Vyvanse

(Lisdexamfetamine)

ApprovedSmall molecule

Lisdexamfetamine is used to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder by helping improve focus and reduce impulsive eating behaviors.[2] Vyvanse is currently approved and in use across 12 indications[4].[1]

Vyvanse is one of 296 small molecule programs targeting Substance Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

295

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Substance DependenceApproved

Bipolar DisorderApproved

Depressive DisorderApproved

Multiple SclerosisApproved

Substance AbuseActive, not recruiting

Brain InjuryActive, not recruiting

TrialRecruiting

MedicationCompleted

Attention Deficit Hyperactivity DisorderCompleted

Executive FunctionCompleted

Substance DependenceApproved

Approved

Bipolar DisorderApproved

Approved

Depressive DisorderApproved

Approved

Multiple SclerosisApproved

Approved

Substance AbusePreclinical

Active, not recruiting

Brain InjuryApproved

Active, not recruiting

TrialPhase 1

Recruiting

MedicationPreclinical

Completed

Attention Deficit Hyperactivity DisorderApproved

Completed

Executive FunctionApproved

Completed

Showing 10 of 12 indications

Competition

Competitive Landscape

145 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Vyvanse

Takeda

Approved

29 2

Rinvoq

AbbVie

Phase 3

1 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

9 4

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

2 5

Versed

CConrado Roberto Hoffmann Filho

Phase 3

2 6

Zyrtec

KKenvue Brands

Phase 3

1 7

Vumerity

Biogen

Phase 3

4 8

Frexalimab

Sanofi

Phase 3

2 9

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

2 10

PBR06

UUniversity Hospital, Bordeaux

Phase 3

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

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Type 1 Diabetes

NCT05957055

Clinical

Trials by Indication[1]

Treatment3 trials

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

Terminated·NNew York State Psychiatric Institute·N/A·NCT02259517·38 enrolled

E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy

Withdrawn·UUniversity of Pennsylvania·N/A·NCT01986764

Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

Completed·NNYU Langone Health·Phase 2·NCT02635035·38 enrolled

Attention Deficit Hyperactivity Disorder2 trials

Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults

Completed·MMassachusetts General Hospital·Phase 4·NCT00753012·24 enrolled

Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

Completed·FFlorida International University·Phase 4·NCT01127607·38 enrolled

Bipolar Depression2 trials

Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Terminated·LLindner Center of HOPE·Phase 3·NCT01093963·25 enrolled

Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Terminated·LLindner Center of HOPE·Phase 3·NCT01131559·50 enrolled

Eating Disorder2 trials

Lisdexamfetamine in Binge Eating Disorder (BED): fMRI Effects

Unknown status·LLindner Center of HOPE·Phase 2·NCT02659488·40 enrolled

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Completed·LLindner Center of HOPE·Phase 3·NCT01090713·50 enrolled

Cocaine Dependence2 trials

Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

Completed·NNew York State Psychiatric Institute·Phase 1/2·NCT01486810·17 enrolled

Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

Terminated·UUniversity of Minnesota·Phase 1·NCT01490216·43 enrolled

17 more indications

Magnetic Resonance Imaging2 trials

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

Terminated·SSteward St. Elizabeth's Medical Center of Boston, Inc.·Phase 4·NCT01051440·2 enrolled

LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Completed·UUniversity of Pennsylvania·Phase 4·NCT01977625·18 enrolled

Mood1 trial

Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation

Completed·UUniversity of California, Los Angeles·Phase 2·NCT01714310·34 enrolled

Executive Function1 trial

IMProving Executive Function Study

Completed·UUniversity of Pennsylvania·Phase 4·NCT03187353·69 enrolled

Cognitive Function1 trial

LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy

Withdrawn·UUniversity of Pennsylvania·N/A·NCT01986777

Memory Impairment1 trial

Attention & Memory Impairments in Menopausal Women

Completed·UUniversity of Pennsylvania·Phase 4·NCT01324024·35 enrolled

Medication1 trial

Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD

Completed·NNew York State Psychiatric Institute·N/A·NCT01415440·117 enrolled

Attention Deficit Disorder1 trial

The Use of Lisdexamfetamine for Children Aged 7-13 With Attention Deficit Disorders

Unknown status·—··NCT04727476·413 enrolled

Brain Injury1 trial

Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits in Children

Completed·VVanderbilt University·Phase 4·NCT02712996·20 enrolled

Adult1 trial

Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation

Completed·JJeffrey Newcorn·Phase 4·NCT01924429·30 enrolled

Cognition1 trial

Lisdexamfetamine's Effect In ADHD in the Brain and Cognition

Terminated·UUniversity of California, Davis·Phase 4·NCT02170298·6 enrolled

Trial1 trial

A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

Recruiting· Otsuka logo

Otsuka·Phase 1·NCT07314333·42 enrolled

Abuse Potential1 trial

A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users

Completed·NNeurovance, Inc.·Phase 1·NCT02144415·80 enrolled

Fasting Conditions1 trial

To Compare and Evaluate the Oral Bioavailability of Lisdexamfetamine 70 mg Capsule With That of Elvanse® 70 mg Capsules, Hard Lisdexamfetamine Dimesylate in Healthy, Adult, Human Subjects Under Fasting Conditions.

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT07098585·48 enrolled

Substance Abuse1 trial

A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04132557·430,000 enrolled

Type 1 Diabetes1 trial

Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes

Recruiting·MMedical University of Lodz·Phase 2·NCT05957055·150 enrolled

Methamphetamine Dependence1 trial

Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

Completed·UUniversity of Arkansas·Phase 1·NCT02034201·19 enrolled

Bariatric Surgery1 trial

Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients

Unknown status·NNorth Dakota State University·Phase 4·NCT03070509·20 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 30, 2014

VYVANSE

NDA NDA021977

Jan 28, 2017

VYVANSE

NDA NDA208510

Jun 16, 2025

ARYNTA

NDA NDA219847

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Lisdexamfetamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vyvanse drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lisdexamfetamine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lisdexamfetamine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219847). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Vyvanse. U.S. Food & Drug Administration.
[7]
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[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

Apr 16, 2040

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12433859Apr 16, 2040

12582620Apr 16, 2040

11576878Aug 30, 2040

Vyvanse

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Treatment3 trials

Attention Deficit Hyperactivity Disorder2 trials

Bipolar Depression2 trials

Eating Disorder2 trials

Cocaine Dependence2 trials

Magnetic Resonance Imaging2 trials

Mood1 trial

Executive Function1 trial

Cognitive Function1 trial

Memory Impairment1 trial

Medication1 trial

Attention Deficit Disorder1 trial

Brain Injury1 trial

Adult1 trial

Cognition1 trial

Trial1 trial

Abuse Potential1 trial

Fasting Conditions1 trial

Substance Abuse1 trial

Type 1 Diabetes1 trial

Methamphetamine Dependence1 trial

Bariatric Surgery1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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