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guanfacine

Trade name: tenex

Small moleculeapproved

Approved

Oct 27, 1986

Guanfacine (marketed under the brand names Estulic, Tenex and the extended release Intuniv) is a sympatholytic drug, indicated for the management of hypertension. Tenex (guanfacine hydrochloride) is an orally active antihypertensive agent whose principal mechanism of action appears to be stimulation of central α2-adrenergic receptors. By stimulating these receptors, guanfacine reduces sympathetic nerve impulses from the vasomotor center to the heart and blood vessels. This results in a decrease in peripheral vascular resistance and a reduction in heart rate. Guanfacine is also used in the treatment of attention deficit hyperactivity disorder. Intuniv is an extended-release version of guanfacine that is used to treat symptoms of ADHD. It can be used by itself or with stimulant medications also used to treat symptoms of ADHD. — NCATS

Clinical trial activity

74 trials · 55 clinical orgs · 24 marketing orgs

Phase 1
9
Phase 2
35
Phase 3
14
Phase 4
22

Earliest trial started Sep 1, 1994 (NCT00004376)

Timeline

1980s

  1. Oct 27, 1986

    Dr. Reddy's Laboratories — Earliest FDA Approval

  2. Oct 27, 1986

    Dr. Reddy's Laboratories — NDA Organization

  3. Oct 27, 1986

    Dr. Reddy's Laboratories — NDA Secondary Org

1990s

  1. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  2. Oct 17, 1995

    Watson Pharmaceuticals — Marketing Organization

  3. Jan 27, 1997

    Mylan — Marketing Organization

  4. Jan 27, 1997

    Aurobindo Pharma — Marketing Organization

  5. Feb 28, 1997

    Epic Pharma Llc — Marketing Organization

  6. Nov 25, 1998

    Amneal Pharmaceuticals — Marketing Organization

  7. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Shire — Earliest Phase 2 Sponsor(trial)

  2. Sep 2, 2009

    Shire — NDA Secondary Org

  3. Sep 2, 2009

    Takeda — Marketing Organization

  4. Sep 2, 2009

    Takeda — NDA Secondary Org

2010s

  1. Oct 5, 2012

    Actavis — Marketing Organization

  2. Jun 2, 2015

    Teva — Marketing Organization

  3. Jun 2, 2015

    TWi Biotechnology, Inc. — Marketing Organization

  4. Jun 3, 2015

    Sandoz — Marketing Organization

  5. Jun 3, 2015

    Novartis — Marketing Organization

  6. Oct 20, 2015

    Impax Laboratories — Marketing Organization

  7. Nov 16, 2017

    Sun Pharmaceuticals — Marketing Organization

  8. Jul 25, 2018

    Apotex — Marketing Organization

2020s

  1. Nov 25, 2020

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  2. Mar 3, 2021

    Unichem — Marketing Organization

  3. Apr 27, 2023

    Ajanta Pharma Ltd — Marketing Organization

  4. Aug 7, 2023

    Alembic — Marketing Organization

  5. Oct 5, 2023

    I3 Pharms — Marketing Organization

  6. Oct 17, 2023

    Rubicon Research — Marketing Organization

  7. Feb 23, 2024

    Exeltis — Marketing Organization

  8. Jun 12, 2024

    WANBANG BIOPHARMS — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 27, 1986

Chemistry & pharmacology

Loading structure…

SMILES

N=C(N)NC(=O)Cc1c(Cl)cccc1Cl
Mol. weight
246.1 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • akfen
  • bs-100-141
  • bs-100-141
  • estulic
  • estulic
  • estulic
  • guanfacina
  • guanfacina
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine
  • guanfacine hcl
  • guanfacine hcl
  • guanfacine hcl
  • guanfacine hydrochloride
  • guanfacine hydrochloride
  • guanfacine hydrochloride
  • guanfacine hydrochloride
  • guanfacine hydrochloride
  • guanfacine hydrochloride
  • guanfacine monohydrochloride
  • guanfacinum
  • guanfacinum
  • intuniv
  • intuniv
  • spd503
  • spd503
  • tenex
  • tenex
  • tenex
  • tenex

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07300956Phase 4Feb 28, 2026Harvard University, Patient-Centered Outcomes Research Institute, Stanford University, University of Cincinnati, University of Kansas, University of Pennsylvania
NCT06408246Phase 2Feb 1, 2026Stanford University
NCT06642181Phase 1Jan 2, 2025National Institute on Drug Abuse (NIDA), Rutgers University
NCT06629259Phase 2Dec 1, 2024Indiana University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT06042257Phase 2Dec 31, 2023Duke University, National Institutes of Health (NIH), The EMMES Corporation
NCT05957848Phase 2Jul 27, 2023ORYGEN Youth Health, University of Melbourne
NCT05273567Phase 2Jun 1, 2022Columbia University, National Institute on Drug Abuse (NIDA)
NCT04742673Phase 2May 4, 2021Harvard University, National Institute on Aging (NIA), Vanderbilt University
NCT05657860Phase 4Dec 17, 2020Maimonides Medical Center
NCT04578886Phase 3Nov 23, 2020University of Alabama, Birmingham
NCT04181736Phase 4Jan 15, 2020Stanford University
NCT04198116Phase 2Jan 1, 2020National Institute on Drug Abuse (NIDA), Yale University
NCT04066088Phase 4Dec 31, 2019New York University, Winthrop University
NCT04085172Phase 4Sep 27, 2019Shire
NCT03865940Phase 2Jul 31, 2019Vanderbilt University
NCT03980184Phase 2Jul 1, 2019Yale University
NCT03764098Phase 2Mar 1, 2019National Institute on Alcohol Abuse and Alcoholism (NIAAA), Yale University
NCT03258476Phase 4Jul 31, 2018Shire, University of Connecticut, Yale University
NCT03333668N/AMar 1, 2018Shire, University of London
NCT03116126Phase 3May 1, 2017University of London
Showing 20 of 74 trials
Page 1 / 4

Organizations

Research & Development (55)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit251552003
Yale UniversityAcademic/Hospital151251994
National Institute on Drug Abuse (NIDA)Government10042006
Harvard UniversityAcademic/Hospital7242006
Icahn School of Medicine at Mount SinaiAcademic/Hospital7441995
Columbia UniversityAcademic/Hospital5442011
Department of Veteran AffairsGovernment4131995
National Institute of Mental Health (NIMH)Government4121995
National Institutes of Health (NIH)Government4032010
Vanderbilt UniversityAcademic/Hospital4432001
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government3012014
Stanford UniversityAcademic/Hospital3222020
University of LondonAcademic/Hospital3332010
Emory UniversityAcademic/Hospital2012011
Gilead SciencesFor profit2212006
National Institute on Aging (NIA)Government2022009
New York UniversityAcademic/Hospital2112012
University of California, Los AngelesAcademic/Hospital2112007
University of CincinnatiAcademic/Hospital2112010
3C Family ServicesAcademic/Hospital1012010
55 organizations
Page 1 / 3

Marketing (30)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGOct 5, 2012
Ajanta Pharma LtdFor profitMKTGApr 27, 2023
AlembicFor profitMKTGAug 7, 2023
Amneal PharmaceuticalsFor profitMKTGNov 25, 1998
ApotexFor profitMKTGJul 25, 2018
ApotexFor profitSYNJul 25, 2018
Aurobindo PharmaFor profitMKTGJan 27, 1997
Dr. Reddy's LaboratoriesFor profitNDAOct 27, 1986
Dr. Reddy's LaboratoriesFor profitNDA2Oct 27, 1986
Epic Pharma LlcFor profitMKTGFeb 28, 1997
ExeltisFor profitMKTGFeb 23, 2024
I3 PharmsFor profitMKTGOct 5, 2023
Impax LaboratoriesFor profitMKTGOct 20, 2015
MylanFor profitMKTGJan 27, 1997
MylanFor profitSYNJun 2, 2015
NovartisFor profitMKTGJun 3, 2015
Rubicon ResearchFor profitMKTGOct 17, 2023
SandozFor profitMKTGJun 3, 2015
SandozFor profitSYNJun 3, 2015
ShireFor profitNDA2Sep 2, 2009
Sun PharmaceuticalsFor profitMKTGNov 16, 2017
Sun PharmaceuticalsFor profitSYNNov 16, 2017
TWi Biotechnology, Inc.For profitMKTGJun 2, 2015
TakedaFor profitMKTGSep 2, 2009
TakedaFor profitNDA2Sep 2, 2009
TevaFor profitMKTGJun 2, 2015
UnichemFor profitMKTGMar 3, 2021
WANBANG BIOPHARMSFor profitMKTGJun 12, 2024
Watson PharmaceuticalsFor profitMKTGOct 17, 1995
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGNov 25, 2020