Latest news with #Takeda
National Post
2 days ago
- Business
- National Post
Takeda Receives FDA 510(k) Clearance for HyHubTM and HyHubTM Duo Devices to Simplify HYQVIA® Administration
Article content HyHub and HyHub Duo Reduce the Number of Steps Required to Prepare HYQVIA 1 First Devices Customized for a Plasma-Derived Therapy in Takeda's Broad and Differentiated Portfolio Reflect Company's Commitment to Providing a Patient-Centric Ecosystem of Support Created With Input from Patients and Caregivers to Help Improve In-Home Infusion Article content OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHub TM and HyHub TM Duo, devices for patients 17 years of age and older that allow HYQVIA ® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle in a home environment or clinical setting. 2 The HYQVIA administration process consists of dual vial units (DVUs) including one vial of immunoglobulin (IG) and one vial of hyaluronidase. HyHub and HyHub Duo, which act as docking stations for these vials, were developed to simplify administration of HYQVIA by reducing the number of steps required to prepare the infusion of two DVUs or more. 1 HYQVIA is a combination of IG and hyaluronidase for facilitated subcutaneous immunoglobulin (SCIg) infusion that is approved for treatment of adults and children two years of age and older with primary immunodeficiency (PI) and as maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in the United States. 2 Depending on the indication, HYQVIA can be infused up to once monthly (every two, three or four weeks). Article content 'This milestone exemplifies our dedication to advancing innovative solutions that can enhance the treatment administration experience for people who rely on infusions of facilitated immunoglobulin like HYQVIA,' said Kristina Allikmets, senior vice president and head of Research & Development for Takeda's Plasma-Derived Therapies Business Unit. 'We designed HyHub and HyHub Duo, Takeda's first customized devices for use with a plasma-derived therapy, with input from patients and caregivers, demonstrating our focus on leveraging technology and deep insights to offer a patient-centric ecosystem of support throughout the treatment journey.' Article content HyHub and HyHub Duo reduce the number of steps required to prepare the IG and hyaluronidase of the HYQVIA infusion by up to half compared to infusing with a pooling bag depending on the device and number of DVUs used. 1* HyHub and HyHub Duo also reduce the ancillary supplies required to prepare the infusion and a dedicated carrier bag is available for convenience that enables room-to-room mobility. 3 'For people living with primary immunodeficiency, innovative devices that can help simplify the administration process of their immunoglobulin treatment can be especially meaningful as many require lifelong treatment for their disease,' said Jorey Berry, president and chief executive officer of the Immune Deficiency Foundation. Article content HyHub and HyHub Duo are intended for use only with HYQVIA and the devices will be available at no additional cost to patients. Article content Takeda anticipates making HyHub and HyHub Duo available in the United States starting in the second half of fiscal year 2025. Takeda also submitted a CE Mark application for HyHub and HyHub Duo in the European Union during the first quarter of fiscal year 2025 and will evaluate making the device available in other markets in the future. Article content * HyHub reduces the number of steps by approximately half for four DVUs. HyHub Duo reduces the number of steps by about one third for two DVUs. Article content ® Article content is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig) and is approved in the United States to treat adults and children two years of age and older with primary immunodeficiency (PI), and as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adult patients with CIDP. It is also approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with PI and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. In addition, it is approved by the EMA as maintenance therapy in adults, children and adolescents (0-18 years) with CIDP after stabilization with intravenous immunoglobulin therapy (IVIG). HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains IG collected from human plasma. IG are antibodies that maintain the body's immune system. The hyaluronidase part of HYQVIA facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. HYQVIA is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI). Article content HyHub/HyHub Duo Important Information for Healthcare Providers Article content Intended Use: Article content HyHub/HyHub Duo are stand-alone, single-use, disposable vial access devices. Article content Indications for Use: Article content HyHub/HyHub Duo are indicated for patients 17 years of age and older to allow HYQVIA [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting. Article content Contraindications: Article content Do not use HyHub/HyHub Duo with a pooling bag. Do not connect HyHub/HyHub Duo to a syringe driver infusion pump. Article content Selected Information for Patients: Article content HyHub/HyHub Duo are for SINGLE USE ONLY, even if all docks are not used during a single infusion. Re-use will increase risk of infection. Patients should always use a new HyHub/HyHub Duo for each infusion. Only use HyHub/HyHub Duo when patients are ready to administer HYQVIA. Patients should not use HyHub/HyHub Duo at home until receiving instructions and training from a healthcare provider. HYQVIA is the only medication that may be used with HyHub/HyHub Duo. Patients should not exceed the maximum infusion volume per infusion site or infusion rate as indicated in the HYQVIA prescribing information. Article content For safe and proper use of HyHub/HyHub Duo, please refer to the complete Instructions for Use included with the devices when they become available in the second half of FY2025. Article content For information about HYQVIA, please see Prescribing Information for HYQVIA. Article content INDICATIONS FOR HYQVIA Article content HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age and older and for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. HYQVIA is for subcutaneous use only. Article content WARNING: THROMBOSIS Thrombosis may occur with immune globulin (IG) products, including HYQVIA. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. Article content Contraindications Article content History of anaphylactic or severe systemic hypersensitivity reactions to human IG IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG Known systemic hypersensitivity to hyaluronidase including Recombinant Human Hyaluronidase of HYQVIA Known systemic hypersensitivity to human albumin (in the hyaluronidase solution) Article content Warnings and Precautions Article content Hypersensitivity: Article content Severe hypersensitivity reactions may occur, even in patients previously treated with IG products. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis. Article content Thrombosis: Article content Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Article content Immunogenicity of Recombinant Human Hyaluronidase (rHuPH20): Article content Has been reported to occur following treatment with IG products, including HYQVIA and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Article content Aseptic Meningitis Syndrome: Article content Has been reported to occur with use of IG, including HYQVIA. The syndrome usually begins within several hours to two days following IG treatment. Article content Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. Article content Hemolysis: Article content HYQVIA contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing. Article content Renal Dysfunction/Failure: Article content Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, may occur with IG products, including HYQVIA. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, administer HYQVIA at the minimum rate of infusion practicable. Assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation. Article content Spread of Localized Infection: Article content Do not infuse HYQVIA into or around an infected area due to potential risk of spreading a localized infection. Article content Transfusion-Related Acute Lung Injury: Article content Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. Manage using oxygen therapy with adequate ventilatory support. Article content Transmittable Infectious Agents: Article content Because HYQVIA is made from human plasma, there is a risk of transmitting infectious agents (e.g. viruses, other pathogens). Article content Interference with Lab Tests: Article content False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies. Article content Adverse Reactions Article content The most common adverse reactions observed in >5% of patients in the clinical trials were: Article content Primary Immunodeficiency (PI) Article content : Local reactions, headache, antibody formation against rHuPH20, fatigue, nausea, pyrexia, and vomiting. Article content Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Article content : Local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity. Article content Drug Interactions Article content Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella). Article content Use in Specific Populations Article content Pregnancy: Article content Limited human data are available on the use of HYQVIA during pregnancy. The effects of antibodies to the Recombinant Human Hyaluronidase on the human embryo or fetal development are unknown. It is not known whether HYQVIA can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. HYQVIA should be given to a pregnant woman only if clearly needed. Article content Please click for Article content For European Union Summary of Product Characteristics, please visit: Article content About Takeda Article content Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit Article content . Article content For the purposes of this notice, 'press release' means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ('Takeda') regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. Article content Article content The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, 'Takeda' is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words 'we', 'us' and 'our' are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Article content Forward-Looking Statements Article content This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as 'targets', 'plans', 'believes', 'hopes', 'continues', 'expects', 'aims', 'intends', 'ensures', 'will', 'may', 'should', 'would', 'could' 'anticipates', 'estimates', 'projects' or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Article content Article content . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Article content Medical information Article content This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Article content Data on File. Takeda Pharmaceuticals. Article content Article content Article content Article content View source version on Article content Article content Contacts Article content U.S. Media Taryn Corbino +1 (617) 588-8737 Article content Article content
Local Spain
3 days ago
- Business
- Local Spain
Why Vienna is Europe's hidden gem for life sciences
With its impressive architecture and coffee house-lined streets, Vienna is a city like no other. Situated on the banks of the Danube, it is steeped in history and has long been a cultural capital of Europe. These days, however, the city is just as defined by its future as its past. Thanks to forward-thinking research centres, top-ranked universities and an expanding base of life sciences companies, Vienna is a rising powerhouse in biotech, medtech, and pharmaceutical research. Vienna is the European leader in life sciences 'Life sciences are one of Vienna's key drivers of innovation,' said Dominic Weiss, Managing Director of the Vienna Business Agency, which supports the ecosystem through funding programs, location scouting and other expert support, such as immigration advice. 'Over many years, life sciences companies ranging from international pharmaceutical giants to startups working on the bleeding edge of technology have repeatedly chosen to move to, invest and expand in this city, collaborating with local universities to create an internationally competitive hub that produces game-changing therapies, devices and diagnostic tools.' The sector is made up of over 750 organisations, generating about €22.7 billion a year. The vast majority of revenue – just over 80 percent – stems from the biotech and pharmaceutical sectors alone. More than 49,000 people currently work in life sciences – and the numbers are rising as ever more international experts are drawn into the ecosystem. 'Part of what makes Vienna an attractive location for life science companies is that the city combines an excellent research landscape and university talent pool with a great deal of attractiveness for top international researchers and executives,' Weiss added. 'Moving to Vienna is not a hard sell.' Combining top-ranked livability, affordability and a strong work-life balance, it's no wonder that international researchers and entrepreneurs are choosing to call Vienna home. In fact, around 40 percent of the Austrian capital's two million residents were born abroad, giving the city a truly diverse feel. Thriving life sciences hub Some of the world's top life science firms – including pharma giants Takeda, Boehringer Ingelheim and Novartis – have offices in Vienna. Meanwhile, cutting-edge research institutions working on everything from tissue regeneration and cancer therapies to prosthetics are well established in the Austrian capital. What really sets Vienna apart is how closely connected this ecosystem is. Research labs, clinical research facilities and companies are often within walking distance of each other. 'This spatial density creates collaboration opportunities and translational potential that researchers find on par with top global locations,' says Dr Michael Stampfer, Managing Director of the Vienna Science and Technology Fund (WWTF). Groundbreaking research is underway in facilities such as the Vienna BioCenter, which has more than 2,000 scientists covering fields like cancer biology, immunology, and RNA therapeutics. One standout project is US biochemist Elly Tanaka's work in regeneration biology. By studying animals that can regrow limbs and tissues, Tanaka's lab at the IMP is researching potential treatments for human diseases. And the city isn't slowing down. The soon-to-launch AITHYRA Institute, a revolutionary research hub for biomedical AI, will be one of the first of its kind in Europe. With Michael Bronstein, DeepMind Professor of AI at the University of Oxford, at the helm, the institute will bring together experts and apply state-of-the-art technology to better understand diseases, speed up diagnoses, and help develop new treatments. Dr Stampfer sees this growth as part of a larger trend. He describes Vienna's life sciences sector as being 'on a qualitative and quantitative growth course', which means there are 'lots of attractive positions available' for international talent. Young pharmacy researchers. Supportive community and funding opportunities Moving to a new country can feel daunting but there is plenty of support for newcomers. The Vienna Business Agency offers free consultations, events and guidance to researchers and entrepreneurs on everything from funding applications to finding a flat. Support is also available at the WWTF, which provides research funding as well as a Dual Career Service to assist researchers and their partners in settling in Vienna. According to Dr Stampfer, researchers are 'pleasantly surprised by our comprehensive support system for international scientists and the efficiency of our funding administration'. LISAvienna, the city's life sciences platform, offers targeted support for biotech and digital health startups, including help with grants, contacts and networking. Vienna is also gaining recognition on the global stage. Researchers are publishing in prestigious journals, while centres such as the Institute of Science and Technology Austria (ISTA), are winning competitive European Research Council grants. 'We also witness an expanding life sciences startup ecosystem, and venture capital funds taking a closer look at what is happening in Vienna,' Dr Stampfer adds. Meanwhile, international recruitment is strong, particularly among early-career scientists. This can be seen in initiatives such as the WWTF's Vienna Research Groups programme. Dr Stampfer says the rising number of young people coming to Vienna 'creates a vibrant research environment with fresh perspectives'. Working in one of Vienna's many welcoming cafés. Life beyond the lab Science isn't the only reason for choosing Wien. The city is regularly crowned one of the most liveable in the world due to its excellent infrastructure, healthcare, cultural scene and green space. Residents enjoy affordable and efficient public transport alongside family-friendly policies like free childcare for young children. Vienna's international connections are another advantage. Thanks to a major airport and fast train links it's easy to travel around Europe or further afield. 'The central European location and rich cultural landscape exceed expectations, even for those with high initial hopes,' says Dr Stampfer. Of course, there is the odd Viennese quirk. 'Researchers might be a little surprised by the playful grumpiness of our local coffee house waiters – and the many urban legends around it,' adds Dr Stampfer. 'But this is something people get used to quickly.' 'Building the future' From Freud's psychoanalysis to Schrödinger's quantum theory, Vienna has long attracted brilliant minds. That tradition has continued with major contributions to fields such as gene editing, attosecond physics and quantum entanglement. Now, new projects in digital medicine and AI-driven health research are opening up even more possibilities. With centres like AITHYRA on the horizon, a flourishing startup scene and a growing international community, Vienna is quickly becoming the top choice for researchers and entrepreneurs looking for a European base. Through the platform ViennaBusiness, the city is now offering expert consultations and other support to international researchers and life-science companies interested in exploring the city. 'It's exciting to see great minds flourish in Vienna,' says Dr Stampfer. 'We are building the future here.'
Globe and Mail
15-07-2025
- Health
- Globe and Mail
Attention Deficit Hyperactivity Disorder Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, ROA, and Companies by DelveInsight
The attention deficit hyperactivity disorder market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as 3Z Pharmaceuticals, Shire, Takeda, and New River Pharmaceuticals. These industry pioneers are transforming treatment strategies and redefining the future of Attention Deficit Hyperactivity Disorder care, bringing new hope to patients worldwide. (Albany, USA) DelveInsight's " Attention Deficit Hyperactivity Disorder Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Attention Deficit Hyperactivity Disorder market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations. For emerging Attention Deficit Hyperactivity Disorder drugs, the Attention Deficit Hyperactivity Disorder pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies. Download DelveInsight's comprehensive report to uncover breakthrough therapies, clinical progress, and future market opportunities @ Attention Deficit Hyperactivity Disorder Pipeline Outlook Key Takeaways from the Attention Deficit Hyperactivity Disorder Pipeline Report DelveInsight's Attention Deficit Hyperactivity Disorder Pipeline analysis depicts a robust space with 20+ active players working to develop 22+ pipeline drugs for Attention Deficit Hyperactivity Disorder treatment. The leading Attention Deficit Hyperactivity Disorder companies include Cingulate Therapeutics, Otsuka Pharmaceutical, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals, KemPharm, Arbor Pharmaceuticals, Ensysce Biosciences, 3Z Pharmaceuticals, Shire, Takeda, New River Pharmaceuticals, Aevi Genomic Medicine LLC, Sumitomo Pharma America Inc., Orient Pharma Co. Ltd., Durect, Rhodes Pharmaceuticals L.P., Purdue Pharma LP, CoMentis, Johnson & Johnson Ltd., Xian-Janssen Pharmaceutical Ltd., Shionogi Inc., Pfizer, Novartis, Neos Therapeutics Inc., Janssen Pharmaceuticals, and others are evaluating their lead assets to improve the Attention Deficit Hyperactivity Disorder treatment landscape. Key Attention Deficit Hyperactivity Disorder pipeline therapies in various stages of development include CTx-1301, Centanafadine, PDC-1421, and others. In January 2025, generic drugmaker Granules received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate Capsules, a medication for Attention Deficit Hyperactivity Disorder (ADHD), available in multiple strengths. In December 2024, Granules India received FDA approval for Lisdexamfetamine Dimesylate chewable tablets, its generic version of Takeda Pharmaceuticals' Vyvanse. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe binge eating disorder (BED). Request a sample and discover the recent breakthroughs happening in the Attention Deficit Hyperactivity Disorder pipeline landscape @ Attention Deficit Hyperactivity Disorder Treatment Drugs Attention Deficit Hyperactivity Disorder Overview ADHD is a neurodevelopmental disorder that significantly impacts a child's ability to function, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Previously classified as separate conditions-Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder-the DSM-IV merged them into a single diagnosis with three subtypes: predominantly inattentive, predominantly hyperactive, and combined type. Symptoms typically emerge in early childhood and include difficulty focusing, disorganization, forgetfulness, and trouble completing tasks. For a diagnosis, these symptoms must appear before age 12, persist for at least six months, and disrupt daily life across multiple settings, such as home and school. ADHD can affect social interactions, academic performance, and even increase the likelihood of risky behaviors and job instability. As a disorder linked to executive dysfunction, ADHD primarily affects the frontal lobe, impairing attention, decision-making, and emotional regulation. Children with ADHD may struggle with frustration, impulsivity, and social interactions, often being misperceived as troublemakers. Brain abnormalities, including reduced size in the anterior cingulate gyrus and dorsolateral prefrontal cortex (DLPFC), contribute to deficits in goal-directed behavior, with decreased activity in the frontostriatal region observed through fMRI scans. The exact cause of ADHD remains unclear but involves both genetic and environmental influences. It is one of the most heritable psychiatric disorders, with higher concordance in identical twins and an increased risk among siblings. Environmental factors such as prenatal exposure to smoking, alcohol, nutritional deficiencies, and viral infections have also been linked to its development. Research suggests that lower dopamine receptor availability in the frontal lobes and noradrenergic system involvement may play a role in the disorder's pathology. Find out more about Attention Deficit Hyperactivity Disorder medication @ ADHD Medication and Companies Attention Deficit Hyperactivity Disorder Treatment Analysis: Drug Profile CTx-1301: Cingulate Therapeutics CTx-1301 leverages Cingulate's Precision Timed Release (PTR) technology to develop an advanced multi-core dexmethylphenidate formulation for ADHD treatment. This innovative tablet integrates immediate and sustained release layers, ensuring precise drug delivery throughout the day. Designed for rapid onset, full-day efficacy, and a controlled decline in plasma levels, CTx-1301 aims to optimize symptom management. Currently, the drug is in Phase III clinical trials for ADHD. Centanafadine: Otsuka Pharmaceutical Centanafadine, a triple-reuptake inhibitor targeting serotonin, norepinephrine, and dopamine, was initially developed by Neurovance before Otsuka Pharmaceutical acquired its rights in 2017. Two Phase III trials, involving approximately 900 adults (ages 18-55) with ADHD, assessed its efficacy through randomized, double-blind, placebo-controlled studies. Participants received either 100 mg or 200 mg doses twice daily, or a placebo. Centanafadine demonstrated significant symptom improvements compared to placebo across primary and key secondary endpoints. Safety data from both studies indicated no adverse events affecting more than 7% of participants. Key Attention Deficit Hyperactivity Disorder Therapies and Companies Attention Deficit Hyperactivity Disorder Therapeutics Assessment By Product Type Mono Combination Mono/Combination. By Stage Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates By Route of Administration Oral Intravenous Subcutaneous Parenteral Topical By Molecule Type Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Scope of the Attention Deficit Hyperactivity Disorder Pipeline Report Coverage: Global Key Attention Deficit Hyperactivity Disorder Companies: Cingulate Therapeutics, Otsuka Pharmaceutical, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals, KemPharm, Arbor Pharmaceuticals, Ensysce Biosciences, 3Z Pharmaceuticals, Shire, Takeda, New River Pharmaceuticals, Aevi Genomic Medicine LLC, Sumitomo Pharma America Inc., Orient Pharma Co. Ltd., Durect, Rhodes Pharmaceuticals L.P., Purdue Pharma LP, CoMentis, Johnson & Johnson Ltd., Xian-Janssen Pharmaceutical Ltd., Shionogi Inc., Pfizer, Novartis, Neos Therapeutics Inc., Janssen Pharmaceuticals, and others. Key Attention Deficit Hyperactivity Disorder Pipeline Therapies: CTx-1301, Centanafadine, PDC-1421, and others. Dive deep into rich insights for drugs used for Attention Deficit Hyperactivity Disorder treatment; visit @ Attention Deficit Hyperactivity Disorder FDA Approvals and Recent Development Table of Contents 1. Introduction 2. Executive Summary 3. Attention Deficit Hyperactivity Disorder Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Attention Deficit Hyperactivity Disorder Pipeline Therapeutics 6. Attention Deficit Hyperactivity Disorder Pipeline: Late-Stage Products (Phase III) 7. Attention Deficit Hyperactivity Disorder Pipeline: Late-Stage Products (Phase III) 8. Attention Deficit Hyperactivity Disorder Pipeline: Mid-Stage Products (Phase II) 9. Attention Deficit Hyperactivity Disorder Pipeline: Early Stage Products (Phase I) 10. Therapeutic Assessment 11. Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix 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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
Yahoo
14-07-2025
- Business
- Yahoo
Takeda's oral narcolepsy drug shines in two Phase III trials
Takeda's oral narcolepsy drug, oveporexton, has met the primary and secondary endpoints in two Phase III trials. The FirstLight (NCT06470828) and RadiantLight (NCT06505031) trials both met all their endpoints in patients with narcolepsy type 1 (NT1) after 12 weeks of treatment. The primary and secondary endpoints measured changes in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions. These were all statistically significant and clinically meaningful improvements, achieving near normal ranges across the broad range of symptoms investigated. The drug also remained generally well-tolerated with a safety profile consistent with other oveporexton studies, with the most common adverse events (AEs) being insomnia, urinary urgency and frequency. No serious treatment-related adverse events were reported. Based on the study results, Takeda plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) and other global regulators during the 2025 fiscal year. Oveporexton (TAK-861) is an investigational oral orexin receptor 2 (OX2R)-selective agonist. It is designed to address the core cause of NT1 by compensating for orexin deficiency, aiming to improve wakefulness and restore normal sleep-wake patterns. Orexin is a natural brain chemical that plays a crucial role in maintaining wakefulness and regulating the sleep-wake cycle. Takeda president Christophe Weber said: 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult-to-treat diseases such as narcolepsy type 1.' Of the patients across the two Phase III studies, more than 95% enrolled in the ongoing long-term extension (LTE) study. In 2020, Jazz Pharmaceuticals' Xywav (calcium, magnesium, potassium, and sodium oxybates) was approved by the FDA and was the first approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years. Other treatment options for NT1 include trying to manage a regular sleeping pattern, as well as therapies, including stimulants such as Provigil (modafinil), Nuvigil (armodafinil), and Ritalin (methylphenidate) to promote wakefulness. Patients may also receive solriamfetol or pitolisant. To help with cataplexy attacks, either sodium oxybate or some antidepressants such as SSRIs [selective serotonin reuptake inhibitors] and SNRIs [serotonin-norepinephrine reuptake inhibitors] can be used to manage symptoms. If approved, GlobalData predicts sales of oveporexton will reach $1bn in 2030. GlobalData is the parent company of Clinical Trials Arena. "Takeda's oral narcolepsy drug shines in two Phase III trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
14-07-2025
- Business
- Yahoo
Takeda's oral narcolepsy drug shines in two Phase III trials
Takeda's oral narcolepsy drug, oveporexton, has met the primary and secondary endpoints in two Phase III trials. The FirstLight (NCT06470828) and RadiantLight (NCT06505031) trials both met all their endpoints in patients with narcolepsy type 1 (NT1) after 12 weeks of treatment. The primary and secondary endpoints measured changes in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions. These were all statistically significant and clinically meaningful improvements, achieving near normal ranges across the broad range of symptoms investigated. The drug also remained generally well-tolerated with a safety profile consistent with other oveporexton studies, with the most common adverse events (AEs) being insomnia, urinary urgency and frequency. No serious treatment-related adverse events were reported. Based on the study results, Takeda plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) and other global regulators during the 2025 fiscal year. Oveporexton (TAK-861) is an investigational oral orexin receptor 2 (OX2R)-selective agonist. It is designed to address the core cause of NT1 by compensating for orexin deficiency, aiming to improve wakefulness and restore normal sleep-wake patterns. Orexin is a natural brain chemical that plays a crucial role in maintaining wakefulness and regulating the sleep-wake cycle. Takeda president Christophe Weber said: 'We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda's strength in discovering and developing a potential new class of medicines for difficult-to-treat diseases such as narcolepsy type 1.' Of the patients across the two Phase III studies, more than 95% enrolled in the ongoing long-term extension (LTE) study. In 2020, Jazz Pharmaceuticals' Xywav (calcium, magnesium, potassium, and sodium oxybates) was approved by the FDA and was the first approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years. Other treatment options for NT1 include trying to manage a regular sleeping pattern, as well as therapies, including stimulants such as Provigil (modafinil), Nuvigil (armodafinil), and Ritalin (methylphenidate) to promote wakefulness. Patients may also receive solriamfetol or pitolisant. To help with cataplexy attacks, either sodium oxybate or some antidepressants such as SSRIs [selective serotonin reuptake inhibitors] and SNRIs [serotonin-norepinephrine reuptake inhibitors] can be used to manage symptoms. If approved, GlobalData predicts sales of oveporexton will reach $1bn in 2030. GlobalData is the parent company of Clinical Trials Arena. "Takeda's oral narcolepsy drug shines in two Phase III trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
