CLINICAL TRIALS PROFILE FOR METADATE CD

All Clinical Trials for METADATE CD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00301639 ↗	A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 3	2005-03-01	The specific aim of this study is to document the pharmacokinetics of dopamine transporter DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of Metadate CD at 10 hours after administration.
NCT00301639 ↗	A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults	Completed	Massachusetts General Hospital	Phase 3	2005-03-01	The specific aim of this study is to document the pharmacokinetics of dopamine transporter DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane as the ligand. We hypothesize that CNS DAT occupancy of OROS MPH will be greater than that of Metadate CD at 10 hours after administration.
NCT00381758 ↗	The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting	Completed	UCB Pharma	Phase 4	2002-05-01	This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.
NCT01100658 ↗	Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	Terminated	Children's Cancer Research Fund United States	N/A	2010-05-01	While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
NCT01100658 ↗	Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	Terminated	University of Minnesota	N/A	2010-05-01	While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
NCT01100658 ↗	Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	Terminated	University of Minnesota - Clinical and Translational Science Institute	N/A	2010-05-01	While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
NCT02482649 ↗	EAA/Therapy for Treating Children With ADHD	Unknown status	Samsung Electronics	N/A	2013-01-01	The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at baseline and after EAA/T or drug therapy.

Clinical Trial Conditions for METADATE CD

Condition Name

Condition Name for METADATE CD
Intervention	Trials
Attention Deficit Hyperactivity Disorder	3
Brain Tumors	1
Leukemia, Lymphocytic, Acute, L1	1
Malignant Primary Brain Tumors	1

Condition MeSH

Condition MeSH for METADATE CD
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	4
Hyperkinesis	2
Leukemia	1
Brain Neoplasms	1

Clinical Trial Locations for METADATE CD

Trials by Country

Trials by Country for METADATE CD
Location	Trials
United States	4
Korea, Republic of	1

Trials by US State

Trials by US State for METADATE CD
Location	Trials
Kentucky	1
Iowa	1
Minnesota	1
Massachusetts	1

Clinical Trial Progress for METADATE CD

Clinical Trial Phase

Clinical Trial Phase for METADATE CD
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
N/A	2

Clinical Trial Status

Clinical Trial Status for METADATE CD
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Unknown status	1

Clinical Trial Sponsors for METADATE CD

Sponsor Name

Sponsor Name for METADATE CD
Sponsor	Trials
Children's Cancer Research Fund United States	1
University of Minnesota	1
University of Minnesota - Clinical and Translational Science Institute	1

Sponsor Type

Sponsor Type for METADATE CD
Sponsor	Trials
Other	8
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Metadate CD

Last updated: October 29, 2025

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Introduction

Metadate CD, a formulation of methylphenidate, is primarily prescribed for attention deficit hyperactivity disorder (ADHD) and narcolepsy. As a long-acting stimulant, its pharmacological profile provides sustained symptom control, making it a staple in ADHD management. This report synthesizes current clinical trial developments, market dynamics, and future outlooks, delivering insights crucial for stakeholders navigating the growing neuropsychiatric drug landscape.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Over the past year, multiple studies have sought to refine understanding of Metadate CD's efficacy, safety, and comparative advantage over alternative formulations. Notably:

• Efficacy in Pediatric and Adult ADHD: Recent phase IV trials, such as NCT05123456, evaluate long-term safety and cognitive outcomes in both children and adults. Preliminary data confirm sustained symptom control with minimal adverse effects, reinforcing its position as a preferred stimulant.

• Comparative Effectiveness: Head-to-head studies (e.g., NCT04768910) compare Metadate CD against other extended-release methylphenidate formulations, including Concerta and Adderall XR. Results indicate comparable efficacy but highlight differences in side-effect profiles and dosing flexibility, influencing prescribing patterns.

• Novel Combinations and Delivery Systems: Innovational trials are examining combination therapies involving Metadate CD and non-stimulant agents, aiming to optimize therapeutic outcomes while mitigating adverse events [1].

Regulatory and Safety Considerations

Regulatory bodies continue to surveil for misuse potential, with recent updates emphasizing Prescription Drug Monitoring Programs (PDMPs). While Metadate CD maintains a favorable safety profile, concerns about abuse potential persist, leading to enhanced post-marketing surveillance and risk management strategies.

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Market Analysis

Market Size and Growth Drivers

The ADHD therapeutics market has exhibited consistent expansion over the last decade, driven by:

• Rising Prevalence: ADHD diagnoses have increased globally, with reports suggesting prevalence rates of approximately 5-7% among children and 2-5% in adults [2].

• Broadening Patient Demographics: Increased diagnosis and medication acceptance among adolescents and adults expand markets for formulations like Metadate CD.

• Evolving Prescribing Trends: Healthcare providers favor sustained-release formulations that improve adherence and reduce abuse potential compared to immediate-release variants.

The global ADHD therapeutics market was valued at USD 12.8 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 6.2% through 2030 [3].

Competitive Landscape

Metadate CD competes with several established competitors:

• Concerta (Janssen): The market leader in extended-release methylphenidate.
• Ritalin LA (Novartis) and Adderall XR (Shire): Diversify product options with varying mechanisms.
• Emerging Generics: Increased generic participation has exerted downward pricing pressure.

Key differentiators include formulation characteristics, tolerability profiles, and formulary coverage, influencing prescribing choices.

Market Challenges

• Generic Substitutes: Patent expirations and generics pressure decline revenue margins.
• Regulatory Constraints: Abuse-deterrent formulations face stringent approval processes.
• Concerns over Misuse: Heightened scrutiny affects on-label prescribing and patient access.

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Future Market Projection

Growth Trajectory

By 2030, the ADHD medication market, with Metadate CD integrated into broader therapeutic portfolios, is expected to expand markedly. Factors influencing growth include:

• Increased Awareness and Diagnosis: Societal shifts destigmatize ADHD, prompting earlier diagnosis.
• Healthcare Policy: Reimbursement improvements and policy incentives facilitate drug accessibility.
• Product Innovations: Development of abuse-deterrent, flexible-dosing formulations will maintain market relevance.

Innovations and Strategic Opportunities

• Pharmacogenomics: Personalizing therapy based on genetic profiles can enhance efficacy, positioning Metadate CD for targeted therapeutic approaches.
• Digital Health Integration: Companion apps for dose adherence and behavioral tracking could bolster adherence and patient outcomes.
• Expanding Indications: Ongoing trials exploring off-label uses (e.g., treatment-resistant depression) may open new revenue streams.

Forecasted Market Share

Given current competitive dynamics, Metadate CD is poised to maintain a significant share of the methylphenidate segment, albeit with challenges from generics and new entrants. It is projected to sustain a 15-20% share within the natural stimulant market by 2030, assuming continuous clinical validation and strategic marketing.

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Regulatory Outlook and Opportunities

Regulatory updates emphasizing abuse mitigation strategies present both challenges and opportunities. Companies investing in abuse-deterrent formulations and comprehensive risk management programs will likely benefit from favorable reimbursement and formulary placements.

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Key Takeaways

• Ongoing clinical trials affirm Metadate CD’s efficacy and safety, reinforcing its clinical utility.
• The ADHD treatment market is expanding, driven by increased diagnosis rates and preference for long-acting formulations.
• Market competition from generics and new formulations necessitates continual innovation and strategic positioning.
• Personalized medicine and digital health integration offer significant growth avenues.
• Regulatory focus on abuse deterrence presents opportunities for differentiation but requires ongoing investment.

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FAQs

1. How does Metadate CD compare to other extended-release methylphenidate formulations?
Metadate CD offers a unique delivery system with a bimodal release pattern, providing an initial rapid symptom control followed by sustained effects. Clinical trials show comparable efficacy to Concerta, with some studies suggesting less variability in plasma levels.

2. Are there any recent regulatory changes affecting Metadate CD?
Regulatory updates focus on abuse deterrence and risk management. While no significant approval changes have occurred recently, enhanced post-marketing surveillance underscores ongoing safety evaluation.

3. What are the main market challenges for Metadate CD?
Generic competition, evolving prescribing guidelines, concerns over misuse, and patent expirations pose challenges to revenue growth.

4. What future developments could influence Metadate CD’s market position?
Advances in pharmacogenomics, novel delivery technologies, and expanding indications could bolster its market presence.

5. How significant is the growth potential of the ADHD pharmaceutical market?
The market is projected to grow at a CAGR of over 6% through 2030, driven by increased awareness, diagnosis, and adoption of long-acting formulations like Metadate CD.

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References

[1] ClinicalTrials.gov. Ongoing studies on ADHD medication combinations.
[2] American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
[3] Grand View Research. ADHD Therapeutics Market Size, Share & Trends Analysis. 2023.