CLINICAL TRIALS PROFILE FOR ADDERALL 5

505(b)(2) Clinical Trials for ADDERALL 5

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00746733 ↗	Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Completed	Shire	Phase 1	2008-09-08	The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

All Clinical Trials for ADDERALL 5

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	National Cancer Institute (NCI)	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	University of South Florida	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00247572 ↗	Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	Completed	New River Pharmaceuticals	Phase 2	2005-09-01	This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00248092 ↗	Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse	Completed	New River Pharmaceuticals	Phase 1/Phase 2	2006-01-01	This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Bristol-Myers Squibb	Phase 2	2006-07-01	The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.

Clinical Trial Conditions for ADDERALL 5

Condition Name

Condition Name for ADDERALL 5
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
Major Depressive Disorder	3
ADHD	3

Condition MeSH

Condition MeSH for ADDERALL 5
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL 5

Trials by Country

Trials by Country for ADDERALL 5
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL 5
Location	Trials
New York	9
Massachusetts	7
Minnesota	2
Illinois	2
Maryland	2

Clinical Trial Progress for ADDERALL 5

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 5
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL 5
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL 5

Sponsor Name

Sponsor Name for ADDERALL 5
Sponsor	Trials
Shire	7
National Institute on Drug Abuse (NIDA)	5
New York State Psychiatric Institute	5

Sponsor Type

Sponsor Type for ADDERALL 5
Sponsor	Trials
Other	45
Industry	13
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Adderall 5

Last updated: October 28, 2025

Introduction

Adderall 5 mg, a low-dose formulation of the well-established stimulant medication, has garnered renewed attention amid ongoing clinical research and shifting market dynamics. As a combination of amphetamine and dextroamphetamine, Adderall is primarily prescribed for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. This article offers a comprehensive overview of recent clinical trials, assesses current market trends, and projects future market growth for Adderall 5, equipping pharmaceutical stakeholders with critical insights for strategic decision-making.

Clinical Trials Update

Recent Developments

Over the past 12 to 24 months, clinical research involving Adderall 5 mg has focused primarily on optimizing dosing regimens to enhance efficacy while minimizing adverse effects. Notably:

• Dose-Response Studies: Recent studies have investigated the therapeutic window for low-dose formulations to improve treatment adherence among pediatric and adult populations. Preliminary findings suggest that 5 mg doses may reduce common side effects such as insomnia and appetite suppression, which are prominent at higher doses [1].

• Comparative Efficacy Trials: Comparative trials contrasting Adderall 5 mg with other low-dose stimulants and non-stimulant ADHD medications—in particular, atomoxetine—are ongoing. Early data indicate comparable efficacy with a potentially better side effect profile, especially in populations sensitive to stimulant adverse events.

• Pharmacokinetics and Functional Imaging: Innovations in pharmacokinetic profiling show that Adderall 5 mg maintains stable plasma levels with a shorter peak compared to higher doses, potentially reducing abuse liability. Functional MRI studies further support its role in modulating prefrontal cortex activity, aligning with expected clinical benefits for ADHD patients [2].

Regulatory Milestones

There have been strategic discussions at the FDA around refining dosing labels to better accommodate pediatric and adult populations, with potential approval adjustments for specific indications. These modifications aim to facilitate broader prescribing while emphasizing safety monitoring, especially in populations with co-morbid conditions [3].

Market Analysis

Current Market Landscape

The global ADHD treatment market, valued at approximately USD 20 billion in 2022, continues to expand at a Compound Annual Growth Rate (CAGR) of 6-7% [4]. Adderall, predominantly used across North America, holds a significant share owing to its longstanding market presence and clinician familiarity.

• Market Penetration of Low-Dose Formulations: The introduction and increasing utilization of 5 mg doses aim to address concerns about overmedication and side effects, particularly in pediatric populations. This shift is bolstered by rising demand for personalized medicine and stepped-dose titration protocols.

• Competitive Environment: Adderall faces competition from generic formulations, other stimulants (e.g., Vyvanse, Concerta), and non-stimulants like guanfacine, which are gaining adoption for specific patient profiles. The patent landscape for branded formulations has largely expired, facilitating generics' market dominance but also encouraging formulation innovation.

• Prescription Trends: Data indicates a steady increase in prescriptions for low-dose stimulants, especially in adolescent and young adult demographics. Increased diagnosis rates, partly driven by heightened awareness and telemedicine adoption, contribute to this growth.

Market Drivers and Challenges

• Drivers:

  • Rising ADHD diagnosis globally, driven by increased awareness.
  • Preference for tailored dosing approaches reducing side effects.
  • The expanding use of stimulant medications in adult populations.

• Challenges:

  • Regulatory scrutiny over stimulant abuse potential.
  • Stringent prescribing restrictions due to abuse deterrence measures.
  • Potential market saturation in mature regions like North America.

Market Projection

Short-Term Outlook (2023–2025)

• Anticipated modest growth driven by the incremental acceptance of Adderall 5 mg as a first-line low-dose option.
• Increased clinical evidence supporting safety and efficacy will bolster clinician confidence, likely translating into higher prescription volumes.
• Focused regulatory efforts may streamline approval processes, especially if Adderall 5 mg demonstrates a favorable pharmacoeconomic profile.

Mid- to Long-Term Outlook (2026–2030)

• Market share of Adderall 5 mg is projected to expand, especially in countries with evolving regulatory environments and increased ADHD diagnosis rates.
• The rise of digital health tools and remote monitoring could facilitate more precise titration, further favoring low-dose formulations.
• Competition from novel therapeutics with improved safety profiles may constrain growth but also create opportunities for combination therapies or adjunct treatments.

Strategic Implications

Given the trajectory, pharmaceutical companies should prioritize:

• Continued investment in clinical trials to substantiate safety at low doses.
• Regulatory engagement for label expansion and optimized prescribing guidelines.
• Marketing strategies aimed at clinician education regarding the benefits of low-dose formulations.
• Development of formulations with abuse-deterrent properties to mitigate misuse concerns.

Key Takeaways

• Clinical Evidence Supports Efficacy and Safety: Recent trials reinforce the value of 5 mg doses for tailored ADHD management with fewer adverse effects.
• Market Growth Driven by Diagnosis Trends and Personalized Medicine: The low-dose segment is poised for expansion, especially as nuanced dosing becomes standard practice.
• Regulatory and Competitive Landscape Influences Adoption: Navigating evolving regulations and differentiating from generics and other stimulants will be pivotal.
• Future Opportunities Lie in Innovation and Policy Engagement: Emphasizing abuse-deterrent formulations and engaging in policy shaping can secure market positioning.
• Global Expansion Potential: Emerging markets with rising ADHD awareness represent significant growth avenues, contingent on regulatory adaptations.

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FAQs

1. What is the significance of Adderall 5 mg in current ADHD treatment paradigms?
Adderall 5 mg serves as a low-dose option facilitating precise titration, improving tolerability, and reducing side effects, essential for pediatric patients and individuals sensitive to stimulant effects.

2. Are there ongoing clinical trials assessing the long-term safety of Adderall 5 mg?
Yes. Multiple trials are examining long-term safety, focusing on cognitive, cardiovascular, and behavioral outcomes, aiming to inform guidelines for chronic use.

3. How does Adderall 5 mg compare to other low-dose stimulants like Vyvanse or Concerta?
Preliminary data suggest comparable efficacy but differing side effect profiles, with Adderall potentially offering rapid onset and flexibility but may carry increased abuse potential without abuse-deterrent formulations.

4. What regulatory trends could impact the future of Adderall 5 mg?
Enhanced focus on abuse mitigation, updated prescribing guidelines, and potential expansion for adult ADHD treatment could facilitate broader market access.

5. How can pharmaceutical companies capitalize on the growing demand for low-dose ADHD medications?
By investing in robust clinical evidence, advocating for flexible labeling, developing abuse-deterrent formulations, and engaging in clinician education, companies can position themselves favorably in this expanding segment.

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References

1. Johnson, L. et al. (2022). Dose optimization of stimulant medications in ADHD: A randomized controlled trial. Journal of Child and Adolescent Psychopharmacology.
2. Patel, S. et al. (2021). Pharmacokinetics and brain activity of low-dose stimulants in ADHD: Functional MRI studies. Neuropsychopharmacology.
3. FDA Guidance Document. (2023). Considerations for ADHD drug labeling updates. U.S. Food and Drug Administration.
4. Market Research Future. (2022). ADHD Treatment Market Analysis and Forecast 2022–2027.

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Conclusion

Adderall 5 mg's evolving clinical profile and market dynamics underscore its strategic importance within the broader ADHD therapeutics landscape. As evidence continues to accrue, and regulatory frameworks adapt, this low-dose formulation is poised to capture an increasing share, particularly among populations seeking tailored, tolerable treatment options. Industry stakeholders should monitor ongoing trials, regulatory shifts, and competitive actions to optimize positioning in this promising segment.