Lisdexamfetamine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed attention deficit-hyperactivity disorder 1 milestone | |||||
| Filed | UK (MHRA) | Elvanse Adult | attention deficit-hyperactivity disorder | — | “Elvanse Adult was accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2014.” takeda.com ↗ |
| 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 | “The FDA has granted priority review for Shire’s sNDA of Lisdexamfetamine dimesylate (active ingredient in VYVANSE) in Binge Eating Disorder (BED).” takeda.com ↗ “The US Food and Drug Administration accepted with priority review our supplemental new drug application for VYVANSE” takeda.com ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Enrollment |
| Phase 1 | NCT01235338 | Oct → Dec 2010 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00776555 | Nov 2008 → Mar 2009 | — | Shire | Terminated | No outcome recorded Stop: Business |
| Phase 1/22 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 28 trials · 3 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| Phase 2 | NCT01291173 | May 2011 → Jan 2012 | binge eating disorder | Shire | Completed | Met primary |
| 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 | Met primary |
| 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 · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT01718509 | Nov 2012 → Sep 2013 | binge eating disorder | Shire | Completed | Met primary |
| Phase 3 | NCT01718483 | Nov 2012 → Sep 2013 | binge eating disorder | Shire | Completed | Met primary |
| Phase 3 | NCT01436149 | Oct 2011 → Dec 2013 | major depressive disorder | Shire | Completed | Missed primary |
| Phase 3 | NCT01436162 | Oct 2011 → Dec 2013 | major depressive disorder | Shire | Completed | Missed primary |
| Phase 3 | NCT01106430 | Jun 2010 → Jul 2012 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| Phase 3 | NCT00763971 | Nov 2008 → Mar 2011 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| 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 | Met primary |
| Phase 411 trials · 2 met primary | ||||||
| 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 Stop: Enrollment |
| 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 | Met primary |
| 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 | Met primary |
| Phase 4 | NCT00753012 | Apr 2008 → Mar 2011 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00500071 | Jun 2007 → Jan 2008 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 missed | ||||||
| — | 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 Stop: Enrollment |
| — | 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 | Missed primary |
| Comparator or background therapy19 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 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 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 | NCT01093963 Comparator | Jan 2010 → Feb 2014 | bipolar depression | Lindner Center of HOPE | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01090713 Comparator | Jan 2010 → Oct 2012 | binge eating disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| 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 Stop: Enrollment |
| 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 |
| — | 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 Stop: Enrollment |
| — | NCT01986777 Comparator | Jul → Dec 2013 | cognitive impairment with or without cerebellar ataxia | University of Pennsylvania | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00807222 Comparator | Apr → Aug 2008 | attention deficit-hyperactivity disorder | Clinical Study Centers, LLC | Completed | 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 15 cited values
Every value below carries the sentence it was read from. 74 sources stand behind the page.
| Field | Value | Cited 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 200858“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 ↗ “Lisdexamfetamine” NCT05551689 ↗ “Lisdexamfetamine” NCT00573859 ↗ |
| 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 |
| 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 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 ↗ |
| Known as | NRP104 | “Vyvanse (lisdexamfetamine dimesylate), NRP104” NCT00337285 ↗ |
| 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)” NCT01457339 ↗ “SPD489 (Lisdexamfetamine dimesylate)” NCT01718509 ↗ “SPD489 (Lisdexamfetamine dimesylate)” NCT01718483 ↗ “lisdexamfetamine dimesylate (SPD489)” NCT01291173 ↗ “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 ↗ |