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

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

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)

Noradrenergic Add-on Therapy With Guanfacine (clinicaltrials.gov) - P3 | N=148 | Active, not recruiting | Sponsor: Imperial College London | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Aug 2024 | Trial primary completion date: Dec 2022 ➔ Aug 2024

Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P4 | N=288 | Recruiting | Sponsor: Shire | Trial completion date: Dec 2025 ➔ Jun 2027 | Trial primary completion date: Dec 2025 ➔ Jun 2027

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

QT-Interval Prolongation Associated with Supratherapeutic Guanfacine Concentration: A Case Report. (PubMed, J Med Toxicol) - "Supratherapeutic serum guanfacine concentrations may induce QT prolongation."

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

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) - P=N/A | N=120 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Pain

ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) - P=N/A | N=632 | Completed | Sponsor: Karolinska Institutet | Active, not recruiting ➔ Completed

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

Drug Utilization Patterns of Guanfacine Hydrochloride Indicated for Attention Deficit Hyperactivity Disorder in European Countries (ISPOR-EU 2023) - "Findings indicate that, in most countries, guanfacine hydrochloride is prescribed mainly within the label."

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

Sex differences in the acute effects of guanfacine on dACC glutamate concentrations in individuals with an alcohol use disorder (ECNP 2023) - "The current preliminary analyses do not provide evidence that guanfacine administration acutely decreases dACC glutamate concentrations in individuals with an AUD, or that this effect is stronger in women compared to men. On the contrary, exploratory analyses suggest that guanfacine (compared to a placebo) decreases dACC glutamate concentrations in men only, while it increases dACC glutamate concentrations in women. Importantly, the current analyses are done on preliminary data of a project which aims to include 30 cisgender men and 30 cisgender women."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders

GRACE: Guanfacine Extended-release for Adolescents With Cannabis Use (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Orygen | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: New York State Psychiatric Institute | Recruiting ➔ Active, not recruiting

Enrollment closed • Substance Abuse