dextroamphetamine
Trade name: Dexedrine
Approved
Sep 9, 1955
DEXTROAMPHETAMINE TANNATE is a salt of dextroamphetamine, amphetamine enantiomer. It is used as CNS stimulant in the treatment of attention deficit hyperactivity disorder. — NCATS
Clinical trial activity
15 trials · 25 clinical orgs · 59 marketing orgs
Earliest trial started Jul 1, 2013 (NCT01886469)
Timeline
1950s
1960s
- Jan 19, 1960
Teva — NDA Secondary Org
1970s
- May 29, 1975
Shire — Marketing Organization
- Oct 29, 1975
Lannett Company, Inc. — Marketing Organization
- Feb 26, 1976
GlaxoSmithKline — Marketing Organization
- Aug 2, 1976
Impax Laboratories — NDA Secondary Org
- Jun 15, 1977
Ferndale Laboratories, Inc. — Marketing Organization
2000s
- Oct 11, 2001
Shire — NDA Secondary Org
- Oct 11, 2001
Takeda — NDA Secondary Org
- Jan 18, 2002
Mayne Pharma — Marketing Organization
- Jan 18, 2002
Dr. Reddy's Laboratories — Marketing Organization
- Feb 11, 2002
Barr Laboratories — Marketing Organization
- Jun 14, 2002
Sandoz — Marketing Organization
- Jun 14, 2002
Novartis — Marketing Organization
- Jun 19, 2002
Epic Pharma Llc — Marketing Organization
- May 6, 2003
Actavis — Marketing Organization
- Sep 9, 2003
Sun Pharmaceuticals — Marketing Organization
- Oct 7, 2003
Specgx Llc — Marketing Organization
- Aug 25, 2004
Able Laboratories — Marketing Organization
- Jan 29, 2008
Outlook Pharmaceuticals — Marketing Organization
- Jan 29, 2008
Prasco LLC — Marketing Organization
2010s
- Oct 25, 2011
Arbor Pharmaceuticals — Marketing Organization
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
- Apr 29, 2013
Teva — Marketing Organization
- May 29, 2013
Tris Pharma, Inc. — Marketing Organization
- Nov 27, 2013
Aurobindo Pharma — Marketing Organization
- Oct 19, 2015
Tris Pharma, Inc. — NDA Secondary Org
- Nov 10, 2015
Mylan — Marketing Organization
- Nov 23, 2015
Avanthi Pharma — Marketing Organization
- Jan 1, 2016
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2016
Earliest Phase 3 Sponsor(trial)
- Feb 5, 2016
Allergan PLC (2015) — Marketing Organization
- Feb 16, 2016
Impax Laboratories — Marketing Organization
- Mar 16, 2016
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Apr 15, 2016
Corepharma — Marketing Organization
- Jul 28, 2017
Alvogen — Marketing Organization
- Oct 31, 2017
Zydus Discovery DMCC — Marketing Organization
- Oct 31, 2017
Vintage — Marketing Organization
- Dec 28, 2017
Nuvo Research Inc. — Marketing Organization
- Dec 7, 2018
Elite Laboratories, Inc — Marketing Organization
- Dec 7, 2018
Praxgen Pharma — Marketing Organization
- Jan 22, 2019
Amerigen Pharmaceuticals — Marketing Organization
- Jan 22, 2019
Ani Pharmaceuticals — Marketing Organization
- Apr 22, 2019
Mallinckrodt (2013) — Marketing Organization
- May 17, 2019
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- May 31, 2019
Par Pharmaceuticals — Marketing Organization
- May 31, 2019
Bristol-Myers Squibb — Marketing Organization
- Jun 21, 2019
Pharmaceutics International, Inc. — Marketing Organization
- Jun 21, 2019
ANDA Repository — Marketing Organization
- Jun 21, 2019
Strides Pharma Science — Marketing Organization
- Jul 17, 2019
Nesher Pharms — Marketing Organization
2020s
- Apr 3, 2020
Bionpharma Inc — Marketing Organization
- Apr 3, 2020
US Pharma — Marketing Organization
- Apr 22, 2021
Ascent Pharmahealth — Marketing Organization
- Apr 22, 2021
AbbVie — Marketing Organization
- Jun 7, 2021
Winder Labs Llc — Marketing Organization
- Nov 22, 2021
Accord Research — Marketing Organization
- Dec 28, 2021
Granules India — Marketing Organization
- Mar 22, 2022
Noven Therapeutics — Marketing Organization
- Mar 22, 2022
Hisamitsu Pharmaceutical Co., Inc. — NDA Secondary Org
- Jul 5, 2022
Cediprof Inc — Marketing Organization
- Oct 6, 2023
Alkem Labs Ltd — Marketing Organization
Indications
Approved for
Studied for
- Affect · Phase 2
- Alopecia · Phase 3
- Attention Deficit and Disruptive Behavior Disorders · Phase 2
- Bipolar Disorder · Phase 1
- Central Nervous System Stimulants · Phase 4
- Cocaine-Related Disorders · Phase 2
- Cognitive Dysfunction · Phase 4
- COVID-19 · Phase 4
- Deception · Phase 4
- Depression · Phase 2
- Fetal Alcohol Spectrum Disorders · Phase 4
- Healthy Volunteers · Phase 3
- Idiopathic Hypersomnia · Phase 2
- Memory, Short-Term · Phase 2
- Motivation · Phase 4
- Narcolepsy · Phase 2
Mechanism of action
- Synaptic vesicular amine transporterINHIBITOR
SLC18A2 inhibitor
- Dopamine transporterRELEASING AGENT
SLC6A3 releasing agent
- Norepinephrine transporterRELEASING AGENT
SLC6A2 releasing agent
Combination products
biphetamine
with amphetamine
Also known as adderall, adderall xr, dextroamp saccharate, amp aspartate, dextroamp sulfate and amp sulfate, dextroamp saccharate,amp aspartate,dextroamp sulfate and amp sulfate, mydayis
Approval history
- approvedSep 9, 1955
Chemistry & pharmacology
SMILES
C[C@H](N)Cc1ccccc1.O=C(O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(=O)O- Mol. weight
- 345.35 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3989844 ↗
- WikipediaDextroamphetamine ↗
- NCATS500Y9JV943 ↗
- ChEMBLCHEMBL612 ↗
- NCATSYYI1A8W4TQ ↗
- NCATSTZ47U051FI ↗
- ChEMBLCHEMBL1200782 ↗
- ChEMBLCHEMBL3544971 ↗
- ChEMBLCHEMBL1200992 ↗
Also known as
- amphetamine sulfate, dextro
- amphetamine sulfate, dextro
- d amphetamine
- d amphetamine
- d-amphetamine
- d-amphetamine
- d-amphetamine
- d-amphetamine
- d-amphetamine
- d-amphetamine saccharate
- d-amphetamine sulfate
- d-amphetamine sulfate
- d-deoxyephedrine
- d-deoxyephedrine
- d-desoxyephedrine
- d-desoxyephedrine
- desoxynorephedrine
- desoxynorephedrine
- dexadrine
- dexamfetamine
- dexamfetamine
- dexamfetamine
- dexamfetamine
- dexamfetamine
- dexamfetamine sulphate
- dexampex
- dexamphetamine
- dexamphetamine
- dexamphetamine
- dexamphetamine
- dexedrine
- dexedrine
- dexedrine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextroamphetamine
- dextro amphetamine
- dextro amphetamine
- dextro-amphetamine
- dextro-amphetamine
- dextroamphetamine adipate
- dextroamphetamine adipate
- dextroamphetamine adipate
- dextroamphetamine resin complex
- dextroamphetamine resin complex
- dextroamphetamine resin complex
- dextroamphetamine saccharate
- dextroamphetamine saccharate
- dextroamphetamine saccharate
- dextro-amphetamine sulfate
- dextro-amphetamine sulfate
- dextroamphetamine sulfate
- dextroamphetamine sulfate
- dextroamphetamine sulfate
- dextroamphetamine sulfate
- dextromethamphetamine
- dextromethamphetamine
- dextrostat
- dextrostat
- dl-amphetaminil
- ferndex
- hld100
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06967857 | Phase 2 | May 15, 2025 | Fraunhofer-Institute of Toxicology and Experimental Medicine |
| NCT06501924 | Phase 3 | Jan 15, 2025 | Applied Biology, Inc., Daniel Alain, Inc., Follea International Limited, University of Roma La Sapienza |
| NCT05529927 | Phase 2 | Sep 30, 2023 | Columbia University, Leiden University, Netherlands Cancer Institute, Parnassia Addiction Research Centre, Radboud University, University of Amsterdam |
| NCT05597722 | Phase 4 | Nov 15, 2022 | The Beckwith Institute, University of Pittsburgh |
| NCT04635826 | Phase 4 | Jul 1, 2022 | University of Alabama, Birmingham |
| NCT04968522 | Phase 4 | Jul 31, 2021 | Monash University |
| NCT04647903 | Phase 1 | Oct 5, 2020 | Vallon Pharmaceuticals, Inc. |
| NCT04296006 | Early Phase 1 (Phase 1) | Jun 30, 2020 | University of Kentucky |
| NCT03935646 | Phase 2 | Sep 2, 2019 | University of Wyoming |
| NCT03772314 | Phase 2 | Apr 15, 2019 | American Academy of Sleep Medicine, Emory University |
| NCT03223844 | N/A | Jan 1, 2018 | Medical University of Vienna |
| NCT03810703 | Phase 1 | Feb 9, 2017 | University of Chicago |
| NCT02884544 | Phase 2 | Aug 1, 2016 | Ironshore Pharmaceuticals and Development, Inc |
| NCT03512171 | Phase 3 | Mar 31, 2016 | Duke University, Vanderbilt University |
| NCT01886469 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2013 | Ironshore Pharmaceuticals and Development, Inc |
Organizations
Research & Development (25)
Marketing (74)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Jun 21, 2019 |
| AbbVie | For profit | MKTG | Apr 22, 2021 |
| Able Laboratories | For profit | MKTG | Aug 25, 2004 |
| Accord Research | For profit | MKTG | Nov 22, 2021 |
| Actavis | For profit | MKTG | May 6, 2003 |
| Alkem Labs Ltd | For profit | MKTG | Oct 6, 2023 |
| Allergan PLC (2015) | For profit | MKTG | Feb 5, 2016 |
| Alvogen | For profit | MKTG | Jul 28, 2017 |
| Amerigen Pharmaceuticals | For profit | MKTG | Jan 22, 2019 |
| Ani Pharmaceuticals | For profit | MKTG | Jan 22, 2019 |
| Ani Pharmaceuticals | For profit | MKTG | Jan 22, 2019 |
| Arbor Pharmaceuticals | For profit | MKTG | Oct 25, 2011 |
| Ascent Pharmahealth | For profit | MKTG | Apr 22, 2021 |
| Aurobindo Pharma | For profit | MKTG | Nov 27, 2013 |
| Avanthi Pharma | For profit | MKTG | Nov 23, 2015 |
| Barr Laboratories | For profit | MKTG | Feb 11, 2002 |
| Barr Laboratories | For profit | SYN | Feb 12, 2013 |
| Bionpharma Inc | For profit | MKTG | Apr 3, 2020 |
| Bristol-Myers Squibb | For profit | MKTG | May 31, 2019 |
| Cediprof Inc | For profit | MKTG | Jul 5, 2022 |
| Corepharma | For profit | MKTG | Apr 15, 2016 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jan 18, 2002 |
| Elite Laboratories, Inc | For profit | MKTG | Dec 7, 2018 |
| Epic Pharma Llc | For profit | MKTG | Jun 19, 2002 |
| Ferndale Laboratories, Inc. | For profit | MKTG | Jun 15, 1977 |
| GlaxoSmithKline | For profit | MKTG | Feb 26, 1976 |
| Granules India | For profit | MKTG | Dec 28, 2021 |
| Halsey | For profit | MKTG | — |
| Hisamitsu Pharmaceutical Co., Inc. | For profit | NDA2 | Mar 22, 2022 |
| Impax Laboratories | For profit | MKTG | Feb 16, 2016 |
| Impax Laboratories | For profit | SYN | Aug 2, 1976 |
| Impax Laboratories | For profit | NDA2 | Aug 2, 1976 |
| Lannett Company, Inc. | For profit | MKTG | Oct 29, 1975 |
| Lannett Company, Inc. | For profit | SYN | Nov 26, 2021 |
| MM Pharma | For profit | MKTG | — |
| Mallinckrodt (2013) | For profit | MKTG | Apr 22, 2019 |
| Mayne Pharma | For profit | MKTG | Jan 18, 2002 |
| Mylan | For profit | MKTG | Nov 10, 2015 |
| Nesher Pharms | For profit | MKTG | Jul 17, 2019 |
| Novartis | For profit | MKTG | Jun 14, 2002 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Mar 16, 2016 |
| Noven Therapeutics | For profit | MKTG | Mar 22, 2022 |
| Nuvo Research Inc. | For profit | MKTG | Dec 28, 2017 |
| Outlook Pharmaceuticals | For profit | MKTG | Jan 29, 2008 |
| Par Pharmaceuticals | For profit | MKTG | May 31, 2019 |
| Pharmaceutics International, Inc. | For profit | MKTG | Jun 21, 2019 |
| Prasco LLC | For profit | MKTG | Jan 29, 2008 |
| Praxgen Pharma | For profit | MKTG | Dec 7, 2018 |
| Puracap Pharmaceutical | For profit | MKTG | — |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | May 17, 2019 |
| Sandoz | For profit | MKTG | Jun 14, 2002 |
| Shire | For profit | NDA2 | Oct 11, 2001 |
| Shire | For profit | SYN | Jun 20, 2017 |
| Shire | For profit | MKTG | May 29, 1975 |
| Specgx Llc | For profit | MKTG | Oct 7, 2003 |
| Strides Pharma Science | For profit | MKTG | Jun 21, 2019 |
| Sun Pharmaceuticals | For profit | MKTG | Sep 9, 2003 |
| Sun Pharmaceuticals | For profit | SYN | Sep 27, 2023 |
| Takeda | For profit | NDA2 | Oct 11, 2001 |
| Teva | For profit | SYN | Jan 31, 2022 |
| Teva | For profit | MKTG | Apr 29, 2013 |
| Teva | For profit | SYN | Sep 30, 2003 |
| Teva | For profit | NDA2 | Jan 19, 1960 |
| Tris Pharma, Inc. | For profit | MKTG | May 29, 2013 |
| Tris Pharma, Inc. | For profit | NDA2 | Oct 19, 2015 |
| UCB | For profit | NDA2 | Sep 9, 1955 |
| UCB | For profit | NDA | Sep 9, 1955 |
| US Pharma | For profit | MKTG | Apr 3, 2020 |
| US Pharma | For profit | SYN | Apr 3, 2020 |
| Vintage | For profit | MKTG | Oct 31, 2017 |
| Vintage | For profit | SYN | May 13, 1999 |
| Vitarine | For profit | MKTG | — |
| Winder Labs Llc | For profit | MKTG | Jun 7, 2021 |
| Zydus Discovery DMCC | For profit | MKTG | Oct 31, 2017 |