Intuniv

(Guanfacine)

ApprovedSmall molecule

Guanfacine is used to treat high blood pressure and to help improve attention and reduce impulsive behavior in children with ADHD (attention-deficit/hyperactivity disorder).[2] Intuniv is currently approved and in use across 28 indications[4].[1]

Intuniv is one of 431 small molecule programs targeting Nicotine Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

430

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Nicotine DependenceApproved

Trigeminal NeuralgiaApproved

Depressive DisorderApproved

Attention Deficit Hyperactivity DisorderCompleted

StrokeApproved

Tic DisorderCompleted

Prader-Willi SyndromeWithdrawn

Alzheimer DiseaseApproved

Borderline Personality DisorderActive, not recruiting

Executive FunctionCompleted

Nicotine DependenceApproved

Approved

Trigeminal NeuralgiaApproved

Approved

Depressive DisorderApproved

Approved

Attention Deficit Hyperactivity DisorderApproved

Completed

StrokeApproved

Approved

Tic DisorderApproved

Completed

Prader-Willi SyndromeApproved

Withdrawn

Alzheimer DiseaseApproved

Approved

Borderline Personality DisorderPreclinical

Active, not recruiting

Executive FunctionApproved

Completed

Showing 10 of 28 indications

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Intuniv

PPromius Pharma, LLC

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Niclocide

Bayer

Preclinical

1 4

Alfenta

Jazz Pharmaceuticals

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Aurlumyn

BBTG International Inc.

Preclinical

1 8

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 9

Norpramin

VValidus Pharmaceuticals

Preclinical

1 10

Lotemax

PPharmos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 1Not yet recruiting

Postural Orthostatic Tachycardia Syndrome (POTS)

NCT07757555

Q1 2029

Phase 2Recruiting

Depression

NCT06408246

Q3 2029

Phase 2Recruiting

Alcohol Use Disorder (AUD)

NCT06629259

Q3 2030

ApprovedRecruiting

Attention Deficit Hyperactivity Disorder

NCT07300956

Clinical

Trials by Indication[1]

Attention Deficit Hyperactivity Disorder6 trials

Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00429273·212 enrolled

Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

Terminated·—·Phase 4·NCT01156051·29 enrolled

Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT01069523·42 enrolled

Show 3 more trials

Language-based Learning Skills and Attention Deficit Hyperactivity Disorder (ADHD): Impact of Treatment With Sustained-release Guanfacine

Completed·NNeurology Group of Bergen County, P.A.·Phase 4·NCT01146002·30 enrolled

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004376·35 enrolled

Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response

Recruiting·CChildren's Hospital Medical Center, Cincinnati·Approved·NCT07300956·370 enrolled

Guanfacine6 trials

Does Guanfacine Attenuate Stress-Induced Drinking?

Completed·YYale University·Phase 2·NCT02164422·70 enrolled

Noradrenergic Add-on Therapy With Guanfacine

Active, not recruiting·IImperial College London·Phase 3·NCT03116126·148 enrolled

CRT-Guanfacine for SPD

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT02524899·45 enrolled

Show 3 more trials

Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse

Completed·YYale University·Phase 1·NCT00585754·75 enrolled

PK/PD Comparison of Guanfacine ER and IR

Completed·YYale University·Phase 2·NCT01904526·5 enrolled

Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance

Completed·IImperial College London·Phase 2·NCT00955253·13 enrolled

Hypertension4 trials

DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

Terminated· Gilead logo

Gilead·Phase 3·NCT00389675·661 enrolled

DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension

Completed· Gilead logo

Gilead·Phase 3·NCT00389779·849 enrolled

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Show 1 more trial

Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic

Completed·UUniversity of California, San Diego·Phase 4·NCT02699125·41 enrolled

Pervasive Developmental Disorder2 trials

Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

Completed·NNational Institute of Mental Health (NIMH)·N/A·NCT00025779·60 enrolled

Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

Completed·YYale University·Phase 4·NCT01238575·62 enrolled

Memory2 trials

The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects

Completed·YYale University·N/A·NCT01600885·16 enrolled

Inuniv and Working Memory

Completed·LLori A. Schweickert, MD·Phase 4·NCT01177306·18 enrolled

27 more indications

Depression2 trials

ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression

Recruiting·SStanford University·Phase 2·NCT06408246·162 enrolled

The BIomarker Guided (BIG) Study for Depression

Completed·SStanford University·Phase 4·NCT04181736·28 enrolled

Medication2 trials

Stress and Medication Effects on Cocaine Cue Reactivity

Completed·MMedical University of South Carolina·Phase 2·NCT00613015·109 enrolled

A Study of Label Compliance for Attention Deficit/Hyperactivity Disorder (ADHD) Medications in Japan

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04113551·17,418 enrolled

Chronic pain2 trials

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance

Terminated·MMassachusetts General Hospital·Approved·NCT01681264·137 enrolled

Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)

Terminated·MMassachusetts General Hospital·Preclinical·NCT02192398·8 enrolled

Children1 trial

Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin

Unknown status·TTechnische Universität Dresden··NCT04016207·40 enrolled

Post-Traumatic Stress Disorder, PTSD1 trial

Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD)

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00018603

Smoking Behavior1 trial

Modeling Stress-precipitated Smoking Behavior for Medication Development

Completed·YYale University·Phase 2·NCT00773357·100 enrolled

Cannabis Dependence1 trial

Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence

Completed·NNew York State Psychiatric Institute·Phase 1·NCT01467999·22 enrolled

Treatment1 trial

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

Terminated·NNew York State Psychiatric Institute·N/A·NCT02259517·38 enrolled

Smoking Cessation1 trial

Guanfacine Clinical Trial for Smoking Cessation

Completed·YYale University·Phase 2·NCT02051309·121 enrolled

Sinus Surgery1 trial

Guanfacine for PONV and Pain After Sinus Surgery

Completed·VVanderbilt University Medical Center·N/A·NCT02882854·84 enrolled

Intravenous1 trial

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

Completed·VVanderbilt University Medical Center·Phase 2·NCT04742673·46 enrolled

Schizotypal Personality Disorder1 trial

Pharmacology of Cognition in Schizotypal Personality Disorder

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT00353379·29 enrolled

Cognitive Dysfunction1 trial

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Completed·YYale University·N/A·NCT00935493·154 enrolled

Cannabis Use1 trial

Guanfacine Extended-release for Adolescents With Cannabis Use

Recruiting·OOrygen·Phase 2·NCT05957848·100 enrolled

Alcohol Use Disorder (AUD)1 trial

Guanfacine for Alcohol Use Disorder (AUD)

Recruiting·IIndiana University·Phase 2·NCT06629259·200 enrolled

Tic Disorder1 trial

Guanfacine in Children With Tic Disorders

Completed·YYale University·Phase 4·NCT01547000·34 enrolled

Mindfulness1 trial

Guanfacine Extended Release and Mindfulness Skills Therapy

Withdrawn·UUConn Health·Phase 4·NCT03258476

Prader-Willi syndrome1 trial

Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injuries Behavior Associated With Prader-Willi Syndrome

Withdrawn·NNYU Langone Health·Phase 4·NCT04066088

Executive Function1 trial

Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD

Completed·JJPM van Stralen Medicine Professional·Phase 4·NCT01985581·50 enrolled

Self-injurious behavior1 trial

Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome

Completed·MMaimonides Medical Center·Phase 4·NCT05657860·15 enrolled

Completed·UUniversity of Alabama at Birmingham·Phase 3·NCT04578886·100 enrolled

Neuropathy1 trial

Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy

Completed·VVanderbilt University Medical Center·Phase 2·NCT03865940·37 enrolled

Substance Use1 trial

Guanfacine to Improve Substance Use Outcomes in Women

Completed·YYale University·Phase 2·NCT03980184·74 enrolled

Postural Orthostatic Tachycardia Syndrome (POTS)1 trial

Efficacy and Mechanisms of Guanfacine and Cromolyn Sodium in Adults With Postural Orthostatic Tachycardia Syndrome (POTS): A Randomized, Double-Blind, Placebo-Controlled Crossover Clinical Trial. Acronym is DBPOTS (Double Blind POTS)

Not yet recruiting·JJohns Hopkins University·Phase 1·NCT07757555·25 enrolled

ADHD1 trial

Experimental fMRI Study on the Comparison of the Brain Function Effects of a Single Dose of Guanfacine and Lisdexamfetamine Relative to Placebo in Children and Adolescents With ADHD.

Completed·KKing's College London·Preclinical·NCT03333668·25 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 27, 1986

TENEX

NDA NDA019032

Sep 2, 2009

INTUNIV

NDA NDA022037

Sep 2, 2009

INTUNIV

NDA NDA022037

Feb 25, 2011

INTUNIV

NDA NDA022037

Jun 8, 2011

INTUNIV

NDA NDA022037

Feb 20, 2013

INTUNIV

NDA NDA022037

Aug 23, 2013

INTUNIV

NDA NDA022037

Nov 19, 2014

INTUNIV

NDA NDA022037

Mar 18, 2015

INTUNIV

NDA NDA022037

Jul 7, 2016

INTUNIV

NDA NDA022037

Nov 27, 2017

INTUNIV

NDA NDA022037

Mar 7, 2018

INTUNIV

NDA NDA022037

Apr 30, 2019

INTUNIV

NDA NDA022037

Dec 27, 2019

INTUNIV

NDA NDA022037

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Guanfacine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Intuniv drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Guanfacine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Guanfacine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022037). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Promius Pharma, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPromius Pharma, LLC

Intuniv

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q1 2029

Q3 2029

Q3 2030

Trials by Indication[1]

Attention Deficit Hyperactivity Disorder6 trials

Guanfacine6 trials

Hypertension4 trials

Pervasive Developmental Disorder2 trials

Memory2 trials

Depression2 trials

Medication2 trials

Chronic pain2 trials

Children1 trial

Post-Traumatic Stress Disorder, PTSD1 trial

Smoking Behavior1 trial

Cannabis Dependence1 trial

Treatment1 trial

Smoking Cessation1 trial

Sinus Surgery1 trial

Intravenous1 trial

Schizotypal Personality Disorder1 trial

Cognitive Dysfunction1 trial

Cannabis Use1 trial

Alcohol Use Disorder (AUD)1 trial

Tic Disorder1 trial

Mindfulness1 trial

Prader-Willi syndrome1 trial

Executive Function1 trial

Self-injurious behavior1 trial

Borderline personality disorder1 trial

Attention1 trial

Delirium1 trial

Neuropathy1 trial

Substance Use1 trial

Postural Orthostatic Tachycardia Syndrome (POTS)1 trial

ADHD1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News