Attention Deficit Hyperactivity Disorder Clinical Trials Analysis 2025: Novel Mechanisms, Extended-Release Formulations, and Non-Pharmacologic Adjuncts Aim to Improve Symptom Control and Functional Outcomes | DelveInsight

DelveInsight's "Attention Deficit Hyperactivity Disorder (ADHD) - Clinical Trials Analysis, 2025" reviews an evolving pipeline focused on enhancing symptom control, reducing side effects, and improving long-term functional outcomes for children, adolescents, and adults living with ADHD. While stimulants and established non-stimulant agents remain the backbone of therapy, gaps in tolerability, onset/duration of effect, and efficacy in specific patient subgroups (eg, comorbid mood or anxiety disorders) continue to drive innovation.

The ADHD clinical landscape is progressing with next-generation stimulant and non-stimulant formulations (including longer-acting and abuse-deterrent delivery systems), novel neurotransmitter-targeting small molecules (beyond traditional monoaminergic approaches), and repurposed agents aimed at cognitive and executive-function deficits. Parallel development tracks include digital therapeutics, neuromodulation technologies, and adjunctive behavioral platforms designed to augment pharmacologic effects and support adherence. Biomarker and patient-reported outcome integration is increasingly used to refine trial populations and demonstrate real-world functional benefits.

With several late-stage formulation and digital therapy programs advancing, the ADHD treatment paradigm is poised to become more individualized-combining precision pharmacotherapy with technology-enabled care to deliver faster onset, longer duration, improved safety, and better functional outcomes across the lifespan.

Interested in learning more about the current treatment landscape and the key drivers shaping the attention deficit hyperactivity disorder pipeline? Click here: https://www.delveinsight.com/report-store/attention-deficit-hyperactivity-disorder-adhd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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 August 2025, Lumos Labs received FDA 510(k) clearance for Prismira, its first digital therapeutic app for treating adult attention deficit hyperactivity disorder (ADHD). Although granted on June 13th, the company has not publicly announced the clearance.
• 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 @ https://www.delveinsight.com/report-store/attention-deficit-hyperactivity-disorder-adhd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Attention Deficit Hyperactivity Disorder Overview
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder typically diagnosed in childhood, though it can persist into adulthood. It is characterized by symptoms of inattention, hyperactivity, and impulsivity that interfere with daily functioning and development. Individuals with ADHD may struggle with focus, organization, staying still, or controlling impulses. The exact cause is not fully understood but is believed to involve genetic, neurological, and environmental factors. Diagnosis is clinical and often involves input from parents, teachers, and mental health professionals. Treatment usually includes behavioral therapy, educational support, and medications such as stimulants or non-stimulants to help manage symptoms and improve functioning.

Find out more about Attention Deficit Hyperactivity Disorder medication @ https://www.delveinsight.com/report-store/attention-deficit-hyperactivity-disorder-adhd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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.

Learn more about the novel and emerging Attention Deficit Hyperactivity Disorder pipeline therapies @ https://www.delveinsight.com/report-store/attention-deficit-hyperactivity-disorder-adhd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr
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 @ https://www.delveinsight.com/report-store/attention-deficit-hyperactivity-disorder-adhd-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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.

This release was published on openPR.