Drugs / Adderall XR

Trials 6

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00746733 Sep → Oct 2008 — Shire Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00069927 Aug 2003 → Jun 2006 childhood malignant neoplasm, depressive disorder, poisoning University of South Florida Terminated No outcome recorded Stop: Enrollment
Phase 2/32 trials
Phase 2/3 NCT02803229 Jul 2016 → Jun 2020 attention deficit-hyperactivity disorder, cannabis dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 2/3 NCT00553319 Dec 2007 → Jul 2013 attention deficit-hyperactivity disorder, cocaine dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 31 trial · 1 met primary
Phase 3 NCT00507065 May 2003 → Mar 2004 attention deficit-hyperactivity disorder Shire Completed Met primary
Phase 41 trial
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
Comparator or background therapy7 trials
Phase 0 NCT04509102 Comparator Sep 2021 → Dec 2027 expected major depressive disorder University of California, Los Angeles Enrolling by invitation No outcome recorded
Phase 1 NCT05650775 Comparator Feb 2023 → Mar 2024 attention deficit-hyperactivity disorder Boston Children's Hospital Completed No outcome recorded
Phase 2 NCT00421603 Comparator Feb 2007 → May 2010 cocaine dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 2 NCT00557011 Comparator Sep → Dec 2004 attention deficit-hyperactivity disorder New River Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT02676739 Comparator May 2016 → Nov 2024 overdue multiple sclerosis Sarah Morrow Active not recruiting No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2024-11-19 Lupin Limited Lupin Receives Approval from U.S. FDA for Mixed Salts of a Single-Entity Amphetamine Extended-Release Capsules lupin.com ↗
2023-01-10 Aytu BioPharma, Inc. Aytu BioPharma, Inc Continues Availability of Adzenys XR-ODT(R) as the Only FDA-Approved Orally Disintegrating Tablet (ODT) Medication that is Bioequivalent to Adderall XR(R) for ADHD Patients aytubio.com ↗
2018-03-23 Takeda District Court Issues Ruling Finding Adderall XR® Patents Infringed takeda.com ↗
2017-08-28 Takeda MYDAYIS™ (mixed salts of a single-entity amphetamine product), Shire’s New Once-Daily ADHD Treatment, Now Available in the U.S. takeda.com ↗
2017-06-20 Takeda U.S. FDA Approves Mydayis™ (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Older takeda.com ↗
2016-06-28 Prasco LLC Prasco Expands Its Portfolio Through Acquisition of Teva’s Authorized Generic of Adderall XR® (Mixed Salts of a Single-Entity Amphetamine Product) Extended Release Capsules, CII prasco.com ↗
2016-02-17 Impax Laboratories, LLC Impax Receives FDA Approval for Generic Version of Adderall XR® (mixed salts of a single-entity amphetamine product) Capsules, CII amneal.com ↗
2013-12-02 Takeda Shire Enters Into Agreement To Supply Adderall XR® Authorized Generic takeda.com ↗
2013-02-08 Takeda Shire And Impax Settle Litigation Concerning Supply Of Adderall XR Authorized Generic takeda.com ↗
2009-04-02 Teva Branded Pharmaceutical Products R&D, Inc. Teva Introduces First Generic Adderall XR® Capsules in the United States tevapharm.com ↗
2003-12-30 Impax Laboratories, LLC IMPAX Comments on Shire's Lawsuit Related to Generic Version of Adderall XR amneal.com ↗
2003-11-19 Impax Laboratories, LLC IMPAX ANDA Filing for Generic Version of Adderall XR Accepted by FDA amneal.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Adderall XR “Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression” NCT00069927 ↗
14

“Adderall XR (n=15) versus placebo (n=15)” NCT04509102 ↗

“Adderall XR” NCT02566824 ↗

“Adderall XR” NCT02210728 ↗

NCT02676739 ↗

NCT05650775 ↗

NCT00069927 ↗

NCT01667484 ↗

NCT00421603 ↗

NCT00557011 ↗

NCT04509102 ↗

Show 4 more sources

Known as amphetamine “one 15 mg pill once daily of Adderall XR (amphetamine)” NCT04509102 ↗
Known as ER-MAS “Adderall-XR (ER-MAS)” NCT00421603 ↗
Known as Extended-Release Mixed Amphetamine Salts (Adderall-XR) “Extended-Release Mixed Amphetamine Salts (Adderall-XR)” NCT00553319 ↗
Known as MAS “examining pre-treatment EEG and ERP biomarkers of response to methylphenidate (MPH; Concerta) among all children and to mixed amphetamine salts (MAS; Adderall-XR) among...” NCT05650775 ↗
Known as MAS-XR “This study's lead PI recently completed a pre-post dose study with a mixed amphetamine salts formulation with an extended release delivery system (MAS-XR), trade name Adderall...” NCT02676739 ↗
1

“Extended-release mixed amphetamine salt (Adderall-XR, MAS-XR)” NCT02803229 ↗

Known as Mixed Amphetamine Salts “examining pre-treatment EEG and ERP biomarkers of response to methylphenidate (MPH; Concerta) among all children and to mixed amphetamine salts (MAS; Adderall-XR) among...” NCT05650775 ↗
1

“Mixed Amphetamine Salts (Adderall-XR)” NCT00421603 ↗

Known as mixed salts amphetamine “Adderall XR (mixed salts amphetamine)” NCT00746733 ↗
Route Oral “Patients receive oral dextroamphetamine-amphetamine once daily for 3 weeks” NCT00069927 ↗