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lisdexamfetamine

Trade name: vyvanse

Small moleculeapproved

Approved

Feb 23, 2007

Lisdexamfetamine (LDX) is a d-amphetamine (d-AMPH) pro-drug used to treat Attention Deficit and Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). After oral administration, lisdexamfetamine dimesylate is rapidly absorbed from the gastrointestinal tract and converted to dextroamphetamine, which is responsible for the drug’s activity. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Most common adverse reactions in children, adolescents and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Needs to adjust Lisdexamfetamine dosage accordingly. — NCATS

Clinical trial activity

111 trials · 61 clinical orgs · 27 marketing orgs

Phase 1
15
Phase 2
55
Phase 3
33
Phase 4
34

Earliest trial started Sep 1, 2004 (NCT00557011)

Timeline

2000s

  1. Jan 1, 2004

    New River Pharmaceuticals — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    New River Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    New River Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

  4. Feb 23, 2007

    New River Pharmaceuticals — Earliest FDA Approval

  5. Feb 23, 2007

    New River Pharmaceuticals — NDA Organization

  6. Feb 23, 2007

    Avon and Wiltshire Mental Health Partnership NHS Trust — NDA Secondary Org

  7. Feb 23, 2007

    Takeda — Marketing Organization

  8. Feb 23, 2007

    Takeda — NDA Secondary Org

2010s

  1. Jun 23, 2014

    Roxane Laboratories — Marketing Organization

  2. Jun 23, 2014

    Boehringer Ingelheim — Marketing Organization

  3. Jun 25, 2014

    Amneal Pharmaceuticals — Marketing Organization

  4. Jun 25, 2014

    Mylan — Marketing Organization

  5. Aug 17, 2015

    Sandoz — Marketing Organization

  6. Aug 17, 2015

    Novartis — Marketing Organization

  7. Oct 30, 2015

    Actavis — Marketing Organization

  8. Jan 28, 2017

    Shire — NDA Secondary Org

2020s

  1. Jun 21, 2022

    Norwich Eaton Company — Marketing Organization

  2. Aug 12, 2022

    AbbVie — Marketing Organization

  3. Nov 28, 2022

    Teva — Marketing Organization

  4. Apr 25, 2023

    Apotex — Marketing Organization

  5. Aug 25, 2023

    Alkem Labs Ltd — Marketing Organization

  6. Aug 25, 2023

    Ascent Pharmahealth — Marketing Organization

  7. Aug 25, 2023

    Hikma — Marketing Organization

  8. Aug 25, 2023

    Lannett Company, Inc. — Marketing Organization

  9. Aug 25, 2023

    Prinston Inc — Marketing Organization

  10. Aug 25, 2023

    Rhodes Pharmaceuticals, L.P. — Marketing Organization

  11. Aug 25, 2023

    Specgx Llc — Marketing Organization

  12. Aug 25, 2023

    Sun Pharmaceuticals — Marketing Organization

  13. Feb 2, 2024

    MSN Laboratories — Marketing Organization

  14. Nov 15, 2024

    Elite Laboratories, Inc — Marketing Organization

  15. Dec 16, 2024

    Granules India — Marketing Organization

  16. Jun 16, 2025

    Azurity — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 23, 2007

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H](Cc1ccccc1)NC(=O)[C@@H](N)CCCCN
Mol. weight
263.38 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • elvanse
  • elvanse
  • elvanse adult
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine
  • lisdexamfetamine dimesylate
  • lisdexamfetamine dimesylate
  • lisdexamfetamine dimesylate
  • lisdexamfetamine dimesylate
  • lisdexamfetamine dimesylate
  • lisdexamfetamine dimesylate
  • lisdexamphetamine
  • lisdexamphetamine
  • lisdexamphetamine
  • nrp104
  • nrp104
  • nrp104
  • nrp104
  • spd489
  • spd489
  • vyvanse
  • vyvanse
  • vyvanse
  • vyvanse
  • vyvanse

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06788587Phase 2Jul 18, 2025Government of France, Health Canada, University of Montreal
NCT06847399Phase 2Jun 1, 2025Eli Lilly, Johns Hopkins University
NCT05854667Phase 2Dec 5, 2023Canadian Institutes of Health Research (CIHR), University of Montreal
NCT05416125Early Phase 1 (Phase 1)Jul 1, 2023University of Minnesota
NCT05621174N/ADec 1, 2022University of Amsterdam
NCT04599504Phase 2/Phase 3 (Phase 3)Jan 2, 2022National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University
NCT04152629Phase 4Sep 19, 2019Purdue Pharmaceuticals
NCT03926052Phase 3Aug 9, 2019Yale University
NCT04181957N/AMay 1, 2019University of Birmingham
NCT03924193Phase 3Mar 25, 2019Yale University
NCT03337646Phase 4Sep 26, 2018JPM van Stralen Medicine Professional, Shire
NCT03397446Phase 2Jun 21, 2018Dalhousie University, Government of Canada
NCT03446885Phase 4Apr 1, 2018State University of New York, Buffalo
NCT03333668N/AMar 1, 2018Shire, University of London
NCT03260205Phase 3Sep 6, 2017Shire
NCT03187353Phase 4Jul 1, 2017University of Pennsylvania
NCT03070509Phase 4May 12, 2017Neuropsychiatric Research Institute, Fargo, ND, North Dakota State University, Shire
NCT02712996Phase 4Feb 6, 2017Shire, Vanderbilt University
NCT02668926Phase 1May 1, 2016University of Basel, University of Bern
NCT02675400Phase 4Dec 1, 2015University of Washington
Showing 20 of 111 trials
Page 1 / 6

Organizations

Research & Development (61)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit704152004
Harvard UniversityAcademic/Hospital8442004
University of CincinnatiAcademic/Hospital8422010
New River PharmaceuticalsFor profit6622004
The University of Texas, DallasAcademic/Hospital5022009
University of PennsylvaniaAcademic/Hospital5522011
Columbia UniversityAcademic/Hospital4432008
Duke UniversityAcademic/Hospital4332007
New York UniversityAcademic/Hospital4222009
University of California, IrvineAcademic/Hospital4232006
Canadian Institutes of Health Research (CIHR)Academic/Hospital3032010
Case Western Reserve UniversityAcademic/Hospital3022007
Johns Hopkins UniversityAcademic/Hospital3112005
University of MinnesotaAcademic/Hospital3322009
Yale UniversityAcademic/Hospital3312019
Clinical Study Centers, LLCFor profit2122004
Desert Pacific Mental Illness Research, Education, and Clinical CenterAcademic/Hospital2012012
JPM van Stralen Medicine ProfessionalAcademic/Hospital2212013
McGill UniversityAcademic/Hospital2222010
Mclean HospitalAcademic/Hospital2122010
61 organizations
Page 1 / 4

Marketing (33)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGAug 12, 2022
ActavisFor profitMKTGOct 30, 2015
Alkem Labs LtdFor profitMKTGAug 25, 2023
Amneal PharmaceuticalsFor profitMKTGJun 25, 2014
Amneal PharmaceuticalsFor profitSYNAug 25, 2023
ApotexFor profitMKTGApr 25, 2023
ApotexFor profitSYNAug 25, 2023
Ascent PharmahealthFor profitMKTGAug 25, 2023
Avon and Wiltshire Mental Health Partnership NHS TrustGovernmentNDA2Feb 23, 2007
AzurityFor profitMKTGJun 16, 2025
Boehringer IngelheimFor profitMKTGJun 23, 2014
Elite Laboratories, IncFor profitMKTGNov 15, 2024
Granules IndiaFor profitMKTGDec 16, 2024
HikmaFor profitMKTGAug 25, 2023
Lannett Company, Inc.For profitMKTGAug 25, 2023
MSN LaboratoriesFor profitMKTGFeb 2, 2024
MylanFor profitMKTGJun 25, 2014
MylanFor profitSYNAug 25, 2023
New River PharmaceuticalsFor profitNDAFeb 23, 2007
Norwich Eaton CompanyFor profitMKTGJun 21, 2022
NovartisFor profitMKTGAug 17, 2015
Prinston IncFor profitMKTGAug 25, 2023
Rhodes Pharmaceuticals, L.P.For profitMKTGAug 25, 2023
Roxane LaboratoriesFor profitMKTGJun 23, 2014
SandozFor profitMKTGAug 17, 2015
SandozFor profitSYNJul 26, 2024
ShireFor profitNDA2Jan 28, 2017
Specgx LlcFor profitMKTGAug 25, 2023
Sun PharmaceuticalsFor profitMKTGAug 25, 2023
TakedaFor profitMKTGFeb 23, 2007
TakedaFor profitNDA2Feb 23, 2007
TevaFor profitMKTGNov 28, 2022
TevaFor profitSYNAug 25, 2023