NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INTUNIV (guanfacine) is an extended-release oral tablet approved in 2009 as a selective alpha-2A adrenergic receptor agonist. It is indicated for attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. The drug works by enhancing prefrontal cortex function to improve executive function, attention, and impulse control.
$0.228MPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal Part D penetration, indicating a mature, small-scale commercial footprint requiring defensive strategy.
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 (11)
Guanfacine for Hyperactivity in Children With Down Syndrome (HYPEbeGONE_DS)
Started Dec 2024
3 enrolled
Hyperactivity in Children With Down SyndromeImpulsivity in Children With Down Syndrome
Drug Use Study With Intuniv® in Australia
Started Mar 2019
100 enrolled
Attention Deficit Hyperactivity Disorder (ADHD)
Drug Use Study With Intuniv® in European Countries
Started Nov 2018
5,000 enrolled
Attention Deficit Hyperactivity Disorder (ADHD)
Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe
Started Mar 2012
215 enrolled
Attention Deficit Hyperactivity Disorder (ADHD)
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Started Dec 2011
62 enrolled
Pervasive Development Disorders
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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.