Vyvanse

(Lisdexamfetamine Dimesylate)

ApprovedSmall molecule

Vyvanse is a small molecule that works as a Dopamine Transporter Releasing Agent; Norepinephrine Transporter Releasing Agent; Synaptic Vesicular Amine Transporter Inhibitor.[2] It is being used across 10 indications, with its most advanced program in Approved.[1]

Vyvanse is one of 198 small molecule programs targeting Huntington disease. It is currently in Approved.

Indications

Total Trials

Active Trials

197

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Huntington DiseaseUnknown

Alzheimer DiseaseUnknown

Binge EatingUnknown

Arteriosclerosis DisorderUnknown

Morbid ObesityActive, not recruiting

Drug DependenceUnknown

GlaucomaUnknown

Chronic Fatigue SyndromeActive, not recruiting

AutismActive, not recruiting

Anxiety DisorderCompleted

Huntington DiseasePreclinical

Unknown

Alzheimer DiseasePreclinical

Unknown

Binge EatingPreclinical

Unknown

Arteriosclerosis DisorderPreclinical

Unknown

Morbid ObesityPreclinical

Active, not recruiting

Drug DependencePreclinical

Unknown

GlaucomaPreclinical

Unknown

Chronic Fatigue SyndromeApproved

Active, not recruiting

AutismApproved

Active, not recruiting

Anxiety DisorderApproved

Completed

Competition

Competitive Landscape

100 competitors in Alzheimer Disease

#DrugCompanyPhaseTrials

Vyvanse

Takeda

Approved

35 2

Leqembi

Eisai

Approved

1 3

Niacor

Evista

Thalomid

Avelox

Victoza

Quviviq

Idorsia Pharmaceuticals Ltd.

Approved

2 9

Kisunla

Eli Lilly

Phase 3

4 10

Advil

KKenvue Brands

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Obesity and Overweight

NCT06847399

Clinical

Trials by Indication[1]

Attention Deficit Hyperactivity Disorder6 trials

Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)

Completed·—·Phase 4·NCT00889915·228 enrolled

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Completed· Takeda logo

Takeda·Phase 4·NCT01552915·464 enrolled

Effect of Vyvanse on Sleep in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder (ADHD)

Completed·CClinical Study Centers, LLC·N/A·NCT00807222·24 enrolled

Show 3 more trials

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Completed· Takeda logo

Takeda·Phase 4·NCT01552902·549 enrolled

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

Completed· Takeda logo

Takeda·Phase 3·NCT01106430·267 enrolled

Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Completed· Takeda logo

Takeda·Phase 4·NCT01328756·314 enrolled

Eating Disorder5 trials

Open Label Extension in Adults With Binge Eating Disorder (BED)

Completed· Takeda logo

Takeda·Phase 3·NCT01657019·604 enrolled

Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Completed· Takeda logo

Takeda·Phase 3·NCT02009163·418 enrolled

Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment

Completed·YYale University·Phase 3·NCT03924193·141 enrolled

Show 2 more trials

Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment

Completed·YYale University·Phase 3·NCT03926052·61 enrolled

Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder

Completed· Takeda logo

Takeda·Phase 2·NCT01291173·271 enrolled

Safety and Efficacy3 trials

Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

Completed· Takeda logo

Takeda·Phase 3·NCT00763971·336 enrolled

Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17

Completed· Takeda logo

Takeda·Phase 3·NCT00784654·276 enrolled

Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

Completed· Takeda logo

Takeda·Phase 3·NCT00764868·269 enrolled

Treatment1 trial

To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder

Completed·UUniversity Health Network, Toronto··NCT01263548·45 enrolled

Bulimia Nervosa1 trial

Lisdexamfetamine for Adults With Bulimia Nervosa

Terminated·AAaron Keshen·Phase 2·NCT03397446·23 enrolled

19 more indications

Anxiety Disorder1 trial

Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity

Completed·CCentre for Anxiety, Attention Deficit and Trauma, Ontario, Canada·Phase 4·NCT01863459·42 enrolled

Chronic Fatigue Syndrome1 trial

Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome

Completed·RRochester Center for Behavioral Medicine·Phase 4·NCT01071044·26 enrolled

Adult1 trial

Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

Completed· Takeda logo

Takeda·Phase 1·NCT01890785·30 enrolled

Drug Liking1 trial

Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution

Terminated· Takeda logo

Takeda·Phase 1·NCT00776555·3 enrolled

Function1 trial

Effects of LDX on Functioning of College Students With ADHD

Completed·UUniversity of Rhode Island·Phase 4·NCT01342445·50 enrolled

Autism1 trial

Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism

Completed·JJPM van Stralen Medicine Professional·Phase 4·NCT03337646·48 enrolled

ESS1 trial

Effects of LDX on Cognitive Processes and Appetite

Terminated·UUniversity of Birmingham·N/A·NCT04181957·22 enrolled

Major Depressive Disorder1 trial

Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.

Completed·MMclean Hospital·Phase 4·NCT01148979·35 enrolled

Cognition1 trial

Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Completed· Takeda logo

Takeda·Phase 1·NCT01010750·18 enrolled

Efficacy1 trial

Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD

Completed·GGregory Fabiano·Phase 4·NCT03446885·22 enrolled

Efficacy and Safety1 trial

Real World Evidence of the Efficacy and Safety of FOQUEST

Completed·PPurdue Pharma, Canada·Phase 4·NCT04152629·257 enrolled

Acute Lymphoblastic Leukemia1 trial

Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC

Completed· Takeda logo

Takeda·Phase 1·NCT00746733·24 enrolled

Bariatric Surgery1 trial

Bariatric Surgery and Pharmacokinetics of Lisdexamphetamine

Completed·NNorwegian University of Science and Technology··NCT03497169·12 enrolled

Driving1 trial

A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD

Completed·RRhodes Pharmaceuticals, L.P.·Phase 3·NCT02555150·40 enrolled

Obesity and Overweight1 trial

Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder: A Randomized Clinical Trial

Recruiting·JJohns Hopkins University·Phase 2·NCT06847399·105 enrolled

ADHD1 trial

Experimental fMRI Study on the Comparison of the Brain Function Effects of a Single Dose of Guanfacine and Lisdexamfetamine Relative to Placebo in Children and Adolescents With ADHD.

Completed·KKing's College London·Preclinical·NCT03333668·25 enrolled

Obesity, Childhood1 trial

Lisdexamfetamine for the Treatment of Severe Obesity in Children Aged 6 to 12 Years

Completed·UUniversity of Minnesota·Phase 1·NCT05416125·44 enrolled

Loss-of-control Eating1 trial

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b)

Completed·YYale University·Preclinical·NCT04599504·16 enrolled

Unspecified1 trial

The Day-time Response Variation of (Lis)Dexamphetamine

Completed·AAmsterdam UMC, location VUmc··NCT04946461·16 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 30, 2014

VYVANSE

NDA NDA021977

Jan 28, 2017

VYVANSE

NDA NDA208510

Jun 16, 2025

ARYNTA

NDA NDA219847

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Lisdexamfetamine Dimesylate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lisdexamfetamine Dimesylate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lisdexamfetamine Dimesylate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219847). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine Transporter Releasing Agent; Norepinephrine Transporter Releasing Agent; Synaptic Vesicular Amine Transporter Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Takeda

Vyvanse

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Attention Deficit Hyperactivity Disorder6 trials

Eating Disorder5 trials

Safety and Efficacy3 trials

Treatment1 trial

Bulimia Nervosa1 trial

Anxiety Disorder1 trial

Chronic Fatigue Syndrome1 trial

Adult1 trial

Drug Liking1 trial

Function1 trial

Autism1 trial

ESS1 trial

Major Depressive Disorder1 trial

Cognition1 trial

Efficacy1 trial

Efficacy and Safety1 trial

Acute Lymphoblastic Leukemia1 trial

Bariatric Surgery1 trial

Driving1 trial

Obesity and Overweight1 trial

ADHD1 trial

Obesity, Childhood1 trial

Loss-of-control Eating1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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