LISDEXAMFETAMINE DIMESYLATE
LISDEXAMFETAMINE DIMESYLATE is indicated for the treatment of Attention Deficit Hyperactivity Disorder; Binge Eating Disorder.
How LISDEXAMFETAMINE DIMESYLATE Works
Lisdexamfetamine is a prodrug that is converted in the body to dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. While the exact mode of therapeutic action for ADHD and binge eating disorder is unknown, it is categorized as a central nervous system stimulant.
Details
- Status
- Prescription
- First Approved
- 2023-08-25
- Routes
- ORAL
- Dosage Forms
- TABLET, CHEWABLE, CAPSULE
Companies
LISDEXAMFETAMINE DIMESYLATE Approval History
What LISDEXAMFETAMINE DIMESYLATE Treats
2 indicationsLISDEXAMFETAMINE DIMESYLATE is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
- Binge Eating Disorder
LISDEXAMFETAMINE DIMESYLATE Boxed Warning
ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing lisdexamfetamine dimesylate ...
WARNING: ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing lisdexamfetamine dimesylate capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout lisdexamfetamine dimesylate capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1 ), and Drug Abuse and Dependence (9.2) ]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing lisdexamfetamine dimesylate capsules, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
LISDEXAMFETAMINE DIMESYLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LISDEXAMFETAMINE DIMESYLATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
20 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03926052 results posted | 2000022480 1R01DK114075-01A1 | Ph 3 | completed | Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment |
| NCT06847399 LIBERATE | IRB00474917 | Ph 2 | recruiting | Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder |
| NCT01071044 results posted | RCBM11 | Ph 4 | completed | Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome |
| NCT01342445 results posted | Shire-80000311112 | Ph 4 | completed | Effects of LDX on Functioning of College Students With ADHD |
| NCT03924193 results posted | 2000022480_b 1R01DK114075-01A1 | Ph 3 | completed | Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment |
| NCT03337646 | RES 16-002 | Ph 4 | completed | Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism |
| NCT04152629 reFOQus | CAN-MA-FOQ-001 | Ph 4 | completed | Real World Evidence of the Efficacy and Safety of FOQUEST |
| NCT00746733 results posted | SPD489-113 | Ph 1 | completed | Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC |
| NCT02009163 results posted | SPD489-346 2012-004457-88 | Ph 3 | completed | Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder |
| NCT01106430 results posted | SPD489-317 2009-011745-94 | Ph 3 | completed | Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate |
| NCT01328756 results posted | SPD489-404 2010-020951-30 | Ph 4 | completed | Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) |
| NCT01552902 results posted | SPD489-406 2011-005452-34 | Ph 4 | completed | Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder |
| NCT00776555 results posted | SPD489-112 | Ph 1 | terminated | Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution |
| NCT01657019 results posted | SPD489-345 2012-003313-34 | Ph 3 | completed | Open Label Extension in Adults With Binge Eating Disorder (BED) |
| NCT01552915 results posted | SPD489-405 | Ph 4 | completed | Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder |
| NCT01890785 results posted | SPD489-123 | Ph 1 | completed | Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers |
| NCT03397446 | LDXBN | Ph 2 | terminated | Lisdexamfetamine for Adults With Bulimia Nervosa |
| NCT01863459 | LDX-COMORB-1 | Ph 4 | completed | Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity |
| NCT02555150 | 063-013 | Ph 3 | completed | A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD |
| NCT00889915 results posted | Pro00014075 P30MH066386-02, DSIR CTM 4571; Pro00014075 | Ph 4 | completed | Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LISDEXAMFETAMINE DIMESYLATE FDA Label Details
Indications & Usage
LISDEXAMFETAMINE DIMESYLATE is indicated for the treatment of Attention Deficit Hyperactivity Disorder; Binge Eating Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in...
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Full clinical data, patents, trials, and competitive landscape for lisdexamfetamine dimesylate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.