Amphetamine

also known as Adzenys XR-ODT · AMP · AMPH EROS · Amphetamine Sulfate · Adderall · Adderall XR · Adzenys ER · AMPH ER TAB · +7 more

Developed for: attention deficit-hyperactivity disorder · ischemic stroke
Investigated by: National Institute of Mental Health (NIMH) · Tris Pharma, Inc. · Arbor Pharmaceuticals, Inc. · Aytu BioPharma, Inc. · Emory University · Göteborg University
+10 more
· National Cancer Institute (NCI) · National Institute of Neurological Disorders and Stroke (NINDS) · National Institute on Drug Abuse (NIDA) · National Institutes of Health (NIH) · Premier Research · The University of Texas Health Science Center, Houston · University Hospital, Basel, Switzerland · University of California, San Diego · Virginia Commonwealth University · Yale University

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	EVEKEO ODT	—	2021-04-16	fda.gov ↗
Approved	US (FDA)	ADDERALL 5	—	1960-01-19	fda.gov ↗

Trials 10

today

US approved 1960

NCT07169162 · Ph 4 NCT03659929 · Ph 3 NCT03610464 · Ph 4 NCT03019822 · Ph 0 NCT03250013 · Ph 4 NCT02083783 · Ph 3 NCT01699607 · not/applicable NCT02020408 · Ph 4 NCT00733993 · Ph 1/2 NCT00715520 · not/applicable

1959196019611962196319641965196619671968196919701971197219731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03019822	Feb 2017 → Aug 2018	—	University Hospital, Basel, Switzerland	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT00733993	Apr 2008 → Jul 2011	cocaine dependence	Virginia Commonwealth University	Completed	No outcome recorded
Phase 32 trials · 2 met primary
Phase 3	NCT03659929	Sep 2018 → Apr 2019	attention deficit-hyperactivity disorder	Arbor Pharmaceuticals, Inc.	Completed	Met primary
Phase 3	NCT02083783	Mar → Oct 2014	attention deficit-hyperactivity disorder	Tris Pharma, Inc.	Completed	Met primary
Phase 44 trials
Phase 4	NCT07169162	May 2019 → Sep 2025	attention deficit-hyperactivity disorder	Aytu BioPharma, Inc.	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT03610464	May 2018	attention deficit-hyperactivity disorder	Tris Pharma, Inc.	Completed	No outcome recorded
Phase 4	NCT03250013	Apr 2014 → Jan 2022	attention deficit-hyperactivity disorder	Göteborg University	Completed	No outcome recorded
Phase 4	NCT02020408	May 2011 → Dec 2017	eating disorder	University of California, San Diego	Completed	No outcome recorded
Phase not applicable2 trials
—	NCT01699607	Jun 2012 → Jul 2013	nicotine dependence	Yale University	Completed	No outcome recorded
—	NCT00715520	Apr 2007 → Sep 2016	ischemic stroke	Emory University	Completed	No outcome recorded
Comparator or background therapy11 trials
Phase 1	NCT02959892 Background	Dec 2016 → May 2017	—	Neurocrine Biosciences	Completed	No outcome recorded
Phase 2	NCT04027361 Comparator	Oct 2019 → Oct 2021	attention deficit-hyperactivity disorder	Tris Pharma, Inc.	Completed	No outcome recorded
Phase 2	NCT03242772 Comparator	Dec 2018 → Dec 2020	attention deficit-hyperactivity disorder, autism spectrum disorder	Duke University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT01399827 Comparator	Feb 2012 → Nov 2017	attention deficit-hyperactivity disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 2	NCT00151996 Background	Aug → Dec 2004	attention deficit-hyperactivity disorder	Shire	Completed	Met primary
Phase 3	NCT03834766 Comparator	Feb → Oct 2019	attention deficit-hyperactivity disorder	Tris Pharma, Inc.	Completed	No outcome recorded
Phase 3	NCT03088267 Comparator	Feb 2017	attention deficit-hyperactivity disorder	Tris Pharma, Inc.	Completed	No outcome recorded
Phase 4	NCT05916339 Comparator	Oct 2023 → Jan 2027 expected	attention deficit-hyperactivity disorder, autism spectrum disorder	Daniel Coury	Recruiting	No outcome recorded
Phase 4	NCT02204410 Background	Jul 2014 → May 2016	attention deficit-hyperactivity disorder	Massachusetts General Hospital	Completed	No outcome recorded
—	NCT02788851 Comparator	Apr 2016 → Dec 2018	attention deficit-hyperactivity disorder	McGill University Health Centre/Research Institute of the McGill University Health Centre	Unknown	No outcome recorded
—	NCT01740206 Comparator	Nov 2012 → Dec 2015	attention deficit-hyperactivity disorder	Nationwide Children's Hospital	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2024-11-19	Lupin Limited	Regulatory Lupin Receives Approval from U.S. FDA for Mixed Salts of a Single-Entity Amphetamine Extended-Release Capsules lupin.com ↗
2023-04-27	Aytu BioPharma, Inc.	Regulatory Aytu BioPharma Announces Approval of Adzenys XR-ODT(R)Manufacturing Site Transfer aytubio.com ↗ This approval enables the transfer of manufacturing of Adzenys to the Company's third-party manufacturer.
2019-07-19	Zydus Lifesciences Limited	Regulatory Zydus Nesher Pharmaceuticals receives final approval from the USFDA zyduslife.com ↗
2016-02-17	Impax Laboratories, LLC	Regulatory Impax Receives FDA Approval for Generic Version of Adderall XR® (mixed salts of a single-entity amphetamine product) Capsules, CII amneal.com ↗

All press releases naming this drug 23 releases

Date	Issuer	Release
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 ↗
2024-10-01	Aytu BioPharma, Inc.	Aytu BioPharma Announces Exclusive Agreement with Lupin Pharma Canada Ltd to Commercialize Adzenys XR-ODT(R) and Cotempla XR-ODT(R) in Canada aytubio.com ↗
2023-07-31	Aytu BioPharma, Inc.	Aytu BioPharma Announces Exclusive Agreement with Medomie Pharma Ltd. to Commercialize Adzenys XR-ODT(R) and Cotempla XR-ODT(R) in Israel and the Palestinian Authority aytubio.com ↗
2023-04-27	Aytu BioPharma, Inc.	Aytu BioPharma Announces Approval of Adzenys XR-ODT(R)Manufacturing Site Transfer aytubio.com ↗
2023-03-09	Glenmark Pharmaceuticals Ltd. India	Glenmark and Cediprof Announce Exclusive Distribution Agreement in the United States for U.S. FDA Approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg glenmarkpharma.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 ↗
2022-11-30	Aytu BioPharma, Inc.	Aytu BioPharma Announces Highest Weekly Adzenys XR-ODT(R) Prescriptions Generated Since Inception of RxConnect aytubio.com ↗
2022-10-05	Aytu BioPharma, Inc.	Aytu BioPharma Announces Continuing Availability of ADHD Medication Adzenys XR-ODT(R) in Response to Reported Generic Adderall(R) XR Supply Disruptions aytubio.com ↗
2020-03-31	Lannett Company, Inc.	Lannett Begins Marketing Generic Adderall® XR investorroom.com ↗
2019-12-12	Lannett Company, Inc.	Lannett To Commence Marketing Generic Adderall® XR investorroom.com ↗
2019-07-19	Zydus Lifesciences Limited	Zydus Nesher Pharmaceuticals receives final approval from the USFDA zyduslife.com ↗
2019-05-16	Lannett Company, Inc.	Lannett Begins Marketing Generic Adderall® investorroom.com ↗
2018-03-23	Takeda	District Court Issues Ruling Finding Adderall XR® Patents Infringed takeda.com ↗
2017-09-15	Takeda	Shire Debuts MYDAYIS® and New Research at the 30th Annual Psych Congress 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 17 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

Field	Value	Cited text
Known as	amphetamine	“Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With...” PMID 35857716 ↗ Jul 2022 17 “ADZENYS XR-ODT™ (amphetamine) is an extended-release orally disintegrating tablet approved for once-daily oral administration for the treatment of ADHD in patients 6 years and older.” NCT07169162 ↗ “Medications (methylphenidate, amphetamine, atomoxetine) will be provided by the pharmacy according to routines in standard clinical treatment.” NCT03250013 ↗ “Amphetamine” NCT01399827 ↗ “Amphetamine” NCT02204410 ↗ NCT02959892 ↗ NCT03019822 ↗ NCT03242772 ↗ NCT05916339 ↗ NCT04027361 ↗ NCT03088267 ↗ Show 7 more sources
Known as	Adderall	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Adderall XR	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Adzenys ER	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Adzenys XR-ODT	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗ 1 NCT07169162 ↗
Known as	AMP	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗ 1 “methylphenidate (MPH) or amphetamine (AMP) alone” PMID 19877974 ↗ Oct 2009
Known as	AMPH ER TAB	“Objective: To evaluate the efficacy and safety of amphetamine extended-release tablets (AMPH ER TAB) in adults with attention-deficit/hyperactivity disorder (ADHD).” PMID 35857716 ↗ Jul 2022
Known as	AMPH EROS	“whether amphetamine extended-release oral suspension (AMPH EROS) has an onset of effect at 30 minutes postdose in children with attention-deficit/hyperactivity disorder (ADHD).” PMID 30575407 ↗ Dec 2018 1 “DYANAVEL® XR is an extended-release oral suspension that contains 2.5 mg/mL amphetamine base (amphetamine extended-release oral suspension; AMPH EROS).” NCT03610464 ↗
Known as	Amphetamine Extended-Release Tablets	“Objective: To evaluate the efficacy and safety of amphetamine extended-release tablets (AMPH ER TAB) in adults with attention-deficit/hyperactivity disorder (ADHD).” PMID 35857716 ↗ Jul 2022
Known as	Amphetamine Sulfate	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00715520 ↗ 1 NCT03659929 ↗
Known as	Dayanavel XR	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Dexedrine (spansule)	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Dexedrine (tablet)	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Mydayis	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	Procentra	“Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid” NCT05916339 ↗
Known as	TRI102	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02083783 ↗
Route	Oral	“Participants will receive one oral dose of amphetamine sulfate 10mg 2 hours prior to measuring wrist extension movements.” NCT00715520 ↗