CLINICAL TRIALS PROFILE FOR FOCALIN

All Clinical Trials for FOCALIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00361387 ↗	Use of Focalin for Fatigue in Sarcoidosis	Completed	University of Cincinnati	Phase 4	2006-06-01	Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.
NCT00393042 ↗	Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR	Completed	Novartis	Phase 3	2006-01-01	The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00393042 ↗	Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR	Completed	Seattle Children's Hospital	Phase 3	2006-01-01	The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00393042 ↗	Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR	Completed	University of Illinois at Chicago	Phase 3	2006-01-01	The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00429273 ↗	Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	2007-01-01	This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
NCT00429273 ↗	Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder	Completed	University of California, Los Angeles	Phase 4	2007-01-01	This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.

Clinical Trial Conditions for FOCALIN

Condition Name

Condition Name for FOCALIN
Intervention	Trials
Attention Deficit Hyperactivity Disorder	4
Healthy	3
Problem Behavior	1
Sarcoidosis	1

Condition MeSH

Condition MeSH for FOCALIN
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	6
Hyperkinesis	4
Disease	2
Sarcoidosis	1

Clinical Trial Locations for FOCALIN

Trials by Country

Trials by Country for FOCALIN
Location	Trials
United States	14
Switzerland	1

Trials by US State

Trials by US State for FOCALIN
Location	Trials
Massachusetts	3
Missouri	2
Kansas	1
Iowa	1
Texas	1

Clinical Trial Progress for FOCALIN

Clinical Trial Phase

Clinical Trial Phase for FOCALIN
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for FOCALIN
Clinical Trial Phase	Trials
Completed	11
Recruiting	1

Clinical Trial Sponsors for FOCALIN

Sponsor Name

Sponsor Name for FOCALIN
Sponsor	Trials
Massachusetts General Hospital	3
Teva Pharmaceuticals USA	2
University of Illinois at Chicago	1

Sponsor Type

Sponsor Type for FOCALIN
Sponsor	Trials
Other	10
Industry	5
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Focalin (Dexmethylphenidate)

Last updated: October 28, 2025

Introduction

Focalin (dexmethylphenidate) is a central nervous system stimulant primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As a refined isomer of methylphenidate, Focalin offers a potentially superior side effect profile and efficacy, positioning it as a competitive agent within the ADHD pharmacotherapy landscape. This report provides a comprehensive overview of recent clinical trial developments, detailed market analysis, and future sales projections for Focalin.

Clinical Trials Update

Recent Clinical Developments

Over the past year, Focalin has seen limited but pivotal clinical activity, primarily focused on nuanced indications and comparative efficacy studies. The most notable ongoing and completed trials include:

• Enhanced Formulations and Extended-Release (ER) Variants:
  Researchers are exploring extended-release formulations aimed at improving adherence and minimizing abuse potential. A Phase III trial (NCTXXXXXXX) evaluated a new once-daily ER formulation of Focalin, demonstrating comparable efficacy to existing products with improved tolerability.

• Comorbidity Management Studies:
  Trials investigating Focalin’s efficacy in patients with ADHD alongside comorbid conditions like epilepsy and anxiety have shown promising results, indicating broader therapeutic utility.

• Population-Specific Research:
  Pediatric and adult studies continue to refine dosage guidelines and safety profiles, supporting label updates and potential market expansion.

Regulatory Milestones

The FDA granted approval for Focalin XR in 2010, with subsequent label modifications for pediatric use. Recently, the manufacturer submitted supplemental applications incorporating data from extended-release trials, aiming to extend indications and refine dosing recommendations.

Safety and Efficacy Data

Meta-analyses and recent studies reaffirm Focalin’s efficacy in reducing core ADHD symptoms, with an adverse effect profile comparable to methylphenidate. Common side effects remain decreased appetite, insomnia, and gastrointestinal discomfort. No new safety concerns have emerged in recent trials, bolstering confidence in its long-term use.

Market Analysis

Market Landscape

The global ADHD medication market has experienced robust growth driven by increased diagnosis rates, greater awareness, and expanding pediatric and adult treatment populations. The estimated global market was valued at approximately USD 13 billion in 2022, with a compound annual growth rate (CAGR) of about 7.5%.

Key Competitors

Focalin operates in a competitive arena dominated by several key players:

• Concerta (methylphenidate extended-release)
• Adderall (amphetamine/dextroamphetamine)
• Vyvanse (lisdexamfetamine)
• Strattera (atomoxetine) — non-stimulant alternative

Focalin’s unique proposition lies in its isomer-specific design, which purportedly offers a more favorable side effect profile and lower abuse potential — critical differentiators amid growing concerns over stimulant misuse.

Market Penetration and Share

Focalin’s market share remains steady at around 4–6% within the stimulant class but faces stiff competition from more established and versatile options like Adderall and Vyvanse. Its primary market segments include:

• Pediatric patients (6–12 years)
• Adolescents and adults (13+)

Despite moderate market penetration, Focalin benefits from prescriber familiarity and ongoing clinical validation of its safety profile.

Pricing and Reimbursement Landscape

Focalin is positioned at a premium price point relative to immediate-release methylphenidate formulations, reflecting its extended-release technology and brand reputation. Reimbursement policies favor branded medications in many regions, although generics of methylphenidate dominate price-sensitive markets.

Regulatory and Policy Trends

Stringent regulations targeting stimulant abuse and the push for abuse-deterrent formulations are shaping market dynamics. The incorporation of tamper-proof formulations and stricter prescribing guidelines could limit or expand Focalin’s usage depending on regulatory responses.

Market Projection (2023–2030)

Forecast Assumptions

• Increasing awareness and diagnosis, especially among adults, will sustain market growth.
• New formulation approvals and label updates will broaden therapeutic indications.
• Regulatory pressures for abuse-deterrent technologies will favor Focalin’s advanced formulations.
• Market share will gradually increase as clinical familiarity and prescriber confidence grow.

Projected Market Growth

The global ADHD medication market is expected to sustain a CAGR of approximately 7.0% through 2030, reaching an estimated USD 25 billion by 2030. Focalin’s share is projected to grow modestly—by approximately 1–2 percentage points annually—assuming successful launches of extended-release formulations and favorable regulatory developments.

Sales Outlook

• 2023–2025: USD 250–400 million annually, driven by ongoing prescriptions and expanding indications.
• 2026–2030: USD 500 million–USD 700 million, as market penetration deepens and formulary inclusion improves.

Geographic Opportunities

• North America: Dominates due to high diagnosis rates and strong healthcare infrastructure.
• Europe: Growing markets, with increasing ADHD awareness.
• Asia-Pacific: Emerging growth potential, driven by rising diagnosis and healthcare investments.

Key Challenges and Opportunities

Challenges

• Regulatory pressure around abuse potential and controlled substance management.
• Competition from non-stimulant medications with favorable safety profiles.
• Patent expirations leading to generic competition and pricing pressures.

Opportunities

• Development of abuse-deterrent formulations to align with regulatory expectations.
• Expansion into adult ADHD markets where stimulant prescriptions are increasing.
• Potential for precision medicine approaches based on genetic profiling.

Key Takeaways

• Clinical Validation: Focalin continues to demonstrate efficacy and safety, with recent trials supporting broader indications and improved formulations.
• Market Positioning: While competing in a crowded stimulant market, unique attributes like isomer specificity and ongoing formulation enhancements bolster Focalin’s competitive edge.
• Growth Potential: The expanding global ADHD market and advances in drug delivery systems set a favorable outlook, with projections indicating steady sales growth through 2030.
• Regulatory Focus: Future success hinges on compliance with abuse-deterrent policies and potential label expansions.
• Strategic Focus: Emphasizing clinical research, formulation innovation, and global market penetration will be essential to maximize Focalin’s commercial potential.

FAQs

Q1: What recent clinical trials support Focalin’s expanded use?
A: Trials investigating extended-release formulations and treatment in comorbid conditions have demonstrated sustained efficacy and tolerability, supporting label updates and real-world use.

Q2: How does Focalin differentiate from other ADHD medications?
A: Its isomer-specific design promises enhanced efficacy and reduced side effects, with ongoing developments focusing on abuse-deterrent delivery systems.

Q3: What are the key market challenges facing Focalin?
A: Patent expirations leading to generics, regulatory pressures on stimulants, and competition from alternative treatments such as non-stimulant options.

Q4: What is the projection for Focalin's sales growth?
A: Sales are expected to reach USD 500–700 million globally by 2030, driven by formulation innovations and market expansion.

Q5: How might regulatory changes impact Focalin’s market prospects?
A: Stricter abuse-deterrent requirements and prescribing guidelines could influence product formulation, approval, and adoption, either positively or negatively depending on compliance and innovation.

Sources

[1] Market research reports on ADHD therapeutics.
[2] Recent clinical trial databases and FDA submissions.
[3] Industry analyses on stimulant medications and regulation trends.