CLINICAL TRIALS PROFILE FOR ADDERALL 10

505(b)(2) Clinical Trials for ADDERALL 10

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 10

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.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	National Institute of Mental Health (NIMH)	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.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Otsuka Pharmaceutical Co., Ltd.	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 10

Condition Name

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

Condition MeSH

Condition MeSH for ADDERALL 10
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL 10

Trials by Country

Trials by Country for ADDERALL 10
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL 10
Location	Trials
New York	9
Massachusetts	7
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for ADDERALL 10

Clinical Trial Phase

Clinical Trial Phase for ADDERALL 10
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL 10
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for ADDERALL 10

Sponsor Name

Sponsor Name for ADDERALL 10
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for ADDERALL 10
Sponsor	Trials
Other	45
Industry	13
NIH	8

Clinical Trials Update, Market Analysis and Projection for Adderall 10

Last updated: October 29, 2025

Introduction

Adderall 10 mg, a central nervous system stimulant primarily indicated for Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, remains a globally significant pharmaceutical asset. Its active ingredients—amphetamine salts—play a crucial role in psychiatric therapeutics, with the drug’s market evolving alongside regulatory landscapes, clinical advancements, and demographic demands. This report synthesizes recent clinical trial updates, analyzes current market conditions, and projects future growth trajectories for Adderall 10.

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Clinical Trials Update

Ongoing Trials and Emerging Data

While Adderall 10 mg is a longstanding medication with established efficacy and safety profiles, recent advancements focus on optimizing its therapeutic window, reducing abuse potential, and exploring expanded indications. Currently, there are no major phase III clinical trials explicitly targeting Adderall 10 mg alone; however, the broader Adderall formulation continues to be part of investigator-initiated studies and post-marketing surveillance efforts.

One notable development pertains to biosimilars and novel formulations—including extended-release (XR) versions—aimed at improving compliance. For instance, the 10 mg dose within Adderall XR formulations is under continual assessment for pharmacokinetic modifications to enhance convenience and reduce misuse.

In terms of safety, recent post-marketing observational studies confirm the long-term safety profile consistent with existing data, emphasizing the importance of appropriate dosing to minimize adverse effects such as cardiovascular risks and dependency, especially in pediatric populations.

Regulatory Activity and Approvals

The U.S. Food and Drug Administration (FDA) continues to monitor abuse potential, reaffirming the controlled substance schedule II classification for Adderall. There are no recent approvals for new indications or formulations specifically targeting Adderall 10 mg but ongoing research may influence future labeling, especially concerning adolescent use and psychiatric comorbidities.

Innovations in Abuse-Deterrent Formulations

Innovations include abuse-deterrent formulations (ADFs), which incorporate physical or chemical barriers to misuse. Some formulations integrate crush-resistant technology, positioning Adderall 10 mg within evolving therapeutic strategies to mitigate diversion and dependence.

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Market Analysis

Current Market Size and Segmentation

The global Adderall market, chiefly driven by the United States, was valued at approximately USD 1.5 billion in 2022 (MarketWatch), driven by increasing diagnoses of ADHD and narcolepsy. North America accounts for roughly 70-75% of the market, owing to high prevalence rates and established prescribing patterns.

Within this landscape, Adderall 10 mg remains the most commonly prescribed dose for initial treatment and titration, constituting approximately 40% of total prescriptions**. The drug’s established reputation, combined with robust insurance coverage, sustains steady demand.

Key Market Drivers

• Growing ADHD diagnoses: The CDC estimates that 9.4% of children and 4.4% of adults in the U.S. are diagnosed with ADHD, fueling stimulant medication prescriptions.
• Expanded access in adult populations: Treatment among adults rose by over 50% between 2016 and 2022, indicating broader acceptance and recognition of adult ADHD.
• Increased awareness and destigmatization: Public health campaigns aim to improve diagnosis rates and medication adherence.
• Pipeline innovations: Development of misuse-resistant formulations and novel delivery mechanisms aim to sustain market engagement.

Challenges and Market Constraints

• Regulatory scrutiny: As a Schedule II controlled substance, prescribing is tightly regulated, constraining market expansion.
• Safety concerns: Cardiovascular risks and potential for abuse limit off-label growth.
• Competitive landscape: Alternative stimulants (e.g., Vyvanse, Ritalin) and non-stimulant drugs (e.g., Strattera) offer substitutes, influencing prescribing behavior.

Emerging Market Opportunities

• Global expansion: While U.S. dominance persists, emerging markets such as China, South Korea, and parts of Europe exhibit rising ADHD awareness, presenting growth opportunities.
• Generic proliferation: Increased availability of generic formulations, including Adderall 10 mg, enhances market accessibility and affordability.
• Digital therapeutics integration: Complementary non-pharmacologic treatments and digital adherence tools may expand therapeutic paradigms.

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Market Projection and Future Outlook

Forecasting Methodology

Using current trends, epidemiological data, and market dynamics, industry analysts project the Adderall market to grow at a CAGR of 4-6% over the next five years. The Australian and European markets are expected to double their footprint due to increasing recognition and diagnosis.

Projected Market Size (2027)

Based on current trajectories, the global ADHD stimulant market, inclusive of Adderall 10 mg, is projected to reach USD 2.4–2.7 billion by 2027. The U.S. market will retain dominant share, while Asia-Pacific and Europe will account for the fastest growth.

Key Factors Influencing Growth

• Regulatory environment changes: Regulatory relaxations or tightened controls will directly affect market size.
• Innovations in formulations: Extended-release and abuse-deterrent options will sustain demand.
• Policy shifts in mental health: An emphasis on diagnosis and early intervention will bolster prescription rates.
• Public perception and stigma reduction: Improved awareness will facilitate broader acceptance and adherence.

Risks and Considerations

• Regulatory restrictions: Potential reinstatement of stricter prescribing caps.
• Market saturation: Maturation of the market could temper growth.
• Generic competition: Price erosion due to high generic competition may impact revenues.
• Potential lawsuits and safety concerns: Ongoing litigation or adverse event reports could diminish confidence.

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Conclusion

Adderall 10 mg remains a cornerstone in ADHD and narcolepsy management, underpinned by a mature clinical profile and a sizable, growing market. While no novel clinical trials currently focus solely on this dose, ongoing enhancements in formulation technology and abuse mitigation techniques underscore a strategic evolution aimed at balancing efficacy with safety.

Market projections highlight sustained growth driven by rising diagnosis rates, expanded demographic reach, and technological advancements. However, regulatory and safety challenges necessitate agile adaptation by stakeholders.

In sum, Adderall 10 mg continues to demonstrate resilience and adaptability, with future success closely linked to innovation, regulatory landscape navigation, and evolving consumer perceptions.

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Key Takeaways

• Clinical landscape: Adderall 10 mg benefits from ongoing post-market surveillance and incremental formulation innovations, particularly abuse-resistant technologies.
• Market size and drivers: High prevalence of ADHD, especially among adults and in North America, sustains steady demand, with global expansion possible through emerging markets.
• Growth projection: The market is expected to grow at 4-6% CAGR through 2027, driven by demographic shifts, policy changes, and product innovation.
• Challenges: Tight regulatory controls, safety concerns, and competition from generics and non-stimulant therapies remain key market hurdles.
• Strategic focus: Companies should prioritize formulation innovation, compliance with regulatory standards, and targeted expansion into developing markets to capitalize on growth opportunities.

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FAQs

1. Is there ongoing research to develop abuse-deterrent formulations of Adderall 10 mg?
Yes. Multiple pharmaceutical developers are working on abuse-deterrent formulations employing physical barriers, chemical modifications, and novel delivery systems to minimize misuse and diversion.

2. How does the regulatory environment impact global sales of Adderall 10 mg?
Stringent regulations, such as Schedule II controls in the U.S. and similar policies elsewhere, limit prescribing flexibility. However, growing awareness and acceptance are gradually expanding access, especially in emerging markets.

3. Are there any new indications for Adderall 10 mg under clinical investigation?
Currently, no new indications are in late-stage clinical trials for Adderall 10 mg. Focus remains on optimizing existing uses and improving safety profiles.

4. What is the competitive landscape for Adderall 10 mg?
The market faces competition from other stimulants like Vyvanse and Ritalin, as well as non-stimulants such as atomoxetine. Generics have also diminished pricing power for branded versions.

5. What trends are shaping the future of the ADHD medication market?
Key trends include personalized medicine approaches, digital health integrations, expanding global awareness, and development of non-addictive alternatives.

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References

1. MarketWatch. "Global ADHD Medications Market Size, Share & Trends Analysis Report" (2022).
2. CDC. "Data and Statistics on ADHD" (2022).
3. Research and Markets. "ADHD Therapeutics Market Forecast" (2023).
4. U.S. FDA. "Abuse-Deterrent Opioids and Medications" (2022).
5. IQVIA. "Pharmaceutical Market Data and Trends" (2022).