Lisdexamfetamine dimesylate
Lisdexamfetamine Dimesylate, Vyvanse (lisdexamfetamine dimesylate) is a small molecule pharmaceutical. Lisdexamfetamine dimesylate 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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Arynta, Lisdexamfetamine dimesylate, Vyvanse
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lisdexamfetamine dimesylate | ANDA | 2025-09-19 |
| vyvanse | New Drug Application | 2025-10-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| binge drinking | — | D063425 | — |
| attention deficit disorder with hyperactivity | EFO_0003888 | D001289 | F90 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
126 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 | 9 | 13 | 28 | 13 | 65 |
| Hyperkinesis | D006948 | — | — | 2 | 7 | 7 | 16 | 8 | 39 |
| 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 | 2 | 3 | 1 | — | 6 |
| 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 | — | 3 | 7 | — | 2 | 12 |
| Binge-eating disorder | D056912 | — | F50.2 | — | 3 | 7 | — | 2 | 12 |
| Feeding and eating disorders | D001068 | — | F50 | — | 2 | 7 | — | 1 | 10 |
| 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 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | 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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 1 | 1 |
| 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 dimesylate |
| INN | — |
| 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) | CS(=O)(=O)O.CS(=O)(=O)O.C[C@@H](Cc1ccccc1)NC(=O)[C@@H](N)CCCCN |
Identifiers
| PDB | — |
| CAS-ID | 608137-32-2 |
| RxCUI | 700810 |
| ChEMBL ID | CHEMBL1201178 |
| ChEBI ID | — |
| PubChem CID | 11597698 |
| DrugBank | DB01255 |
| UNII ID | — |
Target
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Financial
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Safety
Black-box Warning
Black-box warning for: Lisdexamfetamine dimesylate, Vyvanse
Adverse Events
Top Adverse Reactions
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21,258 adverse events reported
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