Drugs / Lisdexamfetamine Dimesylate
Lisdexamfetamine Dimesylate
also known as
Vyvanse · SPD489 · LDX · NRP-104 · lisdexamfetamine · lisdexamfetamine dimestylate · lisdexamphetamine · lisdexamphetamine dimesylate · +1 more
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (9) | US (FDA) | VYVANSE | — | 2008-04-23 – 2021-07-29 | fda.gov ↗ |
| Approved | US (FDA) | VYVANSE | — | 2007-02-23 | fda.gov ↗ |
Trials 35 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04737512 | Feb 2021 → Oct 2024 | attention deficit-hyperactivity disorder | Yale University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT01890785 | Jul → Aug 2013 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00746733 | Sep → Oct 2008 | — | Shire | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00248092 | Jan → May 2006 | attention deficit-hyperactivity disorder, substance-related disorder | New River Pharmaceuticals | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT03397446 | Jun 2018 → May 2020 | bulimia nervosa | Aaron Keshen | Terminated | No outcome recorded |
| Phase 2 | NCT02402166 | Apr 2015 → Jun 2016 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01435759 | May 2011 → Jan 2014 | major depressive disorder | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01096680 | Apr → Jul 2010 | — | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00985725 | Oct 2009 → Apr 2011 | major depressive disorder | Shire | Completed | No outcome recorded |
| Phase 2 | NCT00247572 | Sep → Nov 2005 | attention deficit-hyperactivity disorder, substance-related disorder | New River Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00557011 | Sep → Dec 2004 | attention deficit-hyperactivity disorder | New River Pharmaceuticals | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT03260205 | Sep 2017 → Oct 2018 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02466386 | Aug 2015 → Jan 2020 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02009163 | Jan 2014 → Apr 2015 | binge eating disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01760889 | Feb → Apr 2013 | schizophrenia | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01760993 | Feb → Apr 2013 | schizophrenia | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01738698 | Nov 2012 → Apr 2013 | schizophrenia | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01657019 | Aug 2012 → Oct 2014 | binge eating disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01436175 | Feb 2012 → Mar 2014 | major depressive disorder | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT01234298 | Jan 2012 → Feb 2014 | — | Shire | Withdrawn | No outcome recorded |
| Phase 3 | NCT00784654 | Jan 2009 → Oct 2011 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00500149 | Jun → Dec 2007 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00556296 | Oct 2004 → Sep 2005 | attention deficit-hyperactivity disorder | New River Pharmaceuticals | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT03420339 | Oct 2018 → Mar 2027 expected | attention deficit-hyperactivity disorder | Matthew J O'Brien, PhD, BCBA-D | Recruiting | No outcome recorded |
| Phase 4 | NCT03446885 | Apr 2018 → Feb 2019 | attention deficit-hyperactivity disorder | Gregory Fabiano | Completed | No outcome recorded |
| Phase 4 | NCT01863459 | Apr 2013 → Mar 2017 | attention deficit-hyperactivity disorder | Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada | Completed | No outcome recorded |
| Phase 4 | NCT01816074 | Oct 2012 → Oct 2016 | attention deficit-hyperactivity disorder | Seattle Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01552915 | Apr 2012 → Jan 2014 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT01552902 | Apr 2012 → May 2014 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT01328756 | Jul 2011 → Sep 2014 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT02566824 | Oct 2010 → Aug 2020 | attention deficit-hyperactivity disorder | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 4 | NCT01148979 | Sep 2010 → Sep 2014 | major depressive disorder | Mclean Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00877487 | Apr 2009 → Jul 2010 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT00733356 | Jul 2008 → Sep 2009 | attention deficit-hyperactivity disorder | Kimberley Lakes | Completed | No outcome recorded |
| Phase 4 | NCT00573534 | Mar 2008 → Jan 2010 | attention deficit-hyperactivity disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
Also used as a comparator or background therapy in 22 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05416125 Comparator | Dec 2023 → Jun 2026 | obesity disorder | University of Minnesota | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT01010750 Comparator | Jan → Mar 2010 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00919867 Comparator | Jun → Jul 2009 | — | Shire | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06847399 Comparator | Sep 2025 → Dec 2027 expected | binge eating disorder, obesity disorder | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT01399827 Comparator | Feb 2012 → Nov 2017 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01074294 Background | Mar 2010 → Jun 2011 | attention deficit-hyperactivity disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT03926052 Comparator | Aug 2019 → Nov 2024 | binge eating disorder, obesity disorder | Yale University | Completed | No outcome recorded |
| Phase 3 | NCT01913912 Comparator | Jan 2014 | attention deficit-hyperactivity disorder | University Ghent | Withdrawn | No outcome recorded |
| Phase 3 | NCT01274221 Comparator | Mar → May 2011 | attention deficit-hyperactivity disorder | Shire | Withdrawn | No outcome recorded |
| Phase 3 | NCT01000064 Comparator | Oct 2009 → Dec 2013 | attention deficit hyperactivity disorder, inattentive type, traumatic brain injury | Vanderbilt University | Terminated | No outcome recorded |
| Phase 3 | NCT00735371 Comparator | Oct 2008 → Apr 2009 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00697515 Comparator | Jul → Dec 2008 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT04152629 Comparator | Sep 2019 → Jul 2021 | attention deficit-hyperactivity disorder | Purdue Pharma, Canada | Completed | No outcome recorded |
| Phase 4 | NCT02675400 Comparator | Dec 2015 → Aug 2018 | attention deficit-hyperactivity disorder | Seattle Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02204410 Background | Jul 2014 → May 2016 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01985581 Background | Oct 2013 → Mar 2015 | attention deficit-hyperactivity disorder | JPM van Stralen Medicine Professional | Completed | No outcome recorded |
| Phase 4 | NCT01101022 Comparator | May → Nov 2010 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 4 | NCT01071044 Comparator | Nov 2009 → Mar 2011 | cognitive disorder, myalgic encephalomeyelitis/chronic fatigue syndrome | Rochester Center for Behavioral Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00801229 Comparator | Dec 2008 → Jul 2010 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT04181957 Comparator | May 2019 → Mar 2020 | binge eating disorder | University of Birmingham | Terminated | No outcome recorded |
| — | NCT02142140 Comparator | Dec 2012 → Feb 2019 | attention deficit-hyperactivity disorder | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| — | NCT02210728 Comparator | Apr 2006 → Oct 2018 | attention deficit-hyperactivity disorder | Lily Hechtman | Unknown | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 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 ↗ |
| 2014-02-06 | Takeda | Shire Reports Top-Line Results From Two Phase 3 Studies For Vyvanse® (Lisdexamfetamine Dimesylate) Capsules (CII) As An Adjunctive Treatment For Adults With Major Depressive Disorder takeda.com ↗ |
| 2013-11-05 | Takeda | Positive Top-Line Results Shown For Vyvanse(R) (Lisdexamfetamine Dimesylate) Capsules (CII) In Adults With Binge Eating Disorder takeda.com ↗ |
| 2013-05-01 | Takeda | Vyvanse® (Lisdexamfetamine Dimesylate) Capsules, (CII) Now Approved In The US For Maintenance Treatment In Children And Adolescents With ADHD takeda.com ↗ |
| 2013-02-12 | Takeda | Elvanse ® (Lisdexamfetamine Dimesylate) Receives UK Marketing Authorisation, Providing A New Option For The Treatment Of ADHD In Children And Adolescents In The UK takeda.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lisdexamfetamine dimesylate | “BACKGROUND: Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using...” PMID 20576091 ↗ Jun 201028“Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized,...” PMID 17577466 ↗ Mar 2007 “Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.” NCT01074294 ↗ “Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)” NCT00735371 ↗ “SPD489 (Lisdexamfetamine dimesylate) + Antidepressant” NCT01436175 ↗ “Vyvanse (lisdexamfetamine dimesylate)” NCT00500149 ↗ “SPD489 (Lisdexamfetamine dimesylate)” NCT00877487 ↗ “SPD489 (Lisdexamfetamine dimesylate)” NCT00985725 ↗ “Drug: Lisdexamfetamine dimesylate” NCT02009163 ↗ “Lisdexamfetamine dimesylate (LDX)” NCT01913912 ↗ |
| Known as | LDX | “BACKGROUND: Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using...” PMID 20576091 ↗ Jun 20107“This study will test the effectiveness of lisdexamfetamine (LDX) medication as a maintenance therapy for the treatment of binge-eating disorder (BED) in patients with obesity.” NCT03926052 ↗ “The current study characterizes the effects of lisdexamfetamine dimesylate (LDX; Vyvanse(®), Shire US Inc.), at peak efficacy, on reading performance in children with ADHD.” PMID 20978273 ↗ Oct 2010 “Lisdexamfetamine dimesylate (LDX) is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6 to 12 years of age and in adults.” PMID 19508731 ↗ Jun 2009 “OBJECTIVE: To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD).” PMID 21421179 ↗ Mar 2011 “This study will investigate the effect of lisdexamfetamine dimesylate (LDX) on the mediating factors of reward and cognition on appetite.” NCT04181957 ↗ “Lisdexamfetamine Dimesylate (LDX)” NCT01010750 ↗ “Lisdexamfetamine dimesylate (LDX)” NCT01913912 ↗ |
| Known as | lisdexamfetamine | “This study examined the feasibility, safety, and potential efficacy of lisdexamfetamine (LDX) as a treatment for adults with bulimia nervosa.” PMID 33534199 ↗ Feb 2021 |
| Known as | lisdexamfetamine dimestylate | “including a recent open-label feasibility trial examining the use of lisdexamfetamine dimestylate (LDX) for BN.” PMID 37218020 ↗ May 2023 |
| Known as | lisdexamphetamine | “Vyvanse (lisdexamphetamine)” NCT01816074 ↗ |
| Known as | lisdexamphetamine dimesylate | “Long acting formulations of amphetamines such as lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and improve classroom performance.” NCT01913912 ↗ |
| Known as | Lisdexamphetamine is marketed as Vyvanse | “Lisdexamphetamine is marketed as Vyvanse” NCT00573534 ↗ |
| Known as | NRP-104 | “Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized,...” PMID 17577466 ↗ Mar 2007 |
| Known as | SPD489 | “SPD489 (Lisdexamfetamine dimesylate) 10 mg” NCT01435759 ↗14“Lisdexamfetamine Dimesylate (LDX, SPD489)” NCT00697515 ↗ |
| Known as | Vyvanse | “However, the potential for pharmacokinetic drug-drug interactions (DDIs) between GXR and lisdexamfetamine dimesylate (LDX, Vyvanse®; Shire US LLC, Wayne, PA, USA) has not been...” PMID 23615868 ↗ Jun 201317“If Concerta +/- Ritalin is ineffective or not tolerated, participants will progress to Vyvanse; Adderall may be started if the effect of Vyvanse wears off mid-day;” NCT04737512 ↗ “patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)” NCT01985581 ↗ “newly-approved stimulant medication, lisdexamfetamine dimesylate (Vyvanse), on specific residual symptoms of depression” NCT01148979 ↗ “Vyvanse” NCT02142140 ↗ “Vyvanse” NCT02204410 ↗ “Vyvanse” NCT02566824 ↗ “Vyvanse” NCT02210728 ↗ “Vyvanse” NCT03420339 ↗ “Vyvanse” NCT01399827 ↗ |
| Modality | Small molecule | “Long acting formulations of amphetamines such as lisdexamphetamine dimesylate (LDX)” NCT01913912 ↗ |
| Route | Intravenous | “IV Administered NRP104 25 mg and 50 mg” NCT00247572 ↗ |