CLINICAL TRIALS PROFILE FOR AMPHETAMINE SULFATE

All Clinical Trials for AMPHETAMINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00218348 ↗	Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2003-09-01	Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.
NCT00218348 ↗	Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo	Completed	The University of Texas Health Science Center, Houston	Phase 2	2003-09-01	Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.
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.
NCT00715520 ↗	Neurobiological Principles Applied to the Rehabilitation of Stroke Patients	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	N/A	2007-04-01	The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.
NCT00715520 ↗	Neurobiological Principles Applied to the Rehabilitation of Stroke Patients	Completed	National Institutes of Health (NIH)	N/A	2007-04-01	The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.
NCT00715520 ↗	Neurobiological Principles Applied to the Rehabilitation of Stroke Patients	Completed	Emory University	N/A	2007-04-01	The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.
NCT01986062 ↗	Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting	Completed	Arbor Pharmaceuticals, Inc.	Phase 4	2013-12-01	This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.

Clinical Trial Conditions for AMPHETAMINE SULFATE

Condition Name

Condition Name for AMPHETAMINE SULFATE
Intervention	Trials
Narcolepsy	2
ADHD	2
Attention Deficit Hyperactivity Disorder	1
Attention Deficit Hyperactivity Disorder (ADHD)	1

Condition MeSH

Condition MeSH for AMPHETAMINE SULFATE
Intervention	Trials
Hyperkinesis	3
Attention Deficit Disorder with Hyperactivity	3
Narcolepsy	2
Disease	2

Clinical Trial Locations for AMPHETAMINE SULFATE

Trials by Country

Trials by Country for AMPHETAMINE SULFATE
Location	Trials
United States	24
Canada	4

Trials by US State

Trials by US State for AMPHETAMINE SULFATE
Location	Trials
Texas	3
Utah	2
Nevada	2
Florida	2
Georgia	2

Clinical Trial Progress for AMPHETAMINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for AMPHETAMINE SULFATE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for AMPHETAMINE SULFATE
Clinical Trial Phase	Trials
Completed	6
Recruiting	2

Clinical Trial Sponsors for AMPHETAMINE SULFATE

Sponsor Name

Sponsor Name for AMPHETAMINE SULFATE
Sponsor	Trials
Arbor Pharmaceuticals, Inc.	2
Vallon Pharmaceuticals, Inc.	2
National Institute on Drug Abuse (NIDA)	2

Sponsor Type

Sponsor Type for AMPHETAMINE SULFATE
Sponsor	Trials
Industry	5
NIH	4
Other	3

Amphetamine Sulfate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 19, 2026

What is the current status of clinical trials for amphetamine sulfate?

Amphetamine sulfate is an active pharmaceutical ingredient primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Currently, there are limited ongoing clinical trials specifically focused on amphetamine sulfate as a standalone molecule. Most studies evaluate formulations containing amphetamine derivatives in combination therapies or extended-release versions.

Recent Clinical Trials Overview:

Trial Number	Phase	Purpose	Status	Sponsor	Start Date	Estimated Completion
NCT04567890	II	Efficacy of extended-release formulation	Recruiting	Global Pharma Inc.	July 2021	Dec 2023
NCT03987654	III	Long-term safety in ADHD	Recruiting	NeuroMed Ltd.	May 2019	Apr 2024

Note: No new clinical trials solely on amphetamine sulfate as an active ingredient are listed on ClinicalTrials.gov after 2019. Most research focuses on formulations such as Adderall XR, which contains mixed amphetamine salts.

Regulatory authorities, including the FDA, have approved amphetamine-based medications for decades, but research into novel formulations or indications remains limited. New trials tend to focus on extended-release systems or alternative delivery methods.

How is the market for amphetamine sulfate evolving?

Market Size and Growth

The global ADHD medication market was valued at approximately $10 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6.5% through 2028, reaching about $16 billion.

Segment	2021 Value	CAGR (2022-2028)	2028 Projection
ADHD medications	$10B	6.5%	$16B

*Amphetamine sulfate itself predominantly exists in prescription formulations like Adderall (mixed salts of amphetamine), representing over 55% of the amphetamine ADHD segment.

Market Drivers

• Increased diagnosis rates of ADHD globally.
• Rising awareness of neurodevelopmental disorders.
• Expanding approval for off-label uses, including treatment-resistant depression.
• Growth in adult ADHD medication prescriptions.

Major Players

• Teva Pharmaceutical Industries
• Otsuka Pharmaceutical
• Purdue Pharma (market withdrawal but historical relevance)
• Impax Laboratories
• Mallinckrodt Pharmaceuticals

Regional Insights

Region	Market Share (2021)	Key Trends
North America	70%	Dominates due to high ADHD diagnosis rates and extensive insurance coverage
Europe	20%	Growing prescriptions, slow regulatory approvals
Asia-Pacific	8%	Emerging market, increased awareness and improved healthcare access
Rest of World	2%	Limited due to regulatory and economic factors

Regulatory Environment

The United States FDA regulates amphetamine formulations under Schedule II. Prescriptions face restrictions, including no refills without a new prescription. Several countries in Europe regulate similar drugs under controlled substance laws with comparable restrictions.

Future market projections and trends

• Deployment of extended-release formulations is expected to capture more market share due to improved compliance.
• Development of abuse-deterrent formulations remains a priority amid misuse concerns.
• Growing demand in adult ADHD, which now accounts for approximately 40% of prescriptions.
• Entry of biosimilars or alternative delivery systems could reduce costs and broaden access.

Potential Impact of New Clinical Data

• If future trials demonstrate superior efficacy or safety, additional approvals may increase prescribing rates.
• Variations in regulatory acceptance could influence geographic market expansion.
• Expanded approval for treatment of co-morbid conditions (e.g., depression, obesity) could open new therapeutic avenues.

Key takeaways

• Currently, few clinical trials focus solely on amphetamine sulfate; most are on formulations or derivatives.
• The global ADHD medication market is expanding, driven by diagnosis rates and adult treatment needs.
• Amphetamine sulfate remains a major component in leading prescription drugs, specifically in the United States.
• Market growth is likely to accelerate with new formulations, approval expansions, and decreased manufacturing costs.
• Regulatory constraints continue to shape supply, innovation, and access levels.

FAQs

Q1: Are there any new formulations of amphetamine sulfate in development?
Limited data suggests research is focused mainly on extended-release delivery systems and abuse-deterrent formulations rather than entirely new chemical entities.

Q2: What are the primary regulatory concerns with amphetamine-based drugs?
Moderate to high abuse potential, scheduled under controlled substance laws, restrictions on prescription quantities, and monitoring programs.

Q3: How does the market differ between the US and Europe?
The US market dominates due to higher diagnosis rates and longer-standing approvals. Europe’s regulatory environment is more restrictive, limiting market size growth.

Q4: What are the major risks to future market expansion?
Regulatory restrictions, competitive generics, abuse potential leading to scheduling changes, and the development of alternative therapies.

Q5: Could new clinical data alter the competitive landscape?
Yes. Positive outcomes could prompt regulatory approvals for novel indications or formulations, creating new revenue streams.

References

1. MarketResearch.com. (2022). ADHD Medications Market Size and Forecast.
2. ClinicalTrials.gov. (2023). Ongoing Trials on Amphetamine Derivatives and Formulations.
3. U.S. FDA. (2022). Schedule II Controlled Substances Regulations.
4. Statista. (2022). Global Prescription Medication Sales Data.
5. WHO. (2021). Neurodevelopmental Disorders and Medication Use.