NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
Drug data last refreshed 17h 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 for ADHD, functioning as an alpha-2A adrenergic receptor agonist that enhances prefrontal cortex noradrenergic signaling. It is used as monotherapy or adjunctive therapy to improve attention, impulse control, and hyperactivity in pediatric and adult patients with attention-deficit/hyperactivity disorder.
$0.228MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare spending signals a mature, consolidating portfolio requiring defensive commercial strategies and operational efficiency.
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 (12)
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)
Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents
Started Oct 2018
25 enrolled
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)
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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.