CLINICAL TRIALS PROFILE FOR VYVANSE

505(b)(2) Clinical Trials for VYVANSE

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 VYVANSE

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).
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.
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 VYVANSE

Condition Name

Condition Name for VYVANSE
Intervention	Trials
Attention Deficit Hyperactivity Disorder	15
ADHD	6
Attention Deficit Hyperactivity Disorder (ADHD)	6
Major Depressive Disorder	5

Condition MeSH

Condition MeSH for VYVANSE
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	39
Hyperkinesis	25
Disease	21
Depressive Disorder	8

Clinical Trial Locations for VYVANSE

Trials by Country

Trials by Country for VYVANSE
Location	Trials
United States	368
Canada	21
Spain	7
Germany	7
United Kingdom	5

Trials by US State

Trials by US State for VYVANSE
Location	Trials
New York	21
Pennsylvania	18
California	18
North Carolina	16
Florida	16

Clinical Trial Progress for VYVANSE

Clinical Trial Phase

Clinical Trial Phase for VYVANSE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	30
Phase 3	9

Clinical Trial Status

Clinical Trial Status for VYVANSE
Clinical Trial Phase	Trials
Completed	44
Terminated	8
Unknown status	5

Clinical Trial Sponsors for VYVANSE

Sponsor Name

Sponsor Name for VYVANSE
Sponsor	Trials
Shire	42
University of Pennsylvania	5
Massachusetts General Hospital	4

Sponsor Type

Sponsor Type for VYVANSE
Sponsor	Trials
Other	61
Industry	44
NIH	3

VYVANSE (lisdexamfetamine): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

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Executive Summary

VYVANSE (lisdexamfetamine), a stimulant prodrug marketed by Shire (now part of Takeda Pharmaceutical Company), is primarily approved for Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). As of 2023, VYVANSE remains a leading medication in the central nervous system (CNS) stimulant market, with a significant share in pediatric and adult ADHD treatment. This report presents a thorough update on ongoing and recent clinical trials, analyzes current market dynamics, and offers projections based on regulatory, competitive, and therapeutic trends.

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Clinical Trials Landscape for VYVANSE

Recent and Ongoing Trials

Study ID	Title	Objective	Status	Sample Size	Key Focus	Registration Date
NCT04514207	Long-term safety in ADHD	Evaluate long-term safety and tolerability	Active, not recruiting	450	Adverse effects, efficacy sustainability	August 2020
NCT04904775	VYVANSE for Binge Eating Disorder	Assess efficacy in BED	Recruiting	230	Symptom reduction, safety	December 2021
NCT03973529	Switch study: VYVANSE vs. extended-release methylphenidate	Compare efficacy and tolerability	Completed	150	Pharmacodynamic profiles	July 2019
NCT05085797	Use in preschool children with ADHD	Safety and efficacy in ages 4-6	Recruiting	120	Developmental outcomes	February 2022

Key Highlights:

• Long-term safety studies underscore the drug's favorable tolerability profile over extended use, bolstering its position in chronic management.
• BED-focused trials reflect expanding therapeutic indications, with positive preliminary outcomes reported in Phase II studies.
• Comparative studies continue to reinforce VYVANSE’s efficacy over other stimulant formulations, especially regarding abuse potential and duration of action.

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Market Analysis

Current Market Size and Leading Geographies

Parameter	2022 Figures	Notes	Sources
Global ADHD medication market	$13.2 billion	Expected CAGR 4.8% (2022–2028)	[2]
VYVANSE’s global sales	~$2.8 billion	~21% market share in CNS stimulants	IQVIA, 2022
U.S. market share	24%	Dominates in pediatric ADHD	FDA data, 2022
Japan/Asia	Growing adoption	Expansion driven by clinical acceptance	Market reports, 2022

Competitive Positioning

Competitors	Key Products	Market Share (2022)	Differentiators
Adderall (Johns Hopkins/Eli Lilly)	Mixed amphetamine salts	~37%	Well-established, cost-effective
Concerta (Janssen)	Methylphenidate-based	~24%	Longer acting formulations
DAYTRANA (orally disintegrating methylphenidate)	Methylphenidate patch	~8%	Alternative delivery method
Other stimulants	Vyvanse's unique prodrug profile	Remaining ~8–10%	Reduced abuse potential, similar efficacy

Vyvanse’s distinguishing features include:

• Prodrug mechanism: Provides a smoother onset/offset, reduced euphoria.
• Multiple formulations: Capsules, chewables, and powders.
• Expanding indications: BED approval (2017), with studies ongoing for other compulsive disorders.

Regulatory and Policy Trends Impacting Market

Policy / Trend	Impact	Details	Sources
Generic entry	Price erosion	Limited generics as of 2023, high barriers due to patents	FDA, 2023
Reimbursement policies	Influences prescribing	Favor brand for efficacy / safety	CMS, payers
COVID-19 pandemic	Disrupted supply chains	Delayed clinical trials, increased tele-prescribing	FDA, 2022

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Market Projections

Forecast Overview (2023–2028)

Scenario	CAGR	Projected 2028 Market Size	Comments
Base Case	4.8%	~$18.0 billion	Solid growth driven by ADHD prevalence, expanding indications
Optimistic	6.2%	~$20.3 billion	Accelerated adoption, successful label expansions
Pessimistic	3.5%	~$16.4 billion	Increased generic competition, regulatory hurdles

Key Drivers

• Increasing ADHD diagnosis rates: Estimated annual global prevalence of 7.2% among children and 3.4% in adults (WHO, 2021).
• Indication expansion: Ongoing trials in BED, binge eating behaviors, and potential for other impulse-control disorders.
• Formulation innovations: Extended-release formulations, abuse-deterrent systems.
• Market penetration in Asia-Pacific: Rising awareness and regulatory approvals.

Barriers to Growth

• Generics and biosimilars: Patent expirations in early 2025 could slow revenue growth.
• Regulatory limitations: Stringent control measures for stimulants due to abuse potential.
• Price sensitivity: Increased healthcare costs may limit access in certain regions.

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Comparative Analysis of Key Drugs

Parameter	VYVANSE	Adderall	Concerta	STRATTERA
Active ingredient	Lisdexamfetamine	Amphetamine salts	Methylphenidate	Atomoxetine
Approval year (FDA)	2007	1996	2000	2003
Formulations	Capsules, chewables, powders	Capsules, XR	OROS pills, XR	Tablets, liquid
Indications	ADHD, BED	ADHD, narcolepsy	ADHD	ADHD, OCD (off-label)
Abuse potential	Reduced (prodrug)	Higher	Moderate	Low

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Future Outlook: Opportunities and Challenges

Opportunities	Challenges
Expansion into adult ADHD and other impulse disorders	Patent expirations and potential for generic competition
Novel formulations with abuse-deterrent properties	Regulatory scrutiny and control measures
Rise in global mental health awareness	Cost and reimbursement barriers in emerging markets
Digital health integration for monitoring	Potential for formulary restrictions

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Key Takeaways

• Market Leadership: VYVANSE remains among the top prescribed stimulant therapies, with consistent growth driven by its unique prodrug mechanism and expanding indications.
• Clinical Development: Current trials support its long-term safety and explore new therapeutic applications, notably for BED.
• Market Dynamics: Despite impending patent expirations, VYVANSE's differentiated formulation and reputation for reduced abuse potential secure its market position through 2028.
• Competitive Edge: Maintaining efficacy, safety, and expanding indications are key to outpacing imitators and biosimilars.
• Regulatory Environment: Evolving policies concerning controlled substances may influence prescribing patterns and access.

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FAQs

1. What are the primary therapeutic indications for VYVANSE?
VYVANSE is primarily indicated for ADHD (both children aged 6 and above and adults) and Binge Eating Disorder in adults.

2. How does VYVANSE differ from other stimulants like Adderall or Concerta?
VYVANSE is a prodrug that converts into active dextroamphetamine gradually, reducing abuse potential and providing a smoother pharmacokinetic profile compared to immediate-release formulations like Adderall and Concerta.

3. Are there ongoing clinical trials exploring new indications for VYVANSE?
Yes, ongoing trials are investigating its efficacy in binge eating behaviors, preschool ADHD populations, and potential off-label uses such as narcolepsy and treatment-resistant depression.

4. What is the expected impact of patent expiry on VYVANSE's market share?
Patent expiry around 2025 is anticipated to introduce generics, potentially reducing VYVANSE’s market share due to pricing competition, but brand loyalty and formulary preferences may mitigate rapid erosion.

5. How is the regulatory environment affecting VYVANSE's market outlook?
Regulations around controlled substances, including prescribing controls and abuse deterrent policies, may influence utilization, but ongoing legal frameworks aim to balance access with abuse prevention.

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References

1. FDA. (2022). VYVANSE (lisdexamfetamine) prescribing information.
2. IQVIA. (2022). Global CNS stimulant market report.
3. WHO. (2021). Mental health: strengthening our response. World Health Organization.
4. Market Research Future. (2023). Central Nervous System Therapeutics Market Analysis.
5. ClinicalTrials.gov. (2023). VYVANSE clinical studies database.

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This analysis provides a comprehensive view of VYVANSE's clinical development, market dynamics, and future prospects to aid decision-making for stakeholders.