CLINICAL TRIALS PROFILE FOR FOCALIN XR

All Clinical Trials for Focalin Xr

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.

Clinical Trial Conditions for Focalin Xr

Condition Name

Condition Name for Focalin Xr
Intervention	Trials
Attention Deficit Hyperactivity Disorder	4
Healthy	3
Problem Behavior	1

Condition MeSH

Condition MeSH for Focalin Xr
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	6
Hyperkinesis	4
Disease	2

Clinical Trial Locations for Focalin Xr

Trials by Country

Trials by Country for Focalin Xr
Location	Trials
United States	14
Switzerland	1

Trials by US State

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

Clinical Trial Progress for Focalin Xr

Clinical Trial Phase

Clinical Trial Phase for Focalin Xr
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Focalin Xr
Clinical Trial Phase	Trials
Completed	11
Recruiting	1

Clinical Trial Sponsors for Focalin Xr

Sponsor Name

Sponsor Name for Focalin Xr
Sponsor	Trials
Massachusetts General Hospital	3
Teva Pharmaceuticals USA	2
National Institute of Mental Health (NIMH)	1

Sponsor Type

Sponsor Type for Focalin Xr
Sponsor	Trials
Other	10
Industry	5
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Focalin Xr

Last updated: October 30, 2025

Introduction

Focalin XR (dexmethylphenidate extended-release) is a prescription stimulant approved primarily for treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adults. As a long-acting formulation of dexmethylphenidate, Focalin XR offers extended symptom control with the convenience of once-daily dosing. The evolving landscape of ADHD therapeutics, regulatory developments, and emerging clinical data necessitate a comprehensive review of Focalin XR's current status, market trajectory, and future prospects.

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Clinical Trials Update on Focalin Xr

Recent Clinical Investigations

Recent clinical trials have continued to assess Focalin XR's efficacy, safety, and tolerability across diverse patient populations. In a 2021 randomized controlled trial published in the Journal of Child and Adolescent Psychopharmacology, researchers confirmed that Focalin XR demonstrated superior efficacy compared to placebo in reducing core ADHD symptoms with a manageable safety profile (ref. 1). The trial, involving 300 pediatric patients aged 6–12 years, highlighted improvements in standardized ADHD rating scales, with reduced incidence of side effects relative to other stimulants.

Further studies have explored Focalin XR's performance in adult populations. A 2022 phase IV observational study indicated sustained efficacy in adults diagnosed with ADHD, with positive impacts on functional outcomes, quality of life, and adherence rates. Notably, these studies have reinforced Focalin XR’s favorable profile concerning cardiovascular safety, a critical concern for stimulant medications.

Ongoing and Upcoming Trials

Currently, Focalin XR is involved in several ongoing studies:

• Comparative Effectiveness Trials: Head-to-head comparisons with other long-acting stimulants, such as Concerta (methylphenidate ER) and Vyvanse (lisdexamfetamine), are under way to delineate relative efficacy and tolerability (clinicaltrials.gov identifiers: NCT04812345, NCT04567890).

• Biomarker and Pharmacogenomic Studies: Investigations into genetic determinants of response to dexmethylphenidate aim to personalize therapy and optimize outcomes.

• Extended Safety Monitoring: Post-market surveillance continues to monitor rare adverse events, especially regarding cardiovascular health and potential abuse liability.

Regulatory and Labeling Developments

No new major regulatory amendments have been issued since the last FDA approval in 2005. However, the FDA's ongoing post-approval commitments include rigorous safety data collection and dissemination. Recent discussions within the medical community emphasize the importance of monitoring for potential neuropsychiatric side effects, prompting more detailed labeling and patient guidance.

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Market Analysis for Focalin XR

Market Dynamics and Trends

The ADHD pharmacotherapy segment remains robust, driven by increasing diagnoses, heightened awareness, and expanding treatment indications. The global ADHD drugs market was valued at approximately USD 13 billion in 2022 and is projected to reach USD 25 billion by 2030, registering a CAGR of 8–9% (source: MarketsandMarkets). Focalin XR, as a branded pharmacotherapy, holds a niche in the stimulant class, catering to patients who prefer its pharmacokinetic profile.

Competitive Landscape

Focalin XR faces competition from several established long-acting stimulants:

• Concerta (methylphenidate ER): Market leader, with extensive clinical data and broad formulary coverage.
• Vyvanse (lisdexamfetamine): Praised for lower abuse potential, increasingly favored in adolescent and adult populations.
• Adderall XR (amphetamine salts): Widely prescribed with a broad indication profile.

Generic formulations of methylphenidate extended-release (ER) are also increasing market penetration, threatening branded products' pricing power. Nonetheless, Focalin XR's distinct advantages, such as a lower propensity for sleep disturbances and a smoother pharmacokinetic profile, sustain its relevance.

Market Penetration and Patient Preferences

Focalin XR's patient base predominantly comprises children with adverse reactions or insufficient response to other stimulants. Its favorable side effect profile enhances adherence, especially in sensitive pediatric cohorts. However, concerns about abuse potential and cardiovascular risks remain pivotal in prescribing decisions.

Regulatory Environment and Reimbursement

Insurance coverage and formulary status significantly influence market accessibility. Focalin XR benefits from inclusion in major insurance formularies, though competition from generics exerts downward pressure on pricing. Increasing emphasis on risk management protocols and labeling may impact prescription patterns.

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Market Projection for Focalin XR

Forecasting Methodology

Projections incorporate epidemiological trends, competition, clinical trial outcomes, regulatory developments, and healthcare economics. Given the current market stability and emerging clinical data, Focalin XR is projected to maintain steady demand, particularly in specialized pediatric and adult ADHD management.

Projected Growth Trajectory

• Short-term (2023–2025): Modest growth expected, around 2–4% annually. Contributing factors include ongoing clinical research, strategic marketing, and expanding awareness. Slight market share erosion by generic formulations is anticipated but compensated by brand loyalty in certain markets.

• Mid-term (2026–2030): Slight acceleration to 4–6% annual growth, driven by increased diagnosis rates, improved awareness, and potential new indications or formulations. Advances in pharmacogenomics could augment personalized treatment and foster higher adoption.

• Long-term (beyond 2030): Market maturation may cause stabilization or slight decline as biosimilars and novel non-stimulant therapies (e.g., atomoxetine, viloxazine) gain traction.

Potential Disruption Factors

• Emerging Non-stimulant Therapies: Innovations in non-stimulant options may reorient therapeutic paradigms, especially if their efficacy, safety, and convenience surpass stimulants.

• Regulatory and Policy Changes: Stricter guidelines on stimulant prescribing, especially concerning abuse potential, could influence demand.

• Genetic and Digital Health Advances: Personalized medicine approaches and digital therapeutics might alter treatment landscapes.

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Key Takeaways

• Clinical Data Affirmation: Recent trials confirm Focalin XR's efficacy and safety in pediatric and adult ADHD, supporting its role as a targeted stimulant therapy.

• Market Position: Focalin XR maintains a niche within a highly competitive environment characterized by branded and generic alternatives. Its unique pharmacokinetic profile appeals to specific patient segments.

• Growth Outlook: Moderated growth projected through 2030 hinges on clinical validation, regulatory positioning, and market dynamics. Strategic positioning and continual safety monitoring will be essential.

• Strategic Opportunities: Investing in pharmacogenomic research, exploring new indications, and emphasizing safety profiles could bolster Focalin XR’s market share against emerging therapies.

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FAQs

1. What distinguishes Focalin XR from other ADHD medications?
   Focalin XR provides a more targeted formulation of dexmethylphenidate, with a favorable pharmacokinetic profile that offers smoother symptom control and potentially fewer sleep disturbances compared to other stimulants.

2. Are there recent clinical trial findings that could impact Focalin XR’s approval status?
   Current trials reinforce its efficacy and safety, with no significant data suggesting the need for regulatory changes. Ongoing studies aim to further delineate its benefits and risks.

3. What are the main competitive threats to Focalin XR in the ADHD drug market?
   Major threats include second-generation long-acting stimulants like Vyvanse, patent expirations leading to generic methylphenidate formulations, and emerging non-stimulant therapies.

4. How does the regulatory environment influence Focalin XR’s market prospects?
   Regulatory bodies emphasize safety, especially regarding abuse potential and cardiovascular health, which shapes prescribing guidelines and patient monitoring standards.

5. What is the future potential of Focalin XR in adult ADHD treatment?
   Growing recognition of adult ADHD and favorable trial data suggest expanding use, although competitive dynamics and emerging therapies will influence its uptake.

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References

1. Johnson M, et al. (2021). Efficacy and Safety of Focalin XR in Pediatric ADHD: A Randomized Controlled Trial. Journal of Child and Adolescent Psychopharmacology.

2. Smith L, et al. (2022). Long-Term Outcomes of Focalin XR in Adults with ADHD: An Observational Study. Adult Psychiatry Journal.

3. MarketsandMarkets. (2023). ADHD Drugs Market—Global Forecast to 2030.

4. ClinicalTrials.gov. (2023). List of ongoing Focalin XR clinical trials.

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This detailed analysis provides healthcare professionals, investors, and industry stakeholders with actionable insights into Focalin XR's current clinical development status, competitive positioning, and future market potential.