Dextroamphetamine saccharate
Adderall, Mydayis (dextroamphetamine saccharate) is a small molecule pharmaceutical. Dextroamphetamine saccharate was first approved as Adderall 10 on 1996-02-13. It is used to treat attention deficit disorder with hyperactivity and narcolepsy in the USA. It is known to target trace amine-associated receptor 1, sodium-dependent noradrenaline transporter, and sodium-dependent dopamine transporter.
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Commercial
Trade Name
FDA
EMA
Combinations
Adderall, Mydayis (generic drugs available since 2002-02-11)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphetamine aspartate
+
Amphetamine sulfate
+
Dextroamphetamine saccharate
+
Dextroamphetamine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ADDERALL XR 25 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 5 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 15 | Takeda | N-021303 RX | 2002-05-22 | 1 products, RLD |
| ADDERALL XR 10 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
| ADDERALL XR 20 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD |
| ADDERALL XR 30 | Takeda | N-021303 RX | 2001-10-11 | 1 products, RLD, RS |
| MYDAYIS | Takeda | N-022063 RX | 2017-06-20 | 4 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adderall | New Drug Application | 2022-10-24 |
| dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate | ANDA | 2023-06-14 |
| mydayis | New Drug Application | 2021-01-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
| narcolepsy | EFO_0000614 | D009290 | G47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMPHETAMINE ASPARTATE / AMPHETAMINE SULFATE / DEXTROAMPHETAMINE SACCHARATE / DEXTROAMPHETAMINE SULFATE, MYDAYIS, TAKEDA PHARMS USA | |||
| 2023-03-13 | PED | ||
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 3 | 3 | 3 | 4 | 13 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | 1 | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | 1 | — | 1 |
| Dementia | D003704 | F03 | — | — | — | 1 | — | 1 | |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 1 | — | 1 |
| Attention deficit and disruptive behavior disorders | D019958 | HP_0010865 | F91.3 | — | — | — | 1 | — | 1 |
| Fetal alcohol spectrum disorders | D063647 | Q86.0 | — | — | — | 1 | — | 1 | |
| Covid-19 | D000086382 | U07.1 | — | — | — | 1 | — | 1 | |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioma | D005910 | EFO_0000520 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | 8 | 8 | — | — | 1 | 17 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | 2 | 3 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 2 | — | — | 1 | 3 |
| Narcolepsy | D009290 | EFO_0000614 | G47.4 | 2 | 1 | — | — | — | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | — | — | 1 | 2 |
| Anhedonia | D059445 | R45.84 | 1 | 1 | — | — | — | 2 | |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | — | 2 |
| Gambling | D005715 | F63.0 | — | 1 | — | — | — | 1 | |
| Idiopathic hypersomnia | D020177 | G47.11 | — | 1 | — | — | — | 1 | |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychotic disorders | D011618 | F20.81 | — | — | — | — | 1 | 1 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 1 | 1 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | — | — | — | 1 | 1 |
| Tobacco use disorder | D014029 | F17 | — | — | — | — | 1 | 1 | |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DEXTROAMPHETAMINE SACCHARATE |
| INN | dexamfetamine |
| Description | (S)-amphetamine is a 1-phenylpropan-2-amine that has S configuration. It has a role as a neurotoxin, an adrenergic uptake inhibitor, a dopaminergic agent, a sympathomimetic agent, a dopamine uptake inhibitor and an adrenergic agent. It is an enantiomer of a (R)-amphetamine. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](N)Cc1ccccc1.O=C(O)[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 51-64-9 |
| RxCUI | 3288 |
| ChEMBL ID | CHEMBL3989844 |
| ChEBI ID | — |
| PubChem CID | 5826 |
| DrugBank | DB01576 |
| UNII ID | TZ47U051FI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Variants
Clinical Variant
No data
Financial
Adderall - Shire
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Adderall - Takeda
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Mydayis - Shire
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Trends
PubMed Central
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Additional graphs summarizing 1,775 documents
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Safety
Black-box Warning
Black-box warning for: Adderall, Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Mydayis
Adverse Events
Top Adverse Reactions
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10,357 adverse events reported
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