Coronary Arteries (MINOCA) or Nonischemic Myocardial Injury affects approximately 1 in 9 patients presenting with acute coronary syndrome, yet evidence-based therapies are lacking. Coronary microvascular dysfunction is implicated in the pathogenesis of suspected MINOCA, but its prevalence, prognostic implications and treatment are uncertain. The objectives are, first, to assess the prevalence of coronary microvascular dysfunction in patients with suspected MINOCA and, second, to implement endotype-informed stratified medicine involving patients with coronary microvascular dysfunction to treatment with eplerenone, a cardio- and vasculo-protective mineralocorticoid receptor antagonist.

METHODS:

This is a prospective, registry-based, multicenter, diagnostic study and nested, randomized, controlled, open-label, blinded-endpoint (PROBE) basket trial. Up to 400 patients with clinically suspected MINOCA and one or more cardiovascular risk factors will be enrolled into a registry-based diagnostic study. Coronary microvascular function will be assessed during invasive angiography using thermodilution. Patients with an index of coronary microvascular resistance (IMR) ≥ 25 will be randomized 1:1 to eplerenone (25-50 mg daily for 6 months) or standard care without eplerenone (control group) (n = 150 randomized). Final endotypes will be centrally adjudicated by a panel of blinded cardiologists. The primary outcome of the diagnostic study is the proportion of patients with IMR ≥ 25 during index coronary angiography. Secondary outcomes include coronary flow reserve, cardiovascular MRI parameters, patient-reported outcome measures, biomarkers of myocardial fibrosis and vascular inflammation, health outcomes and health economic assessments. The primary outcome of the randomized trial is the within-individual change in NT-proBNP at baseline, 1 month, and 6 months, based on intention-to-treat. Secondary outcomes include mechanistic blood biomarkers and patient-reported outcome measures.

VALUE:

This registry-based randomized trial will provide novel evidence on endotype-informed secondary prevention therapy with eplerenone for suspected MINOCA.

News (Medical) associated with Eplerenone

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

13 Aug 2026

·www.fiercepharma.com

AZ's blood pressure newcomer Baxfendy fails to meet cost-effectiveness bar, ICER says

AstraZeneca’s newly approved, first-in-class hypertension drug Baxfendy does not clear the bar for effectiveness relative to its price, according to the Institute for Clinical and Economic Review (ICER), a U.S. non-profit drug price watchdog. In a draft report (PDF), ICER concludes Baxfendy is too expensive to meet traditional cost-effectiveness measures. For its assessment, ICER used a wholesale acquisition cost (WAC) of $900 for a supply of 30 Baxfendy tablets, adding up to an annual cost before discounts and rebates of $10,800. The WAC, or 'list price,' of a drug does not represent what patients ultimately pay at the pharmacy counter. ICER also used the same price as a placeholder to assess Mineralys Therapeutics’ investigational treatment lorundrostat, which carries the same mechanism of action as Baxfendy and is up for an FDA decision in December. ICER came to the same conclusion that Mineralys’ aldosterone synthase inhibitor (ASI) does not measure up. “At their current WAC-based price and placeholder price, the incremental cost-effectiveness ratios for baxdrostat and lorundrostat were well above commonly used cost-effectiveness thresholds,” ICER wrote. While acknowledging the limitations of cross-trial comparisons, ICER added that their analysis could not differentiate whether “one agent has superior blood pressure lowering over the other.” ICER wrote that the health benefits of baxdrostat or lorundrostat are “promising but inconclusive” compared to those for generic blood pressure medicines such as spironolactone, eplerenone and amiloride. Baxfendy was approved by the FDA in May of this year to be used with other antihypertensive therapies in patients with high blood pressure that can’t be adequately controlled. In its report, ICER also said that questions remain about the “long-term effects of ASIs,” and their efficacy and safety in subgroups, specifically those with chronic kidney disease. In response, an AZ spokesperson pointed out that millions of people in the U.S. do not have their blood pressure under control despite being on multiple medications. “Aldosterone synthase inhibitors, including Baxfendy, represent the first new innovation in hypertension management in more than two decades. Baxfendy offers patients clinically meaningful blood pressure reductions supported by a robust body of scientific evidence, and we are continuing to support access to this new therapy for patients across the U.S.," the spokesperson added. The approval of Baxfendy was backed by results from a phase 3 trial which showed that it helped curb blood pressure at statistically significant and clinically meaningful levels in patients who were already taking two or more hypertension meds. At week 12 of the study, a 2 mg dose of Baxfendy helped reduce patients’ blood pressure on average by nearly 10 mmHg when adjusted for placebo. The reduction in mean seated systolic blood pressure in the trial’s placebo cohort clocked in at 5.8 mmHg. AZ leadership has pegged the peak sales potential of Baxfendy at $5 billion, with the medication expected to play a role in the company achieving its goal to reach annual sales of $80 billion by 2030. AZ acquired Baxfendy in a $1.3 billion buyout of its developer CinCor Pharma in 2023.

AcquisitionPhase 3Drug ApprovalNDAClinical Result

13 Aug 2026

·firstwordpharma.com

ICER raises value questions for AstraZeneca, Mineralys' blood pressure drugs

A cost-effectiveness analysis out this week suggests that two aldosterone synthase inhibitors (ASIs) — AstraZeneca's newly approved Baxfendy (baxdrostat) and Mineralys Therapeutics' lorundrostat, which is still under review — do lower blood pressure effectively and may cause fewer side effects than older hypertension drugs. Their price, however, may be harder to justify."In cost-effectiveness analyses, treatment with baxdrostat and lorundrostat (at its placeholder price) generally provided small benefits in quality-adjusted life years (QALYs) and equal-value life-years (evLYs) compared to spironolactone, eplerenone, and amiloride, but at a much higher total cost," according to a draft evidence report Wednesday from the Institute for Clinical and Economic Review (ICER).Baxfendy is an oral drug that was approved by the FDA in May, in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. The decision was based on "gamechanger" data from the Phase III BaxHTN study — the therapy lowered seated office systolic blood pressure (SBP) by a placebo-adjusted average of 9.8 mmHg — that made it the first drug in the ASI class authorised for this population.AstraZeneca also sees Baxfendy as a $5-billion asset, and possibly double that if other indications are eventually tacked on (see – Physician Views Results: Clinicians back Baxfendy's efficacy, but safety monitoring may define early uptake).Meanwhile, the FDA is currently reviewing Mineralys' application for lorundrostat, which is also taken orally. The filing includes data from the Phase III Launch-HTN trial showing it reduced automated office SBP by 11.7 mmHg compared to placebo. The US regulator is slated to render its verdict by Dec. 22.However, against older drugs, the ICER analysis found that the ASIs offered only small additional health benefits, at least based on currently available evidence.Pricy gainsThe cost per QALY gained with Baxfendy ranged from about $833,000 versus spironolactone and $851,000 versus amiloride, to more than $2 million versus eplerenone, far above the $100,000-$150,000 thresholds commonly used to judge cost-effectiveness. Using a placeholder price for lorundrostat that is equivalent to Baxfendy's price, ICER estimated costs of around $1.4 million to $1.5 million per QALY versus spironolactone and amiloride, while lorundrostat was "more costly and less effective" than eplerenone."Despite effective blood pressure lowering," the group said that "questions remain about the long-term effects of ASIs, as well as their impact on patient-important outcomes," such as cardiovascular events, kidney disease, dementia, quality of life, or mortality. "The other comparators in our review have demonstrated a positive impact on patient-important outcomes."ICER also highlighted the potential budget impact, estimating that at Baxfendy's net price of $10,950 per year, switching to the drug would add about $8300 per patient in healthcare costs in the first year, rising to $15,700 by year five. For lorundrostat, using the same annual placeholder price, the corresponding figures were $8500 and $16,300.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Eplerenone

External Link

KEGG	Wiki	ATC	Drug Bank
D01115	Eplerenone	C03DA04	DB00700

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute myocardial infarction	Australia	Viatris Pty Ltd.	22 Jun 2005
Chronic heart failure	Australia	Viatris Pty Ltd.	22 Jun 2005
Left ventricular systolic dysfunction	Australia	Viatris Pty Ltd.	22 Jun 2005
Ventricular Dysfunction, Left	Austria	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Belgium	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Cyprus	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Denmark	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Finland	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	France	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Germany	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Greece	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Hungary	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Iceland	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Ireland	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Italy	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Luxembourg	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Netherlands	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Norway	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Poland	Baxter Deutschland GmbH	05 Aug 2004
Ventricular Dysfunction, Left	Portugal	Baxter Deutschland GmbH	05 Aug 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	Canada	Pfizer Inc.	01 May 2014
Hyperparathyroidism, Primary	Phase 3	Austria	Pfizer Inc.	09 Oct 2012
Hypoparathyroidism	Phase 3	Austria	Pfizer Inc.	09 Oct 2012
Diabetes Mellitus, Type 2	Phase 3	Canada	Pfizer Inc.	01 Mar 2012
Glucose Intolerance	Phase 3	Canada	Pfizer Inc.	01 Mar 2012
Chronic systolic heart failure	Phase 3	United States	Viatris, Inc.	01 Mar 2006
Chronic systolic heart failure	Phase 3	Argentina	Viatris, Inc.	01 Mar 2006
Chronic systolic heart failure	Phase 3	Australia	Viatris, Inc.	01 Mar 2006
Chronic systolic heart failure	Phase 3	Belgium	Viatris, Inc.	01 Mar 2006
Chronic systolic heart failure	Phase 3	Canada	Viatris, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04519164 (CTgov)	Phase 4	Metabolic Syndrome \| Obesity \| Hypertension	79	potassium chloride+Chlorthalidone	auvihrhquh(szfiexkdmo) = yokllibpvn khkpaupydo (wskyifwuej, cngduylkop - sayghurlnv) View more	-	15 Sep 2026
HEBRO (ESC2026)	Not Applicable	First line	198	Eplerenone 25mg bd	lgytyvppyi(ctmydetnhe): P-Value = 0.208 View more	Positive	31 Aug 2026
				Irbesartan 150mg od
HEBRO (ESC2026)	Not Applicable	Hypertension First line	162	Eplerenone 25 mg	yyxmkejfid(acadjwdzpv) = ldnkgzqlha fzsgjbpqxv (twtcjmwuef ) View more	Positive	30 Aug 2026
				Irbesartan 150 mg	yyxmkejfid(acadjwdzpv) = kalbcjxezl fzsgjbpqxv (twtcjmwuef ) View more
HEBRO (ESC2026)	Phase 4	Hypertension First line	198	Eplerenone 25mg bd	yopaigcfxc(xekbjnjnih) = ztzwusfmdh yxladfhixq (uneqamvyks, 8.2) View more	Non-inferior	28 Aug 2026
				Irbesartan 150mg od	yopaigcfxc(xekbjnjnih) = syahcvgtgg yxladfhixq (uneqamvyks, 6.7) View more
NCT02871648 (Pubmed \| Clin Endocrinol (Oxf))	Phase 2	-	23	Eplerenone	edrpnvtkrb(bhlfqbeqkv) = puzqexvvby ekqbfmkcov (vkygflslnm, 2.01)	Positive	12 Aug 2026
				Placebo	-
NCT03683069 (CTgov)	Phase 4	Hypertension	90	Eplerenone+Amlodipine	ltfourjuqo(pgqqjbnxkq) = vncqvshahj kccgqcrrwi (jlzfhdnwri, 10.5) View more	-	19 Mar 2025
NCT02740179 (MIRACLE HIV Study, Pubmed \| Clin Infect Dis)	Not Applicable	HIV Infections	40	Eplerenone 50 mg PO BID	fcssrivdkc(cimrluyggx) = ggkyigplob ffbnitgsvc (umzkxfnlfr, -38 to 286) View more	Positive	13 Oct 2023
				Placebo	gosyplttsr(pbkeozdnol) = yxrfyfmpnz syfonvxcem (qpovxtzlas, -2.2 to −0.1) View more
SPECTRA (EURETINA2023)	Phase 3	Central Serous Chorioretinopathy	96	Half-dose photodynamic therapy (PDT)	rzkncyypgv(zabjnszbqz) = nuvccopkfu wmnqxtjmco (mskbvntdlg )	Positive	05 Oct 2023
				Oral eplerenone treatment	rzkncyypgv(zabjnszbqz) = azzetrvssy wmnqxtjmco (mskbvntdlg )
NCT00232180 (EMPHASIS-HF, Pubmed \| J Am Coll Cardiol)	Phase 3	Chronic systolic heart failure	-	Eplerenone	yutecuudhv(uacelqhqtq) = lfzebghsio ykglzkpefl (llcnavfntp, 8.4 - 11.4)	Positive	12 Sep 2023
NCT02740179 (MIRABELLA HIV \| MIRACLE HIV Study, CTgov)	Not Applicable	Cardiovascular Diseases \| HIV Infections	40	Lifestyle Modification+Eplerenone (Eplerenone)	lnpecsnlqv(utwyeupjal) = mqkgcsxvbh ksoqopjilk (igjiuucuqj, 0.64) View more	-	02 Jun 2023
				Placebo (Placebo)	lnpecsnlqv(utwyeupjal) = dhgohwsrin ksoqopjilk (igjiuucuqj, 0.48) View more

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