Attention Deficit Hyperactivity Disorder Clinical Trials 2025: 22+ Pipeline Therapies and Digital Therapeutics Redefine ADHD Treatment Beyond Stimulants

DelveInsight's "Attention Deficit Hyperactivity Disorder - Clinical Trials, 2025" reviews over 22 therapies in development for ADHD, a highly prevalent neurodevelopmental disorder affecting both children and adults, with rising diagnosis rates across the 7MM. Traditionally managed with stimulant medications like methylphenidate and amphetamines, ADHD care is now undergoing a paradigm shift as pharmaceutical companies and digital health innovators explore new mechanisms of action and non-pharmacologic interventions.

The clinical pipeline is advancing beyond standard stimulants, with non-stimulant agents targeting dopamine and norepinephrine modulation, selective adrenergic receptor activity, and novel neurotransmitter pathways. Companies such as Supernus Pharmaceuticals, Otsuka, Axsome Therapeutics, and Medice are leading development with candidates designed to reduce abuse potential, improve tolerability, and provide longer-lasting symptom control.

In parallel, prescription digital therapeutics (PDTs) and cognitive training platforms are gaining ground as adjunctive or standalone interventions. Akili Interactive's EndeavorRx, already FDA-approved as the first digital therapeutic for pediatric ADHD, has paved the way for expanded trials of app-based and gamified therapies aimed at improving attention and executive function.

With multiple Phase II and Phase III studies ongoing, the ADHD treatment landscape is broadening to include precision-driven pharmacologic and digital solutions. As late-stage candidates move closer to regulatory approval, and as technology-enabled therapies demonstrate real-world efficacy, the ADHD market is set to transform, offering more tailored, safer, and comprehensive approaches for patients across all age groups.

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/sample-request/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, MM-120, TRN-148, CX717, KP922, AR19, PF8001, 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 August 2025, Cingulate submitted an NDA to the FDA for CTx-1301 (dexmethylphenidate HCl), an extended-release tablet for Attention Deficit/Hyperactivity Disorder (ADHD) designed to provide rapid onset and full-day efficacy with a single dose.
• In May 2025, Cingulate Inc. (NASDAQ: CING) announced receiving formal pre-NDA meeting minutes from the FDA for its lead drug CTx-1301 (dexmethylphenidate), targeting Attention Deficit/Hyperactivity Disorder (ADHD).
• 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.

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Attention Deficit Hyperactivity Disorder Overview
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder that typically begins in childhood and can persist into adulthood. It is characterized by symptoms of inattention, hyperactivity, and impulsivity, which can vary in severity and presentation. Individuals with ADHD may struggle with focus, organization, time management, and controlling impulses, affecting academic, occupational, and social functioning.

The exact cause is not fully understood, but genetic, neurological, and environmental factors play a role. Diagnosis is clinical, based on criteria outlined in the DSM-5.

Treatment often includes a combination of behavioral therapy, psychoeducation, and medication, such as stimulants (e.g., methylphenidate, amphetamines) and non-stimulants (e.g., atomoxetine, guanfacine). Early diagnosis and comprehensive management are key to improving outcomes.

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
Centanafadine - Otsuka Pharmaceutical
Centanafadine is a triple reuptake inhibitor targeting serotonin, norepinephrine, and dopamine. Originally developed by Euthymics Bioscience and later acquired by Otsuka Pharmaceutical through its 2017 acquisition of Neurovance, centanafadine is being evaluated for ADHD in adults. Two Phase III randomized, double-blind, placebo-controlled trials involving around 900 adults (aged 18-55) showed statistically significant improvements in primary and key secondary endpoints compared to placebo. The drug was generally well tolerated, with no adverse event occurring in more than 7% of participants.

MM120 - MindMed
MM120 (lysergide D-tartrate) is being developed by MindMed for ADHD. It is a serotonergic psychedelic derived from lysergide (LSD) and acts as a partial agonist at 5-HT2A receptors. MM120 is currently in Phase II clinical development for the treatment of ADHD.

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, MM-120, TRN-148, CX717, KP922, AR19, PF8001, 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
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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.

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