Intuniv (guanfacine XR) / Shionogi, Takeda 
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 14 Diseases   9 Trials   9 Trials   207 News 


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  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Journal:  A Case of Prolonged Bradycardia and Hypotension After Ingestion of Incorrect Guanfacine Formulation. (Pubmed Central) -  Feb 14, 2025   
    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.
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New P2 trial:  Guanfacine for Alcohol Use Disorder (AUD) (clinicaltrials.gov) -  Oct 8, 2024   
    P2,  N=200, Not yet recruiting, 
  • ||||||||||  Chantix (varenicline) / Pfizer
    Trial completion date, Trial primary completion date:  Combining Varenicline and Guanfacine for Smoking Cessation (clinicaltrials.gov) -  Aug 11, 2024   
    P2,  N=140, Recruiting, 
    Recruiting --> Completed | N=33 --> 15 Trial completion date: Aug 2024 --> Jul 2026 | Trial primary completion date: Aug 2024 --> Jul 2026
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion, Enrollment change:  Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD) (clinicaltrials.gov) -  Jun 4, 2024   
    P1/2,  N=32, Completed, 
    Trial completion date: Aug 2024 --> Jul 2026 | Trial primary completion date: Aug 2024 --> Jul 2026 N=60 --> 32 | Unknown status --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed, Trial completion date, Trial primary completion date:  Noradrenergic Add-on Therapy With Guanfacine (clinicaltrials.gov) -  May 12, 2024   
    P3,  N=148, Active, not recruiting, 
    Trial primary completion date: Feb 2026 --> Feb 2025 Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Aug 2024 | Trial primary completion date: Dec 2022 --> Aug 2024
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date:  Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) -  Jan 4, 2024   
    P=N/A,  N=120, Active, not recruiting, 
    Supratherapeutic serum guanfacine concentrations may induce QT prolongation. Trial completion date: Dec 2023 --> Dec 2024
  • ||||||||||  NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) -  Oct 17, 2023   
    P=N/A,  N=632, Completed, 
    Trial completion date: Dec 2023 --> Dec 2024 Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed:  A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) -  Aug 14, 2023   
    P2,  N=90, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  Drug Use Study With Intuniv (clinicaltrials.gov) -  Aug 4, 2023   
    P=N/A,  N=5000, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New trial:  Drug Use Study With Intuniv (clinicaltrials.gov) -  May 23, 2023   
    P=N/A,  N=5000, Active, not recruiting, 
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date:  Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) -  Mar 14, 2023   
    P=N/A,  N=120, Active, not recruiting, 
    Trial completion date: Feb 2023 --> Jan 2024 | Trial primary completion date: Feb 2023 --> Jan 2024 Trial completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date:  Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) -  Mar 14, 2023   
    P4,  N=200, Active, not recruiting, 
    Trial completion date: Dec 2022 --> Dec 2023 Trial completion date: Dec 2022 --> Dec 2023
  • ||||||||||  NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial termination:  An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) -  Feb 2, 2023   
    P=N/A,  N=38, Terminated, 
    Trial completion date: Dec 2022 --> Dec 2023 Completed --> Terminated; Recruitment/enrollment ended early due to the COVID-19 pandemic
  • ||||||||||  lisdexamfetamine / Generic mfg.
    Enrollment closed, Trial completion date:  AGUALIS: Experimental fMRI Study of Guanfacine and Lisdexamfetamine in ADHD Adolescents (clinicaltrials.gov) -  Aug 17, 2022   
    P=N/A,  N=20, Active, not recruiting, 
    Completed --> Terminated; Recruitment/enrollment ended early due to the COVID-19 pandemic Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Mar 2025
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD) (clinicaltrials.gov) -  Aug 1, 2022   
    P4,  N=288, Recruiting, 
    The NorAD trial aims to determine whether guanfacine, a noradrenergic alpha-2 agonist, improves attention and cognition when used in addition to standard cholinergic treatment. Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: May 2025 --> Dec 2025
  • ||||||||||  Qelbree (viloxazine) / Supernus Pharma
    Review, Journal:  Nonstimulant Treatments for ADHD. (Pubmed Central) -  Jun 21, 2022   
    We present detailed information regarding the 4 FDA-approved nonstimulant medications-the norepinephrine reuptake inhibitors, atomoxetine and viloxazine extended release, and the α-2 adrenergic agonists, clonidine XR and guanfacine XR...Variability across and within drug classes in nature of response, approach to titration, and temporal characteristics of treatment allow a nuanced treatment approach for individuals with comorbid disorders and complicated clinical presentations. Availability of nonstimulant medications enhances our opportunity to offer personalized treatment of ADHD across the lifespan.
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment open:  A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) -  Jun 8, 2022   
    P2,  N=90, Recruiting, 
    Availability of nonstimulant medications enhances our opportunity to offer personalized treatment of ADHD across the lifespan. Not yet recruiting --> Recruiting
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance (clinicaltrials.gov) -  Apr 6, 2022   
    P4,  N=200, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Tenex (guanfacine immediate release tablet) / Dr. Reddy's, NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion date, Trial primary completion date:  Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH) (clinicaltrials.gov) -  Apr 6, 2022   
    P=N/A,  N=120, Active, not recruiting, 
    Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New P2 trial:  A Trial of Guanfacine-er for Cannabis Use Disorder (clinicaltrials.gov) -  Mar 9, 2022   
    P2,  N=90, Not yet recruiting, 
  • ||||||||||  NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment change:  Guanfacine Clinical Trial for Smoking Cessation (clinicaltrials.gov) -  Dec 29, 2021   
    P2,  N=121, Completed, 
    Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 N=250 --> 121
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Alpha-2 Agonists In Children And Adolescents With Ptsd: A Systematic Review () -  Dec 18, 2021 - Abstract #AACAP2021AACAP_934;    
    No double-blind placebo-controlled trial was found during the literature search.Conclusions Alpha-2 agonists (clonidine and guanfacine) have shown to be effective in treating symptoms associated with PTSD in children and adolescents. Future placebo-controlled trials are needed to assess the efficacy and safety of alpha-2 agonists.PPC, TRA, TREAT
  • ||||||||||  NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion, Enrollment change, Trial completion date:  An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) -  Dec 14, 2021   
    P=N/A,  N=38, Completed, 
    Future placebo-controlled trials are needed to assess the efficacy and safety of alpha-2 agonists.PPC, TRA, TREAT Active, not recruiting --> Completed | N=160 --> 38 | Trial completion date: Sep 2022 --> Nov 2021
  • ||||||||||  NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  ADAPT: ADHD Medication and Predictors of Treatment Outcome (clinicaltrials.gov) -  Oct 8, 2021   
    P=N/A,  N=632, Active, not recruiting, 
    The findings demonstrate the efficacy of GXR for treating ADHD in children and adolescents with comorbid ODD. Enrolling by invitation --> Active, not recruiting | N=2000 --> 632 | Trial completion date: Jan 2022 --> Jul 2022 | Trial primary completion date: Apr 2021 --> Jul 2021
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Trial completion:  Drug Use Study With Intuniv (clinicaltrials.gov) -  Oct 3, 2021   
    P=N/A,  N=100, Completed, 
    In Canadian routine clinical practice, most children and adolescents with ADHD treated with GXR experienced improvements in ADHD symptoms and in functionality both at school and at home. Active, not recruiting --> Completed
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    Journal:  Guanfacine's Mechanism of Action in Treating Prefrontal Cortical Disorders: Successful Translation Across Species. (Pubmed Central) -  Sep 29, 2021   
    In addition to therapeutic actions in PFC, stress-related disorders may also benefit from additional α2-AR actions, such as weakening plasticity in the amygdala, reducing NE release, and anti-inflammatory actions by deactivating microglia. Altogether, these NE α2-AR actions optimize top-down control by PFC networks, which may explain guanfacine's benefits in a variety of mental disorders.
  • ||||||||||  NN1213 / Novo Nordisk, Intuniv (guanfacine XR) / Shionogi, Takeda
    Enrollment closed:  An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (clinicaltrials.gov) -  Aug 24, 2021   
    P=N/A,  N=160, Active, not recruiting, 
    Altogether, these NE α2-AR actions optimize top-down control by PFC networks, which may explain guanfacine's benefits in a variety of mental disorders. Recruiting --> Active, not recruiting
  • ||||||||||  methylphenidate tablet / Generic mfg.
    Journal:  Not Really "The Same Thing". (Pubmed Central) -  May 1, 2021   
    Susie's parents contacted the pharmacy and were told that Susie's prescription was filled with "the same thing as before." The pharmacist explained that the tablets looked different because the manufacturer had changed in order to comply with the preferences of Susie's insurance provider. What would be your next steps in Susie's care?
  • ||||||||||  Intuniv (guanfacine XR) / Shionogi, Takeda
    New trial:  Drug Use Study With Intuniv (clinicaltrials.gov) -  Apr 28, 2021   
    P,  N=100, Active, not recruiting,