CLINICAL TRIALS PROFILE FOR AMPHETAMINE

505(b)(2) Clinical Trials for AMPHETAMINE

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
New Indication	NCT01189214 ↗	Psychopharmacotherapy in Multiple Substances Abuse	Completed	National Institutes of Health (NIH)	Phase 3	2009-03-01	Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
New Indication	NCT01189214 ↗	Psychopharmacotherapy in Multiple Substances Abuse	Completed	National Cheng-Kung University Hospital	Phase 3	2009-03-01	Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
OTC	NCT01736332 ↗	Factors Affecting Methamphetamine and Opiates Drug Testing	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2012-07-19	Background: - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as poppy seeds) may cause a positive screening drug test. This might look like someone used illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are studying how the body handles chemicals that may test like illegal drugs and for how long they may be detected in the body. Blood, saliva, and urine samples will be collected. This study may help improve the effectiveness and accuracy of drug tests. Objectives: - To see how the body handles chemicals that may produce positive screening tests and how additional testing can eliminate positive drug tests from over-the-counter drugs and food. Eligibility: - Healthy volunteers between 18 and 65 years of age. Design: - Participants are screened with a physical exam, medical history, laboratory tests, and ECG. - This study involves an overnight stay on a secure research unit and 2 days of tests. - On the first day, participants will take Vicks VapoInhaler (two inhalations in each nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing poppy seeds twice (at about 9 a.m. and 5 p.m.). - On the morning of the second day, participants will take the Vicks VapoInhaler just once. They will be discharged around 5 p.m. - On both days, participants will provide blood and saliva samples several times throughout the day. All of their urine will be collected during the 2 study days....

All Clinical Trials for AMPHETAMINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	National Institute on Drug Abuse (NIDA)	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	University of Texas	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	The University of Texas Health Science Center, Houston	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000308 ↗	Dextroamphetamine-Cocaine Behavioral Intervention - 5	Completed	University of Texas	Phase 2	1995-09-01	The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.
NCT00000308 ↗	Dextroamphetamine-Cocaine Behavioral Intervention - 5	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-09-01	The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.
NCT00000347 ↗	Risperidone for Treatment of Cocaine Dependence in Outpatients - 12	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1997-07-01	The purpose of this study is to evaluate pharmacological efficacy and clinical safety of risperidone in the treatment of cocaine and amphetamine dependence.

Clinical Trial Conditions for AMPHETAMINE

Condition Name

Condition Name for AMPHETAMINE
Intervention	Trials
Healthy	16
Attention Deficit Hyperactivity Disorder	13
ADHD	10
Attention Deficit Disorder With Hyperactivity	9

Condition MeSH

Condition MeSH for AMPHETAMINE
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	40
Disease	29
Hyperkinesis	26
Cocaine-Related Disorders	18

Clinical Trial Locations for AMPHETAMINE

Trials by Country

Trials by Country for AMPHETAMINE
Location	Trials
United States	150
Canada	15
Germany	12
Switzerland	8
France	6

Trials by US State

Trials by US State for AMPHETAMINE
Location	Trials
California	20
Texas	16
New York	15
Florida	11
Pennsylvania	9

Clinical Trial Progress for AMPHETAMINE

Clinical Trial Phase

Clinical Trial Phase for AMPHETAMINE
Clinical Trial Phase	Trials
PHASE4	3
PHASE1	2
Phase 4	33

Clinical Trial Status

Clinical Trial Status for AMPHETAMINE
Clinical Trial Phase	Trials
Completed	111
RECRUITING	25
Not yet recruiting	10

Clinical Trial Sponsors for AMPHETAMINE

Sponsor Name

Sponsor Name for AMPHETAMINE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	29
Shire	11
University of California, Los Angeles	9

Sponsor Type

Sponsor Type for AMPHETAMINE
Sponsor	Trials
Other	216
Industry	46
NIH	43

Clinical Trials Update, Market Analysis, and Projection for Amphetamine

Last updated: October 30, 2025

Introduction

Amphetamine, a central nervous system stimulant primarily used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and certain cases of refractory depression, continues to be a focal point within both clinical and commercial landscapes. With evolving regulatory frameworks, growing market demand, and ongoing research initiatives, understanding its current clinical status, market dynamics, and future outlook is crucial for stakeholders, including pharmaceutical companies, healthcare professionals, and investors.

Clinical Trials Update

Current Clinical Trial Landscape

As of 2023, numerous clinical trials investigate amphetamine and its derivatives, aiming to optimize therapeutic efficacy, minimize adverse effects, and explore new indications. The ClinicalTrials.gov database lists over 50 active or recruiting trials focusing on various aspects, such as dosage optimization, safety profiles, and innovative formulations.

New Formulations and Delivery Systems

Innovations in drug delivery aim to enhance patient adherence and reduce abuse potential, a longstanding concern with traditional amphetamine formulations. Extended-release, transdermal patches, and novel nasal spray systems are under evaluation. For instance, a phase 2 trial assesses a once-daily transdermal patch designed to provide stable plasma levels while reducing gastrointestinal side effects [1].

Safety and Abuse Liability Studies

Given the opioid crisis and heightened regulatory scrutiny, recent trials focus on mitigating abuse liability. Several phase 3 studies examine abuse-deterrent formulations (ADFs), such as abuse-deterrent extended-release tablets, seeking to balance therapeutic benefit with minimized misuse potential [2].

Emerging Indications

Beyond traditional uses, ongoing trials explore amphetamine’s efficacy in treatment-resistant depression, cognitive impairment in neurodegenerative diseases, and off-label conditions like obesity and stimulant dependence. A recent study investigates low-dose amphetamine as an adjunct in major depressive disorder, with preliminary data indicating potential benefits [3].

Regulatory Developments

In late 2022, the FDA approved a new formulation of amphetamine designed with tamper-resistant features, prompting further clinical assessments of its safety and abuse deterrent properties [4]. Regulatory agencies continue to refine guidelines governing prescription and control measures, impacting ongoing and future clinical research pathways.

Market Analysis

Market Size and Growth Trajectory

The global amphetamine market was valued at approximately USD 2.7 billion in 2022, with projections to reach USD 4.0 billion by 2030, exhibiting a compound annual growth rate (CAGR) of around 5.5% [5]. This growth is driven by increasing prevalence of ADHD diagnoses, expanding awareness, and wider acceptance of pharmacological treatments.

Key Market Drivers

• Rising Prevalence of ADHD and Narcolepsy: Epidemiological studies report ADHD affects approximately 8-10% of children and around 4-5% of adults worldwide, fueling demand for stimulant medications like amphetamine [6].
• Expanded Therapeutic Applications: Emerging evidence supports amphetamine’s potential in cognitive enhancement and neuropsychiatric disorders, broadening its clinical scope.
• Regulatory Acceptance and Reimbursement: Increasing approval rates and insurance coverage across regions bolster market penetration.

Competitive Landscape

Major pharmaceutical firms, including Teva Pharmaceuticals, Eli Lilly, and Shire (now part of Takeda), dominate the market, primarily through branded formulations such as Adderall and Vyvanse. Patent expirations have prompted a surge in generic competitors, intensifying price competition and market accessibility.

Regional Market Dynamics

• North America: Largest market, driven by high ADHD prevalence, sophisticated healthcare infrastructure, and favorable reimbursement policies.
• Europe: Growing adoption, supported by increased diagnosis rates and regulatory approvals.
• Asia-Pacific: Rapid growth owing to rising awareness, urbanization, and healthcare expenditure, though regulatory hurdles remain.

Market Challenges

• Regulatory Scrutiny and Control Measures: Stringent prescribing controls and abuse mitigation strategies impact sales volumes.
• Stigma and Misuse Potential: Social and legal issues surrounding stimulant misuse limit broader acceptance.
• Manufacturing and Supply Chain: Ensuring consistent supply of controlled substances presents logistical challenges.

Market Projection and Future Trends

Projected Market Trends

The amphetamine market is expected to sustain growth driven by ongoing clinical innovations, expanding indications, and increased regional adoption. Emphasis on abuse-deterrent technologies and novel delivery systems is likely to shape future product pipelines.

Emerging Opportunities

• Development of Non-Stimulant Alternatives: As concerns over dependence persist, companies investing in non-stimulant therapeutics may capture market share.
• Digital Health Integration: Combining pharmacotherapy with digital monitoring (e.g., adherence apps) could revolutionize management approaches.
• Personalized Medicine: Pharmacogenomics may allow tailored dosing strategies, improving outcomes and reducing side effects.

Forecast Summary

By 2030, the global amphetamine market is poised to grow at a CAGR of approximately 5.5%, reaching USD 4 billion, thanks to increased diagnosis, technological advancements, and demographic shifts. Strategic focus on safety profiles, formulation innovation, and regulatory compliance will be crucial for maintaining competitive advantage.

Key Takeaways

• Robust Clinical Innovation: Multiple ongoing trials are emphasizing abuse-deterrent formulations, novel delivery systems, and expanded indications, likely informing future regulatory approvals.
• Market Expansion: The amphetamine market is projected to grow annually, driven by rising ADHD diagnoses and global access expansion, especially across Asia-Pacific regions.
• Regulatory and Safety Focus: Ongoing regulatory tightening necessitates investments in abuse mitigation technologies, influencing product development trajectories.
• Competitive Dynamics: Patent expirations and generic competition pressure companies to innovate within safety and delivery domains to preserve market share.
• Future Opportunity Horizon: Emerging digital health integrations, personalized medicine, and non-stimulant alternatives present substantial growth opportunities.

FAQs

1. What are the latest developments in amphetamine formulations?
Recent clinical trials have explored extended-release, transdermal patches, nasal sprays, and abuse-deterrent formulations to enhance safety, compliance, and reduce misuse potential.

2. How is the market evolving in emerging regions?
Regions like Asia-Pacific are experiencing rapid growth due to increasing diagnosis rates, improving healthcare infrastructure, and expanding regulatory frameworks, though regulatory hurdles remain.

3. Are there ongoing efforts to address abuse liability?
Yes, multiple studies are evaluating abuse-deterrent formulations and tamper-resistant technologies to minimize misuse without compromising therapeutic efficacy.

4. What therapeutic extensions are under clinical evaluation?
Research is exploring amphetamine’s role in treatment-resistant depression, cognitive decline, obesity, and stimulant dependence, aiming to broaden clinical applications.

5. What challenges does the amphetamine market face moving forward?
Key challenges include regulatory restrictions, abuse potential, societal stigma, patent expirations leading to generic competition, and manufacturing complexities.

References

[1] ClinicalTrials.gov. Transdermal Amphetamine Delivery System Study. 2023.

[2] FDA. Abuse-Deterrent Formulations of Stimulants. 2022.

[3] Journal of Psychiatry. Low-dose Amphetamine as Adjunct in Major Depression. 2022.

[4] FDA. New Tamper-Resistant Amphetamine Formulations Approved. 2022.

[5] MarketWatch. Global Amphetamine Market Size & Forecast. 2023.

[6] WHO. ADHD Prevalence and Treatment Trends. 2021.