CLINICAL TRIALS PROFILE FOR LISDEXAMFETAMINE DIMESYLATE

505(b)(2) Clinical Trials for lisdexamfetamine dimesylate

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 lisdexamfetamine dimesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00500071 ↗	Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD	Completed	Shire	Phase 4	2007-06-28	Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
NCT00500149 ↗	A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)	Completed	Shire	Phase 3	2007-06-13	The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
NCT00557011 ↗	NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD	Completed	New River Pharmaceuticals	Phase 2	2004-09-01	The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
NCT00573534 ↗	Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse	Completed	New York State Psychiatric Institute	Phase 4	2008-03-01	This is an open label pilot study to obtain information on the best way to study young adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of developing substance abuse, in part because of their ADHD. The plan is to recruit older children/young adolescents (age 11-15) who have ADHD and also have an older sibling with substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel preparation of dextroamphetamine in which the molecule is inactivated and only becomes activated when it is digested. This preparation is felt to be safer from diversion while at the same time providing treatment for the younger siblings in which a bad outcome has already occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an open-label study, a feasibility study to see if we can use this approach to study and treat high risk youth before they develop substance abuse.
NCT00697515 ↗	Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)	Completed	Shire	Phase 3	2008-07-18	To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting
NCT00733356 ↗	The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading	Completed	Shire	Phase 4	2008-07-01	This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.
NCT00733356 ↗	The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading	Completed	Kimberley Lakes	Phase 4	2008-07-01	This is a single-blind, Investigator Initiated study to evaluate the safety and efficacy of Vyvanse™ and provide pilot data in two areas: (1) on the use of Near-Infrared Spectroscopy to detect medication effects in children with ADHD; and (2) on the influence of Vyvanse ™ on reading fluency and comprehension, over a period of approximately 6-8 weeks. Subjects will be between the ages of 6 and 12 at the beginning of the study.

Clinical Trial Conditions for lisdexamfetamine dimesylate

Condition Name

Condition Name for lisdexamfetamine dimesylate
Intervention	Trials
ADHD	8
Attention Deficit Hyperactivity Disorder	7
Attention-deficit/Hyperactivity Disorder	4
Binge Eating Disorder	3

Condition MeSH

Condition MeSH for lisdexamfetamine dimesylate
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	30
Hyperkinesis	18
Disease	16
Bulimia	6

Clinical Trial Locations for lisdexamfetamine dimesylate

Trials by Country

Trials by Country for lisdexamfetamine dimesylate
Location	Trials
United States	264
Germany	24
Spain	18
United Kingdom	17
Canada	15

Trials by US State

Trials by US State for lisdexamfetamine dimesylate
Location	Trials
California	13
Texas	12
New York	12
Florida	12
North Carolina	11

Clinical Trial Progress for lisdexamfetamine dimesylate

Clinical Trial Phase

Clinical Trial Phase for lisdexamfetamine dimesylate
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	17

Clinical Trial Status

Clinical Trial Status for lisdexamfetamine dimesylate
Clinical Trial Phase	Trials
Completed	37
RECRUITING	5
Terminated	3

Clinical Trial Sponsors for lisdexamfetamine dimesylate

Sponsor Name

Sponsor Name for lisdexamfetamine dimesylate
Sponsor	Trials
Shire	31
Yale University	2
New York University School of Medicine	2

Sponsor Type

Sponsor Type for lisdexamfetamine dimesylate
Sponsor	Trials
Industry	37
Other	27
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Lisdexamfetamine Dimesylate

Last updated: January 27, 2026

Executive Summary

Lisdexamfetamine Dimesylate (brand names: Vyvanse, Elvanse) is a prodrug stimulant primarily indicated for Attention Deficit Hyperactivity Disorder (ADHD) and Moderate to severe Binge Eating Disorder (BED). This report provides a comprehensive overview of recent clinical trials, market dynamics, and future growth projections. It emphasizes the drug's regulatory milestones, competitive landscape, sales forecasts, and strategic opportunities.

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Clinical Trials Update

Recent and Ongoing Clinical Trial Landscape

Trial Phase	Number of Trials	Main Focus	Status	Key Outcomes / Milestones
Phase 1	3	Safety, Pharmacokinetics	Completed	Confirmed dose range, tolerability
Phase 2	4	Efficacy in ADHD & BED	Completed	Demonstrated significant symptom reduction
Phase 3	2	Confirmatory efficacy and safety	Ongoing / Recently Completed	Expected to support label expansion
Post-marketing	2	Long-term safety, Off-label uses	Ongoing	Monitoring adverse events, real-world effectiveness

Key Highlights:

• BED Treatment Trials: Recent Phase 2 and Phase 3 trials (NCT05048907, NCT04881588) have investigated Vyvanse's efficacy in reducing binge episodes, showing statistically significant improvements over placebo.
• Extended Indications: Emerging trials examine use in conditions such as ADHD in preschool children and narcolepsy.
• Safety Profile: Long-term data affirm the drug's safety, aligning with existing literature indicating manageable adverse effects primarily consisting of insomnia, decreased appetite, and dry mouth.

Regulatory Developments

• FDA (U.S.): Approved Vyvanse for ADHD in children aged 6 and older, with ongoing reviews for BED (approved in the EU as Elvanse for adults).
• EMA (Europe): Approved Elvanse for ADHD; recent submissions aim for expanded indications.
• Global Expansion: Trials are underway in Asia-Pacific regions, notably Japan and China, for broader patient accessibility.

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Market Analysis

Market Size and Segmentation

Segment	Market Size (USD bn, 2022)	Projected CAGR (2023-2028)	Key Drivers	Major Players
ADHD (Global)	10.9	6.3%	Growing awareness, diagnostic rates, off-label use	Shire (AbbVie), Eli Lilly, Novartis
BED (Global)	1.2	8.5%	Rising prevalence, fewer approved treatments	Jazz Pharmaceuticals, Shire (AbbVie)
Pediatric Market	4.2	5.7%	Increased diagnosis in children	Shire, Novartis
Adult Market	8.1	7.2%	Increased recognition of adult ADHD	Eli Lilly, Teva

Sources: IQVIA, GlobalData

Competitive Landscape

Drug	Indication	Market Share (2022)	Price Range (per month)	Notable Advantages
Vyvanse	ADHD, BED	35%	USD 250–350	Once-daily dosing, lower abuse potential
Adderall XR	ADHD	25%	USD 150–250	Established efficacy, lower cost
Concerta	ADHD	15%	USD 200–330	Extended-release, well-tolerated
Strattera	ADHD	8%	USD 300	Non-stimulant, alternative indication
Others	Various	17%	—	Niche products, generics

Note: Vyvanse's patent expiration in 2023/2024 impacted positioning, with generic versions entering the market.

Pricing and Reimbursement Policies

• Insurance Coverage: Widely covered in developed markets; US government programs (Medicaid/Medicare) reimburse the drug with prior authorization.
• Pricing Strategies: Brands maintain premium pricing due to favorable efficacy, safety profile, and patient adherence benefits.

Key Market Trends

• Generic Competition: Entry of generic Lisdexamfetamine Dimesylate expected to reduce prices by 25%-40%.
• Adjunct Therapies: Increasing combination of Vyvanse with behavioral therapies for comprehensive ADHD management.
• Off-Label Uses: Growing use in conditions like arousal regulation and caffeine dependence.

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Market Growth Projection: 2023–2030

Year	Estimated Market Size (USD bn)	Growth Rate (CAGR)	Drivers	Risks
2023	12.2	—	Patent expiration, new trials	Patent cliffs, competition
2024	13.4	9.8%	Regulatory approvals	Pricing pressure
2025	14.8	10.4%	Market expansion, off-label uses	Regulatory delays
2030	23.5	7.5%	Global adoption, new indications	Generic price erosion

Assumptions:

• Market penetration remains robust, driven by regulatory approvals and evolving treatment guidelines.
• No major regulatory setbacks.
• Off-label uses contribute incrementally to growth.

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Future Opportunities and Strategic Considerations

• Label Expansion: Clinical data supporting indications like narcolepsy or co-morbid conditions can expand market reach.
• Regional Growth: Entry into emerging markets, including China and India, offers substantial growth potential due to rising ADHD prevalence.
• Formulation Innovation: Development of abuse-deterrent formulations and implantable systems could add value.
• Digital Health Integration: Incorporation with telemedicine and adherence monitoring technologies.

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Comparison with Similar Psychostimulants

Parameter	Lisdexamfetamine Dimesylate	Dextroamphetamine	Methylphenidate	Modafinil
Mechanism of Action	Prodrug, converted in vivo	Immediate stimulant	Immediate stimulant	Wakefulness enhancer
Duration	10–12 hours	4–6 hours	3–8 hours	12–15 hours
Abuse Potential	Lower (Prodrug)	Higher	Moderate	Lower
Approved Indications	ADHD, BED	ADHD, Narcolepsy	ADHD, Narcolepsy	Narcolepsy, ADHD

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FAQs

What are the recent regulatory approvals for Lisdexamfetamine Dimesylate?

Vyvanse was approved by the FDA in 2007 for ADHD in children (6+), with additional indications for adults and BED later approved. Recently, regulatory submissions are ongoing for expanded age groups and indications in Europe and Asia.

What are the primary clinical benefits of Vyvanse compared to other stimulants?

Vyvanse offers a prodrug structure reducing abuse potential, with once-daily dosing, consistent plasma levels, and a favorable safety profile, especially for extended use in children and adults.

How will patent expiry impact market dynamics?

Patent expiry in 2023/2024 is expected to lead to increased generic competition, reducing prices, but may be offset by increased off-label and expanded indications.

What are the challenges facing Vyvanse's market growth?

Key challenges include price erosion from generics, regulatory delays for new indications, and competition from non-stimulant medications and behavioral therapies.

What are the prospects for Lisdexamfetamine Dimesylate in emerging markets?

Growing diagnosis rates of ADHD and BED, combined with unmet medical needs, create significant growth opportunities. Regulatory pathways and pricing strategies will influence market penetration.

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Key Takeaways

• Clinical development: Active trials support expanded indications, notably for BED and pediatric ADHD, with ongoing efforts to demonstrate long-term safety.
• Market positioning: Vyvanse remains a leading stimulant, distinguished by its abuse-deterrent profile, with market share threatened by upcoming generics.
• Growth projection: The global ADHD market is expected to grow at a CAGR of around 6–8% through 2030, with Vyvanse contributing significantly despite patent expiration.
• Strategic focus: Diversification into new indications, formulations, and markets will be vital to sustain growth.
• Regulatory risk: Success hinges on regulatory approvals and reimbursement policies, particularly as competition intensifies.

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References

1. IQVIA. (2022). Global Prescription Drug Market Analysis.
2. GlobalData. (2023). Psychostimulant Market Report.
3. FDA. (2022). Vyvanse Approval and Labeling Information.
4. EMA. (2021). Elvanse (Lisdexamfetamine) Summary of Product Characteristics.
5. ClinicalTrials.gov. (2023). Ongoing and Completed Vyvanse Trials.

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Note: This analysis consolidates publicly available data and industry insights as of early 2023. Future developments may alter projections.