Drugs / Amphetamine
Amphetamine
also known as
Adzenys XR-ODT · AMP · AMPH EROS · Amphetamine Sulfate · Adderall · Adderall XR · Adzenys ER · AMPH ER TAB · +8 more
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 11 · a red edge is where a trial was stopped
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| 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 | ||||||
| Phase 3 | NCT03659929 | Sep 2018 → Apr 2019 | attention deficit-hyperactivity disorder | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02083783 | Mar → Oct 2014 | attention deficit-hyperactivity disorder | Tris Pharma, Inc. | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07169162 | May 2019 → Sep 2025 | attention deficit-hyperactivity disorder | Aytu BioPharma, Inc. | Withdrawn | No outcome recorded |
| 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 | NCT01986062 | Dec 2013 → May 2014 | attention deficit-hyperactivity disorder | Arbor Pharmaceuticals, Inc. | 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 |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02959892 Background | Dec 2016 → May 2017 | — | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase 32 trials | ||||||
| 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 42 trials | ||||||
| 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 |
| Phase not applicable2 trials | ||||||
| — | 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 |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 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 ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 24 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 202217“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” NCT02204410 ↗ “Amphetamine” NCT01399827 ↗ |
| 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 ↗ |
| 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 20181“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 ↗ |
| Known as | AR11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01986062 ↗ |
| 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 ↗ |