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Drug

Guanfacine

Approved · FDA
Emerging researchLate-stage development
Also known as Intuniv, Tenex, Guanfacina, GuanFACINE Hydrochloride+1 more

Intuniv, Tenex, Guanfacina, GuanFACINE Hydrochloride, Guanfacinum.

RxNorm40114ChEMBLCHEMBL862UNII30OMY4G3MK
1
Research papers
2
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Accelerating Cognition-guided Signatures to Enhance Translation in Depression Aim 3: Clinical Cognitive Trial

Clinical trial2026-03-05Results expected Q4 2028 · ClinicalTrials.gov

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

Clinical trial2026-02-19Results posted · ClinicalTrials.gov

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

Clinical trial2026-01-07Results expected Q1 2030 · ClinicalTrials.gov

The Effect of Guanfacine on Delirium in Critically Ill Patients

Clinical trial2025-04-15Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, 2-Way Crossover Trial to Assess the Efficacy of Guanfacine and Lidocaine Combination Versus Lidocaine Alone in Trigeminal Nerve Block for Pain Management in Painful Trigeminal Neuropathy Patients

Clinical trial2025-03-30Results posted · ClinicalTrials.gov

Precision Mental Health: Evaluating Biotype-guided Interventions for Depression

Clinical trial2025-03-20Results posted · ClinicalTrials.gov

Label change: GUANFACINE (ANDA201408)

Regulatory2025-02-12FDA

Randomised Clinical Trial of Noradrenergic Add-on Therapy With Extended-Release Guanfacine in Alzheimer's Disease

Clinical trial2024-08-05Primary completion · ClinicalTrials.gov

Label change: GUANFACINE (ANDA201408)

Regulatory2019-07-30FDA

Label change: GUANFACINE (ANDA201408)

Regulatory2019-07-30FDA

Label change: GUANFACINE (ANDA201408)

Regulatory2019-07-30FDA

Randomised, double-blind, placebo-controlled crossover study of single-dose guanfacine in unilateral neglect following stroke.

Research2018-02-07Journal of neurology, neurosurgery, and psychiatry

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Guanfacine
Aliases & brands
IntunivTenexGuanfacinaGuanFACINE HydrochlorideGuanfacinum
RxNorm CUI
40114
ChEMBL ID
CHEMBL862
UNII
30OMY4G3MK
Regulatory jurisdictions
fda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-06-02
Latest approval
2015-06-02
Authorities
FDA
Total events
5
fdaU.S. Food and Drug Administration· 5 events
2025-02-12Label change
Label change: GUANFACINE (ANDA201408)
Evidence ↗
2019-07-30Label change
Label change: GUANFACINE (ANDA201408)
Evidence ↗
2019-07-30Label change
Label change: GUANFACINE (ANDA201408)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
34
registered trials across all phases
LATEST COMPLETION 2025
2
Active studies
2
Recruiting
20
Late-stage (III+)
25
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 34
Phase 14Phase 210Phase 35Phase 48Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Not yet recruitingPH IVChildren's Hospital Medical Center, Cincinnatin=3702030

Precision Mental Health: Evaluating Biotype-guided Interventions for Depression

CompletedPH IVStanford Universityn=282024

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

TerminatedPH IVMassachusetts General Hospitaln=1372023

A Placebo Controlled Double Blinded Crossover Study of the Antihypertensive Efficacy of Guanfacine vs Hydrochlorothiazide in Obstructive Sleep Apnea (OSA) Associated Hypertension

CompletedPH IVUniversity of California, San Diegon=412016

Reading ICARD: Interventions for Children With Attention and Reading Disorders

CompletedPH IVThe University of Texas Health Science Center, Houstonn=2222015

Recent completions

Trials that read out recently, adding to the completed evidence base.

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

CompletedPH IIVanderbilt University Medical Centern=462025

Precision Mental Health: Evaluating Biotype-guided Interventions for Depression

CompletedPH IVStanford Universityn=282024

A Randomized, Double-Blind, 2-Way Crossover Trial to Assess the Efficacy of Guanfacine and Lidocaine Combination Versus Lidocaine Alone in Trigeminal Nerve Block for Pain Management in Painful Trigeminal Neuropathy Patients

CompletedPH IIVanderbilt University Medical Centern=372024

The Effect of Guanfacine on Delirium in Critically Ill Patients

CompletedPH IIIUniversity of Alabama at Birminghamn=1002023

The Use of Guanfacine (GUA) (3mg/Day) to Reduce Drug Craving, Improve Cognitive Flexibility and Result in Associated Lower Drug Use in Women With Substance Use Disorder (SUD).

CompletedPH IIYale Universityn=742022

Modeling Stress-precipitated Smoking Behavior for Medication Development

CompletedPH IIYale Universityn=1002021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Randomised, double-blind, placebo-controlled crossover study of single-dose guanfacine in unilateral neglect following stroke.

Journal of neurology, neurosurgery, and psychiatry · 2018 · 14 cites
Journals, researchers & institutions
Top journals
  • Journal of neurology, neurosurgery, and psychiatry1
Leading researchers
  • Cohen DL1
  • Dalmaijer ES1
  • Gorgoraptis N1
  • Husain M1
  • Leff AP1
  • Li KMS1
  • Malhotra PA1
  • Parton AD1
Leading institutions
free-text, unnormalised
  • Brunel University1
  • Centre for Restorative Neuroscience1
  • Institute of Cognitive Neuroscience1
  • Institute of Neurology1
  • Northwick Park Hospital1
  • Nuffield Department of Clinical Neurosciences1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.