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 degrees 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.

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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).

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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.

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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

* CTx-1301: Cingulate Therapeutics
* Centanafadine: Otsuka Pharmaceutical
* PDC-1421: BioLite, Inc.

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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.

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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.

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