VYVANSE (lisdexamfetamine dimesylate)
Vyvanse is a central nervous system stimulant used for adults and children six years of age and older who have Attention Deficit Hyperactivity Disorder (ADHD). It also helps adults manage moderate to severe binge eating disorder (BED). This medication is not used for weight loss or obesity, and it is not recommended for children under six due to an increased risk of side effects.
How VYVANSE Works
This medication works by acting as a prodrug of dextroamphetamine, a type of stimulant that affects the central nervous system. While the exact process that helps patients with ADHD and binge eating disorder is unknown, the drug functions as a sympathomimetic amine to provide therapeutic activity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-02-23
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, CHEWABLE
VYVANSE Approval History
What VYVANSE Treats
2 indicationsVYVANSE is approved for 2 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
- Binge Eating Disorder
VYVANSE Boxed Warning
ABUSE, MISUSE, AND ADDICTION VYVANSE has 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 VYVANSE, 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 VYVANSE, assess each patient's risk for abuse, misuse, and addiction. Educate patients ...
WARNING: ABUSE, MISUSE, AND ADDICTION VYVANSE has 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 VYVANSE, 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 VYVANSE, 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 VYVANSE 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) , Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. VYVANSE has 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 VYVANSE, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing VYVANSE, 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.
VYVANSE 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 VYVANSE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
26 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 |
| NCT00919867 results posted | SPD503-115 | Ph 1 | completed | A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers |
| 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 |
| NCT02675400 | Fathers Too | Ph 4 | completed | Treatments for Fathers With ADHD and Their At-Risk Children (Fathers Too) |
| NCT00733356 VBHR results posted | VBHR | Ph 4 | completed | The Effects of Vyvanse(TM) on Brain Hemodynamics and Reading |
| NCT01863459 | LDX-COMORB-1 | Ph 4 | completed | Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity |
| NCT01000064 results posted | TBI 090563 | Ph 3 | terminated | Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits |
| NCT00573534 results posted | 5522 | Ph 4 | completed | Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse |
| NCT02555150 | 063-013 | Ph 3 | completed | A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD |
| NCT00801229 results posted | 2008P000971 | Ph 4 | completed | Effect of Vyvanse on Driving in Young 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.
VYVANSE FDA Label Details
Indications & Usage
FDA Label (PDF)VYVANSE is indicated for the treatment of Attention Deficit Hyperactivity Disorder; Binge Eating Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION VYVANSE has 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 VYVANSE, can result in overdose and death [see Overdosage (10) ] , and this risk ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment