Drugs / Lisdexamfetamine
last change Apr 2026 re-read 2 minutes ago

Lisdexamfetamine

Other / unclassified

Developed for
attention deficit-hyperactivity disorder · binge eating disorder · major depressive disorder · cocaine dependence · cognitive disorder · schizophrenia · eating disorder · methamphetamine dependence
+10 more · mood disorder · multiple sclerosis · nicotine dependence · obesity disorder · premature menopause · substance abuse · bipolar depression · bipolar disorder · cognitive impairment with or without cerebellar ataxia · depressive disorder
Investigated by
Shire · New York State Psychiatric Institute · NYU Langone Health · New River Pharmaceuticals · University of Pennsylvania · American Academy of Child Adolescent Psychiatry.
+28 more · Columbia University · Duke University · Florida International University · Health Canada · Humanis · JPM van Stralen Medicine Professional · Jeffrey Newcorn · King's College London · Lehigh University · Lindner Center of HOPE · Massachusetts General Hospital · Ministere de la Sante et des Services Sociaux · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Mental Health (NIMH) · National Institute on Drug Abuse (NIDA) · Neuropsychiatric Research Institute, Fargo, North Dakota · North Dakota State University · Otsuka Pharmaceutical Development & Commercialization, Inc. · State University of New York at Buffalo · University Hospital, Basel, Switzerland · University of California, Davis · University of California, Irvine · University of California, Los Angeles · University of Cincinnati · University of Minnesota · University of Montreal Hospital Centre (CHUM) · University of Rhode Island · Yale University

Trials 42 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07314333 Feb → Mar 2026 attention deficit-hyperactivity disorder Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded
Phase 1 NCT07098585 May → Jun 2025 attention deficit-hyperactivity disorder Humanis Completed No outcome recorded
Phase 1 NCT02668926 May → Jun 2016 University Hospital, Basel, Switzerland Completed No outcome recorded
Phase 1 NCT01457339 Oct 2011 → Jan 2012 schizophrenia Shire Completed No outcome recorded
Phase 1 NCT01490216 Jul 2011 → Jan 2013 cocaine dependence University of Minnesota Terminated No outcome recorded
Phase 1 NCT01235338 Oct → Dec 2010 Shire Completed No outcome recorded
Phase 1 NCT00776555 Nov 2008 → Mar 2009 Shire Terminated No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT01486810 Dec 2011 → Dec 2013 cocaine dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 1/2 NCT00573859 Sep 2006 → Jun 2010 attention deficit-hyperactivity disorder University of California, Irvine Completed No outcome recorded
Phase 28 trials
Phase 2 NCT06788587 Jul 2025 → Aug 2027 expected methamphetamine dependence, substance abuse University of Montreal Hospital Centre (CHUM) Recruiting No outcome recorded
Phase 2 NCT02635035 Nov 2015 → Jan 2019 attention deficit-hyperactivity disorder NYU Langone Health Completed No outcome recorded
Phase 2 NCT02659488 Sep 2015 → Sep 2017 binge eating disorder Lindner Center of HOPE Unknown No outcome recorded
Phase 2 NCT01714310 Jan 2013 → Jun 2016 mood disorder University of California, Los Angeles Completed No outcome recorded
Phase 2 NCT01291173 May 2011 → Jan 2012 binge eating disorder Shire Completed No outcome recorded
Phase 2 NCT01615887 Nov 2009 → Aug 2011 multiple sclerosis State University of New York at Buffalo Completed No outcome recorded
Phase 2 NCT00922272 Sep 2009 → Jan 2011 schizophrenia Shire Completed No outcome recorded
Phase 2 NCT00905424 Jul 2009 → Aug 2010 major depressive disorder Shire Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04599504 Jan 2022 → May 2027 expected eating disorder, obesity disorder Yale University Active not recruiting No outcome recorded
Phase 39 trials
Phase 3 NCT01718483 Nov 2012 → Sep 2013 binge eating disorder Shire Completed No outcome recorded
Phase 3 NCT01718509 Nov 2012 → Sep 2013 binge eating disorder Shire Completed No outcome recorded
Phase 3 NCT01436149 Oct 2011 → Dec 2013 major depressive disorder Shire Completed No outcome recorded
Phase 3 NCT01436162 Oct 2011 → Dec 2013 major depressive disorder Shire Completed No outcome recorded
Phase 3 NCT01106430 Jun 2010 → Jul 2012 attention deficit-hyperactivity disorder Shire Completed No outcome recorded
Phase 3 NCT00763971 Nov 2008 → Mar 2011 attention deficit-hyperactivity disorder Shire Completed No outcome recorded
Phase 3 NCT00764868 Nov 2008 → Apr 2010 attention deficit-hyperactivity disorder Shire Completed No outcome recorded
Phase 3 NCT00337285 Jul 2006 → Nov 2007 attention deficit-hyperactivity disorder New River Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00334880 May → Nov 2006 attention deficit-hyperactivity disorder New River Pharmaceuticals Completed No outcome recorded
Phase 411 trials
Phase 4 NCT03337646 Sep 2018 → Mar 2023 attention deficit-hyperactivity disorder, autism spectrum disorder JPM van Stralen Medicine Professional Completed No outcome recorded
Phase 4 NCT03187353 Sep 2017 → Apr 2022 cognitive disorder University of Pennsylvania Completed No outcome recorded
Phase 4 NCT03070509 May 2017 → Jul 2019 North Dakota State University Unknown No outcome recorded
Phase 4 NCT02170298 Feb 2014 → Jun 2015 attention deficit-hyperactivity disorder University of California, Davis Terminated No outcome recorded
Phase 4 NCT01924429 Mar → Dec 2013 attention deficit-hyperactivity disorder Jeffrey Newcorn Completed No outcome recorded
Phase 4 NCT01324024 May 2011 → Apr 2014 cognitive disorder, premature menopause University of Pennsylvania Completed No outcome recorded
Phase 4 NCT01127607 Nov 2010 → Jul 2012 attention deficit-hyperactivity disorder Florida International University Completed No outcome recorded
Phase 4 NCT01070394 Feb 2010 → Jul 2012 attention deficit-hyperactivity disorder NYU Langone Health Completed No outcome recorded
Phase 4 NCT01342445 Sep 2009 → Dec 2010 attention deficit-hyperactivity disorder University of Rhode Island Completed No outcome recorded
Phase 4 NCT00753012 Apr 2008 → Mar 2011 attention deficit-hyperactivity disorder Massachusetts General Hospital Completed No outcome recorded
Phase not applicable4 trials
NCT03333668 Oct 2018 → Dec 2022 attention deficit-hyperactivity disorder King's College London Unknown No outcome recorded
NCT02259517 Sep 2014 → Nov 2021 attention deficit-hyperactivity disorder New York State Psychiatric Institute Terminated No outcome recorded
NCT01415440 Aug 2011 → Jun 2018 attention deficit-hyperactivity disorder New York State Psychiatric Institute Completed No outcome recorded
NCT00736255 Dec 2007 → Jul 2011 attention deficit-hyperactivity disorder, nicotine dependence Duke University Completed No outcome recorded
Also used as a comparator or background therapy in 19 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02144415 Comparator May → Jul 2014 Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded
Phase 1 NCT02034201 Comparator Feb 2014 → May 2016 methamphetamine dependence University of Arkansas Completed No outcome recorded
Phase 23 trials
Phase 2 NCT05957055 Comparator Feb 2024 → Dec 2027 expected attention deficit-hyperactivity disorder, type 1 diabetes mellitus Medical University of Lodz Recruiting No outcome recorded
Phase 2 NCT05854667 Comparator Dec 2023 → Dec 2027 expected methamphetamine dependence, substance abuse University of Montreal Hospital Centre (CHUM) Recruiting No outcome recorded
Phase 2 NCT00958282 Comparator Jul 2009 → Jan 2013 cocaine dependence University of Minnesota Completed No outcome recorded
Phase 35 trials
Phase 3 NCT03924193 Comparator Mar 2019 → Sep 2023 binge eating disorder, obesity disorder Yale University Completed No outcome recorded
Phase 3 NCT02555150 Comparator Sep 2015 → Jan 2017 attention deficit-hyperactivity disorder Rhodes Pharmaceuticals, L.P. Completed No outcome recorded
Phase 3 NCT01131559 Comparator Jan 2010 → Feb 2014 bipolar disorder, depressive disorder Lindner Center of HOPE Terminated No outcome recorded
Phase 3 NCT01090713 Comparator Jan 2010 → Oct 2012 binge eating disorder Lindner Center of HOPE Completed No outcome recorded
Phase 3 NCT01093963 Comparator Jan 2010 → Feb 2014 bipolar depression Lindner Center of HOPE Terminated No outcome recorded
Phase 45 trials
Phase 4 NCT02712996 Comparator Feb 2017 → Jul 2019 attention deficit-hyperactivity disorder, traumatic brain injury Vanderbilt University Completed No outcome recorded
Phase 4 NCT01977625 Comparator Dec 2011 → Apr 2014 University of Pennsylvania Completed No outcome recorded
Phase 4 NCT01051440 Comparator Feb 2010 → Jun 2011 bipolar depression Steward St. Elizabeth's Medical Center of Boston, Inc. Terminated No outcome recorded
Phase 4 NCT01017263 Comparator Dec 2009 → Aug 2012 attention deficit-hyperactivity disorder, glucose intolerance, obesity disorder Duke University Terminated No outcome recorded
Phase 4 NCT00889915 Comparator Apr → Dec 2009 attention deficit-hyperactivity disorder Duke University Completed No outcome recorded
Phase not applicable4 trials
NCT05551689 Background May 2021 → Sep 2022 attention deficit-hyperactivity disorder Hospital de Clinicas de Porto Alegre Completed No outcome recorded
NCT01986764 Comparator Jul 2013 University of Pennsylvania Withdrawn No outcome recorded
NCT01986777 Comparator Jul → Dec 2013 cognitive impairment with or without cerebellar ataxia University of Pennsylvania Withdrawn No outcome recorded
NCT00807222 Comparator Apr → Aug 2008 attention deficit-hyperactivity disorder Clinical Study Centers, LLC Completed No outcome recorded

Press releases naming this drug 16 releases

DateIssuerRelease
2017-04-18 Takeda Vyvanse® (lisdexamfetamine dimesylate) CII Available in a New Chewable Tablet Formulation takeda.com
2016-10-17 Takeda Shire Announces Update to Vyvanse® (lisdexamfetamine dimesylate) U.S. Labeling to Include New Longer-Term Maintenance of Efficacy Data in Adults with Moderate to Severe Binge Eating Disorder takeda.com
2016-04-14 Takeda Shire Submits NDA to FDA for New Formulation of Vyvanse® (lisdexamfetamine dimesylate) CII as Chewable Tablets takeda.com
2015-09-24 Takeda Appeals Court Affirms Shire’s Vyvanse® (lisdexamfetamine dimesylate) Patents Are Valid Until 2023 takeda.com
2015-07-22 Takeda Vyvanse® (lisdexamfetamine dimesylate) Positive Top-Line Results in Maintenance of Efficacy Study in Adults with Moderate to Severe Binge Eating Disorder takeda.com
2015-03-23 Takeda Vyvanse Capsules as a Titration Dose takeda.com
2015-01-30 Takeda Vyvanse® (Lisdexamfetamine Dimesylate) Capsules (CII) Becomes First And Only Treatment Approved By The FDA For Adults With Moderate To Severe Binge Eating Disorder takeda.com
2015-01-22 Takeda Positive Response From European Decentralised Procedure For Elvanse Adult® In Adults With ADHD takeda.com
2014-09-15 Takeda Shire Announces FDA Acceptance For Filing With Priority Review Of Supplemental New Drug Application (Snda) For Vyvanse® (Lisdexamfetamine Dimesylate) Capsules (CII) For Adults With Binge Eating Disorder takeda.com
2014-07-17 Takeda Top-Line Results From Two Head-To-Head Studies Comparing Vyvanse® (Lisdexamfetamine Dimesylate), CII, With Concerta® (Methylphenidate Hcl), CII, In Adolescents With ADHD takeda.com
2014-06-25 Takeda Vyvanse Patents Found To Be Infringed And Valid By U.S. District Court takeda.com
2014-06-12 Takeda Shire Agrees To FDA Request To Conduct Clinical Trials Investigating The Potential Use Of Vyvanse® (Lisdexamfetamine Dimesylate) In Preschool-Age Children With ADHD takeda.com

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 74 sources stand behind the page.

FieldValueCited text
Known as lisdexamfetamine “OBJECTIVE: To evaluate the efficacy and safety of 30, 50, and 70 mg/day lisdexamfetamine dimesylate compared with placebo in adults with attention-deficit/hyperactivity disorder (ADHD).” PMID 19012818 Sep 2008
58

“BACKGROUND: Lisdexamfetamine dimesylate (LDX), a prodrug consisting of d-amphetamine and l-lysine, is being studied in clinical trials of major depressive disorder.” PMID 23512639 Apr 2013

“Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial.” PMID 25295646 Sep 2014

“using Lisdexamfetamine (LDX-01) on top of treatment-as-usual (TAU)” NCT06788587

LisdexamfetamineNCT05551689

LisdexamfetamineNCT00573859

NCT01714310

NCT03337646

NCT01615887

NCT00500071

NCT02668926

NCT01106430

NCT07098585

NCT01415440

NCT01436162

NCT01986764

NCT02259517

NCT03187353

NCT00807222

NCT05854667

NCT01457339

NCT02659488

NCT01986777

NCT05957055

NCT02712996

NCT01324024

NCT00764868

NCT00905424

NCT00337285

NCT00763971

NCT01924429

NCT01127607

NCT01436149

NCT00922272

NCT00753012

NCT02034201

NCT01131559

NCT01718483

NCT01342445

NCT01977625

NCT01051440

NCT03070509

NCT01718509

NCT00776555

NCT04599504

NCT00958282

NCT02555150

NCT01490216

NCT01291173

NCT02144415

NCT00889915

NCT03924193

NCT01486810

NCT01090713

NCT02170298

NCT01093963

NCT02635035

NCT03333668

NCT07314333

Known as 608137-32-2 “Once-daily pharmacotherapy with lisdexamfetamine (608137-32-2, SUB32146), administered orally” NCT05957055
Known as Elvanse Elvanse® (Lisdexamfetamine dimesylate capsules, hard)” NCT07098585
1

Elvanse (Lisdexamfetamine): 100mg p.o, single dose” NCT02668926

Known as LDEX “a long-acting amphetamine, lisdexamfetamine (LDEX), in patients with ADHD” PMID 35141898 Feb 2022
Known as LDX “This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57,...” NCT01977625
19

“Objective: To examine the efficacy of lisdexamfetamine (LDX) versus placebo on behavioral attributes of sluggish cognitive tempo (SCT) in adults with...” PMID 34232582 Jun 2021

“OBJECTIVE: This study aims to determine the impact of the psychostimulant lisdexamfetamine (LDX) on subjective and objective cognitive function among menopausal women who...” PMID 26063677 Jun 2015

“This multicenter study examined lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug, as adjunctive therapy to antipsychotics in adults with clinically stable...” PMID 23756608 May 2013

“This study addresses these issues - examining the extent to which clinical improvement following lisdexamfetamine (LDX) treatment is associated with changes in brain reward...” PMID 38101205 Dec 2023

“OBJECTIVE: The aim of this study was to assess the effectiveness and safety of lisdexamfetamine dimesylate (LDX) in children with attention-deficit/hyperactivity disorder (ADHD).” PMID 20035583 Dec 2009

“An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD)” NCT00753012

“Titration during which subjects will be titrated from a starting dose of 30 mg/day of lisdexamfetamine up to his/her final dose (30, 50 or 70 mg/day of LDX).” NCT02555150

“Vyvanse (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who report onset of EF difficulties after oophorectomy.” NCT03187353

“The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine.” NCT01486810

“Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD).” PMID 23708466 May 2013

“OBJECTIVE: This study examines the effects of parental lisdexamfetamine (LDX) treatment on parent-child interactions.” PMID 24796970 Jul 2014

“This study evaluated the efficacy and tolerability of lisdexamfetamine (LDX) in the treatment of bipolar depression.” PMID 25340384 Jan 2015

“Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine (LDX) to optimal dose” NCT01714310

“This analysis evaluated the effect of lisdexamfetamine dimesylate (LDX) on sleep in children with ADHD.” NCT00807222

“All participants will receive Lisdexamfetamine Dimesylate (LDX) at an optimized dose based on protocol” NCT03337646

“the prodrug psychostimulant lisdexamfetamine dimesylate (LDX) and the non-stimulant” PMID 23959815 Dec 2013

“lisdexamfetamine dimesylate (LDX) efficacy in a long-term study of adults with” PMID 21438796 Mar 2011

“Lisdexamfetamine Dimesylate (LDX)” NCT00764868

“lisdexamfetamine (LDX)” NCT03924193

Known as LDX-01 “using Lisdexamfetamine (LDX-01) on top of treatment-as-usual (TAU)” NCT06788587
1

“treatment as usual plus lisdexamfetamine (LDX-01)” NCT05854667

Known as Lis-dexamphetamine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00736255
1

NCT01017263

Known as Lisdexamfetamine dimesylate “A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended...” NCT00889915
21

“This multicenter study examined lisdexamfetamine dimesylate (LDX), a d-amphetamine prodrug, as adjunctive therapy to antipsychotics in adults with clinically stable...” PMID 23756608 May 2013

“This study tested the effect of the psychostimulant prodrug lisdexamfetamine dimesylate on amygdala activation and connectivity during the emotional bias of response execution...” PMID 29661516 Mar 2018

“Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment” NCT02635035

“Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD” NCT00500071

Lisdexamfetamine dimesylate (LDX) was examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30-, 50-, and 70-mg LDX per day).” PMID 22166471 Dec 2011

Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD).” PMID 23708466 May 2013

“This analysis evaluated the effect of lisdexamfetamine dimesylate (LDX) on sleep in children with ADHD.” NCT00807222

Lisdexamfetamine dimesylate (30mg for smaller, 50mg for larger boys) tablet” NCT03333668

“Antidepressant + SPD489 (Lisdexamfetamine dimesylate )” NCT01436162

“Elvanse® (Lisdexamfetamine dimesylate capsules, hard)” NCT07098585

“Antidepressant + SPD489 (lisdexamfetamine dimesylate)” NCT00905424

“Vyvanse (lisdexamfetamine dimesylate), NRP104” NCT00337285

Lisdexamfetamine Dimesylate (Medication)” NCT04599504

Lisdexamfetamine dimesylate (Vyvanse®)” NCT03337646

“SPD489 (Lisdexamfetamine dimesylate )” NCT01436149

lisdexamfetamine dimesylate (SPD489)” NCT01291173

“SPD489 (Lisdexamfetamine dimesylate)” NCT01718483

“SPD489 (Lisdexamfetamine dimesylate)” NCT01457339

“SPD489 (Lisdexamfetamine dimesylate)” NCT01718509

Lisdexamfetamine Dimesylate (LDX)” NCT00764868

“Drug: Lisdexamfetamine DimesylateNCT00776555

Known as NRP104 “Vyvanse (lisdexamfetamine dimesylate), NRP104NCT00337285
Known as Racemic mixture of dextroamphetamine and lisdexamfetamine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00776555
Known as SPD489 “Antidepressant + SPD489 (Lisdexamfetamine dimesylate )” NCT01436162
7

“Antidepressant + SPD489 (lisdexamfetamine dimesylate)” NCT00905424

SPD489 (Lisdexamfetamine dimesylate )” NCT01436149

SPD489 (Lisdexamfetamine dimesylate)” NCT01718483

SPD489 (Lisdexamfetamine dimesylate)” NCT01718509

“lisdexamfetamine dimesylate (SPD489)” NCT01291173

SPD489 (Lisdexamfetamine dimesylate)” NCT01457339

SPD489 (lisdexamfetamine dimesylate)” NCT00922272

Known as SUB32146 “Once-daily pharmacotherapy with lisdexamfetamine (608137-32-2, SUB32146), administered orally” NCT05957055
Known as Vyvanse “A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended...” NCT00889915
6

Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment” NCT02635035

“Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD” NCT00500071

“Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients” NCT03070509

“the psychostimulant, lisdexamphetamine (LDX; Vyvanse®)” NCT01986764

Vyvanse (lisdexamfetamine dimesylate), NRP104” NCT00337285

“Lis-dexamphetamine (Vyvanse)” NCT00736255

Modality Other / unclassified “the prodrug psychostimulant lisdexamfetamine dimesylate (LDX)” PMID 23959815 Dec 2013
Route Oral “NRP104 capsule once-a-day orally” NCT00337285