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 · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed attention deficit-hyperactivity disorder 8 1 milestone | |||||
| Filed | US (FDA) | Vyvanse | attention deficit-hyperactivity disorder 8 | 2016-04-14 | “recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new, alternate formulation of Vyvanse®” takeda.com ↗ |
| Filed binge eating disorder 1 milestone | |||||
| Filed | US (FDA) | Vyvanse | binge eating disorder | 2014-09-15 | “FDA has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse” takeda.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| 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
| 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 | Mixed |
| 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 · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT03397446 | Jun 2018 → May 2020 | bulimia nervosa | Aaron Keshen | Terminated | No outcome recorded Stop: Business |
| 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 | Missed primary |
| Phase 2 | NCT01096680 | Apr → Jul 2010 | — | Shire | Completed | Met primary |
| Phase 2 | NCT00985725 | Oct 2009 → Apr 2011 | major depressive disorder | Shire | Completed | Met primary |
| 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 · 5 met primary | ||||||
| Phase 3 | NCT03260205 | Sep 2017 → Oct 2018 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01760993 | Feb → Apr 2013 | schizophrenia | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01760889 | Feb → Apr 2013 | schizophrenia | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01738698 | Nov 2012 → Apr 2013 | schizophrenia | Shire | Terminated | No outcome recorded Stop: Business |
| 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 Stop: Business |
| Phase 3 | NCT00784654 | Jan 2009 → Oct 2011 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| Phase 3 | NCT00500149 | Jun → Dec 2007 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| Phase 3 | NCT00556296 | Oct 2004 → Sep 2005 | attention deficit-hyperactivity disorder | New River Pharmaceuticals | Completed | Met primary |
| Phase 412 trials · 3 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT01552902 | Apr 2012 → May 2014 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| 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 | Met primary |
| Phase 4 | NCT00877487 | Apr 2009 → Jul 2010 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| 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 |
| Comparator or background therapy22 trials | ||||||
| Phase 0 | NCT05416125 Comparator | Dec 2023 → Jun 2026 | obesity disorder | University of Minnesota | Completed | No outcome recorded |
| 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 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 | Missed primary |
| 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 Stop: Enrollment |
| 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 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 | Met primary |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2023-09-06 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate amneal.com ↗
Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate |
| 2023-08-31 | Roxane Laboratories | Regulatory Hikma launches generic version of Vyvanse® following FDA approval hikma.com ↗
London, 31 August 2023 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces it has received FDA approval for and launched its generic version of Vyvanse® (lisdexamfetamine dimesylate) 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg capsules in the US. |
| 2016-10-17 | Takeda | Regulatory 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 ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announces an update to the Vyvanse® (lisdexamfetamine dimesylate) labeling to include information regarding the approval of a supplemental New Drug Application (sNDA) by the U.S. Food and Drug Administration (FDA). |
| 2016-04-14 | Takeda | Regulatory Shire Submits NDA to FDA for New Formulation of Vyvanse® (lisdexamfetamine dimesylate) CII as Chewable Tablets takeda.com ↗ |
| 2015-07-22 | Takeda | Results Vyvanse® (lisdexamfetamine dimesylate) Positive Top-Line Results in Maintenance of Efficacy Study in Adults with Moderate to Severe Binge Eating Disorder takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today reported positive top-line results from a 39-week, long-term maintenance of efficacy study of Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) in adults with moderate to severe Binge Eating Disorder (B.E.D.). |
| 2015-01-30 | Takeda | Regulatory 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 ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) approved Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults, shown to significantly reduce the mean number of binge days per week. |
| 2015-01-22 | Takeda | Regulatory Positive Response From European Decentralised Procedure For Elvanse Adult® In Adults With ADHD takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announces the positive response from the European Decentralised Procedure (DCP) for Elvanse Adult® in the three European countries participating in the procedure (UK, Denmark and Sweden). |
| 2014-09-15 | Takeda | Regulatory 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 | Results 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 ↗
In SPD489-406, the forced-dose titration study, Vyvanse was found to be statistically superior to Concerta on the primary efficacy analysis (p = 0.0013) with mean reductions on the ADHD RS-IV total score of 25.4 and 22.1 points, respectively. |
| 2014-06-12 | Takeda | Regulatory 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 ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has agreed to a Written Request by the Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate the potential use of Vyvanse ® (lisdexamfetamine dimesylate) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, ages 4 to 5. |
| 2014-02-06 | Takeda | Results 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 ↗
Vyvanse did not meet the primary efficacy endpoint versus placebo for either study. |
| 2013-11-05 | Takeda | Results Positive Top-Line Results Shown For Vyvanse(R) (Lisdexamfetamine Dimesylate) Capsules (CII) In Adults With Binge Eating Disorder takeda.com ↗
In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (p-value <0.001) of the change from baseline at weeks 11 to 12 in terms of number of binge days per week. |
| 2013-05-01 | Takeda | Regulatory Vyvanse® (Lisdexamfetamine Dimesylate) Capsules, (CII) Now Approved In The US For Maintenance Treatment In Children And Adolescents With ADHD takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) as a maintenance treatment in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). |
| 2013-02-12 | Takeda | Regulatory 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 ↗
The Medicines and Healthcare products Regulatory Agency (MHRA) grants Elvanse licence for use in attention deficit/hyperactivity disorder (ADHD) |
All press releases naming this drug 18 releases
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)” NCT00985725 ↗ “SPD489 (Lisdexamfetamine dimesylate)” NCT00877487 ↗ “Lisdexamfetamine dimesylate (LDX)” NCT01913912 ↗ “Drug: Lisdexamfetamine dimesylate” NCT02009163 ↗ |
| 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” NCT01399827 ↗ “Vyvanse” NCT03420339 ↗ “Vyvanse” NCT02204410 ↗ “Vyvanse” NCT02210728 ↗ “Vyvanse” NCT02566824 ↗ “Vyvanse” NCT02142140 ↗ |
| 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 ↗ |