Dextroamphetamine saccharate
Adderall, Amphetamine / Amphetamine / Dextroamphetamine / Dextroamphetamine, 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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
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
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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 | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
60 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 | 2 | 6 | 7 | 8 | 8 | 29 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | 1 | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 1 | 2 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 1 | 1 | 1 | — | 2 |
| Problem behavior | D000066553 | — | — | — | — | — | 1 | — | 1 |
| Motivation | D009042 | — | — | — | — | — | 1 | — | 1 |
| Deception | D008192 | — | — | — | — | — | 1 | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | 1 | — | 1 |
| Conduct disorder | D019955 | EFO_0004216 | F91 | — | — | — | 1 | — | 1 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | 1 | 4 | 2 | — | — | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | 1 | 2 |
| Short-term memory | D008570 | EFO_0004335 | — | — | 1 | — | — | — | 1 |
| Affect | D000339 | — | — | — | 1 | — | — | — | 1 |
| Narcolepsy | D009290 | HP_0030050 | G47.4 | — | 1 | — | — | — | 1 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | 1 | — | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Hemodynamics | D006439 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv | D006678 | — | O98.7 | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dextroamphetamine saccharate |
| INN | — |
| 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 | — |
Target
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Variants
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Financial
Estimated US medical usage
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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11,310 adverse events reported
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