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Attention Deficit Hyperactivity Disorder Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, ROA, and Companies by DelveInsight
Attention Deficit Hyperactivity Disorder Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, ROA, and Companies by DelveInsight

Globe and Mail

time15-07-2025

  • 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.

3Z Pharmaceuticals Publishes Breakthrough Study on Shared Metabolic Pathways in ADHD Therapeutics
3Z Pharmaceuticals Publishes Breakthrough Study on Shared Metabolic Pathways in ADHD Therapeutics

Yahoo

time24-02-2025

  • Health
  • Yahoo

3Z Pharmaceuticals Publishes Breakthrough Study on Shared Metabolic Pathways in ADHD Therapeutics

REYKJAVIK, Iceland, Feb. 24, 2025 /PRNewswire/ -- 3Z Pharmaceuticals, a CNS-focused therapeutic development specialist, today announced the publication of a groundbreaking study in The Journal of Pharmacology and Experimental Therapeutics, unveiling novel insights into the metabolic mechanisms of ADHD treatments. This research, utilizing untargeted metabolomic and lipidomic profiling, addresses a critical knowledge gap in ADHD treatment. It reveals a convergence of molecular pathways among stimulant and non-stimulant ADHD medications and supports 3Z's earlier announced discovery of amlodipine as an L-type calcium channel blocker candidate. ADHD is a highly prevalent neurodevelopmental disorder with complex underlying mechanisms and limited treatment options. While both stimulant and non-stimulant medications are widely used, their precise metabolic effects on the brain remain poorly understood. "This study represents a major leap forward in our understanding of ADHD therapeutics," commented Dr. Karl Karlsson, CEO of 3Z Pharmaceuticals, emphasizing the study's significance, "By leveraging advanced metabolomics and lipidomics, we have uncovered a shared metabolic signature across treatments—highlighting the potential of L-type calcium channel modulation as the foundation for a new non-stimulant ADHD therapy. These findings not only validate our drug discovery platform but also pave the way for much-needed new treatment options." To bridge this gap, 3Z Pharmaceuticals employed an advanced systems biology approach, integrating cross-species analysis using the zebrafish adgrl3.1 ADHD model with targeted metabolomic profiling to explore common metabolic pathways underlying ADHD therapeutics. Key Findings from the Study: Metabolic Pathway Convergence: The study demonstrated that existing ADHD treatments—methylphenidate, guanfacine, and atomoxetine—as well as the novel candidate amlodipine, modulate share metabolic pathways related to amino acid and lipid metabolism. These include glycine, serine, threonine, lysophosphatidylcholine, and sphingomyelin metabolism. Systemic impact: Rather than acting through distinct, isolated mechanisms, ADHD medications appear to exert a broader, systemic impact on neurotransmitter precursors, oxidative stress markers, and energy metabolism. Amlodipine's Overlapping Effects with ADHD Medications: The metabolic profile of amlodipine significantly overlapped with that of established ADHD treatments, supporting L-type calcium channel engagement as a potential therapeutic pathway for ADHD. Full Study: Building on these findings, 3Z Pharmaceuticals is advancing its metabolomics-driven approach to CNS drug discovery, focusing on refining therapeutic targets and optimizing treatment strategies for future clinical development. About 3Z Pharmaceuticals 3Z Pharmaceuticals, based in Reykjavik, Iceland, identifies and advances next-generation therapies for CNS disorders through both novel discovery and strategic repurposing. The company is pioneering a state-of-the-art drug development platform that integrates high-throughput screening, multi-omics, and AI analytics. With a strong focus on translational validation, 3Z de-risks CNS drug development by combining multi-species assessment with human Mendelian randomization, polygenic risk scoring, and genetic studies to enhance clinical predictability. Contact For more information or media inquiries, please contact: Karl KarlssonCEO, 3Z PharmaceuticalsKarlsson@ +354 825 66467 This information was brought to you by Cision View original content: SOURCE 3Z ehf Sign in to access your portfolio

3Z Pharmaceuticals Unveils Landmark Study Supporting Calcium Channel Blocker as a Groundbreaking ADHD Therapy
3Z Pharmaceuticals Unveils Landmark Study Supporting Calcium Channel Blocker as a Groundbreaking ADHD Therapy

Yahoo

time21-02-2025

  • Health
  • Yahoo

3Z Pharmaceuticals Unveils Landmark Study Supporting Calcium Channel Blocker as a Groundbreaking ADHD Therapy

REYKJAVIK, Iceland, Feb. 17, 2025 /PRNewswire/ -- 3Z Pharmaceuticals today announced the publication of a transformative study in Neuropsychopharmacology, highlighting compelling scientific evidence that positions the mechanisms engaged by amlodipine, an L-type calcium channel blocker (LTCC), as a foundation for a novel therapy for ADHD. The findings provide robust validation of 3Z's cutting-edge high-throughput drug discovery platform and introduce new avenues for non-stimulant-based ADHD treatment. ADHD is a prevalent neurodevelopmental disorder with limited treatment options. Current stimulant medications, such as methylphenidate, offer benefits to some but are often associated with side effects, abuse potential, and a high non-response rate. 3Z Pharmaceuticals is committed to addressing these gaps by pioneering alternative, non-stimulant therapeutics. In this newly published study, researchers at 3Z, integrated cross-species behavioral assays, Mendelian Randomization analysis, and human genetic data to demonstrate amlodipine's therapeutic potential. Key findings include: Behavioral Rescue in ADHD Models: Amlodipine significantly reduced hyperactivity in Spontaneously Hypertensive Rats and improved impulsivity in the adgrl3.1-/- zebrafish model of ADHD, providing cross-species validation of its efficacy. Blood-Brain Barrier Penetration & Neural Impact: Surprisingly traditional penetration studies confirmed that amlodipine crosses the blood-brain barrier, where it modulates neuronal activation, countering the assumption of poor brain penetration. Genetic Evidence via Mendelian Randomization: Human genetic analysis linked ADHD risk to variations in LTCC genes (CACNA1C, CACNB1, CACNA2D3), which are direct targets of amlodipine, reinforcing its mechanistic potential in ADHD therapy. Clinical Relevance in Human Populations: Polygenic risk score analysis using the UK Biobank demonstrated that individuals with a high ADHD genetic burden who were prescribed amlodipine exhibited reduced ADHD-related symptoms, independent of its antihypertensive effects. Dr. Karl Karlsson a neuroscientist, CEO of 3Z Pharmaceuticals and Professor of Biomedical Engineering at Reykjavik University, commented on the study's impact: "This research represents a paradigm shift in ADHD therapeutics. Our findings not only validate the mechanism impacted by amlodipine as a promising candidate for non-stimulant ADHD treatment but also underscore the power of our high-throughput screening and genetic modeling approaches, performed in close alliance with This is an exciting step forward in our mission to deliver more effective and well-tolerated treatments for ADHD." Building on these findings, 3Z Pharmaceuticals is advancing a variant of the therapeutic towards clinical development, leveraging its established safety profile and precise mechanism of action to introduce transformative ADHD therapy. Media Contact:Name: Karl Ægir KarlsonTitle: CEO3Z PharmaceuticalsEmail: Karlsson@ +354-8256467 Link to paper: This information was brought to you by Cision View original content: SOURCE 3Z ehf Sign in to access your portfolio

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