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Globe and Mail
12-03-2025
- Health
- Globe and Mail
Tisento Therapeutics, Tricida, Advicenne Pharma, expected to boost the market
The Metabolic Acidosis market growth is driven by factors like increase in the prevalence of Metabolic Acidosis, investments in research and development, entry of emerging therapies during the study period 2020-2034. The Metabolic Acidosis market report also offers comprehensive insights into the Metabolic Acidosis market size, share, Metabolic Acidosis epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Metabolic Acidosis market size growth forward. Some of the key highlights from the Metabolic Acidosis Market Insights Report: In February 2025, Milla Pharmaceuticals, via its U.S. subsidiary, obtained FDA approval for a generic formulation of Hospira's THAM Solution Tromethamine Injection 18GM/500ml, designed for the prevention and treatment of metabolic acidosis. In 2023, the U.S. market for metabolic acidosis therapies was valued at approximately USD 117.6 million, accounting for around 70% of the total market across the seven major markets (7MM). Metabolic acidosis is a condition marked by a drop in blood pH due to excess acid accumulation or a loss of bicarbonate, disrupting the body's acid-base balance. It can arise from various underlying conditions, including kidney failure, diabetic ketoacidosis, lactic acidosis, and prolonged diarrhea, which depletes bicarbonate levels. Across the 7MM, there were about 1.7 million diagnosed cases of metabolic acidosis in 2023. In the United States, approximately 850,000 of these cases were linked to chronic kidney disease (CKD) stages 3 to 5, while the rest were associated with diagnosed cases of distal renal tubular acidosis (dRTA), both inherited and acquired. Males accounted for nearly 55% of all metabolic acidosis cases, a trend attributed to the higher prevalence of underlying conditions such as CKD and diabetes in men, both of which are major contributors to the disease. In 2023, treated cases of dRTA, both inherited and acquired, made up less than 1.5% of all treated metabolic acidosis cases in the U.S. This is largely due to the rarity of dRTA as a cause of metabolic acidosis, especially in comparison to more common conditions like diabetic ketoacidosis and lactic acidosis. Currently, no drugs have received direct FDA approval specifically for metabolic acidosis. However, several medications are available to manage its symptoms and underlying causes, offering indirect treatment options for patients. The metabolic acidosis treatment pipeline remains limited, with only a few companies actively advancing drug candidates through clinical trials. One notable therapy in development is Zagociguat by Tisento Therapeutics, which is currently in Phase II trials. Several key pharmaceutical companies, including Tisento Therapeutics, Tricida, Advicenne Pharma, and others, are developing novel products to improve the Metabolic Acidosis treatment outlook. Metabolic Acidosis therapies are Zagociguat, and others. As per DelveInsight analysis, the Metabolic Acidosis market is anticipated to witness growth at a considerable CAGR Strategise your business goals by understanding market dynamics @ Metabolic Acidosis Market Landscape Metabolic Acidosis Overview Metabolic acidosis is a condition in which blood pH decreases due to an excess accumulation of acid or a loss of bicarbonate, disrupting the body's acid-base balance. This imbalance can arise from various causes, such as kidney failure, diabetic ketoacidosis, lactic acidosis, or prolonged diarrhea, which depletes bicarbonate reserves. When metabolic acidosis develops, the body's buffering mechanisms become overwhelmed, leading to a drop in blood pH below the normal range (7.35-7.45), creating a more acidic environment. It is classified into high anion gap acidosis or normal anion gap acidosis, depending on the underlying cause and biochemical markers. Diagnosis starts with clinical suspicion, particularly in individuals with conditions like kidney disease, diabetes, or significant fluid loss. Blood tests are crucial for confirming the diagnosis, with an arterial blood gas (ABG) test measuring pH, partial pressure of carbon dioxide (PaCO2), and bicarbonate (HCO3-) levels. The anion gap, derived from serum electrolyte levels (Na+, Cl-, HCO3-), helps identify the cause of acidosis. A high anion gap indicates the presence of unmeasured anions, commonly associated with conditions such as diabetic ketoacidosis or lactic acidosis, while a normal anion gap suggests bicarbonate loss, as seen in cases like diarrhea or renal tubular acidosis. Do you know the treatment paradigms for different countries? Download our Metabolic Acidosis Market Sample Report Metabolic Acidosis Epidemiology Insights In 2023, an estimated 1.7 million cases of metabolic acidosis were identified across the seven major markets (7MM). Among these, approximately 850,000 cases in the United States were associated with metabolic acidosis in individuals with chronic kidney disease (CKD) stages 3 to 5. The remaining cases were linked to diagnosed instances of distal renal tubular acidosis (dRTA), including both inherited and acquired forms. Metabolic Acidosis Epidemiology Segmentation DelveInsight's Metabolic Acidosis market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Metabolic Acidosis historical patient pools and forecasted Metabolic Acidosis patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Metabolic Acidosis Market report proffers epidemiological analysis for the study period 2020-34 in the 7MM segmented into: Metabolic Acidosis Prevalence Age-Specific Metabolic Acidosis Prevalence Gender-Specific Metabolic Acidosis Prevalence Diagnosed and Treatable Cases of Metabolic Acidosis Visit for more @ Metabolic Acidosis Epidemiological Insights Metabolic Acidosis Market Outlook The metabolic acidosis market varies across major global regions, influenced by differences in demand and healthcare infrastructure. In 2023, the market for metabolic acidosis treatments showed notable differences in size and growth potential among the seven major markets (7MM). The United States dominated the market, reaching approximately USD 117.6 million, while European countries, including Germany, France, Italy, Spain, and the UK, displayed varying market sizes. In 2023, the U.S. market for metabolic acidosis treatments reached around USD 117.6 million, accounting for approximately 70% of the total market across the seven major markets (7MM). This dominant share highlights the United States as the leading market, driven by its advanced healthcare infrastructure and strong demand for effective therapies. Among the EU4 countries and the UK, Germany held the largest market share for metabolic acidosis, valued at USD 9.1 million. This solidifies Germany's position as a key player in the European market, reflecting its well-developed healthcare system and commitment to innovative treatment solutions. Metabolic Acidosis Emerging Therapies Zagociguat: Tisento Therapeutics Metabolic Acidosis Key Companies Tisento Therapeutics, Tricida, Advicenne Pharma, and others For more information, visit Metabolic Acidosis Market Analysis, Patient Pool, and Emerging Therapies Scope of the Metabolic Acidosis Market Report: 11 Years Forecast 7MM Coverage Descriptive overview of Metabolic Acidosis, causes, signs and symptoms, diagnosis, treatment Comprehensive insight into Metabolic Acidosis epidemiology in the 7MM Metabolic Acidosis marketed and emerging therapies Metabolic Acidosis companies Metabolic Acidosis market drivers and barriers Table of Contents: 1 Metabolic Acidosis Market Key Comprehensive Insights 2 Metabolic Acidosis Market Report Introduction 3 Competitive Intelligence Analysis for Metabolic Acidosis 4 Metabolic Acidosis Market Analysis Overview at a Glance 5 Executive Summary of Metabolic Acidosis 6 Metabolic Acidosis Epidemiology and Market Methodology 7 Metabolic Acidosis Epidemiology and Patient Population 8 Metabolic Acidosis Patient Journey 9 Metabolic Acidosis Treatment Algorithm, Metabolic Acidosis Current Treatment, and Medical Practices 10 Key Endpoints in Metabolic Acidosis Clinical Trials 11 Metabolic Acidosis Marketed Therapies 12 Metabolic Acidosis Emerging Therapies 13 Metabolic Acidosis: 7 Major Market Analysis 14 Attribute analysis 15 Access and Reimbursement Overview of Metabolic Acidosis 16 Metabolic Acidosis Market Key Opinion Leaders Reviews 18 Metabolic Acidosis Market Drivers 19 Metabolic Acidosis Market Barriers 20 SWOT Analysis 21 Disclaimer 22 DelveInsight Capabilities 23 About DelveInsight Related Reports: Metabolic Acidosis Epidemiology 2034 DelveInsight's "Metabolic Acidosis - Epidemiology Forecast to 2034" report delivers an in-depth understanding of the disease, historical and forecasted Metabolic Acidosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Metabolic Acidosis Pipeline 2024 "Metabolic Acidosis Pipeline Insights, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Metabolic Acidosis market. A detailed picture of the Metabolic Acidosis pipeline landscape is provided, which includes the disease overview and Metabolic Acidosis treatment guidelines. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Kritika Rehani Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Yahoo
27-01-2025
- Health
- Yahoo
First Participant Dosed in Tisento Therapeutics' Global Phase 2b PRIZM Study Evaluating Zagociguat for the Treatment of MELAS
Patient-Centered PRIZM Study Measures Impact of Once-Daily Oral Zagociguat on Fatigue and Cognitive Impairment, Hallmark Features of this Rare Mitochondrial Disease CAMBRIDGE, Mass., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Tisento Therapeutics today announced that the first patient has been dosed in its global Phase 2b PRIZM study. The study is investigating the impact of once-daily oral zagociguat treatment on fatigue, cognitive impairment, and other key aspects of the rare mitochondrial disease MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes). The PRIZM study is centered in multiple ways on what matters to people living with MELAS. The study incorporates features that maximize convenience for participants, including at-home assessments, the potential for at-home study visits, and door-to-door travel support. In addition, all participants will receive zagociguat during one period of this crossover study, and participants who complete the study may be eligible for continued access via an open-label extension study. Importantly, the clinical outcome assessments and endpoint strategy for the PRIZM study were informed by Tisento's interview study in which individuals living with MELAS described the symptoms and impacts of the disease that are most important to them. PRIZM is a global study now enrolling in North America, Europe, and Australia. Patients and families interested in learning more can visit Tisento's PRIZM page, (NCT06402123), or discuss with their physician. 'Since Tisento's founding, we have been focused on initiating a thoughtful, well-designed clinical study to evaluate zagociguat for the treatment of MELAS, and we are humbled by the enthusiastic response we have received from physicians and the mitochondrial disease community,' said Peter Hecht, PhD, chief executive officer of Tisento. 'We are pleased that the first participants are enrolling in the global PRIZM study, which was designed with patient perspectives at the forefront. We will continue to put patients first every step of the way as we work to develop creative solutions to address what matters most for people with serious diseases.' 'MELAS is the most common condition we see in our mitochondrial clinic, with profound effects on patients' daily lives and wellbeing. Right now, we have no approved treatments, making the search for effective therapies absolutely critical,' said Dr. Austin Larson, associate professor of pediatric clinical genetics and metabolism at the University of Colorado School of Medicine and PRIZM study investigator. 'I am excited about zagociguat's potential to address both the severe fatigue and cognitive challenges that so significantly impact our MELAS patients.' About the PRIZM Study PRIZM – a Phase 2b Randomized, Placebo-Controlled Trial Investigating Zagociguat in MELAS – is evaluating the efficacy and safety of oral zagociguat 15 mg or 30 mg compared to placebo when administered once-daily for 12 weeks in participants with genetically and phenotypically defined MELAS. The PRIZM study has a crossover design, with two 12-week treatment periods separated by a 4-week washout period. All participants will receive zagociguat during one of the 12-week periods and placebo during the other. Participants who complete the study may be eligible for an open-label extension study. PRIZM is a global study that will enroll approximately 44 participants at mitochondrial disease centers of excellence in the U.S., Italy, Germany, United Kingdom, Australia, and Canada. For more information, please visit or (NCT06402123) for more information. Interested individuals can also reach out to their physicians for participation details. About Zagociguat Zagociguat is a once-daily, oral, clinical-stage investigational medicine with potential to positively impact both peripheral and central nervous system manifestations of mitochondrial diseases. Zagociguat stimulates soluble guanylate cyclase (sGC), an enzyme that is found in virtually every cell in every tissue of the body and is part of a system of cellular mechanisms that control critical physiological functions including neuronal function and blood flow. A first-in-class, brain-penetrant sGC stimulator, zagociguat is hypothesized to rebalance dysregulated cellular pathways in MELAS. By restoring cellular functions that support mitochondria, zagociguat may help restore mitochondrial energy production and physiological function. In a Phase 2a study in patients with MELAS, zagociguat exhibited a favorable safety profile, exposure throughout the body including in the central nervous system, and improvements in neuronal function, mitochondrial function, and blood flow in the brain. Zagociguat is currently being evaluated as a treatment for MELAS in the Phase 2b PRIZM study. For more information, visit About Tisento Therapeutics Tisento Therapeutics, a privately held biotech company, is developing novel medicines to treat diseases with significant unmet need, beginning with MELAS and other genetic mitochondrial diseases. Ti sento means 'I hear you' in Italian; our approach to innovation begins with listening to patients and then channeling what we learn into decisive actions that shape our research and clinical programs. Tisento is guided by a high-caliber internal team of biopharma veterans and an extensive external network of expert physicians, patient advocacy groups, researchers, industry-leading vendors, and other close collaborators who are partners in our mission to develop meaningful treatments for mitochondrial diseases. Learn more at our website, or connect with us on LinkedIn (Tisento Therapeutics) or X (@tisentotx). Contact Tisento Media RelationsJessi Rennekamp, Astrior CommunicationsEmail: jessi@ in to access your portfolio
