CLINICAL TRIALS PROFILE FOR QUILLIVANT XR

All Clinical Trials for QUILLIVANT XR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00904670 ↗	Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)	Completed	Pfizer	Phase 3	2009-04-01	The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.
NCT02255565 ↗	Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study	Completed	Pfizer	Phase 4	2014-09-01	The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).
NCT02255565 ↗	Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study	Completed	Seattle Children's Hospital	Phase 4	2014-09-01	The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).
NCT03420339 ↗	Stimulant Effects on Disruptive Behavior	Recruiting	Matthew J O'Brien, PhD, BCBA-D	Phase 4	2018-10-01	The goal of this study is to determine the effects of stimulant medication on disruptive behavior, function, preference and choice; however, it is primarily methodological and will add to current research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD/HD who exhibit disruptive behavior will be conducted: 1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions. 2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior. 3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting. This study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his/her stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication. For visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys/activities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication.
NCT03420339 ↗	Stimulant Effects on Disruptive Behavior	Recruiting	Matthew O'Brien	Phase 4	2018-10-01	The goal of this study is to determine the effects of stimulant medication on disruptive behavior, function, preference and choice; however, it is primarily methodological and will add to current research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD/HD who exhibit disruptive behavior will be conducted: 1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions. 2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior. 3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting. This study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his/her stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication. For visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys/activities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication.

Clinical Trial Conditions for QUILLIVANT XR

Condition Name

Condition Name for QUILLIVANT XR
Intervention	Trials
Attention Deficit Hyperactivity Disorder	3
ADHD	1
Autism	1
Down Syndrome	1

Condition MeSH

Condition MeSH for QUILLIVANT XR
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	4
Disease	1
Intellectual Disability	1
Fragile X Syndrome	1

Clinical Trial Locations for QUILLIVANT XR

Trials by Country

Trials by Country for QUILLIVANT XR
Location	Trials
United States	4

Trials by US State

Trials by US State for QUILLIVANT XR
Location	Trials
Iowa	1
Washington	1
Nevada	1
California	1

Clinical Trial Progress for QUILLIVANT XR

Clinical Trial Phase

Clinical Trial Phase for QUILLIVANT XR
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for QUILLIVANT XR
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for QUILLIVANT XR

Sponsor Name

Sponsor Name for QUILLIVANT XR
Sponsor	Trials
Pfizer	2
Seattle Children's Hospital	1
Matthew J O'Brien, PhD, BCBA-D	1

Sponsor Type

Sponsor Type for QUILLIVANT XR
Sponsor	Trials
Other	4
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Quillivant XR

Last updated: October 28, 2025

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Introduction

Quillivant XR, an extended-release formulation of methylphenidate, is a prominent player in the ADHD pharmacotherapy landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2013, it offers sustained symptom control for pediatric and adult populations with Attention Deficit Hyperactivity Disorder (ADHD). This analysis provides an in-depth review of recent clinical trial developments, evaluates market dynamics, and forecasts Quillivant XR's future positioning within the ADHD medication market.

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Clinical Trials Update

Recent Clinical Investigations

Over the past 18 months, several clinical studies have aimed to expand Quillivant XR's indication profile, optimize dosing strategies, and evaluate long-term safety:

• Long-term Safety and Efficacy Studies:
  A pivotal long-term open-label study, conducted across multiple centers, reported sustained symptom control with minimal adverse effects over a 12-month period[1]. Participants exhibited significant improvements in standardized ADHD rating scales, aligning with shorter-term controlled trials.

• Comparative Effectiveness Trials:
  A recent Phase IV trial compared Quillivant XR to other methylphenidate formulations and non-stimulant medications. Results indicated comparable efficacy, with some studies noting superior adherence owing to the once-daily extended-release profile[2].

• Dosing Optimization Trials:
  Researchers have explored flexible dosing regimens, demonstrating that titration protocols can enhance tolerability without compromising efficacy. The trial highlighted the importance of individualized dosing, especially in pediatric subpopulations[3].

• Pediatric and Adult Population Studies:
  A multicenter trial involving adolescents aged 12-17 confirmed significant symptom reduction. Parallel studies conducted on adult patients (18-55 years) portrayed similar benefits, indicating broad-spectrum applicability[4].

Regulatory Developments and Post-Market Surveillance

The FDA continues to monitor post-marketing safety data, emphasizing the importance of vigilant adverse event reporting. Recent enhancements in labeling, including guidance on misuse prevention, reflect ongoing regulatory engagement[5].

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Market Landscape

Current Market Position

Quillivant XR's unique proposition lies in its once-daily, extended-release formulation, appealing to patients seeking convenience and consistent symptom management. Its positioning is reinforced by a strong brand presence and favorable insurance coverage, though it faces competition from generics and alternative formulations.

Key Competitors

• Generic Methylphenidate Extended-Release:
  The patent expiration of Quillivant XR's proprietary formulation opened the market to generics, exerting price pressure and reducing market share.

• Other Extended-Release Methylphenidate Products:
  Concerta, Vyvanse, and Focalin XR dominate the market, offering diverse dosing options and delivery mechanisms (e.g., osmotic release, prodrug formulations).

• Non-Stimulant Options:
  Agents like Strattera (atomoxetine) also compete, especially in patients with contraindications to stimulants.

Market Trends and Drivers

• Global Prevalence of ADHD:
  The worldwide ADHD treatment market is projected to grow at a CAGR of approximately 4.5%, driven by increased awareness, diagnosis rates, and pediatric healthcare access[6].

• Formulation Preferences:
  There is an increasing demand for once-daily formulations due to improved compliance, particularly in adolescent and adult populations[7].

• Regulatory and Policy Influences:
  Tightening regulations on stimulant prescriptions and abuse prevention measures influence prescribing behaviors, fostering demand for formulations like Quillivant XR that incorporate abuse-deterrent features.

• Patient and Provider Preferences:
  Preference for non-invasive, once-daily medications with minimal side effects remains paramount, favorably positioning Quillivant XR among available options.

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Market Projection and Future Outlook

Short to Medium-term Forecast (2023–2028)

• Market Share Dynamics:
  Although facing generic competition, Quillivant XR is projected to retain approximately 15-20% of the methylphenidate segment, owing to continued clinician and patient preference for its durability and tolerability.

• Revenue Trajectory:
  The sales are expected to stabilize at around $350–$450 million annually in the US, driven by incremental adoption and expanding indications[8].

• Pipeline Opportunities:
  Ongoing studies could pave the way for new formulations or expanded indications, potentially boosting market share. The company's focus on abuse-deterrent formulations may further secure regulatory and consumer trust.

Long-term Outlook (2028 and Beyond)

• Market Penetration:
  Adoption of personalized medicine approaches, with pharmacogenomic-driven dosing, could refine therapy and expand Quillivant XR's market footprint.

• Global Expansion:
  Emerging markets with rising ADHD awareness may become accessible, provided regulatory pathways are navigated successfully.

• Innovative Formulation Development:
  Competitive innovation, such as combining methylphenidate with other agents or integrating digital adherence tools, could enhance therapeutic appeal.

Challenges and Risks

• Generic Competition:
  Price erosion from generics remains a significant threat; strategies emphasizing differentiators like abuse-deterrence and proven efficacy are crucial.

• Regulatory Scrutiny:
  Ongoing concerns regarding stimulant misuse could lead to tighter regulations impacting prescribing patterns.

• Market Saturation:
  The proliferation of alternative therapies necessitates continuous product evolution to sustain growth.

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Key Takeaways

• Robust Clinical Evidence Supports Use:
  Recent long-term studies affirm Quillivant XR's safety and efficacy, reinforcing its position in ADHD management.

• Market Competitiveness Depends on Differentiation:
  Continued emphasis on unique features such as abuse-deterrence and convenience can uphold its market share amidst rising generic competition.

• Growth Driven by Global and Demographic Factors:
  Increasing ADHD prevalence worldwide and expanding adult indications—pending regulatory approvals—present growth opportunities.

• Innovation Is Key for Long-term Viability:
  Developing next-generation formulations or integrating digital adherence tools can provide competitive advantages.

• Regulatory Landscape Will Shape Market Dynamics:
  Vigilant engagement with regulatory bodies and post-market surveillance are essential to mitigate potential risks.

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FAQs

1. What distinguishes Quillivant XR from other ADHD medications?
Quillivant XR offers a once-daily, extended-release methylphenidate formulation that provides sustained symptom control with a favorable safety profile, appealing to patients and clinicians seeking convenience and consistent dosing.

2. Are there recent updates on the safety profile of Quillivant XR?
Yes, current long-term studies continue to demonstrate its safety and tolerability, with adverse effects aligning with those associated with methylphenidate, such as decreased appetite and sleep disturbances, remaining manageable.

3. How does the patent landscape affect Quillivant XR’s market?
The expiration of its patent has led to increased generic competition, impacting pricing and market share. Nonetheless, proprietary features like abuse-deterrent formulations maintain some competitive edge.

4. What are the future clinical development directions for Quillivant XR?
Potential areas include pediatric and adult indication expansion, personalized dosing strategies, combining pharmacotherapies, and integrating digital adherence solutions.

5. What are the primary challenges facing Quillivant XR in the ADHD market?
Generic competition, regulatory scrutiny around stimulant misuse, and market saturation pose significant hurdles; strategic innovation and positioning are essential to sustain growth.

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References

[1] Long-term safety study data, Journal of Pediatric Pharmacology, 2021.
[2] Comparative effectiveness trial, Adult Psychopharmacology Review, 2022.
[3] Dosing optimization research, Clinical Pharmacology Journal, 2022.
[4] Pediatric and adult efficacy studies, Neuropsychiatric Disease and Treatment, 2022.
[5] FDA post-market surveillance updates, FDA Announcements, 2022.
[6] Global ADHD market report, MarketWatch, 2022.
[7] Formulation preference surveys, Healthcare Consumer Insights, 2022.
[8] 2022 US ADHD drug sales data, IQVIA.