A Multicentric, Prospective, Active Controlled, Parallel Group, Randomized, Double Blind, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Dapagliflozin plus Eplerenone Tablets Versus Concomitant Administration of Dapagliflozin Tablets and Eplerenone Tablets in Patients with Chronic Kidney Disease. - NIL

Start Date24 Mar 2025

Sponsor / Collaborator

Exemed Pharmaceuticals

NCT06749418

/ RecruitingEarly Phase 1IIT

Role of the Mineralocorticoid Receptor in Microvascular Endothelial Dysfunction After Preeclampsia

Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. Importantly, women who had preeclampsia have an exaggerated vascular responsiveness to hypertensive stimuli, such as high-salt intake, compared to women who had a healthy pregnancy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. While the association between a history of preeclampsia and vascular dysfunction leading to elevated CVD risk is well known, the mechanisms underlying this dysfunction remains unclear.
The purpose of this study is to examine the role of vascular mineralocorticoid receptor, the terminal receptor in the angiotensin system that contributes to blood pressure regulation, in mediating exaggerated microvascular endothelial dysfunction before and after a high-salt stimulus. This will help us better understand the mechanisms of microvascular dysfunction these women, and how inhibition of these receptors may improve microvascular function.
In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickel-sized area of the skin.

Start Date02 Jan 2025

Sponsor / Collaborator

University of Iowa

NCT06556732

/ RecruitingPhase 1IIT

Potential Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease

This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.

Start Date10 Aug 2024

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Eplerenone

100 Translational Medicine associated with Eplerenone

100 Patents (Medical) associated with Eplerenone

2,094

Literatures (Medical) associated with Eplerenone

01 May 2025·Value in Health Regional Issues

Cost-Effectiveness of Mineralocorticoid Receptor Antagonists in Ischemic and Nonischemic Heart Failure With Reduced Ejection Fraction: Perspective From a Universal Healthcare System

Article

Author: Sposito, Andrei C ; Nogueira, Ana Claudia Cavalcante ; Neiva, Yasmim Botelho ; Fernandez, Marta Duran ; Rohde, Luís Eduardo ; de Souza, Alexandre Magno Oliveira ; Koeche, Cristiane ; de Carvalho, Luiz Sérgio F ; Guimarães, Adriana J B A ; Amaral, Giselle Pinto da Silva

OBJECTIVES:

Mineralocorticoid receptor antagonists (MRAs) are cornerstones in the management of heart failure (HF) with reduced ejection fraction (HFrEF). New MRAs with improved safety profile, such as finerenone and eplerenone, were recently introduced. However, because of typical budget restrictions in middle-income countries, evaluating their cost-effectiveness is essential for optimizing treatment strategies.

METHODS:

We used a Bayesian network and Markov influence diagrams to estimate the incremental cost-effectiveness ratios (ICERs) in international dollars (Int$) per quality-adjusted life-year (QALY). Our model was fed by a systematic review and a network meta-analysis to compare MRAs effectiveness and used data from a cohort of 1066 Brazilian individuals with HFrEF (36% with ischemic and 64% with nonischemic disease).

RESULTS:

Over a 10-year time horizon, the treatment with spironolactone, eplerenone, and finerenone compared with no MRA utilization yielded discounted QALY per person of 0.072, 0.111, and 0.034, respectively. The ICERs were Int$7955, Int$6460, and Int$109 840 per QALY gained, respectively. Compared with spironolactone, eplerenone showed an ICER of Int$6178 per QALY gained. Assuming a willingness-to-pay threshold of 1 Brazilian per capita gross domestic product (Int$17 589) per QALY gained, the probabilistic sensitivity analyses suggest that spironolactone and eplerenone were cost-effective, respectively, in 87% and 92% of iterations. The 95% CIs were Int$2282 to Int$13 149 for spironolactone and Int$1795 to Int$12 351 for eplerenone per QALY gained. These findings were consistent across several scenarios including ischemic/nonischemic HF.

CONCLUSIONS:

Eplerenone is likely the most cost-effective MRA in Brazil considering individuals with both ischemic and nonischemic HFrEF.

01 May 2025·CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION

Targeting aldosterone to improve cardiorenal outcomes: from nonsteroidal mineralocorticoid receptor antagonists to aldosterone synthase inhibitors

Review

Author: Hundemer, Gregory L. ; Helmeczi, Wryan

Purpose of review:

Aldosterone dysregulation plays a major role in the pathogenesis of hypertension, cardiovascular disease, and kidney disease. Traditionally, steroidal mineralocorticoid receptor (MR) antagonists, namely spironolactone and eplerenone, have been the only available options to target aldosterone. Over recent years, a host of promising novel aldosterone-targeted pharmacologic agents have been developed thereby providing new options to mitigate aldosterone-mediated cardiovascular and kidney disease.

Recent findings:

Recently, a number of nonsteroidal MR antagonists (finerenone, esaxerenone, and ocedurenone) and highly specific aldosterone synthase inhibitors (baxdrostat, lorundrostat, dexfadrostat, and vicadrostat) have been developed. The early clinical data for these novel medications looks promising regarding their efficacy in improving blood pressure control, preventing adverse cardiovascular outcomes, and slowing chronic kidney disease progression. Moreover, they appear to be generally safe and well tolerated.

Summary:

In the coming years, nonsteroidal MR antagonists and aldosterone synthase inhibitors are likely to play an increasingly large role in routine medical practice to help improve cardiovascular and kidney outcomes.

01 May 2025·CLINICAL NEPHROLOGY

Unraveling hypertension through mineralocorticoid receptor activation in Cushing’s syndrome: A case report

Article

Author: Hommos, Musab S. ; Thomson, Holly ; Westphal, Sydney

BACKGROUND:

Cushing's syndrome is a rare cause of secondary hypertension. There are several mechanisms reported as contributing factors for blood pressure elevation in hypercortisolism patients. This case highlights the central role of mineralocorticoid receptors' activation by the excess cortisol in the development of hypertension.

CASE PRESENTATION:

A 45-year-old male presented with several months of cushingoid features and refractory hypertension on maximum doses of five antihypertensive drugs, not including a mineralocorticoid receptor blocker. Workup for other causes of secondary hypertension revealed sleep apnea but was otherwise negative. Further evaluation revealed a carcinoid lung tumor as the cause of Cushing's syndrome with its ectopic production of adrenocorticotropic hormone (ACTH). Prior to the resection of this tumor, the addition of eplerenone, a mineralocorticoid receptor blocker, resulted in significant improvement in blood pressure within 4 weeks, highlighting that cortisol activation of mineralocorticoid receptors is one of the main mechanisms of hypertension in this patient with hypercortisolism.

CONCLUSION:

In hypercortisolism patients, some excess cortisol escapes deactivation by the 11β-hydroxysteroid dehydrogenase 2 enzyme in the kidney and directly activates mineralocorticoid receptors. Recent literature suggests that specific patient populations have subtle elevations in cortisol levels, and cortisol's effect on end-organ damage follows a spectrum from high-normal cortisol to overt hypercortisolism. Other data suggest a decline in 11β-hydroxysteroid dehydrogenase 2 enzyme activity with age. Additional research is needed to further define the role of cortisol- mineralocorticoid receptor interaction in hypertension among patients without overt hypercortisolism but with high-normal cortisol or low 11β-hydroxysteroid dehydrogenase 2 enzymatic activity.

News (Medical) associated with Eplerenone

17 Apr 2025

·www.prnewswire.com

TRYVIO/JERAYGO Positioned to Redefine Treatment of Resistant Hypertension | DelveInsight

TRYVIO (aprocitentan) in the US and JERAYGO in Europe present significant market potential as novel therapies for patients with hypertension inadequately controlled by existing treatments. TRYVIO, approved by the FDA in March 2024 and commercially available since October 2024, targets systemic hypertension in adults not adequately controlled on other drugs. LAS VEGAS, April 17, 2025 /PRNewswire/ -- DelveInsight's " TRYVIO/JERAYGO Market Size, Forecast, and Market Insight Report" highlights the details around TRYVIO/JERAYGO, a dual endothelin receptor antagonist. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TRYVIO/JERAYGO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Idorsia Pharmaceuticals' TRYVIO/JERAYGO (aprocitentan) Overview TRYVIO is a once-daily oral medication that acts as a dual endothelin receptor antagonist, blocking the binding of endothelin-1 (ET-1) to both ETA and ETB receptors. This mechanism makes it particularly effective for reducing blood pressure in adults whose hypertension remains uncontrolled with other treatments. TRYVIO also has a low risk of drug-drug interactions. The active ingredient, aprocitentan, is marketed as TRYVIO in the United States, while in the European Union and the UK, it is available under the brand name JERAYGO. Marketing applications are currently under review in Canada and Switzerland. Notably, TRYVIO is the first oral antihypertensive in a new therapeutic class to receive approval in nearly four decades. Learn more about TRYVIO/JERAYGO projected market size for resistant hypertension @ TRYVIO/JERAYGO Market Potential Resistant hypertension is defined as blood pressure that remains above target levels despite the concurrent use of three antihypertensive agents of different classes, ideally including a diuretic, at optimal doses. This condition affects approximately 10-20% of the hypertensive population and is associated with a higher risk of cardiovascular events, stroke, and renal complications. The pathophysiology is often multifactorial, involving factors such as obesity, high salt intake, secondary hypertension causes, and medication nonadherence. Managing resistant hypertension is challenging due to its complex etiology, requiring a more personalized and multidisciplinary approach. The current treatment paradigm includes intensifying lifestyle interventions, ensuring optimal diuretic use, and exploring secondary causes. In recent years, device-based therapies such as renal denervation and baroreceptor activation therapy have emerged as potential options for select patients, although uptake has been cautious due to mixed clinical trial results. Pharmaceutical innovation has been relatively limited, but there is renewed interest in novel drug classes such as aldosterone synthase inhibitors, endothelin receptor antagonists, and dual-acting agents. The future market outlook is positive, driven by an aging global population, increasing prevalence of obesity and diabetes, and heightened awareness of cardiovascular risk. We expect the resistant hypertension market to grow steadily, with significant commercial opportunity for both drug developers and medtech innovators offering targeted, evidence-based solutions. Discover more about the resistant hypertension market in detail @ Resistant Hypertension Market Report Emerging Competitors of TRYVIO/JERAYGO Some of the competing emerging key players include AstraZeneca (Baxdrostat), Mineralys Therapeutics (Lorundrostat), Tenax Therapeutics (TNX-103), and others. In March 2025, Tenax Therapeutics, Inc. announced that the FDA had completed its review of the company's revised Phase 3 development strategy for TNX-103 (oral levosimendan). This included approval of an amendment to expand patient enrollment and enhance the statistical power of the ongoing Phase III LEVEL trial, as well as the protocol for LEVEL-2, Tenax's second registrational Phase III study. The company stated that it now plans to enroll 230 patients in the LEVEL study, boosting the study's statistical power to over 95%. LEVEL-2, a global trial, is expected to launch in 2025. In March 2025, Mineralys Therapeutics, Inc. reported comprehensive results from the Phase II Advance-HTN trial, one of two key studies assessing lorundrostat in patients with confirmed uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). In this trial, the 50 mg dose of lorundrostat achieved an absolute reduction of 15.4 mmHg in blood pressure and a placebo-adjusted reduction of 7.9 mmHg at week 12. The treatment also showed a favorable safety and tolerability profile, with only minor changes observed in potassium, sodium, and eGFR levels, and a low rate of treatment discontinuation. To know more about the number of competing drugs in development, visit @ TRYVIO/JERAYGO Market Positioning Compared to Other Drugs Key Milestones of TRYVIO/JERAYGO In March 2025, Idorsia announced that the US FDA had fully released TRYVIO from its REMS (Risk Evaluation and Mitigation Strategy) requirement. Idorsia is also released from the post-marketing requirement (PMR) to conduct a worldwide descriptive study that collects prospective and retrospective data in women exposed to TRYVIO during pregnancy and/or lactation, as these data are no longer needed. Idorsia no longer has post-marketing requirements for TRYVIO. In January 2025, Medicines and Healthcare Products Regulatory Agency (MHRA) approved JERAYGO to treat hypertension (high blood pressure) in adults whose blood pressure cannot be adequately controlled by at least three other medicines (also known as resistant hypertension), in the UK. In July 2024, Idorsia received approval from the European Commission for JERAYGO for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure control. In March 2024, Idorsia announced that the US Food and Drug Administration (FDA) has approved TRYVIO for the treatment of hypertension in combination with other antihypertensive drugs to lower blood pressure in adult patients who are not adequately controlled on other drugs. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. It was made commercially available in the US in October 2024. Discover how TRYVIO/JERAYGO is shaping the resistant hypertension treatment landscape @ TRYVIO/JERAYGO Medication TRYVIO/JERAYGO Market Dynamics TRYVIO (also marketed as JERAYGO in select markets) is a promising therapeutic entrant in the treatment landscape for resistant hypertension, representing a novel mechanism of action targeting the aldosterone pathway. As a selective aldosterone synthase inhibitor, TRYVIO addresses a key pathophysiological driver in resistant hypertension—aldosterone excess—offering a more targeted approach compared to traditional mineralocorticoid receptor antagonists (MRAs) like spironolactone or eplerenone. This differentiation positions TRYVIO as an important alternative for patients who are intolerant to MRAs or who do not achieve adequate blood pressure control despite existing therapies. TRYVIO's entry comes at a time when the hypertension market is seeing renewed attention toward personalized, mechanism-based treatments. Early clinical trial data have demonstrated meaningful reductions in systolic blood pressure with a favorable safety and tolerability profile. This has led to increasing interest among specialists in cardiology and nephrology. TRYVIO's potential to be used alongside existing antihypertensive agents without significant drug-drug interactions is a key advantage. However, uptake may be moderated in the short term by p hysician familiarity with MRAs, payer scrutiny on pricing, and the need for broader real-world data to confirm long-term efficacy and safety. From a regulatory standpoint, TRYVIO/JERAYGO has gained approvals in several major markets, including the U.S. and EU, with regulatory filings underway in Asia-Pacific regions. Payers are cautiously optimistic, with reimbursement being granted in many geographies based on unmet needs and pharmacoeconomic models projecting reductions in cardiovascular events and hospitalizations. That said, its premium pricing compared to generics necessitates the generation of robust health economic data to support its value proposition, especially in cost-sensitive healthcare systems. Looking ahead, TRYVIO is well-positioned to capture a substantial share of the resistant hypertension market, particularly as guidelines begin to incorporate newer therapeutic classes. We forecast steady growth driven by expanding physician adoption, increasing diagnosis of resistant hypertension, and potential label expansion into related indications such as heart failure with preserved ejection fraction (HFpEF). Strategic partnerships, post-marketing surveillance, and long-term outcome studies will be critical in shaping TRYVIO's competitive edge and sustaining momentum in a crowded but evolving treatment landscape. Dive deeper to get more insight into TRYVIO/JERAYGO's strengths & weaknesses relative to competitors @ TRYVIO/JERAYGO Market Drug Report Table of Contents Related Reports Resistant Hypertension Pipeline Resistant Hypertension Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key resistant hypertension companies, including Idorsia Ltd, Janssen Biotech, Quantum Genomics SA, CinCor Pharma, Ionis Pharmaceuticals, and Vifor Pharma, among others. Hypertension Market Hypertension Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key hypertension companies such as Mineralys Therapeutics Inc., CinCor Pharma, among others. Hypertension Pipeline Hypertension Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hypertension companies, including Gossamer Bio, Addpharma Inc., Insmed Incorporated, Alnylam Pharmaceuticals, 35Pharma Inc, Pfizer, Pharmosa Biopharm Inc., Guangzhou Magpie Pharmaceuticals Co., Ltd., Suzhou Sanegene Bio Inc., JW Pharmaceutical, among others. Treatment-Resistant Hypertension Market Treatment-Resistant Hypertension Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key TRD companies such as Ionis Pharmaceuticals, KBP Biosciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

02 Oct 2024

·www.globenewswire.com

Santhera Announces Positive Topline Results from LIONHEART Study with AGAMREE® (vamorolone) Demonstrating Unique Mineralocorticoid Receptor Antagonism

October 1, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the positive outcome of the LIONHEART study, confirming vamorolone’s distinctive action also as a mineralocorticoid receptor antagonist, setting it apart from other corticosteroids. The LIONHEART study, an open-label randomized, placebo- and eplerenone-controlled study involving 30 healthy adult male subjects, met its primary endpoint. It demonstrated a statistically significant increase in the urinary sodium/potassium ratio in the vamorolone arm compared to placebo (p<0.0001) following a fludrocortisone challenge. This increased ratio in urine provides clinical evidence for vamorolone’s unique mode of action also as a mineralocorticoid receptor antagonist (MRA) in humans. Combined with its known properties as a dissociative glucocorticoid receptor agonist, these findings further differentiate vamorolone’s pharmacological profile, distinguishing it from other corticosteroids. Cardiac complications such as cardiomyopathy are a leading cause of morbidity and mortality in boys with Duchenne muscular dystrophy (DMD). While treatment with corticosteroids (and ACE inhibitors) has demonstrated a delay in the onset of cardiomyopathy, the addition of MRAs including eplerenone to standard of care has also shown an improvement in left ventricular systolic dysfunction, the benefit of which increases with earlier initiation [1-3]. “Mineralocorticoid receptor antagonists are strongly recommended but late when cardiac function is already reduced and tend to be used in the presence of myocardial fibrosis as detected in magnetic resonance imaging,” explained Prof Karim Wahbi, PhD, MD, Cardiologist at the APHP Hospital Cochin, Paris, France. “What is intriguing about this mechanistic study is whether there is a synergistic benefit of the anti-inflammatory and MRA effects of vamorolone on the evolution of cardiac disease in children who started treatment early or if vamorolone could be of benefit to those who are already experiencing cardiac symptoms and wish to remain on a corticosteroid” “The LIONHEART study is an important milestone to establish the proof of concept for a cardioprotective potential of vamorolone,” stated Shabir Hasham, MD, Chief Medical Officer of Santhera. “We continue to collect data from patients who have been on vamorolone for up to seven years allowing us to better characterize long-term outcomes including any beneficial impact on cardiac complications in DMD.” AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [4-7]. This mechanism has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [4-7]. In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity. Currently available data show that AGAMREE, unlike corticosteroids, has been shown to be a dual mineralocorticoid antagonist and a dissociative glucocorticoid agonist based on animal experiments [7]. It has no restriction of growth [8] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [9]. AGAMREE (vamorolone), an orphan medicinal product, is approved for use in the United States (Prescribing Information), the European Union (Summary of Product Characteristics) and the United Kingdom for the treatment of DMD. The LIONHEART study (SNT-I-VAM-026) is an open label randomized, 3-arm, parallel-group, placebo and eplerenone controlled study to evaluate the mineralocorticoid receptor antagonism (MRA) effect of vamorolone in 30 healthy adult male subjects after challenge with fludrocortisone, a known mineralocorticoid receptor agonist. The primary endpoint was defined as the ratio of sodium to potassium (Na/K) and the corresponding logarithm of the ratio (log10(10*Na/K) in urine at different time-points. Further analysis of the data is ongoing and will be presented at medical conferences. References: [1] Birnkrant et al. (2018) Lancet Neurol. 2018 Apr;17(4):347-361. doi: 10.1016/S1474-4422(18)30025-5. [2] Raman et a. (2015) Lancet Neurol 14: 153–161 doi:10.1016/s1474-4422(14)70318-7 [3] Raman et al. (2017) Orphanet J Rare Dis 12: 39. doi:10.1186/s13023-017-0590-8 [4] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link. [5] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link. [6] Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293 [7] Heier CR et al (2019). Life Science Alliance DOI: 10.26508 [8] Ward et al., WMS 2022, FP.27 - Poster 71. Link. [9] Hasham et al., MDA 2022 Poster presentation. Link. Duchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD. Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultDrug ApprovalLicense out/in

03 Sep 2024

·synapse.patsnap.com

Cardiovascular Mortality Risk Reduced by 16%! Bayer Announces Latest Analysis Data from Finerenone FINE-HEART Study

On September 1, 2024, at the European Society of Cardiology (ESC) Congress, Bayer published the pooled analysis of the Phase III FINE-HEART study on finerenone, along with the latest data from the FINEARTS-HF trial. The results showed that finerenone significantly reduces all-cause mortality, cardiovascular, and renal outcomes. The findings were simultaneously published in 《Nature Medicine》. About the FINE-HEART StudyFINE-HEART is a pooled patient-level analysis, incorporating the FINEARTS-HF, FIDELIO, and FIGARO studies. This analysis aims to explore the impact of finerenone (brand name: Kerendia/Firialta) on cardiovascular and renal outcomes in approximately 19,000 patients with heart failure (HF) and/or chronic kidney disease (CKD) and type 2 diabetes (T2D), including those with a high burden of comorbidities—a characteristic of HF patients with left ventricular ejection fraction (LVEF) ≥40%. The FIDELIO-DKD and FIGARO-DKD trials randomized approximately 13,000 CKD and T2D patients with albuminuria (UACR≥30mg/g) from 48 countries. FINEARTS-HF included around 6,000 patients from 37 countries with symptomatic HF, LVEF ≥40%, elevated natriuretic peptides, and structural heart disease evidence. The results indicated: Primary Endpoint: ··Finerenone vs. Placebo: Cardiovascular (CV) mortality was numerically lower but not statistically significant (11% relative risk reduction, HR 0.89 [95% CI, 0.78-1.01; p=0.076]). ·Pre-specified Sensitivity Analysis: Involving CV death and unspecified death, finerenone reduced relative risk by 12% (HR 0.88 [95% CI, 0.79-0.98; p=0.025]). ·The effect of finerenone on cardiovascular (CV) death was generally consistent across the six subgroups. ·Compared to placebo, finerenone significantly reduced all-cause mortality as well as cardiovascular and renal outcomes. Secondary Endpoints: ·All-Cause Mortality Reduction: 9% (HR 0.91 [95% CI, 0.84-0.99; p=0.027]). ·Composite Renal Endpoint Reduction: Including time to first occurrence of renal failure, sustained eGFR decline ≥50% (≥4 weeks), or renal death, reduced by 20% (HR 0.80 [95% CI, 0.72-0.90; p<0.001]).HF Hospitalization Reduction: 17% (HR 0.83 [95% CI, 0.75-0.92; p<0.001]). About FinerenoneFinerenone (BAY948862) is an investigational non-steroidal selective mineralocorticoid receptor antagonist (MRA) that can block the overactivation of mineralocorticoid receptors (MR). Overactivation of MR can lead to fibrosis and inflammation, contributing to permanent structural damage in the kidneys. In July 2021, the FDA approved finerenone to reduce the risk of renal failure, slow down the decline in estimated glomerular filtration rate (eGFR), reduce cardiovascular death, non-fatal myocardial infarction, and hospitalization due to heart failure in patients with T2D and CKD. FINEARTS-HF Study:A randomized, double-blind, placebo-controlled, multi-center, event-driven Phase III clinical trial for patients diagnosed with symptomatic heart failure (NYHA class II-IV) and LVEF ≥40% measured within the past 12 months, who also received at least 30 days of diuretics before randomization. According to the latest data disclosed at the 2024 ESC, finerenone significantly reduced the risk of cardiovascular death and total HF events (defined as HF hospitalization or urgent HF visits), by 16% (RR 0.84 [95% CI, 0.74-0.95; p=0.0072]). Approximately half of the HF patients had mildly reduced or preserved LVEF. Finerenone is the first MRA to demonstrate clear cardiovascular benefits in this category of heart failure patients in a Phase III study. Based on these positive results, Bayer plans to discuss regulatory applications with the FDA to expand finerenone's indications. FIGARO-DKD:In August 2021, Bayer announced that finerenone achieved its primary endpoint in the Phase 3 clinical trial FIGARO-DKD, conducted among patients with type 2 diabetes and chronic kidney disease (CKD). Unlike previous Phase 3 trials, FIGARO-DKD primarily included patients with milder CKD classified as stages 1-2. In this study, finerenone reduced the risk of the first occurrence of cardiovascular death or non-fatal cardiovascular events by 13% in type 2 diabetes patients with CKD who were already receiving the maximum tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). FIDELIO-DKD:The FIDELIO-DKD study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase 3 clinical trial. It enrolled patients with type 2 diabetes and CKD (including 372 Chinese patients) who were randomly assigned in a 1:1 ratio to receive either finerenone or placebo once daily. According to the data prominently released at the American Society of Nephrology's Kidney Week in 2020, finerenone significantly reduced the risk of the composite renal endpoint by 18% compared to placebo (HR=0.82, 95% CI 0.73-0.93, P=0.001), and significantly reduced the risk of the composite cardiovascular endpoint by 14% (HR=0.86, 95% CI 0.75-0.99, P=0.03). Four months of treatment with finerenone led to a 31% reduction in the urine albumin-to-creatinine ratio from baseline, which remained consistently low, significantly reducing the secondary renal endpoint (HR=0.76; 95% CI 0.65-0.90). Additionally, multiple studies are underway to investigate the broader use of finerenone in heart failure and chronic kidney disease patients, including the MOONRAKER project and the FIND-CKD study. The MOONRAKER project encompasses four studies—FINEARTS-HF, REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF—involving over 15,000 patients. It is one of the largest heart failure research projects to date, aiming to evaluate the efficacy and safety of finerenone in a wide range of heart failure patients, including those with HFrEF, HFmrEF, HFpEF, and heart failure patients regardless of left ventricular ejection fraction. The FIND-CKD study is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial. It will include non-diabetic CKD patients from 270 centers across 19 countries, including China. The study aims to explore the efficacy and safety of finerenone as an add-on therapy to guideline-recommended treatments for non-diabetic chronic kidney disease. About Mineralocorticoid Receptor Antagonists:Mineralocorticoids are a class of steroid hormones secreted by the zona glomerulosa of the adrenal cortex, with aldosterone being the most common. Aldosterone secretion is regulated by various factors, mainly including the renin-angiotensin-aldosterone system (RAAS), as well as other influences such as adrenocorticotropic hormone, sodium (Na+), and potassium (K+) levels. When the concentration of Na+ in the tubular fluid decreases, blood pressure drops, or renal blood flow decreases, these factors stimulate the release of renin into the bloodstream, activating angiotensin II, which, in turn, stimulates the synthesis and secretion of aldosterone. Aldosterone enhances Na+-K+ exchange and increases membrane permeability to Na+, promoting the reabsorption of Na+ in the renal tubules, accompanied by increased water reabsorption, thereby maintaining water and electrolyte balance. However, excessive aldosterone release can cause metabolic disturbances, including hypokalemia and sodium/water retention. It also promotes the generation of inflammatory factors, leading to inflammation and fibrosis in target organs. Additionally, excessive aldosterone can over-activate the mineralocorticoid receptor (MR) and mediate pathological damage to target organs. Aldosterone binds to mineralocorticoid receptors (MR) to exert its effects. MR is widely distributed in multiple tissues, playing a significant role in local substance metabolism and the regulation of pathological injuries, with the most notable expression in the kidneys and cardiovascular system. Overactivation of MR promotes the generation of reactive oxygen species (ROS) and triggers the activation of pro-inflammatory transcription factors such as activator protein-1 (AP-1) and nuclear factor-kappa B (NF-κB), leading to inflammatory responses. Furthermore, MR overactivation participates in the expression of pro-fibrotic molecules, including transforming growth factor-β1 (TGF-β1) and plasminogen activator inhibitor-1 (PAI-1), which collectively promote tissue fibrosis. In addition to triggering inflammation and fibrosis, MR overactivation can activate the immune system, leading to leukocyte infiltration among other responses. In the kidneys, overactivation of MR exacerbates oxidative stress, inflammation, and fibrosis, inducing podocyte injury and constricting glomerular vessels, which leads to a gradual decline in renal function, ultimately progressing to end-stage renal disease (ESRD). In the heart, aldosterone-mediated MR overactivation induces similar inflammatory, fibrotic, and oxidative stress responses, eventually leading to adverse outcomes such as heart failure, malignant arrhythmias, and myocardial infarction. Therefore,Mineralocorticoid receptor antagonists (MRAs), as diuretics, help regulate water and electrolyte balance and are used to treat conditions such as primary aldosteronism, hypertension, heart failure (HF), and chronic kidney disease (CKD). Currently, the most commonly used MRA in clinical practice is spironolactone, which belongs to the steroid class. Due to its low selectivity for MR, its concentration in the kidneys is six times higher than in the heart, resulting in a high incidence of hyperkalemia when administered. Eplerenone, a second-generation MRA, also has a steroid structure but exhibits higher selectivity for MR, stronger anti-aldosterone activity than spironolactone, and fewer side effects. The third generation MRA, represented by non-steroidal finerenone, shows high selectivity for MR and balanced distribution in both the heart and kidneys, making it less likely to cause hyperkalemia. Regarding Diabetic NephropathyDiabetic nephropathy is one of the most significant complications of diabetes and a principal cause of chronic kidney disease and ESRD. Approximately one-third of diabetic patients develop diabetic nephropathy, and if coupled with substantial proteinuria, it progresses to ESRD within roughly five years. According to the International Diabetes Federation (IDF) data from 2021, around 537 million adults (age 20-79) worldwide had diabetes, constituting one-tenth of the adult population, and this number is projected to increase to 783 million by 2045, accounting for 12.2%. According to a report by Kenneth Research, the global market size for diabetic nephropathy treatment drugs was $2.7 billion in 2018. By 2024, the compound annual growth rate (CAGR) is expected to be maintained at 5.9%, reaching a market value of $3.8 billion. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. 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100 Deals associated with Eplerenone

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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
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
Chronic systolic heart failure	Phase 3	Czechia	Viatris, Inc.	01 Mar 2006
Chronic systolic heart failure	Phase 3	France	Viatris, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03683069 (CTgov)	Phase 4	Hypertension	90	Amlodipine+Eplerenone	pasdiqtoun(rxomaweuqy) = yahhyamxum hohwbrajum (ueumyxkxqm, 10.5) View more	-	19 Mar 2025
HEBRO (ESH2024)	Not Applicable	Obesity \| Hypertension	112	Eplerenone 25 mg	bxfcbfhgwa(assxaubqhj) = glqorcqxrb xbdynspmlk (gxhmcvoojh ) View more	Positive	01 May 2024
				Irbesartan 150 mg	bxfcbfhgwa(assxaubqhj) = sounvzghox xbdynspmlk (gxhmcvoojh ) View more
ESC2024	Not Applicable	Myocardial Ischemia \| Tachycardia, Ventricular	563	Eplerenone	tthlqrelfv(emeznosqsa): HR = 0.48, P-Value = 0.003	Positive	09 Apr 2024
				Spironolactone
NCT02740179 (MIRACLE HIV Study, Pubmed \| Clin Infect Dis)	Not Applicable	HIV Infections	40	Eplerenone 50 mg PO BID	dtxzqddclk(lzeaiylvbh) = goqhvapmbp pspkgchmwr (qqpllkcazy, -38 to 286) View more	Positive	13 Oct 2023
				Placebo	adjblnpzki(nwsbtwechm) = rxpollswwq ntiyhuwavd (vfgblvypwm, -2.2 to −0.1) View more
EURETINA2023	Not Applicable	Central Serous Chorioretinopathy	-	Oral Eplerenone 50mg/day	rpgxwinrpb(ybidfjfkce) = ixncfmdqqr gfhnuupotk (xkjrryksef ) View more	-	05 Oct 2023
				Oral eplerenone (Observation)	rpgxwinrpb(ybidfjfkce) = yynjzqpofb gfhnuupotk (xkjrryksef ) View more
SPECTRA (EURETINA2023)	Phase 3	Central Serous Chorioretinopathy	96	Half-dose photodynamic therapy (PDT)	kjbdjbaole(tofqmmdlib) = pwkbhucfca hrvgxwlaez (bxztwmqmca )	Positive	05 Oct 2023
				Oral eplerenone treatment	kjbdjbaole(tofqmmdlib) = vxdfyminbh hrvgxwlaez (bxztwmqmca )
EURETINA2023	Not Applicable	Central Serous Chorioretinopathy	-	Eplerenone	seoxmyvoru(jwqvwmlalt) = ulsjqntvia aqxjzxhnwg (qbzdszyivo )	-	05 Oct 2023
NCT00232180 (EMPHASIS-HF, Pubmed \| J Am Coll Cardiol)	Phase 3	Chronic systolic heart failure	-	Eplerenone	nutxbqwysy(qysbeegcvc) = fhbgjyizaz typpfrxtpd (dwuwitmzet, 8.4 - 11.4)	Positive	12 Sep 2023
NCT02740179 (MIRACLE HIV Study, CTgov)	Not Applicable	Cardiovascular Diseases \| HIV Infections	40	Lifestyle Modification+Eplerenone (Eplerenone)	tlazgemyxp(uthazvpwcs) = kucvvdiite lzxeshvhtc (orohlmocok, 0.64) View more	-	02 Jun 2023
				Placebo (Placebo)	tlazgemyxp(uthazvpwcs) = ifsxcqcbcb lzxeshvhtc (orohlmocok, 0.48) View more
HEBRO STUDY (ESH2023)	Not Applicable	Obesity \| Hypertension	80	Eplerenone 25mg twice daily	ysxskqbuuf(wssyvzlisj) = zfigvewmni mfqthyhmxv (hkyrracdiz ) View more	-	01 Jun 2023
				Irbesartan 150mg once daily	ysxskqbuuf(wssyvzlisj) = odsdsldynn mfqthyhmxv (hkyrracdiz ) View more

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