NDAORALCAPSULE2 Generics Approved
Approved
Feb 2007
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYVANSE (lisdexamfetamine dimesylate) is an oral capsule CNS stimulant approved by the FDA in February 2007 for the treatment of ADHD in adults. It is a prodrug that is converted to dextroamphetamine in the body, exerting its therapeutic effect through sympathomimetic activity. The exact mechanism of action in ADHD remains incompletely understood, though amphetamines are known to enhance catecholamine neurotransmission. VYVANSE represents a foundational therapy in the stimulant-based ADHD treatment landscape.
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Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Started Sep 2025
105 enrolled
Obesity and OverweightBinge Eating Disorder
Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
Started Jun 2019
150 enrolled
Binge-eating Disorder
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Started Jan 2014
418 enrolled
Binge Eating Disorder
Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers
Started Jul 2013
30 enrolled
Healthy Volunteers
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Started Apr 2012
464 enrolled
Attention-deficit/Hyperactivity Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.