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
ADHD	2
Narcolepsy	2
Substance-Related Disorders	1
Amphetamine-Related Disorders	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
Nevada	2
Florida	2
Georgia	2
Utah	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
National Institute on Drug Abuse (NIDA)	2
Arbor Pharmaceuticals, Inc.	2
Vallon Pharmaceuticals, Inc.	2

Sponsor Type

Sponsor Type for Amphetamine Sulfate
Sponsor	Trials
Industry	5
NIH	4
Other	3

Amphetamine Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Amphetamine sulfate, a potent central nervous system (CNS) stimulant, is widely used in the treatment of attention deficit hyperactivity disorder (ADHD) and other conditions. This article delves into the current state of clinical trials, market analysis, and future projections for amphetamine sulfate.

Clinical Trials Update

Focus on Pediatric ADHD

Clinical trials involving amphetamine sulfate, particularly in pediatric populations, have been a significant area of research. A recent study published on Frontiers in Pharmacology analyzed clinical trials listed on ClinicalTrials.gov, focusing on the use of amphetamines in children. Here are some key findings:

• Prevalence and Conditions: The study identified 179 clinical trials related to amphetamines, with 19 trials meeting the inclusion criteria. The predominant condition treated was ADHD, accounting for 84.2% of the studies[2].
• Study Characteristics: The trials included phase 4 studies (36.8%), randomized allocation (63.2%), and parallel intervention models (42.1%). Most studies (78.9%) involved participants from the United States[2].
• Long-term Effects: There is an emerging concern about the long-term effects of amphetamines on the developing brain. Preliminary findings suggest potential structural and functional alterations in brain regions, which could impact cognitive functions, emotional regulation, and social behavior[2].

Safety and Efficacy

The FDA has approved several amphetamine-based medications, including Vyvanse (lisdexamfetamine), which is metabolized into d-amphetamine in the body. Clinical trials have demonstrated the safety and efficacy of these medications in maintaining ADHD treatment. For instance, the pharmacokinetics of d-amphetamine from Vyvanse have been shown to be linear over a range of doses, indicating consistent drug delivery[4].

Market Analysis

Current Market Status

The global market for D-Amphetamine Sulfate API was valued at US$ 53 million in 2023. This market is characterized by a competitive landscape involving key players such as Veranova, Cambrex, Curia Global, and Mallinckrodt Pharmaceuticals[1][3].

Regional Market Share

The market is segmented by region, with North America, Europe, and Asia Pacific being significant contributors. Here is a breakdown of the regional market share:

• North America: This region has seen steady growth, driven by the high prevalence of ADHD and the availability of advanced healthcare infrastructure[1][3].
• Europe: European countries, such as Germany, France, and the UK, also contribute substantially to the market due to their robust healthcare systems and regulatory frameworks[1][3].
• Asia Pacific: Countries like China and Japan are experiencing rapid growth, driven by increasing awareness and diagnosis of ADHD, as well as expanding healthcare capabilities[1][3].

Market Competition

The market is highly competitive, with several companies vying for market share. The competition is both company-wise and country-wise, with each player focusing on different segments and applications of amphetamine sulfate[1][5].

Market Projections

Forecasted Market Size

The global D-Amphetamine Sulfate API market is projected to reach US$ 74 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2030[1][3].

Production and Consumption

The production and consumption of D-Amphetamine Sulfate API are expected to increase, driven by the growing demand for ADHD treatments. Here are some key projections:

• Production: The global production of D-Amphetamine Sulfate API is forecasted to increase, with significant contributions from regions like North America, Europe, and Asia Pacific[1][3].
• Consumption: The consumption of D-Amphetamine Sulfate API is also expected to rise, reflecting the increasing prevalence of ADHD and the expanding use of amphetamine-based treatments[1][3].

Economic Impact

The global macroeconomic environment, including factors such as economic stability, regulatory changes, and geopolitical events, will influence the market. For instance, the COVID-19 pandemic and the Russia-Ukraine war have caused market fluctuations, which are being comprehensively analyzed in market research reports[1][5].

Industry Chain Analysis

Upstream Raw Materials

The production of D-Amphetamine Sulfate API depends on the availability and cost of upstream raw materials. Any disruptions in the supply chain can impact the overall market dynamics[5].

Downstream Industry

The downstream industry includes pharmaceutical companies that use D-Amphetamine Sulfate API to manufacture final products. The demand from these companies drives the market for the API[5].

Market Dynamics

Challenges

The market faces several challenges, including regulatory hurdles, potential side effects of amphetamines, and the risk of addiction. These challenges necessitate continuous research and development to optimize the use of amphetamines in medicine[2].

Opportunities

Despite the challenges, there are significant opportunities for growth. The increasing prevalence of ADHD, advancements in pharmacogenomics for personalized treatments, and the expanding healthcare infrastructure in emerging markets are key drivers of market growth[2][5].

Key Takeaways

• Clinical Trials: Amphetamine sulfate is extensively used in clinical trials for treating ADHD in pediatric populations, with a focus on safety, efficacy, and long-term effects.
• Market Size: The global D-Amphetamine Sulfate API market is valued at US$ 53 million in 2023 and is projected to reach US$ 74 million by 2030.
• Regional Growth: North America, Europe, and Asia Pacific are significant contributors to the market, driven by the prevalence of ADHD and healthcare infrastructure.
• Market Competition: The market is highly competitive, with key players focusing on different segments and applications.
• Economic Impact: Global macroeconomic factors influence the market, and any disruptions in the supply chain can impact market dynamics.

FAQs

What is the current market size of the D-Amphetamine Sulfate API market?

The global D-Amphetamine Sulfate API market was valued at US$ 53 million in 2023[1][3].

What is the projected growth rate of the D-Amphetamine Sulfate API market?

The market is expected to grow at a CAGR of 4.8% from 2024 to 2030[1][3].

Which regions are the major contributors to the D-Amphetamine Sulfate API market?

North America, Europe, and Asia Pacific are the significant contributors to the market[1][3].

What are the main challenges facing the D-Amphetamine Sulfate API market?

Regulatory hurdles, potential side effects, and the risk of addiction are key challenges[2].

What opportunities exist for the growth of the D-Amphetamine Sulfate API market?

Increasing prevalence of ADHD, advancements in pharmacogenomics, and expanding healthcare infrastructure in emerging markets are significant opportunities[2][5].

Sources

1. D-Amphetamine Sulfate API Market Trends, Industry Analysis, Business Outlook, Current and Future Growth By 2029 - OpenPR
2. Amphetamines in child medicine: a review of ClinicalTrials.gov - Frontiers in Pharmacology
3. D-Amphetamine Sulfate API - Market Size - Valuates Reports
4. 21977S Lisdexamfetamine Clinical PREA - FDA
5. Amphetamine-sulfate Market Size, Share, Trend ... - Prof Research