Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trial

Start Date05 Jul 2024

Sponsor / Collaborator

Medical University of Vienna

100 Clinical Results associated with Levosimendan

100 Translational Medicine associated with Levosimendan

100 Patents (Medical) associated with Levosimendan

2,208

Literatures (Medical) associated with Levosimendan

01 May 2025·Current Vascular Pharmacology

The Early Pharmacological Strategy with Inodilator, bEta-blockers, Mineralocorticoid Receptor Antagonists, Sodium-glucose coTransporter-2 Inhibitors and Angiotensin Receptor-neprylisin Inhibitors in Acute Heart Failure (PENTA-HF)

Article

Author: Marek-Iannucci, Stefanie ; Filomena, Domenico ; Myftari, Vincenzo ; Maestrini, Viviana ; D'Amato, Andrea ; Manzi, Giovanna ; Labbro Francia, Aurora ; Cestiè, Claudia ; Severino, Paolo ; Badagliacca, Roberto ; Fedele, Francesco ; Vizza, Carmine Dario ; Mariani, Marco Valerio ; Mancone, Massimo ; Prosperi, Silvia

Purpose:The management of acute heart failure (AHF) is crucial and challenging. Regarding the use of inotropes, correct patient selection and time of administration are of the essence. We hypothesize that the early use of Levosimendan favouring hemodynamic stabilization and enables rapid optimization of guideline-directed medical therapy (GDMT) in patients with HF, eventually impacting the patient’s prognosis during the vulnerable phase.Methods:This prospective, observational study enrolled consecutive patients admitted due to AHF. Propensity score matching (PSM) analysis has been used to homogenize differences between groups. In group 1 (G1), patients were treated with early 24-h Levosimendan infusion followed by in-hospital introduction/up-titration of GDMT. In group 2 (G2), patients were treated with alternative inotropes/ vasopressors followed by in-hospital introduction/up-titration of GDMT. The comparison between the two groups has been performed at the 6-month follow-up in terms of cardiovascular (CV) mortality and HF hospitalizations (HFH).Results:233 patients were included in the present study, and after propensity match adjustments, 176 patients were analysed, 88 patients for each group. No differences in the baseline characteristics have been reported between the groups. At 6 months follow-up, no statistically significant differences were shown in terms of the composite endpoint of CV death and HFH (p = 0.445) and CV death (p = 0.62). Statistically significant differences between the two groups were reported in terms of HFH (p = 0.02). The Kaplan-Meier survival analysis showed that patients in G1 were significantly less hospitalized compared to G2 during the 6 months after the index hospitalization (log-rank p = 0.03).Conclusions:Early 24-hour infusion of Levosimendan followed by rapid optimization of HF diseasemodifying therapies results in a significant reduction of HFH in the vulnerable post-discharge phase.

01 Apr 2025·Journal of Critical Care

Effect of pulmonary artery catheter, type & combination of vasoactives for optimizing lactate clearance in acute myocardial infarction complicated by cardiogenic shock

Article

Author: Valdespino Trejo, Adrian Aquiles ; Manzur-Sandoval, Daniel ; Montañez-Orozco, Álvaro ; Arias-Mendoza, Alexandra ; García-Ruiz, Mauricio ; Araiza-Garaygordobil, Diego ; Ortega-Hernández, Jorge A ; Baeza-Herrera, Luis Augusto ; Sierra-Lara-Martínez, Daniel ; Mendoza-García, Salvador ; Hernández-Montfort, Jaime ; Arzate-Ramírez, Arturo ; Gopar-Nieto, Rodrigo ; Altamirano-Castillo, Alfredo ; González-Pacheco, Héctor

INTRODUCTIONLactate clearance(LC) is critical in managing critically ill patients. We hypothesized that treatment allocation with different vasoactive drugs or the presence of a pulmonary artery catheter (PAC) could affect the behavior of lactate dynamics and, ultimately, the mortality in AMI-CS.MATERIALS AND METHODSIn 651 patients with AMI-CS, we examined the relationship of LC time with clinical, laboratory, and CS-management variables. Complete LC time was defined as serum lactate levels less than <2 mmol/L. We explore the impact of vasoactive drugs and PAC with LC. The CART method defined the vasoactive combinations (permutations) in relation with early (<96 h) complete LC.RESULTSPAC presence correlated with faster LC (-17.54 h) and was independently associated with lower mortality (HR = 0.61). Levosimendan and dobutamine were associated with lower lactate levels and faster LC (-8.82 & -8.77 h), while vasopressin was linked to slower LC (9.16 h). Slow LC (>96 h) was associated with increased mortality. CART analysis identified specific vasoactive drug combinations associated lactate clearance and mortality, without dobutamine, with vasopressin having higher mortality (80.6 %, HR = 5.53), and with dobutamine, with norepinephrine, without vasopressin, with levosimendan the lowest (35 %) and higher complete LC and a trend for higher %LC.CONCLUSIONThe right combination of vasoactive medications and the probable use of a PAC could significantly impact the achievement of complete LC in <96 h. The findings support the need for further research and the development of strategies to optimize lactate clearance and improve overall patient survival in this high-risk population.

01 Mar 2025·Asian Journal of Surgery

Levosimendan for patients with heart failure after aortic valve replacement

Letter

Author: Song, Yanyan ; Wang, Yun ; Ji, Yanxia ; Han, Chao

News (Medical) associated with Levosimendan

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

22 Jan 2025

·www.globenewswire.com

Tenax Therapeutics Appoints Gillian Andor Vice President, Clinical Operations

CHAPEL HILL, N.C., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the appointment of Gillian Andor, MSc, as Vice President, Clinical Operations. Ms. Andor will lead the Company’s expanding Clinical Operations function in support of the ongoing Phase 3 program evaluating oral levosimendan (TNX-103) for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). “We are pleased to welcome Gillian to the Tenax team at a critical time for our Company, as we continue to enroll patients in the Phase 3 LEVEL study and finalize plans to initiate our second pivotal study,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We believe Gillian’s significant experience executing clinical development programs resulting in NDA submissions and approvals will help us accelerate our Phase 3 program, and ensure we are prepared for global regulatory filings.” Ms. Andor has over 20 years of experience in Clinical Operations. She served most recently as Interim Head, Clinical Development Operations with Noema Pharma, focused on CNS disorders, where she led Clinical Operations and Data Management functions. Prior, she served as Head of Portfolio Operations for Sage Therapeutics, achieving multiple promotions during her nine-year tenure and building a high-functioning Clinical Operations department. Ms. Andor led and supervised the global clinical development programs across Sage’s portfolio in neurology and CNS disorders including successful NDA submissions and approvals for Zulresso® and Zurzuvae®, the first approved medications for postpartum depression. Prior to joining Sage, Ms. Andor held multiple positions within Clinical Operations for Ironwood Pharmaceuticals where she successfully planned, managed, and executed U.S. and European clinical studies in GI disorders, most notably contributing to the NDA and approval of Linzess® for IBS-C. Ms. Andor received a BSc Anatomy (Honors) from the University of Glasgow, where she finished with first class honors, and an MSc in Forensic Science from the University of Strathclyde. Tenax Therapeutics also announced the issuance on January 21, 2025 of an inducement equity award to Ms. Andor in connection with her appointment to the position of Vice President, Clinical Operations of the Company effective the same day. The award consists of an option to purchase 250,000 shares of the Company’s common stock. The award will vest in four equal annual installments beginning on the first anniversary of the date of issuance, subject to Ms. Andor’s continued employment with the Company through each applicable vesting date. The exercise price for the option is $6.44. The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4). About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. 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: our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks related to our business strategy, including the prioritization and development of product candidates; 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; 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 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. Contacts Investor Contact:John FrauncesManaging DirectorLifeSci Advisors, LLCC: 917-355-2395jfraunces@lifesciadvisors.com or Brian MullenLifeSci Advisors, LLCC: 203-461-1175bmullen@lifesciadvisors.com

Phase 3Executive ChangeNDA

100 Deals associated with Levosimendan

External Link

KEGG	Wiki	ATC	Drug Bank
D04720	Levosimendan	C01CX08	DB00922

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Heart Failure	Argentina	AbbVie AS	20 Jul 2002
Acute decompensated heart failure	Sweden	Orion Corp.	10 Apr 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Shock	Phase 2	Australia	Abbott Laboratories	01 Oct 2004
Shock, Cardiogenic	Phase 2	Australia	Abbott Laboratories	01 Oct 2004
Shock, Septic	Phase 2	Australia	Abbott Laboratories	01 Oct 2004
Acute decompensated heart failure	Phase 2	United States	Abbott Laboratories	01 Mar 2003
Decompensated chronic heart failure	Phase 2	Israel	Abbott Laboratories	01 Sep 2002
Decompensated chronic heart failure	Phase 2	United States	Abbott Laboratories	01 Sep 2002
Decompensated chronic heart failure	Phase 2	Australia	Abbott Laboratories	01 Sep 2002
Decompensated chronic heart failure	Phase 2	Canada	Abbott Laboratories	01 Sep 2002
Heart Failure	Preclinical	United States	Abbott Laboratories	01 May 2005
Myocardial Infarction	Preclinical	United States	Abbott Laboratories	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	-	349	Levosimendan + dobutamine	kmqpddhfax(dvlwkgkxuu) = hyvrtilbcf botbgrrhbv (vltcjhqhoo )	Positive	02 Sep 2024
				Dobutamine alone	kmqpddhfax(dvlwkgkxuu) = nlbpitkjko botbgrrhbv (vltcjhqhoo )
ESC2024	Not Applicable	Non-St Elevated Myocardial Infarction	-	Levosimendan	(yvylnqrrbs): aHR = 0.573 (95% CI, 0.466 - 0.704), P-Value = < 0.001 View more	-	01 Sep 2024
				Non-Levosimendan
NCT03541603 (HELP, CTgov)	Phase 2	Heart failure with normal ejection fraction \| Secondary malignant neoplasm of lung \| Heart failure with reduced ejection fraction \| Hypertension, Pulmonary	44	Levosimendan (Levosimendan 2.5mg/mL Injectable Solution)	ubbthcdffv(lryhfxhzre) = mifwmmfqmk nbmolhleur (pymapirvpw, kczmzfpgpo - agdreyacru) View more	-	14 May 2024
				Matching Placebo (Matching Placebo)	ubbthcdffv(lryhfxhzre) = ivdwxsetzm nbmolhleur (pymapirvpw, hyrkqicnqf - mdqmfbsham) View more
ESC2024	Not Applicable	Acute decompensated heart failure HFrEF \| LV \| OT ... View more	58	levosimendan (Ischemic HFrEF)	yupnbafnqz(rjashofjaz) = wzcgbzipwz wevkevhvhq (fnjeljwwke ) View more	Positive	13 May 2024
				levosimendan (Non-ischemic HFrEF)	yupnbafnqz(rjashofjaz) = bmvaimvope wevkevhvhq (fnjeljwwke ) View more
ESC2024	Not Applicable	Heart Failure	-	Levosimendan	cmqsokyarj(zbrdkcarja) = 1 patient (3.8%) czhkgedscw (chlwpsonhe ) View more	-	12 May 2024
NCT02232399 (MiLe-1, CTgov)	Phase 2	Acute Kidney Injury \| Heart Defects, Congenital	72	Milrinone (Milrinone)	bvxpnbefdb(mfhqhagkdk) = xbxzwovmtf hisgstwdbe (luysmvjrqp, tsbfebjslm - lqkpnkjems) View more	-	26 Mar 2024
				Levosimendan (Levosimendan)	bvxpnbefdb(mfhqhagkdk) = nbmhznsckk hisgstwdbe (luysmvjrqp, ziwiwmhocq - roztpbxzqe) View more
ESC2024	Not Applicable	-	-	Levosimendan infusion	wcgafzdbeg(bszimbumnm) = bgzxpsplur ofwwjnewew (kczhbodyyr ) View more	-	08 Mar 2024
ESC2023	Not Applicable	Heart Failure	49	Levosimendan	(bzuqwxlrwv) = mknqdrjkts kekqvfsuho (hnramcguck ) View more	-	22 May 2023
ESC2023	Not Applicable	Acute Coronary Syndrome	2,881	Levosimendan	(znsoilgnqc) = brusjntpps jbzmpvyllp (lvtagneqtn ) View more	-	24 Mar 2023
				Dobutamine	(znsoilgnqc) = tssztcggst jbzmpvyllp (lvtagneqtn ) View more
NCT03948178 (REFALS-ES, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	227	Levosimendan	rywibrimyp(mdcfkonnvr) = gauvytdgfe zyvkntymfj (rhxmbcnwyi, olvgmpiwzj - qqvddtmebv) View more	-	09 Mar 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis