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.
NCT00733356 ↗	The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading	Completed	University of California, Irvine	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
Attention-Deficit/Hyperactivity 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
California	18
Pennsylvania	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

Clinical Trials Update, Market Analysis, and Projection for VYVANSE

Last updated: October 27, 2025

Introduction

VYVANSE (lisdexamfetamine dimesylate) is a prescription psychostimulant primarily indicated for Attention Deficit Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). Developed by Shire and now marketed under Takeda Pharmaceuticals, VYVANSE has established itself as a prominent therapeutic option within its segment. This analysis provides an up-to-date overview of clinical trials, evaluates current market dynamics, and forecasts future growth based on recent trends and data.

Clinical Trials Update

Ongoing and Recent Clinical Studies

Recent developments in VYVANSE's clinical pipeline underscore its expanding therapeutic scope. As of late 2022 and early 2023, several trials focus on broader applications:

• ADHD in Adults: Multiple Phase IV studies are evaluating long-term safety and efficacy. For instance, a 2022 multicenter observational study (NCT05398236) analyzed sustained symptom control in adult populations, confirming durable efficacy with a favorable safety profile comparable to pediatric use.

• Binge Eating Disorder (BED): The FDA-approved indication for BED is supported by Phase III trials that demonstrated significant reduction in binge episodes. Current investigations are exploring optimal dosing strategies and the impact on comorbidities like obesity (NCT04877990, ongoing).

• Off-label investigations: Preliminary research investigates VYVANSE's potential for treatment-resistant depression and other neurobehavioral disorders, although these are not yet in advanced trial stages.

Trial Outcomes and Safety Profile

Published data reinforce VYVANSE's safety and efficacy. The pivotal Phase III trials leading to BED approval revealed a 65% reduction in binge episodes compared to placebo, with adverse events mainly involving decreased appetite, dry mouth, and insomnia—consistent with known stimulants' profiles. Long-term extensions indicate sustained benefits without significant cardiovascular risks or dependency concerns when used appropriately [1].

Regulatory Developments

Recent submissions to global agencies show a strategic move to expand indications, particularly targeting adult ADHD and BED. The European Medicines Agency (EMA) reviewed the existing data, with a positive recommendation for further approval extensions. These regulatory advances are crucial for market expansion.

Market Analysis

Current Market Landscape

VYVANSE's global valuation exceeds USD 2.5 billion, driven by its dominant share in ADHD treatment among stimulant-based therapies. The medication holds roughly 18% of the global ADHD treatment market, with a particularly strong presence in North America, where ADHD diagnoses surged during the COVID-19 pandemic, and mental health awareness increased [2].

Competitive Positioning

Key competitors in the stimulant segment include:

• Adderall (amphetamine salts): The largest market share in the US, but with higher abuse potential and regulatory scrutiny.
• Concerta (methylphenidate): Frequently prescribed for both children and adults, presenting stiff competition, especially given its generic availability.
• Strattera (atomoxetine): A non-stimulant option favored in some clinical contexts.

VYVANSE differentiates itself through its unique prodrug formulation, offering smoother onset and longer duration of effect, reducing the need for multiple daily dosing.

Market Drivers

• Rising ADHD diagnoses: A 15% annual increase projected globally over the next five years due to increased awareness and screening.
• Expanding indications: Approval for BED unlocks a new revenue stream, with the global BED market anticipated to reach USD 1.2 billion by 2027.
• Healthcare provider acceptance: Growing preference for medications with established safety profiles and convenient dosing regimens.

Market Challenges

• Regulatory hurdles: Stringent controls on stimulant prescriptions, especially amid concerns over abuse and diversion.
• Generic competition: Patent expirations, notably in the US in 2023, threaten price erosion.
• COVID-19 Impact: Disruptions in healthcare delivery and delays in consultations might influence prescription patterns short-term.

Future Market Projections

By 2030, the global ADHD treatment market is estimated to reach USD 12 billion, with VYVANSE expected to occupy a significant segment due to ongoing expansion and its broadening therapeutic scope. The compound annual growth rate (CAGR) for the VYVANSE segment is projected at approximately 8% over the next five years, powered by new indications and emerging markets.

In particular, the BED indication promises to boost sales, notably in Europe and Asia-Pacific, where cultural shifts reduce stigma around mental health disorders. Additionally, the integration of digital health solutions for monitoring adherence may enhance overall sales efficiency.

Strategic Outlook

Commercialization Strategies

• Global Expansion: Targeted penetration in emerging markets (e.g., China, India) through licensing deals and local manufacturing.
• Combination Therapies: Development of adjunct therapies that enhance efficacy or reduce side effects.
• Digital Initiatives: Leveraging telehealth and mobile apps to improve patient engagement and compliance.

R&D Focus Areas

• Personalized Medicine: Biomarker-driven approaches to tailor doses and minimize side effects.
• Extended Release Formulations: Innovations to improve convenience and adherence.
• Broader Psychiatric Applications: Exploring off-label potential for other neuropsychiatric disorders.

Key Takeaways

• Clinical evidence upholds VYVANSE's efficacy and safety in ADHD and BED, prompting regulatory approvals for broader indications.
• Market dynamics are favorable, with increasing diagnosis rates and new indications supporting long-term growth.
• Competition remains intense, with patent expirations and generic entrants posing challenges.
• Future projections suggest an expanding market with CAGR around 8%, driven by emerging markets and innovative formulations.
• Strategic initiatives such as geographical expansion, digital health integration, and R&D diversification will shape VYVANSE’s market trajectory.

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FAQs

Q1: What are the primary approved indications for VYVANSE?
A: The FDA-approved indications include ADHD in children aged 6 and above, adolescents, and adults; and Binge Eating Disorder (BED) in adults.

Q2: How does VYVANSE’s mechanism differ from other stimulant medications?
A: VYVANSE is a prodrug of dextroamphetamine, converted in the body to active dextroamphetamine, providing a smoother onset and extended duration, which may reduce abuse potential compared to immediate-release stimulants.

Q3: What are recent regulatory developments concerning VYVANSE?
A: Recent submissions in Europe aim to expand indications, with encouraging preliminary reviews. The US continues to see approval extensions and ongoing post-marketing surveillance.

Q4: What are the key challenges impacting VYVANSE’s market growth?
A: Patent expirations, the availability of generics, regulatory scrutiny over abuse potential, and competitive offerings impact overall market expansion.

Q5: What strategic initiatives can enhance VYVANSE’s market share?
A: Expanding into emerging markets, optimizing formulation technology, integrating digital health tools, and diversifying indications are critical avenues.

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References

1. Smith, J. et al. (2022). Long-term safety and efficacy of VYVANSE in adults with ADHD: A multicenter study. Journal of Psychiatric Research.
2. GlobalData Healthcare (2023). ADHD Market Forecast 2023-2030.
3. Takeda Pharmaceuticals (2022). Annual Report.
4. IQVIA (2022). Prescription Drug Market Trends Report.