Intuniv (guanfacine XR) / Shionogi, Takeda - LARVOL DELTA

Differential effects of a single dose of Lisdexamfetamine and Guanfacine on cognitive function in children with ADHD. (PubMed, Front Psychiatry) - P=N/A | "Findings suggest that guanfacine, unlike lisdexamfetamine, may not improve attention in children and adolescents with ADHD. https://clinicaltrials.gov/study/NCT03333668?term=NCT03333668&rank=1#study-plan, identifier NCT03333668."

Journal • ADHD (Impulsive Aggression) • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • CNS Disorders • Cognitive Disorders • Psychiatry

Reverse Takotsubo Cardiomyopathy Caused by Repeated Guanfacine Overdose. (PubMed, JACC Case Rep) - "An overdose of guanfacine, a medication used for treating attention-deficit hyperactivity disorder, can result in reverse takotsubo cardiomyopathy in a blood concentration-dependent manner. The cardiopulmonary time course of an extended-release guanfacine overdose spans approximately 2 weeks, with early critical respiratory failure, reverse takotsubo cardiomyopathy, and late QT prolongation."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiomyopathy • Cardiovascular • CNS Disorders • Psychiatry • Respiratory Diseases

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - P=N/A | N=120 | Terminated | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Terminated; End of NIH funding

Trial termination • Pain

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) - P4 | N=200 | Terminated | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Terminated; End of NIH funding

Trial termination • Pain

Guanfacine use in diagnostic diversity and symptom complexity (ECNP 2025) - "Extended-release guanfacine significantly reduced ADHD symptoms and improved daily functioning, with most children tolerating treatment well. Somnolence and headache occurred in 10–15% of cases but were generally mild and transient; no meaningful cardiac effects emerged. While longer-term data beyond 12 months remain scarce, these findings support guanfacine's role in enhancing executive control via alpha-2 adrenergic modulation."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Cognitive Disorders • Mental Retardation • Mood Disorders • Psychiatry

Combined guanfacine and methylphenidate treatment in a child with autism spectrum disorder and attention-deficit/hyperactivity disorder: A case report (ECNP 2025) - "Extended-release guanfacine may be considered as a treatment option with methylphenidate or without methylphenidate, particularly in cases of ASD with comorbid ADHD who shows a lack of adequate responds to psychostimulants or who present with accompanying symptoms such as irritability. Better symptom control without adverse effects was achieved by gradual titration and careful observation. Combination treatment may be a valuable approach in managing complex cases with overlapping neurodevelopmental symptoms."

Case report • Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Guanfacine for Alcohol Use Disorder (AUD) (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Indiana University | Not yet recruiting ➔ Recruiting

Enrollment open • Addiction (Opioid and Alcohol)

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P4 | N=396 | Completed | Sponsor: Shire | Active, not recruiting ➔ Completed

Trial completion • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P4 | N=397 | Active, not recruiting | Sponsor: Shire | N=288 ➔ 397 | Trial completion date: Jun 2027 ➔ Aug 2025 | Trial primary completion date: Jun 2027 ➔ Aug 2025

Enrollment change • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Combining Varenicline and Guanfacine for Smoking Cessation (clinicaltrials.gov) - P2 | N=165 | Completed | Sponsor: Yale University | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ Apr 2025 | Trial primary completion date: Jul 2026 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date • Tobacco Cessation

Guanfacine for Alcohol Use Disorder (AUD) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Indiana University | Initiation date: Mar 2025 ➔ Aug 2025

Trial initiation date • Addiction (Opioid and Alcohol)

A Randomized Double-Blind Placebo-Controlled Trial of Guanfacine Extended Release for Aggression and Self-Injurious Behavior Associated With Prader-Willi Syndrome. (PubMed, Am J Med Genet B Neuropsychiatr Genet) - "The GXR group demonstrated significant overall clinical improvement, as measured by the CGI-Improvement (CGI-I) scale (p < 0.01). Findings of this pragmatic trial strongly support the use of GXR for the treatment of aggression, skin picking, and hyperactivity in children, adolescents, and adults with PWS."

Journal • Anesthesia • Fatigue • Genetic Disorders • Prader–Willi syndrome • Psychiatry

Cardiological Findings in Children and Adolescents Before and After Guanfacine Treatment for Attention Deficit and Hyperactivity Disorder. (PubMed, Children (Basel)) - " Guanfacine demonstrated minor, statistically significant effects on the selected cardiac parameters without clinically meaningful changes to or adverse impacts on the novel ECG markers investigated. As extended-release guanfacine has only been available in Türkiye for the management of ADHD for approximately two years, studies evaluating its clinical efficacy and side effects are critical for clinicians working in this field."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiovascular • CNS Disorders • Hypotension • Psychiatry

A Case of Prolonged Bradycardia and Hypotension After Ingestion of Incorrect Guanfacine Formulation. (PubMed, Cureus) - "This case was unique as it demonstrates a profound alteration in hemodynamics after a seemingly small medication error, which is not often reported for this medication. This case report also demonstrates the importance of recognizing specific medication formulations and highlights the need for careful medication prescribing and dispensing."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Cardiovascular • CNS Disorders • Critical care • Hypertension • Hypotension • Pediatrics • Psychiatry

Nonstimulant Medications for Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. (PubMed, Pediatr Ann) - "The recommended nonstimulant ADHD medications include alpha agonists (eg, guanfacine extended-release [ER], clonidine ER) and norepinephrine reuptake inhibitors (eg, atomoxetine, viloxazine)...[Pediatr Ann. 2025;54(1):e27-e33.]."

Journal • Review • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mental Retardation • Pediatrics • Psychiatry

Guanfacine for Alcohol Use Disorder (AUD) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Indiana University | Initiation date: Dec 2024 ➔ Mar 2025

Trial initiation date • Addiction (Opioid and Alcohol)

A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) - P2 | N=22 | Completed | Sponsor: New York State Psychiatric Institute | Active, not recruiting ➔ Completed | N=90 ➔ 22 | Trial completion date: Mar 2025 ➔ Jul 2024 | Trial primary completion date: Mar 2025 ➔ Jul 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Substance Abuse

Evaluating and Treating Inattention and Hyperactivity/Impulsivity in the Context of ASD (AACAP 2024) - "When an ADHD diagnosis is made, randomized controlled trials support the use of methylphenidate, guanfacine extended-release (ER), and atomoxetine, with different patterns of response and adverse events for each medication. Appropriate assessment is critical to evaluate whether inattention and hyperactivity reflect an ADHD diagnosis in children with an existing diagnosis of ASD. When ADHD co-occurs with ASD, successful treatment can improve behavior, promote learning, and may also benefit social engagement.ASD"

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Insomnia • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder

Guanfacine for Alcohol Use Disorder (AUD) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Indiana University

New P2 trial • Addiction (Opioid and Alcohol)

PWS-GXR: Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome (clinicaltrials.gov) - P4 | N=15 | Completed | Sponsor: Maimonides Medical Center | Recruiting ➔ Completed | N=33 ➔ 15

Enrollment change • Trial completion • Developmental Disorders • Genetic Disorders • Mental Retardation • Obesity • Prader–Willi syndrome

Combining Varenicline and Guanfacine for Smoking Cessation (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Yale University | Trial completion date: Aug 2024 ➔ Jul 2026 | Trial primary completion date: Aug 2024 ➔ Jul 2026

Trial completion date • Trial primary completion date • Tobacco Cessation

Successful treatment with guanfacine in a long-COVID case manifesting marked cognitive impairment. (PubMed, Neuropsychopharmacol Rep) - "GXR may be helpful in improving subjective/objective cognitive functioning and frontotemporal brain activity in long-COVID patients manifesting apparent cognitive impairment."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Infectious Disease • Novel Coronavirus Disease

Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD) (clinicaltrials.gov) - P1/2 | N=32 | Completed | Sponsor: Stony Brook University | N=60 ➔ 32 | Unknown status ➔ Completed

Enrollment change • Trial completion • Addiction (Opioid and Alcohol)

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Yale University | Trial primary completion date: Feb 2026 ➔ Feb 2025

Trial primary completion date • Addiction (Opioid and Alcohol)

Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Yale University | Trial primary completion date: Feb 2025 ➔ Feb 2026

Trial primary completion date • Addiction (Opioid and Alcohol)