Comparison Of Efficacy Of Levosimendan Versus Milrinone In Catecholamine Resistant Septic Shock With Myocardial Dysfunction In Children : A Single-Center, Open-Label Randomized controlled Trial - Nil

Start Date31 Mar 2025

Sponsor / Collaborator-

NCT06478667

/ CompletedPhase 3IIT

The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity: A Randomized Controlled Trial

To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

Start Date20 Dec 2024

Sponsor / Collaborator

Ain Shams University

ChiCTR2400091067

/ SuspendedNot ApplicableIIT

Clinical analysis of Levosimendan associated arrhythmia in Heart Failure patients

Start Date21 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Levosimendan

100 Translational Medicine associated with Levosimendan

100 Patents (Medical) associated with Levosimendan

2,181

Literatures (Medical) associated with Levosimendan

01 Aug 2025·JOURNAL OF SURGICAL RESEARCH

Effects of Levosimendan on Anastomotic Healing in an Ischemic Colon Anastomosis Model

Article

Author: Köktürk, Fürüzan ; Karakaya, Kemal ; Güven, Berrak ; Seven, Turan Eray ; Baş, Yilmaz

INTRODUCTION:

Anastomotic leakage following ischemic colon anastomosis poses significant morbidity and cost. Levosimendan, with inotropic and vasodilatory properties, may enhance healing. This study evaluated Levosimendan's effects on ischemic colon anastomosis in rats.

METHODS:

Sixty Wistar Albino rats underwent ischemic colon anastomosis and were randomized into six groups: fourth-day control, seventh-day control, fourth-day low-dose Levosimendan, seventh-day low-dose Levosimendan, fourth-day high-dose Levosimendan, and seventh-day high-dose Levosimendan. Anastomotic bursting pressure, myeloperoxidase, hydroxyproline levels, and histopathological changes were assessed.

RESULTS:

Levosimendan, particularly at low doses, significantly increased bursting pressure. The fourth-day low-dose group showed a median (Q1-Q3) bursting pressure of 98.00 (72.00-106.00) mmHg, compared to 53.00 (24.75-64.75) mmHg in the fourth-day control group (P = 0.001). The seventh-day low-dose group had a median (Q1-Q3) bursting pressure of 111.50 (96.50-154.00) mmHg, while the seventh-day control group had 91.00 (59.00-100.50) mmHg (P = 0.007). Histopathology revealed significant improvements in fibrosis (P = 0.020), ischemic necrosis (P < 0.001), and inflammatory cell infiltration in Levosimendan groups. Myeloperoxidase levels were significantly higher in the fourth-day low-dose group compared to the fourth-day control group (P = 0.041), while hydroxyproline levels showed no significant differences.

CONCLUSIONS:

Levosimendan positively impacts ischemic colon anastomosis healing in rats, particularly at low doses.

01 Aug 2025·EUROPEAN JOURNAL OF CLINICAL INVESTIGATION

Afterload mismatch after transcatheter edge‐to‐edge repair in functional mitral regurgitation: A propensity‐score matched analysis

Article

Author: Boretto, Paolo ; Montonati, Carolina ; Frea, Simone ; Crimi, Gabriele ; Cavallone, Elena ; De Ferrari, Gaetano Maria ; D'Ascenzo, Fabrizio ; Giannini, Francesco ; Biasco, Luigi ; Raineri, Claudia ; De Filippo, Ovidio ; Pedrazzini, Giovanni ; Reimers, Bernhard ; Bocchino, Pier Paolo ; Mangieri, Antonio ; Giovannini, Davide ; Angelini, Filippo ; Dusi, Veronica ; Pavon, Anna Giulia ; Tarantini, Giuseppe ; Gallone, Guglielmo ; Pidello, Stefano ; Mandurino Mirizzi, Alessandro

Abstract:

Background:

Transcatheter edge‐to‐edge repair (TEER) for severe functional mitral regurgitation (FMR) in patients with reduced left ventricular ejection fraction (LVEF) may lead to an acute increase in left ventricular afterload, termed afterload mismatch (AM). This study aimed to redefine AM clinically, analyse its determinants, and assess its prognostic impact post‐TEER in FMR patients.

Methods:

A multicenter case–control study was conducted, involving FMR patients with LVEF ≤35% undergoing TEER. AM post‐TEER was defined as the acute (within 24 h) need for escalation of inotropic or mechanical circulatory support. Sixty‐eight AM cases were compared with 68 propensity‐matched patients. Primary endpoints included in‐hospital mortality post‐TEER and 2‐year all‐cause mortality.

Results:

Median age was 68 years, 76% male. Procedural success was achieved in 92% of patients. Proportionate MR was associated with a higher risk of AM (adj‐HR 1.6, 95% CI 1.01–2.6, p = .04). Conversely, pretreatment with levosimendan (adj‐HR .29, 95% CI .12–.70, p < .01) and higher furosemide dose (adj‐HR per furosemide 10 mg increase .86, 95% CI .76–.98, p = .03) were protective. In‐hospital mortality was higher in the AM cohort (10% vs. 2%, p = .03), while 2‐year mortality rates were similar (34% vs. 20%, p = .09). Multivariable analysis revealed higher AM grades and post‐procedural MR as predictors of in‐hospital mortality and lack of procedural success for 2‐year mortality.

Conclusions:

Among patients with LVEF ≤35% and severe FMR undergoing TEER, AM was associated with in‐hospital mortality but did not impact long‐term outcomes. Proportionate MR increased the risk of AM, while pretreatment with levosimendan and higher furosemide doses was protective.

01 Aug 2025·INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

Serum potassium is a critical risk factor for cardiac arrhythmias in acute heart failure patients treated with levosimendan: A retrospective study in a cohort of 250 patients

Article

Author: Liu, Wenguang ; Wang, Xiaowu ; Wu, Dong ; Ning, Bin ; Ma, Zhen

OBJECTIVES:

This study aimed to investigate the risk factors associated with developing cardiac arrhythmias in patients with acute heart failure treated with levosimendan.

MATERIALS AND METHODS:

A retrospective analysis was conducted in patients diagnosed with acute heart failure or acute exacerbation of chronic heart failure treated with levosimendan. The patients were divided into arrhythmia and non-arrhythmia groups based on the presence of rapid-type arrhythmias. Logistic regression analysis was used to identify independent risk factors for levosimendan-induced arrhythmias.

RESULTS:

Among the 250 patients, 49 (19.60%) experienced nine types of cardiac arrhythmias, the most common being atrial fibrillation (28.57%). The highest incidence of arrhythmias occurred within 48 hours of levosimendan infusion (77.6%). Multivariate analysis indicated that the lowest serum potassium concentration within 5 days after drug administration (odds ratio (OR) 0.410, p = 0.010, 95% confidence interval (CI) 0.209 - 0.805), micro-pump speed of > 0.2 μg/kg/min (OR 3.106, p = 0.039, 95% CI 1.584 - 11.789), and concomitant use of drugs that prolong the QT interval (OR 4.226, p = 0.001, 95% CI 1.850 - 9.657) were independent risk factors for levosimendan-induced arrhythmias. The incidence of arrhythmias increased when the lowest serum potassium concentration within 5 days after drug administration was below 3.94 mmol/L.

CONCLUSION:

This study identified risk factors associated with levosimendan-induced arrhythmias. Clinicians should monitor at-risk patients when administering levosimendan. When using levosimendan in clinical practice, it is necessary to maintain a serum potassium concentration above 3.94 mmol/L.

News (Medical) associated with Levosimendan

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

05 Mar 2025

·www.drugs.com

Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF

CHAPEL HILL, N.C., March 05, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced the U.S. Food and Drug Administration (FDA) has completed their review of Tenax Therapeutics’ updated Phase 3 development plan for TNX-103 (oral levosimendan), including an Amendment to expand enrolment and increase the power of the ongoing Phase 3 LEVEL study, and the protocol for LEVEL-2, Tenax Therapeutics’ second registrational Phase 3 study. The Company today announced it expects to enroll 230 patients in the LEVEL study, increasing the statistical powering of the study to over 95%. LEVEL-2, a global study, is expected to commence in 2025. “We are increasing our investment in the clinical development plan for TNX-103 by expanding the ongoing LEVEL study and accelerating our plans to initiate the second registrational study, LEVEL-2. With the momentum provided from our $100 million financing in August 2024 and alignment with the FDA, we are now able to execute on our plan to advance these two Phase 3 registrational studies for TNX-103 in parallel. LEVEL is enrolling well: we are confident that, with more than 50 North American sites already activated, we can complete enrollment of this upsized study around year end, while also commencing the global LEVEL-2 study later this year,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We expect these two registrational studies will satisfy the requirements, including the safety data expectations, to file in the U.S. and other geographies. We are funded well beyond our projected date for the release of topline LEVEL data, positioning us to advance the development of TNX-103 and improve the quality of life for patients living with PH-HFpEF.” LEVEL Study Expansion Enhances Statistical Power The LEVEL study, evaluating TNX-103 for the treatment of PH-HFpEF, will expand enrollment from 152 to at least 230 patients, increasing the statistical powering of the study. The Company is on track to enroll the first 150 subjects in the first half of 2025, expects to complete enrollment by around the end of 2025, and expects to present topline data from the LEVEL study in the middle of 2026. As of late February 2025, blinded LEVEL data reveal TNX-103 to be well-tolerated in patients with PH-HFpEF: Tenax Therapeutics’ Chief Medical Officer, Stuart Rich, MD, summarized: “In addition to high rates of study and therapy continuation, the adherence to the TID regimen has been high, and no new safety signals have been detected. About half the patients in the OLE have been on study for over 6 months, a few of them for more than a year, with very reassuring participation levels observed during the OLE.” LEVEL-2: A Global Registrational Trial Additionally, Tenax Therapeutics received input from the FDA on the protocol for the LEVEL-2 study, and expects this second, global registrational clinical trial to evaluate levosimendan in patients with PH-HFpEF to start enrolling this year, in several countries. The primary endpoint of 6MWD will be assessed at 26 weeks. Tenax intends to enroll a larger sample than LEVEL and evaluate patients for a full year of double-blind, placebo-controlled therapy, providing FDA and European reviewers a robust safety database for their benefit/risk assessments. “TNX-103 has the potential to meaningfully improve the quality of life of patients with PH-HFpEF, an underdiagnosed disease with significant unmet needs and no currently approved treatment options. I remain very hopeful that with positive Phase 3 results, these patients will finally have an approved treatment available,” said Dr. Rich. “We are continuing to work closely with the FDA, and are grateful for their input, which enables Tenax to accelerate development timelines of a potential first therapy for this devastating form of PH.” About the Phase 3 LEVEL Study ( NCT05983250 ) The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan (2 mg/day) or placebo for Weeks 1 to 4 and 3 mg/day or placebo for Weeks 5 to 12. The primary outcome measure for the study is change in six-minute walk distance from Baseline to Week 12. All randomized subjects will have the option to enter the 92-week OLE following the completion of all study endpoints at Week 12. About the Phase 3 LEVEL-2 Study LEVEL-2 is a global Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. Patients will be randomized to receive an oral dose of levosimendan (2mg/day) or placebo for Weeks 1 to 4 and 3mg/day or placebo from Week 5 onward. The primary endpoint of 6MWD will be assessed at 26 weeks. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action, and that is being developed as an oral therapy (TNX-103) for pulmonary hypertension (PH) with heart failure with preserved ejection fraction (PH-HFpEF). Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan has been granted market authorization in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Results of Tenax Therapeutics’ Phase 2 HELP study of levosimendan in patients with HFpEF demonstrated that IV levosimendan (TNX-101) produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that is the basis of LEVEL, the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has demonstrated improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022). About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; risks associated with our cash needs; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Source: Tenax Therapeutics, Inc. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 3Phase 2

22 Jan 2025

·www.prnewswire.com

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, 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

Phase 3Drug ApprovalLicense out/in

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KEGG	Wiki	ATC	Drug Bank
D04720	Levosimendan	C01CX08	DB00922

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	Argentina	AbbVie AS	20 Jul 2002
Acute decompensated heart failure	Austria	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Cyprus	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Finland	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Greece	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Iceland	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Italy	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Norway	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Portugal	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Spain	Orion Oyj	10 Apr 2001
Acute decompensated heart failure	Sweden	Orion Oyj	10 Apr 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart failure with normal ejection fraction	Phase 3	United States	Medpace, Inc.	10 Jan 2024
Heart failure with normal ejection fraction	Phase 3	United States	Tenax Therapeutics, Inc.	10 Jan 2024
Heart failure with normal ejection fraction	Phase 3	Canada	Medpace, Inc.	10 Jan 2024
Heart failure with normal ejection fraction	Phase 3	Canada	Tenax Therapeutics, Inc.	10 Jan 2024
Heart failure with reduced ejection fraction	Phase 3	United States	Medpace, Inc.	10 Jan 2024
Heart failure with reduced ejection fraction	Phase 3	United States	Tenax Therapeutics, Inc.	10 Jan 2024
Heart failure with reduced ejection fraction	Phase 3	Canada	Medpace, Inc.	10 Jan 2024
Heart failure with reduced ejection fraction	Phase 3	Canada	Tenax Therapeutics, Inc.	10 Jan 2024
Hypertension, Pulmonary	Phase 3	United States	Medpace, Inc.	10 Jan 2024
Hypertension, Pulmonary	Phase 3	United States	Tenax Therapeutics, Inc.	10 Jan 2024

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	Shock, Cardiogenic	349	Levosimendan + dobutamine	nlshwpgxih(ebkmhzajyu) = maygbgkfww nonchwbiwo (skavhncesv )	Positive	02 Sep 2024
				Dobutamine alone	nlshwpgxih(ebkmhzajyu) = paiobhhbzl nonchwbiwo (skavhncesv )
NCT03541603 (HELP, CTgov)	Phase 2	Heart failure with normal ejection fraction \| Secondary malignant neoplasm of lung \| Heart failure with reduced ejection fraction ... View more	44	Levosimendan (Levosimendan 2.5mg/mL Injectable Solution)	arxisvumqv(vhcsnddtch) = ivajkalflj xqdvtjqfcj (wydkienvkf, 10.07) View more	-	14 May 2024
				Matching Placebo (Matching Placebo)	arxisvumqv(vhcsnddtch) = inqfmgkcxy xqdvtjqfcj (wydkienvkf, 7.87) View more
ESC2024	Not Applicable	Heart Failure	-	Levosimendan intermittent infusions	cqbplwgzdf(xobxuvnydn) = xfvjqhmsym nepsttgzor (gsufdlbyxa, 8)	-	13 May 2024
ESC2024	Not Applicable	-	-	Intermittent levosimendan infusion every 2 weeks	catpgysrlh(vtvuxhfuob) = bvxvkxyqwa vjuubnmemx (tquvvjvvmu ) View more	-	13 May 2024
ESC2024	Not Applicable	Heart Failure	-	Levosimendan	xtpeauxkds(xuumedcobz) = 1 patient (3.8%) lxurvedgky (ozljjbpdpv ) View more	-	12 May 2024
NCT02232399 (MiLe-1, CTgov)	Phase 2	Atrioventricular Septal Defect \| Acute Kidney Injury \| Heart Defects, Congenital ... View more	72	Milrinone (Milrinone)	uphxssowcd(cviosbxdba) = nfxtgfoyjc tiwtzdvblk (fdjhcurkdh, 6.1) View more	-	26 Mar 2024
				Levosimendan (Levosimendan)	uphxssowcd(cviosbxdba) = zukpxehlud tiwtzdvblk (fdjhcurkdh, 5.9) View more
ESC2023	Not Applicable	Heart failure with normal ejection fraction	195	Intermittent and scheduled levosimendan	pkutvkwkat(anotqefeof) = gflzsuqwmj xsjtcfxucr (alkojnjddc ) View more	Positive	21 May 2023
NCT03948178 (REFALS-ES, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	227	Levosimendan	dzobdnstld = thjqidfjrs iqscypbvqq (vbryhetkvd, djesklguel - wmhbwcqwet) View more	-	09 Mar 2023
NCT03505021 \| NCT03948178 (REFALS, Pubmed) Manual	Phase 3	Amyotrophic Lateral Sclerosis	496	levosimendan	wnooiejmbo(lyonmetwek) = tgqsrcxhwt jhlkwbscha (nkveynymxe ) View more	Negative	01 Oct 2021
				Placebo	wnooiejmbo(lyonmetwek) = fnqwxazaty jhlkwbscha (nkveynymxe ) View more
NCT03505021 (REFALS, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	496	Levosimendan (Levosimendan)	aiaprzlmlm(zapqbrfvql) = xgewbntvlw rfshdaaptu (poyfrydysh, nrihlbihiz - hyamgwmbwy) View more	-	31 Aug 2021
				Placebo for levosimendan (Placebo for Levosimendan)	aiaprzlmlm(zapqbrfvql) = agcuqmanhd rfshdaaptu (poyfrydysh, ynbwrjiwef - tcsnfvlzhz) View more

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