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 29 indications[4].[1]

Intuniv is one of 443 small molecule programs targeting Attention Deficit Hyperactivity Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

442

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Attention Deficit Hyperactivity DisorderTerminated

Borderline Personality DisorderActive, not recruiting

Alcohol DependenceApproved

Alzheimer DiseaseApproved

Trigeminal NeuralgiaApproved

Post-Traumatic Stress DisorderApproved

Depressive DisorderApproved

Alcohol DrinkingApproved

Chronic PainTerminated

Alcohol AbuseApproved

Attention Deficit Hyperactivity DisorderApproved

Terminated

Borderline Personality DisorderPreclinical

Active, not recruiting

Alcohol DependenceApproved

Approved

Alzheimer DiseaseApproved

Approved

Trigeminal NeuralgiaApproved

Approved

Post-Traumatic Stress DisorderApproved

Approved

Depressive DisorderApproved

Approved

Alcohol DrinkingApproved

Approved

Chronic PainApproved

Terminated

Alcohol AbuseApproved

Approved

Showing 10 of 29 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Intuniv

PPromius Pharma, LLC

Approved

1 2

Biltricide

Bayer

Preclinical

4 3

Emtriva

Gilead

Preclinical

1 4

Lamprene

Novartis

Preclinical

1 5

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 6

Theo-Dur

Pfizer

Preclinical

1 7

Minipress

Pfizer

Preclinical

1 8

Niclocide

Bayer

Preclinical

1 9

Foscavir

CClinigen, Inc.

Preclinical

6 10

Aurlumyn

BBTG International Inc.

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]

Guanfacine6 trials

Noradrenergic Add-on Therapy With Guanfacine

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

Show 3 more trials

Does Guanfacine Attenuate Stress-Induced Drinking?

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

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

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

CRT-Guanfacine for SPD

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

Attention Deficit Hyperactivity Disorder6 trials

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

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

Show 3 more trials

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

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

Hypertension4 trials

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 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 OSA Associated Hypertension With Alpha 2 Agonist or Diuretic

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

Show 1 more trial

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

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

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

Medication2 trials

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

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04113551·17,418 enrolled

Stress and Medication Effects on Cocaine Cue Reactivity

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

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

Intravenous1 trial

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

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

Sinus Surgery1 trial

Guanfacine for PONV and Pain After Sinus Surgery

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

Borderline personality disorder1 trial

Guanfacine to Treat Borderline Personality Disorder

Unknown status·IIcahn School of Medicine at Mount Sinai·N/A·NCT00358969

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

Children1 trial

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

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

Substance Use1 trial

Guanfacine to Improve Substance Use Outcomes in Women

Completed·YYale University·Phase 2·NCT03980184·74 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

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

Attention1 trial

Interventions for Children With Attention and Reading Disorders

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT01133847·222 enrolled

Delirium1 trial

The Effect of Guanfacine on Delirium in Critically Ill Patients

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

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

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

Regulatory

FDA Approval Timeline[5]

Oct 27, 1986

TENEX

NDA NDA019032

Sep 2, 2009

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]

Guanfacine6 trials

Attention Deficit Hyperactivity Disorder6 trials

Hypertension4 trials

Depression2 trials

Memory2 trials

Medication2 trials

Pervasive Developmental Disorder2 trials

Chronic pain2 trials

Intravenous1 trial

Sinus Surgery1 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

Treatment1 trial

Smoking Cessation1 trial

Children1 trial

Substance Use1 trial

Post-Traumatic Stress Disorder, PTSD1 trial

Smoking Behavior1 trial

Cannabis Dependence1 trial

Schizotypal Personality Disorder1 trial

Cognitive Dysfunction1 trial

Attention1 trial

Delirium1 trial

Neuropathy1 trial

ADHD1 trial

Postural Orthostatic Tachycardia Syndrome (POTS)1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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