Lisdexamfetamine
Lisdexamfetamine Dimesylate, Vyvanse (lisdexamfetamine) is a small molecule pharmaceutical. Lisdexamfetamine was first approved as Vyvanse on 2007-02-23. It is used to treat attention deficit disorder with hyperactivity and binge drinking in the USA.
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Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lisdexamfetamine dimesylate | ANDA | 2025-03-28 |
| vyvanse | New Drug Application | 2023-10-13 |
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Clinical Trials
124 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 | 4 | 8 | 13 | 28 | 13 | 64 |
| Hyperkinesis | D006948 | — | — | 2 | 6 | 7 | 18 | 9 | 41 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 3 | 5 | 3 | — | 11 |
| Depression | D003863 | — | F33.9 | — | 3 | 5 | 2 | — | 10 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 3 | 3 | 1 | — | 7 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | 3 | 1 | — | 5 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | 2 | 1 | 1 | 4 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | — | 3 | 1 | 4 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | 1 | 1 | — | 2 |
| Brain injuries | D001930 | — | S06.9 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bulimia | D002032 | — | F50.2 | — | 4 | 7 | — | 2 | 13 |
| Binge-eating disorder | D056912 | — | F50.2 | — | 3 | 7 | — | 2 | 12 |
| Feeding and eating disorders | D001068 | — | F50 | — | 3 | 7 | — | 1 | 11 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | 1 | 4 | — | — | 6 |
| Overweight | D050177 | — | E66.3 | — | 2 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 4 | — | — | 1 | 5 |
| Cocaine-related disorders | D019970 | — | F14 | 2 | 2 | — | — | — | 3 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | 2 | — | — | — | 2 |
| Sleep deprivation | D012892 | — | F51.12 | — | 1 | — | — | — | 1 |
| Bulimia nervosa | D052018 | EFO_0005204 | F50.2 | — | 1 | — | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | — | 1 | — | — | — | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | — | 7 |
| Drug misuse | D000076064 | — | — | 1 | — | — | — | — | 1 |
| Pediatric obesity | D063766 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tobacco use disorder | D014029 | — | F17 | — | — | — | — | 1 | 1 |
| Feeding behavior | D005247 | — | — | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lisdexamfetamine |
| INN | lisdexamfetamine |
| Description | Lisdexamfetamine is an amino acid amide. |
| Classification | Small molecule |
| Drug class | amfetamine derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H](Cc1ccccc1)NC(=O)[C@@H](N)CCCCN |
Identifiers
| PDB | — |
| CAS-ID | 608137-32-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201222 |
| ChEBI ID | — |
| PubChem CID | 11597698 |
| DrugBank | DB01255 |
| UNII ID | H645GUL8KJ (ChemIDplus, GSRS) |
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Estimated US medical usage
Lisdexamfetamine
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Additional graphs summarizing 2,084 documents
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Safety
Black-box Warning
Black-box warning for: Lisdexamfetamine dimesylate, Vyvanse
Adverse Events
Top Adverse Reactions
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16,732 adverse events reported
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