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Drug

Amphetamine

Established medicine
ClassDopamine transporter releasing agentResearchActive indication expansion
Also known as 1-phenyl-2-aminopropane, 1-phenylpropan-2-amine, Adderall, Adzenys+14 more

1-phenyl-2-aminopropane, 1-phenylpropan-2-amine, Adderall, Adzenys, Amfetamina, Amfetamine, Amfetaminum, Amphetamine-Dextroamphetamine, Desoxynorephedrine, Dyanavel, Evekeo, Mydayis, alpha-Methylbenzeneethaneamine, beta-Aminopropylbenzene, dl-alpha-methylphenethylamine, rac-(2R)-1-phenylpropan-2-amine, rac-amphetamine, Amphetamine Sulfate.

RxNorm725ChEMBLCHEMBL405ATCN06BA01UNIICK833KGX7E
4
Research papers
2
Protein targets
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: AMPHETAMINE (ANDA209253)

Regulatory2026-10-19FDA

Label change: AMPHETAMINE (ANDA209253)

Regulatory2025-08-08FDA

Label change: AMPHETAMINE (ANDA209253)

Regulatory2025-08-08FDA

Astroglial CB<sub>1</sub> Reveal Sex-Specific Synaptic Effects of Amphetamine.

Research2025-04-28Glia

Astrocytes Mediate Psychostimulant-Induced Alterations of Spike-Timing Dependent Synaptic Plasticity.

Research2025-01-13Glia

A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical trial2024-09-03Results posted · ClinicalTrials.gov

Informing Treatment Decisions in the Central Disorders of Hypersomnolence: A Pragmatic Clinical Trial of Modafinil Versus Amphetamines

Clinical trial2024-05-23Results posted · ClinicalTrials.gov

Generic approval: AMPHETAMINE (ANDA209253)

Regulatory2023-06-22FDA

Randomized Study to Evaluate Strategies to Address Cognitive Fog in Long-COVID-19 Patients

Clinical trial2023-05-18Terminated · ClinicalTrials.gov

Impact of Combined Medication and Behavioral Treatment in Young Children With Comorbid ASD and ADHD

Clinical trial2021-04-19Terminated · ClinicalTrials.gov

Comparison of Caffeine and d-amphetamine in Cocaine-Dependent Subjects: Differential Outcomes on Subjective and Cardiovascular Effects, Reward Learning, and Salivary Paraxanthine.

Research2014-01-01Journal of addiction research & therapy

Animal models of schizophrenia.

Research2011-10-01British journal of pharmacology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Amphetamine
Aliases & brands
1-phenyl-2-aminopropane1-phenylpropan-2-amineAdderallAdzenysAmfetaminaAmfetamineAmfetaminumAmphetamine-DextroamphetamineDesoxynorephedrineDyanavelEvekeoMydayisalpha-Methylbenzeneethaneaminebeta-Aminopropylbenzenedl-alpha-methylphenethylaminerac-(2R)-1-phenylpropan-2-aminerac-amphetamineAmphetamine Sulfate
RxNorm CUI
725
ChEMBL ID
CHEMBL405
ATC codes
N06BA01
UNII
CK833KGX7E
Primary mechanism
Dopamine transporter releasing agent
Regulatory jurisdictions
fda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium-dependent dopamine transporter
SLC6A3 · Q01959
RELEASING AGENTDopamine transporter releasing agent
Sodium-dependent noradrenaline transporter
SLC6A2 · P23975
RELEASING AGENTNorepinephrine transporter releasing agent

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval on record (generic/biosimilar)
2023-06-22
Latest approval
2023-06-22
Authorities
FDA
Total events
4
fdaU.S. Food and Drug Administration· 4 events
2026-10-19Label change
Label change: AMPHETAMINE (ANDA209253)
Evidence ↗
2025-08-08Label change
Label change: AMPHETAMINE (ANDA209253)
Evidence ↗
2025-08-08Label change
Label change: AMPHETAMINE (ANDA209253)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2023
5
Late-stage (III+)
8
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 10
Early Phase 11Phase 11Phase 1 / 21Phase 22Phase 31Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomized Study to Evaluate Strategies to Address Cognitive Fog in Long-COVID-19 Patients

TerminatedPH IVEva Szigethyn=72023

Monoamine Contributions to Neurocircuitry in Eating Disorders

CompletedPH IVUniversity of California, San Diegon=882017

A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)

CompletedPH IIIArbor Pharmaceuticals, Inc.n=3202019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Informing Treatment Decisions in the Central Disorders of Hypersomnolence: A Pragmatic Clinical Trial of Modafinil Versus Amphetamines

CompletedPH IIEmory Universityn=442023

A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)

CompletedPH IIIArbor Pharmaceuticals, Inc.n=3202019

Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing

CompletedPH IUniversity Hospital, Basel, Switzerlandn=282018

Monoamine Contributions to Neurocircuitry in Eating Disorders

CompletedPH IVUniversity of California, San Diegon=882017

A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the CNS After Single-Dose Oral Administration

CompletedPH INeurocrine Biosciencesn=122017

Neurobiological Principles Applied to the Rehabilitation of Stroke Patients

CompletedN/AEmory Universityn=332016

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
2011–2025
Major research themes8
Astrocytes2Central Nervous System Stimulants2Neuronal Plasticity2Action Potentials1Amphetamine1Nucleus Accumbens1Receptor, Cannabinoid, CB11Sex Characteristics1
Journals, researchers & institutions
Top journals
  • Glia2
  • British journal of pharmacology1
  • Journal of addiction research & therapy1
Leading researchers
  • Alberquilla S1
  • Araque A1
  • Bellocchio L1
  • Cannich A1
  • Chaouloff F1
  • Covelo A1
  • Dalla-Tor T1
  • Drago F1
Leading institutions
free-text, unnormalised
  • Cajal Institute1
  • Center for Human Toxicology1
  • Center for Neurobehavioral Research on Addictions1
  • Galicia Sur Health Research Institute (IISGS)1
  • Instituto de Salud Carlos III1
  • National Institute on Drug Abuse1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cocaine

Studied across the same disease area as Amphetamine in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.