amphetamine

Trade name: Adderall

Small moleculeapproved

Approved

Sep 9, 1955

Amphetamine is a central nervous system (CNS) stimulant that is used in the treatment of attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity; it is also used to treat binge eating disorder in the form of its inactive prodrug lisdexamfetamine. Amphetamine was discovered as a chemical in 1887 by Lazăr Edeleanu, and then as a drug in the late 1920s. It exists as two enantiomers: levoamphetamine and dextroamphetamine. Amphetamine properly refers to a specific chemical, the racemic free base, which is equal parts of the two enantiomers in their pure amine forms. The term is frequently used informally to refer to any combination of the enantiomers, or to either of them alone. Historically, it has been used to treat nasal congestion and depression. Amphetamine is also used as an athletic performance enhancer and cognitive enhancer, and recreationally as an aphrodisiac and euphoriant. It is a prescription drug in many countries, and unauthorized possession and distribution of amphetamine are often tightly controlled due to the significant health risks associated with recreational use. — Wikipedia

Clinical trial activity

109 trials · 81 clinical orgs · 65 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Sep 1, 1994 (NCT00000306)

Timeline

1950s

Sep 9, 1955
Earliest FDA Approval
Sep 9, 1955
UCB — NDA Secondary Org

1960s

Jan 19, 1960
Teva — NDA Secondary Org

1970s

Oct 24, 1975
Teva — Marketing Organization
Feb 26, 1976
GlaxoSmithKline — Marketing Organization
Feb 26, 1976
Smith Kline and French — Marketing Organization
Aug 2, 1976
Impax Laboratories — NDA Secondary Org
Jun 15, 1977
Ferndale Laboratories, Inc. — Marketing Organization

1980s

Aug 31, 1984
Lannett Company, Inc. — Marketing Organization

1990s

Jan 1, 1994
Earliest Phase 2 Sponsor(trial)
Jan 1, 1999
Earliest Phase 1 Sponsor(trial)

2000s

Oct 11, 2001
Takeda — NDA Secondary Org
Oct 11, 2001
Shire — Marketing Organization
Jan 18, 2002
Mayne Pharma — Marketing Organization
Jan 29, 2002
Specgx Llc — 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
Jan 1, 2003
Shire — Earliest Phase 3 Sponsor(trial)
May 6, 2003
Actavis — Marketing Organization
Sep 9, 2003
Sun Pharmaceuticals — Marketing Organization
Aug 25, 2004
Able Laboratories — Marketing Organization
Jan 29, 2008
Outlook Pharmaceuticals — Marketing Organization

2010s

Oct 25, 2011
Arbor Pharmaceuticals — Marketing Organization
Aug 9, 2012
Arbor Pharmaceuticals — NDA Secondary Org
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 27, 2016
Neos Therapeutics, Inc — NDA Secondary Org
Jan 27, 2016
AYTU BioScience — NDA Secondary Org
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
Apr 22, 2016
Par Pharmaceuticals — Marketing Organization
Jul 28, 2017
Alvogen — Marketing Organization
Oct 31, 2017
Zydus Discovery DMCC — Marketing Organization
Oct 31, 2017
Vintage — Marketing Organization
Oct 31, 2017
Nesher Pharms — Marketing Organization
Dec 28, 2017
Nuvo Research Inc. — Marketing Organization
Sep 26, 2018
Amneal Pharmaceuticals — 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
Jan 30, 2019
Azurity — Marketing Organization
Jan 30, 2019
Azurity — NDA Secondary Org
Apr 22, 2019
Mallinckrodt (2013) — Marketing Organization
May 17, 2019
Rhodes Pharmaceuticals, L.P. — 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
Aug 5, 2019
Granules India — Marketing Organization
Nov 22, 2019
Bionpharma Inc — Marketing Organization

2020s

Feb 4, 2020
Cerovene — Marketing Organization
Mar 11, 2020
Prinston Inc — Marketing Organization
Apr 3, 2020
US Pharma — Marketing Organization
May 22, 2020
Aavis Pharma — Marketing Organization
May 22, 2020
Senores Pharms — Marketing Organization
May 22, 2020
RISE PHARMA — Marketing Organization
Jul 14, 2020
Dr. Reddy's Laboratories — Marketing Organization
Aug 24, 2020
RiconPharma — Marketing Organization
Aug 24, 2020
Novast Labs — Marketing Organization
Oct 27, 2020
Alkem Labs Ltd — Marketing Organization
Jan 27, 2021
Glenmark Pharmaceuticals — Marketing Organization
Apr 22, 2021
Ascent Pharmahealth — Marketing Organization
Apr 22, 2021
AbbVie — Marketing Organization
Nov 22, 2021
Accord Research — Marketing Organization
Jul 5, 2022
Cediprof Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Dopamine transporterRELEASING AGENT
SLC6A3 releasing agent
- Sodium-dependent dopamine transporter (SLC6A3) ↗
Norepinephrine transporterRELEASING AGENT
SLC6A2 releasing agent
- Sodium-dependent noradrenaline transporter (SLC6A2) ↗

Combination products

biphetamine
with dextroamphetamine
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

Loading structure…

SMILES

OP(O)(O)=O.CC(N)CC1=CC=CC=C1

Mol. weight: 233.2014 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

1-phenyl-2-aminopropane
1-phenyl-2-aminopropane
1-phenylpropan-2-amin
adderall
adderall
adderall
alpha-methylbenzeneethaneamine
alpha-methylbenzeneethaneamine
(+)-alpha-methylphenethylamine
(+)-alpha-methylphenethylamine
(+)-alpha-methylphenylethylamine
(+)-alpha-methylphenylethylamine
alpha-methylphenylethylamine
alpha-methylphenylethylamine
(alphas)-alpha-methylbenzeneethanamine
(alphas)-alpha-methylbenzeneethanamine
amfetamin
amfetamin
amfetamine
amfetamine
amfetamine
amfetamine
amfetamine
amfetamine sulfate
amfetaminil
amfetaminil
amfetaminum
amfetaminum
amphetamin
amphetamin
amphetamine
amphetamine
amphetamine
amphetamine
amphetamine
amphetamine
amphetamine
amphetamine
amphetamine
amphetamine
(+)-amphetamine
(+)-amphetamine
amphetamine adipate
amphetamine adipate
amphetamine aspartate
amphetamine aspartate
amphetamine aspartate monohydrate
amphetamine aspartate monohydrate
amphetamine aspartate monohydrate
amphetamine aspartate monohydrate
amphetamine aspartate monohydrate
amphetamine aspartate monohydrate
amphetamine resin complex
amphetamine resin complex
amphetamine resin complex
amphetamine salt
amphetamine sulfate
amphetamine sulfate
amphetamine sulfate
amphetamine sulfate
amphetaminil
amphetaminil
amphetaminil
amphetaminil
aponeuron
ar11
benzadrine
benzadrine
benzedrex
benzedrex
benzedrine
benzedrine
benzedrine
beta-aminopropylbenzene
beta-aminopropylbenzene
beta-phenylisopropylamin
beta-phenylisopropylamin
beta-phenylisopropylamine
beta-phenylisopropylamine
d-1-phenyl-2-methylaminopropane
d-1-phenyl-2-methylaminopropane
rac-(2r)-1-phenylpropan-2-amine
rac-(2r)-1-phenylpropan-2-amine
rac-amphetamine
rac-amphetamine
(s)-1-phenyl-2-aminopropane
(s)-1-phenyl-2-aminopropane
(s)-1-phenyl-2-propylamine
(s)-1-phenyl-2-propylamine
(s)-alpha-methylbenzeneethanamine
(s)-alpha-methylbenzeneethanamine
(+)-(s)-amphetamine
(+)-(s)-amphetamine
(s)-amphetamine
(s)-amphetamine
(s)-(+)-amphetamine
(s)-(+)-amphetamine
s-amphetamine
(s)-(+)-beta-phenylisopropylamine
(s)-(+)-beta-phenylisopropylamine
shp465
spd465
tri102
α-methylbenzeneethaneamine
α-methylbenzeneethaneamine
α-methylphenethylamine
α-methylphenethylamine
β-aminopropylbenzene
β-aminopropylbenzene
β-phenylisopropylamine
β-phenylisopropylamine

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06853665	Phase 2	Mar 1, 2025	Harvard University
NCT06248229	Phase 4	Sep 1, 2024	Innovaderm, Rochester Center for Behavioral Medicine
NCT05790239	Phase 2	Oct 31, 2023	Department of Veteran Affairs
NCT05650775	Phase 1	Jan 31, 2023	Harvard University
NCT05597722	Phase 4	Nov 15, 2022	The Beckwith Institute, University of Pittsburgh
NCT05011760	Early Phase 1 (Phase 1)	Sep 1, 2021	National Institute on Drug Abuse (NIDA), University of Pittsburgh
NCT04509102	Early Phase 1 (Phase 1)	Aug 19, 2020	University of California, Los Angeles
NCT04240756	Phase 3	Jan 31, 2020	Children's National Medical Center, University of Maryland, University of Michigan, University of Washington
NCT04235686	Phase 2	Jan 20, 2020	Mayo Clinic, University of Cincinnati
NCT04027361	Phase 2	Dec 31, 2019	Harvard University, Massachusetts Institute of Technology, Tris Pharma, Inc.
NCT04094025	Phase 1	Nov 30, 2019	Noven Therapeutics
NCT04170738	Phase 4	Nov 5, 2019	Icahn School of Medicine at Mount Sinai, National Institute on Drug Abuse (NIDA)
NCT03935646	Phase 2	Sep 2, 2019	University of Wyoming
NCT03945175	Phase 4	Jun 30, 2019	New York University
NCT04232644	Phase 1	May 27, 2019	Vallon Pharmaceuticals, Inc.
NCT03772314	Phase 2	Apr 15, 2019	American Academy of Sleep Medicine, Emory University
NCT03834766	Phase 3	Feb 6, 2019	Meridien Research, Premier Research Group, Tris Pharma, Inc.
NCT03530631	Phase 4	Oct 1, 2018	University of Alabama, Birmingham
NCT03659929	Phase 3	Sep 13, 2018	Arbor Pharmaceuticals
NCT03616717	Phase 4	Sep 1, 2018	University of California, San Diego

Showing 20 of 109 trials

Page 1 / 6

Organizations

Research & Development (81)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Shire	For profit	19	19	4	2003
National Institute on Drug Abuse (NIDA)	Government	17	4	4	1994
Harvard University	Academic/Hospital	9	6	4	2004
University of Texas at Houston	Academic/Hospital	8	6	4	1999
Columbia University	Academic/Hospital	6	6	3	2001
The University of Texas, Dallas	Academic/Hospital	6	0	3	1994
National Institute of Mental Health (NIMH)	Government	5	1	1	2004
McGill University	Academic/Hospital	4	4	2	2006
National Institutes of Health (NIH)	Government	4	0	3	2007
Tris Pharma, Inc.	For profit	4	4	2	2014
University of Pittsburgh	Academic/Hospital	4	4	2	2010
Duke University	Academic/Hospital	3	3	2	2001
Emory University	Academic/Hospital	3	2	3	2007
University of California, San Diego	Academic/Hospital	3	3	2	2011
University of Cincinnati	Academic/Hospital	3	1	2	2010
Arbor Pharmaceuticals	For profit	2	2	2	2013
Canadian Institutes of Health Research (CIHR)	Academic/Hospital	2	0	2	2010
Massachusetts Institute of Technology	Academic/Hospital	2	0	2	2017
Mayo Clinic	Academic/Hospital	2	2	2	2016
Meridien Research	For profit	2	0	1	2007

81 organizations

Page 1 / 5

Marketing (87)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Jun 21, 2019
AYTU BioScience	For profit	NDA2	Jan 27, 2016
Aavis Pharma	For profit	MKTG	May 22, 2020
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
Actavis	For profit	SYN	Jun 22, 2023
Alkem Labs Ltd	For profit	MKTG	Oct 27, 2020
Allergan PLC (2015)	For profit	MKTG	Feb 5, 2016
Alvogen	For profit	SYN	Jul 28, 2017
Alvogen	For profit	MKTG	Jul 28, 2017
Amerigen Pharmaceuticals	For profit	MKTG	Jan 22, 2019
Amneal Pharmaceuticals	For profit	MKTG	Sep 26, 2018
Ani Pharmaceuticals	For profit	SYN	Jan 22, 2019
Ani Pharmaceuticals	For profit	MKTG	Jan 22, 2019
Arbor Pharmaceuticals	For profit	NDA2	Aug 9, 2012
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
Azurity	For profit	MKTG	Jan 30, 2019
Azurity	For profit	NDA2	Jan 30, 2019
Barr Laboratories	For profit	MKTG	Feb 11, 2002
Barr Laboratories	For profit	SYN	Feb 12, 2013
Bionpharma Inc	For profit	MKTG	Nov 22, 2019
Bionpharma Inc	For profit	SYN	Nov 22, 2019
Bristol-Myers Squibb	For profit	MKTG	May 31, 2019
Cediprof Inc	For profit	MKTG	Jul 5, 2022
Cerovene	For profit	MKTG	Feb 4, 2020
Corepharma	For profit	MKTG	Apr 15, 2016
Dr. Reddy's Laboratories	For profit	MKTG	Jul 14, 2020
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
Fisons	For profit	NDA2	—
GlaxoSmithKline	For profit	MKTG	Feb 26, 1976
Glenmark Pharmaceuticals	For profit	MKTG	Jan 27, 2021
Granules India	For profit	SYN	Aug 5, 2019
Granules India	For profit	MKTG	Aug 5, 2019
Impax Laboratories	For profit	NDA2	Aug 2, 1976
Impax Laboratories	For profit	MKTG	Feb 16, 2016
Lannett Company, Inc.	For profit	SYN	Nov 26, 2021
Lannett Company, Inc.	For profit	MKTG	Aug 31, 1984
Mallinckrodt (2013)	For profit	MKTG	Apr 22, 2019
Mayne Pharma	For profit	MKTG	Jan 18, 2002
Mylan	For profit	SYN	Nov 10, 2015
Mylan	For profit	MKTG	Nov 10, 2015
Neos Therapeutics, Inc	For profit	NDA2	Jan 27, 2016
Neos Therapeutics, Inc	For profit	SYN	Sep 15, 2017
Nesher Pharms	For profit	MKTG	Oct 31, 2017
Novartis	For profit	MKTG	Jun 14, 2002
Novast Labs	For profit	MKTG	Aug 24, 2020
Novel Anti-Infective Technologies, LLC	For profit	MKTG	Mar 16, 2016
Nuvo Research Inc.	For profit	MKTG	Dec 28, 2017
Outlook Pharmaceuticals	For profit	MKTG	Jan 29, 2008
Par Pharmaceuticals	For profit	MKTG	Apr 22, 2016
Pharmaceutics International, Inc.	For profit	MKTG	Jun 21, 2019
Praxgen Pharma	For profit	MKTG	Dec 7, 2018
Prinston Inc	For profit	MKTG	Mar 11, 2020
R.J. Strasenburgh	For profit	NDA	—
RISE PHARMA	For profit	MKTG	May 22, 2020
Rhodes Pharmaceuticals, L.P.	For profit	MKTG	May 17, 2019
RiconPharma	For profit	MKTG	Aug 24, 2020
Sandoz	For profit	MKTG	Jun 14, 2002
Senores Pharms	For profit	MKTG	May 22, 2020
Shire	For profit	MKTG	Oct 11, 2001
Shire	For profit	SYN	Jun 20, 2017
Smith Kline and French	For profit	MKTG	Feb 26, 1976
Specgx Llc	For profit	MKTG	Jan 29, 2002
Specgx Llc	For profit	SYN	Oct 7, 2003
Sun Pharmaceuticals	For profit	SYN	Jan 27, 2021
Sun Pharmaceuticals	For profit	MKTG	Sep 9, 2003
Takeda	For profit	NDA2	Oct 11, 2001
Teva	For profit	SYN	Jan 31, 2022
Teva	For profit	MKTG	Oct 24, 1975
Teva	For profit	SYN	Sep 30, 2003
Teva	For profit	SYN	Jan 19, 1960
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
US Pharma	For profit	MKTG	Apr 3, 2020
US Pharma	For profit	MKTG	Apr 3, 2020
Vintage	For profit	MKTG	Oct 31, 2017
Vintage	For profit	SYN	May 13, 1999
Zydus Discovery DMCC	For profit	MKTG	Oct 31, 2017