Overview
Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system stimulant known as d-amphetamine, covalently attached to the naturally occurring amino acid L-lysine. Lisdexamfetamine is the first chemically formulated prodrug stimulant and was first approved by the FDA in April 2008. It was also approved by Health Canada in February 2009. Lisdexamfetamine works to treat attention deficit hyperactivity disorder and binge eating disorder by blocking dopamine and norepinephrine reuptake and increasing their levels in the extraneuronal space.
Indication
Lisdexamfetamine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients six years and older. It is also indicated to treat moderate to severe binge eating disorder (BED) in adults. It is approved for use in the US and Canada.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Moderate Binge Eating Disorder (BED)
- Severe Binge Eating Disorder (BED)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/26 | Phase 2 | Not yet recruiting | |||
2023/07/24 | Phase 2 | Recruiting | |||
2023/05/11 | Phase 2 | Recruiting | Centre hospitalier de l'Université de Montréal (CHUM) | ||
2022/06/13 | Early Phase 1 | Recruiting | |||
2021/06/30 | N/A | Completed | Amsterdam UMC, location VUmc | ||
2021/01/27 | N/A | UNKNOWN | Aarhus University Hospital | ||
2020/10/22 | Phase 2 | ENROLLING_BY_INVITATION | |||
2019/12/02 | Not Applicable | Terminated | |||
2019/11/05 | Phase 4 | Completed | |||
2019/10/21 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0054-0370 | ORAL | 20 mg in 1 1 | 1/19/2024 | |
| Ascent Pharmaceuticals, Inc. | 43602-309 | ORAL | 40 mg in 1 1 | 8/28/2023 | |
| Takeda Pharmaceuticals America, Inc. | 59417-116 | ORAL | 20 mg in 1 1 | 10/13/2023 | |
| Sun Pharmaceutical Industries, Inc. | 57664-088 | ORAL | 60 mg in 1 1 | 12/1/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-6858 | ORAL | 50 mg in 1 1 | 12/12/2022 | |
| Takeda Pharmaceuticals America, Inc. | 59417-101 | ORAL | 10 mg in 1 1 | 10/13/2023 | |
| Takeda Pharmaceuticals America, Inc. | 59417-117 | ORAL | 30 mg in 1 1 | 10/13/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-6859 | ORAL | 60 mg in 1 1 | 12/12/2022 | |
| SpecGx LLC | 0406-5112 | ORAL | 20 mg in 1 1 | 1/24/2022 | |
| Amneal Pharmaceuticals LLC | 65162-023 | ORAL | 20 mg in 1 1 | 1/17/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VYVANSE CAPSULES 30 mg | SIN15841P | CAPSULE | 30.0 mg | 11/1/2019 | |
| VYVANSE CAPSULES 70 mg | SIN15845P | CAPSULE | 70.0 mg | 11/1/2019 | |
| VYVANSE CAPSULES 40 mg | SIN15842P | CAPSULE | 40.0 mg | 11/1/2019 | |
| VYVANSE CAPSULES 60 mg | SIN15844P | CAPSULE | 60.0 mg | 11/1/2019 | |
| VYVANSE CAPSULES 50 mg | SIN15843P | CAPSULE | 50.0 mg | 11/1/2019 | |
| VYVANSE CAPSULES 20 mg | SIN15840P | CAPSULE | 20.0 mg | 11/1/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ACTAVANZ lisdexamfetamine dimesilate 50 mg capsules bottle | 406918 | Medicine | A | 1/22/2024 | |
| ACTAVANZ lisdexamfetamine dimesilate 20 mg capsules bottle | 406915 | Medicine | A | 1/22/2024 | |
| VYVANSE lisdexamfetamine dimesilate 70mg capsule bottle | 199228 | Medicine | A | 7/22/2013 | |
| VYVANSE lisdexamfetamine dimesilate 50mg capsule bottle | 199226 | Medicine | A | 7/22/2013 | |
| VYVANSE lisdexamfetamine dimesilate 60 mg capsules bottle | 284021 | Medicine | A | 11/17/2017 | |
| ACTAVANZ lisdexamfetamine dimesilate 60 mg capsules bottle | 406913 | Medicine | A | 1/22/2024 | |
| ACTAVANZ lisdexamfetamine dimesilate 40 mg capsules bottle | 406914 | Medicine | A | 1/22/2024 | |
| ACTAVANZ lisdexamfetamine dimesilate 30 mg capsules bottle | 406917 | Medicine | A | 1/22/2024 | |
| ACTAVANZ lisdexamfetamine dimesilate 70 mg capsules bottle | 406916 | Medicine | A | 1/22/2024 | |
| VYVANSE lisdexamfetamine dimesilate 20 mg capsules bottle | 284019 | Medicine | A | 11/22/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APO-LISDEXAMFETAMINE | 02476983 | Capsule - Oral | 10 MG | N/A | |
| AG-LISDEXAMFETAMINE | angita pharma inc. | 02537583 | Capsule - Oral | 30 MG | N/A |
| APO-LISDEXAMFETAMINE CHEWABLE TABLETS | 02534460 | Tablet (Chewable) - Oral | 30 MG | 5/23/2025 | |
| TARO-LISDEXAMFETAMINE CHEWABLE TABLETS | 02533340 | Tablet (Chewable) - Oral | 10 MG | 6/4/2024 | |
| VYVANSE | takeda canada inc | 02490250 | Tablet (Chewable) - Oral | 40 MG | 8/6/2019 |
| AG-LISDEXAMFETAMINE | angita pharma inc. | 02537575 | Capsule - Oral | 20 MG | N/A |
| AG-LISDEXAMFETAMINE | angita pharma inc. | 02537605 | Capsule - Oral | 50 MG | N/A |
| TEVA-LISDEXAMFETAMINE | teva canada limited | 02545888 | Capsule - Oral | 20 MG | 6/3/2024 |
| PRO-LISDEXAMFETAMINE | PRO DOC LIMITEE | 02547031 | Capsule - Oral | 10 MG | 12/10/2024 |
| JAMP LISDEXAMFETAMINE | 02535157 | Capsule - Oral | 40 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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