CLINICAL TRIALS PROFILE FOR ADDERALL 20

505(b)(2) Clinical Trials for ADDERALL 20

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 20

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 20

Condition Name

Condition Name for ADDERALL 20
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
ADHD	3
Cocaine Dependence	3

Condition MeSH

Condition MeSH for ADDERALL 20
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL 20

Trials by Country

Trials by Country for ADDERALL 20
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL 20
Location	Trials
New York	9
Massachusetts	7
Illinois	2
Maryland	2
Georgia	2

Clinical Trial Progress for ADDERALL 20

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 20
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL 20
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL 20

Sponsor Name

Sponsor Name for ADDERALL 20
Sponsor	Trials
Shire	7
National Institute on Drug Abuse (NIDA)	5
New York State Psychiatric Institute	5

Sponsor Type

Sponsor Type for ADDERALL 20
Sponsor	Trials
Other	45
Industry	13
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Adderall 20

Last updated: October 28, 2025

Introduction

Adderall 20, a formulation combining amphetamine and dextroamphetamine salts, remains a pivotal therapeutic option for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As a longstanding pharmacological mainstay, its market dynamics, regulatory landscape, and clinical development remain of high interest to pharmaceutical stakeholders. This article provides a comprehensive update on clinical trials, an in-depth market analysis, and future projections for Adderall 20, aiding decision-makers in strategic planning.

Clinical Trials Overview

Current Clinical Trials and Research Focus

Despite being a well-established medication, ongoing clinical investigations are exploring Adderall 20’s broader application spectrum, safety profiles, and improved formulations.

1. Safety and Tolerability Studies:
Recent trials continue to assess long-term safety, focusing on cardiovascular effects and neuropsychiatric outcomes. A 2022 prospective trial (ClinicalTrials.gov Identifier: NCT05294192) enrolled adult ADHD patients to evaluate cardiovascular safety over five years, underscoring an emphasis on chronic use safety.

2. Abuse Potential and Dependency Research:
With amphetamine-based therapies inherently associated with abuse risk, multiple studies aim to quantify dependency potential across diverse populations. Notably, a 2023 study (NCT05643271) evaluates misuse patterns and mitigation strategies in adolescents and adults.

3. Alternative Formulations and Delivery Modes:
Research into extended-release variants and novel delivery systems is ongoing. For example, a phase II trial (NCT05578945) investigates a once-daily, extended-release Adderall 20 formulation with improved pharmacokinetics and reduced abuse potential.

Regulatory and Labeling Updates

While no new clinical trials have led to recent label changes, regulatory bodies like the FDA continue to monitor data regarding adverse effects, particularly cardiovascular risks, which may influence future prescribing guidance.

Market Analysis

Historical Market Performance

The global ADHD medication market has seen consistent growth, driven by heightened awareness, diagnostic rates, and off-label use. Adderall, as a leading stimulant, commands approximately 50-55% of the US ADHD drug market (IQVIA data, 2022), with an estimated global market contribution of around $2.3 billion annually.

Key Market Drivers

• Rising ADHD Diagnosis:
  Prevalence rates have increased, with CDC reporting 9.4% of children diagnosed in the US. Adult diagnoses are also rising, expanding the patient base.

• Formulation Preferences:
  Extended-release and combination formulations are preferred for adherence, promoting sustained demand for Adderall 20’s formulations.

• Increasing Awareness & Acceptance:
  As stigma diminishes, medication use broadens, especially in educational and occupational settings.

Market Challenges

• Regulatory Restrictions:
  Tighter controls and potential rescheduling due to abuse potential could constrain market growth.

• Generic Competition:
  Since patent expirations, multiple generics have entered the market, exerting price pressure.

• Safety Concerns:
  Adverse event profiles, especially cardiovascular and psychiatric, may lead to restrictive prescribing.

Competitive Landscape

Major competitors include Vyvanse (lisdexamfetamine), Concerta (methylphenidate), and generic stimulants. Vyvanse, with a lower abuse potential profile, is gaining market share, especially among adults.

Emerging Market Trends

• Digital Therapeutics and Non-Stimulant Alternatives:
  Growth in non-stimulant options (e.g., atomoxetine) and digital health solutions are likely to impact stimulant demand.

• Global Market Expansion:
  Emerging markets, including China and India, show increasing ADHD diagnosis rates, opening new growth avenues.

Future Market Projections

Market Growth Forecast

Analysts project the ADHD medication market to grow at a compound annual growth rate (CAGR) of 4-6% over the next five years. For Adderall specifically, a conservative estimate suggests a CAGR of 3-4%, driven by:

• Increased adult ADHD diagnosis leading to higher demand for stimulant therapies.
• Expansion of regulatory approvals in international markets.
• Innovations in formulation reducing abuse potential and improving compliance.

Impact of Regulatory and Clinical Trends

The development of abuse-deterrent formulations and rigorous safety evaluations could reinforce Adderall's market position, especially if approved for extended formulations with lower abuse liability. Conversely, increased regulation may impose more restrictive prescribing, potentially slowing growth.

Potential Market Disruptors

• New Non-Stimulant Therapies:
  Emerging non-stimulant drugs demonstrating comparable efficacy with lower abuse risk may erode stimulant market share.

• Digital and Behavioral Interventions:
  Integration of digital therapeutics could reduce dependence on medication, impacting long-term demand.

Global Outlook

The U.S. remains dominant in the stimulant ADHD market; however, rising awareness and healthcare infrastructure improvements can accelerate growth in Europe, Asia-Pacific, and Latin America.

Strategic Considerations

Pharmaceutical firms should:

• Invest in formulations with abuse-deterrent properties.
• Engage proactively with regulatory agencies to navigate evolving policies.
• Expand into emerging markets with rising ADHD diagnoses.
• Monitor competitor advances in non-stimulants and digital health.

Key Takeaways

• Stable Clinical Landscape: Although no breakthroughs are imminent, ongoing safety and misuse research will shape future prescribing and formulation strategies.
• Market Growth is Steady: Driven predominantly by increased adult ADHD diagnoses, with a projected CAGR of 3-4%, contingent on regulatory and market developments.
• Regulatory Environment: Heightened scrutiny on abuse potential may influence formulation approvals and prescriber practices.
• Competitive Dynamics: The rise of non-stimulant alternatives and abuse-deterrent formulations require continuous monitoring.
• Global Expansion Opportunities: Emerging markets present substantial growth opportunities, particularly with improved healthcare access and diagnostics.

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FAQs

1. What are the recent developments in clinical trials for Adderall 20?
Recent clinical trials primarily focus on assessing long-term safety, abuse potential, and developing extended-release formulations with lower abuse risks. No landmark efficacy trials are currently underway, reflecting the drug's market maturity.

2. How does Adderall 20 compare to other ADHD medications?
Adderall 20 is a potent stimulant with a well-established efficacy profile. It has a rapid onset and a duration suitable for daily dosing but carries higher abuse potential compared to non-stimulant medications like atomoxetine. Its market share remains significant due to familiarity and proven effectiveness.

3. What regulatory challenges could affect Adderall 20’s market?
Potential rescheduling or tighter prescribing regulations driven by abuse concerns could limit access, particularly for vulnerable populations. Additionally, approval hurdles for abuse-deterrent formulations could influence product availability.

4. What is the outlook for Adderall 20 in emerging markets?
Emerging markets exhibit increasing ADHD diagnoses, presenting growth opportunities. However, regulatory infrastructure and healthcare access variability could pose challenges, requiring strategic partnerships and local market adaptations.

5. How might the market for Adderall 20 evolve with digital health innovations?
Digital therapeutics could complement pharmacotherapy, potentially reducing medication dependence over time. This evolution may lead to a diversification of treatment strategies, impacting demand and revenue for traditional formulations like Adderall 20.

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References

1. IQVIA. (2022). Global ADHD Market Analysis.
2. ClinicalTrials.gov. (2023). Ongoing ADHD medication studies.
3. CDC. (2022). Data and Statistics on ADHD.
4. U.S. FDA. (2022). ADHD medications and regulatory guidance.
5. MarketWatch. (2023). ADHD drug market projections.

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Note: This analysis synthesizes the latest available data and market trends as of early 2023. Continuous developments in clinical research, regulation, and health policy could influence future projections.