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clonidine

Trade name: catapres

Small moleculeapproved

Approved

Sep 3, 1974

Clonidine is a centrally acting α2 adrenergic agonist and imidazoline receptor agonist used to treat high blood pressure, attention deficit hyperactivity disorder, anxiety disorders, tic disorders, withdrawal (from either alcohol, opioids, or smoking), migraine, menopausal flushing, diarrhea, and certain pain conditions. Clonidine treats high blood pressure by stimulating α2 receptors in the brain, which decreases peripheral vascular resistance, lowering blood pressure. It has specificity towards the presynaptic α2 receptors in the vasomotor center in the brainstem. This binding decreases presynaptic calcium levels, thus inhibiting the release of norepinephrine (NE). It has also been proposed that the antihypertensive effect of clonidine is due to agonism on the I1 receptor (imidazoline receptor), which mediates the sympatho-inhibitory actions of imidazolines to lower blood pressure. Clonidines mechanism of action in the treatment of ADHD is to increase noradrenergic tone in the prefrontal cortex (PFC) directly by binding to postsynaptic α2A adrenergic receptors and indirectly by increasing norepinephrine input from the locus coeruleus. Clonidine indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents. The US Food and Drug Administration (FDA) has approved clonidine for the treatment of attention deficit hyperactivity disorder (ADHD), under the trade name of Kapvay alone or with stimulants in 2010, for pediatric patients aged 6–17 years. — NCATS

Clinical trial activity

242 trials · 217 clinical orgs · 44 marketing orgs

Phase 1
34
Phase 2
92
Phase 3
48
Phase 4
75

Earliest trial started Sep 1, 1994 (NCT00000279)

Timeline

1970s

  1. Sep 3, 1974

    Boehringer Ingelheim — Earliest FDA Approval

  2. Sep 3, 1974

    Boehringer Ingelheim — NDA Secondary Org

  3. Sep 3, 1974

    Boehringer Ingelheim — NDA Organization

1980s

  1. Oct 10, 1984

    Lavipharm Labs — Marketing Organization

  2. Oct 10, 1984

    Lavipharm Labs — NDA Secondary Org

  3. Jul 1, 1986

    Watson Pharmaceuticals — Marketing Organization

  4. Dec 16, 1986

    Actavis — Marketing Organization

  5. Feb 9, 1987

    Mylan — Marketing Organization

  6. Jun 9, 1987

    Rising Pharmaceuticals — Marketing Organization

  7. Sep 4, 1987

    Frontida BioPharm — Marketing Organization

  8. Sep 4, 1987

    URL LABS — Marketing Organization

  9. Dec 16, 1987

    Par Pharmaceuticals — Marketing Organization

  10. Apr 5, 1988

    Chartwell Pharmaceuticals — Marketing Organization

  11. Aug 31, 1988

    Aurobindo Pharma — Marketing Organization

1990s

  1. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

  3. Oct 2, 1996

    Mylan — NDA Secondary Org

  4. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Mar 9, 2007

    Prinston Inc — Marketing Organization

  2. Aug 18, 2009

    Aveva Drug Delivery Systems — Marketing Organization

  3. Aug 26, 2009

    Unichem — Marketing Organization

  4. Aug 27, 2009

    Impax Laboratories — Marketing Organization

  5. Sep 29, 2009

    Advanz Pharma — NDA Secondary Org

  6. Oct 8, 2009

    Sankyo — Marketing Organization

  7. Oct 8, 2009

    Lutipold — Marketing Organization

  8. Oct 8, 2009

    Daiichi Sankyo — Marketing Organization

  9. Dec 3, 2009

    Tris Pharma, Inc. — NDA Secondary Org

  10. Dec 3, 2009

    University of Pennsylvania — Marketing Organization

  11. Dec 3, 2009

    University of Pennsylvania — NDA Secondary Org

2010s

  1. Aug 20, 2010

    Mayne Pharma — Marketing Organization

  2. Aug 20, 2010

    Dr. Reddy's Laboratories — Marketing Organization

  3. Jan 26, 2011

    Hikma — Marketing Organization

  4. Jul 8, 2011

    Fresenius — Marketing Organization

  5. Dec 6, 2011

    Alembic — Marketing Organization

  6. Jun 13, 2013

    Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization

  7. Sep 30, 2013

    Anchen Pharmaceuticals, Inc — Marketing Organization

  8. Oct 29, 2013

    X Gen Pharmaceuticals — Marketing Organization

  9. Feb 20, 2014

    Zydus Discovery DMCC — Marketing Organization

  10. Jul 3, 2014

    Sun Pharmaceuticals — Marketing Organization

  11. May 15, 2015

    Allergan PLC (2015) — Marketing Organization

  12. Oct 23, 2017

    Lupin — Marketing Organization

  13. Nov 20, 2017

    Ajanta Pharma Ltd — Marketing Organization

  14. Nov 20, 2017

    Amneal Pharmaceuticals — Marketing Organization

  15. Nov 20, 2017

    LP Pharmaceuticals — Marketing Organization

  16. Jan 29, 2018

    Jubilant Innovation Ltd. — Marketing Organization

  17. Oct 12, 2018

    Upsher-Smith Laboratories — Marketing Organization

  18. Mar 5, 2019

    Novast Labs — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewSep 3, 1974

Chemistry & pharmacology

Loading structure…

SMILES

Clc1cccc(Cl)c1NC1=NCCN1
Mol. weight
230.1 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

  • 2-[(2,6-dichlorophenyl)imino]imidazoline
  • 2-[(2,6-dichlorophenyl)imino]imidazoline
  • 2,6-dichloro-n-2-imidazolidinylidenebenzenamine
  • 2,6-dichloro-n-2-imidazolidinylidenebenzenamine
  • apo-clonidine
  • apo-clonidine
  • catapres
  • catapres
  • catapres
  • catapresan
  • catapresan
  • catapres p.l.
  • catapres tts 1
  • catapres tts 1
  • catapres-tts-1
  • catapres-tts-1
  • catapres tts 2
  • catapres tts 2
  • catapres-tts-2
  • catapres-tts-2
  • catapres tts 3
  • catapres tts 3
  • catapres-tts-3
  • catapres-tts-3
  • chlofazoline
  • chlofazoline
  • chlonixin
  • clonidin
  • clonidin
  • clonidina
  • clonidina
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine
  • clonidine - chlorthalidone - drug combination
  • clonidine, chlorthalidone drug combination
  • clonidine hcl
  • clonidine hcl
  • clonidine hcl
  • clonidine hydrochloride
  • clonidine hydrochloride
  • clonidine hydrochloride
  • clonidine hydrochloride
  • clonidinum
  • clonidinum
  • clonixic acid
  • clonixin
  • clonixin
  • clonixin
  • clonixin
  • clonixin
  • clonixin
  • clonixin
  • clonixin
  • clonixine
  • clonixin lysinate
  • clorpres
  • clorpres
  • combipres
  • combipres
  • combipres
  • combipresan
  • combipresan 75
  • dichloranilino imidazolin
  • dichloranilino imidazolin
  • dixarit
  • dixarit
  • duraclon
  • duraclon
  • jenloga
  • jenloga
  • kapvay
  • kapvay
  • st-155
  • st-155
  • st-155bs
  • st-155bs
  • st-155-bs
  • st-155-bs

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07256938Phase 4Dec 31, 2025Assiut University
NCT07313371Phase 4Dec 31, 2025University of Sao Paulo
NCT07097493Phase 4Dec 1, 2025Atrium Medical Center, Wake Forest University
NCT07092566Phase 3Nov 14, 2025University of North Carolina at Chapel Hill, Wake Forest University
NCT07131657Phase 2Sep 30, 2025PHARMAFINA
NCT07044609Phase 4Jul 31, 2025Las Vegas Medical Research, Tris Pharma, Inc.
NCT06447194Phase 1/Phase 2 (Phase 2)Apr 1, 2025University of Maryland
NCT07062497Phase 2/Phase 3 (Phase 3)Jan 7, 2025Federal University of Rio de Janeiro
NCT06507410N/AJul 20, 2024Tanta University
NCT06488768N/AJun 17, 2024Hospitalsenhed Midt
NCT06230081N/AFeb 1, 2024Region Skane
NCT07235020Phase 2Jan 23, 2024Novartis
NCT06180941N/ADec 31, 2023Assiut University
NCT05750628Phase 2Dec 26, 2023Novartis
NCT06137924Phase 3Dec 2, 2023Universidad Simón Bolívar
NCT05943613Phase 1Dec 1, 2023Assiut University
NCT05790044N/AOct 1, 2023Assiut University
NCT06287151N/AAug 9, 2023Ohio State University
NCT05614648Phase 3Apr 30, 2023Sollis Therapeutics, Inc.
NCT05848531Phase 4Apr 25, 2023Free University of Brussels
Showing 20 of 242 trials
Page 1 / 13

Organizations

Research & Development (217)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Wake Forest UniversityAcademic/Hospital9952004
National Institute on Drug Abuse (NIDA)Government8331994
Johns Hopkins UniversityAcademic/Hospital7642002
University of Sao PauloAcademic/Hospital7742008
Assiut UniversityAcademic/Hospital5542017
Free University of BrusselsAcademic/Hospital5532015
University of IowaAcademic/Hospital5542006
Vanderbilt UniversityAcademic/Hospital5431996
Mayo ClinicAcademic/Hospital4332006
National Institute of Neurological Disorders and Stroke (NINDS)Government4021999
Osaka UniversityAcademic/Hospital4422005
University of CopenhagenAcademic/Hospital4442005
University of OsloAcademic/Hospital4132005
University of PittsburghAcademic/Hospital4232006
University of Texas at HoustonAcademic/Hospital4422011
BioDelivery Sciences InternationalFor profit3312014
Boehringer IngelheimFor profit3232000
Cornell UniversityAcademic/Hospital3322004
Department of Veteran AffairsGovernment3021994
Federal University of Minas GeraisAcademic/Hospital3312008
217 organizations
Page 1 / 11

Marketing (55)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGDec 16, 1986
ActavisFor profitSYNMay 6, 2014
Advanz PharmaFor profitNDA2Sep 29, 2009
Ajanta Pharma LtdFor profitMKTGNov 20, 2017
AlembicFor profitMKTGDec 6, 2011
Allergan PLC (2015)For profitMKTGMay 15, 2015
Am TherapFor profitMKTG—
Amneal PharmaceuticalsFor profitMKTGNov 20, 2017
Anchen Pharmaceuticals, IncFor profitMKTGSep 30, 2013
Aurobindo PharmaFor profitSYNAug 31, 1988
Aurobindo PharmaFor profitMKTGAug 31, 1988
Aveva Drug Delivery SystemsFor profitMKTGAug 18, 2009
Boehringer IngelheimFor profitNDA2Sep 3, 1974
Boehringer IngelheimFor profitNDASep 3, 1974
Chartwell PharmaceuticalsFor profitMKTGApr 5, 1988
Daiichi SankyoFor profitMKTGOct 8, 2009
Dr. Reddy's LaboratoriesFor profitMKTGAug 20, 2010
Duramed ResearchFor profitMKTG—
FreseniusFor profitMKTGJul 8, 2011
Frontida BioPharmFor profitMKTGSep 4, 1987
HikmaFor profitMKTGJan 26, 2011
Impax LaboratoriesFor profitMKTGAug 27, 2009
InterpharmFor profitMKTG—
Jubilant Innovation Ltd.For profitMKTGJan 29, 2018
LP PharmaceuticalsFor profitMKTGNov 20, 2017
Lavipharm LabsFor profitMKTGOct 10, 1984
Lavipharm LabsFor profitNDA2Oct 10, 1984
LupinFor profitMKTGOct 23, 2017
LutipoldFor profitMKTGOct 8, 2009
Mayne PharmaFor profitMKTGAug 20, 2010
Mayne PharmaFor profitSYNApr 30, 2018
MylanFor profitNDA2Oct 2, 1996
MylanFor profitMKTGFeb 9, 1987
MylanFor profitSYNJul 16, 2010
Novast LabsFor profitMKTGMar 5, 2019
Par PharmaceuticalsFor profitMKTGDec 16, 1987
Prinston IncFor profitMKTGMar 9, 2007
Rising PharmaceuticalsFor profitMKTGJun 9, 1987
Rising PharmaceuticalsFor profitSYNJun 9, 1987
SankyoFor profitMKTGOct 8, 2009
Sun PharmaceuticalsFor profitMKTGJul 3, 2014
Sun PharmaceuticalsFor profitSYNSep 4, 1987
TevaFor profitMKTG—
Tris Pharma, Inc.For profitNDA2Dec 3, 2009
URL LABSFor profitMKTGSep 4, 1987
UnichemFor profitMKTGAug 26, 2009
University of PennsylvaniaAcademic/HospitalMKTGDec 3, 2009
University of PennsylvaniaAcademic/HospitalNDA2Dec 3, 2009
Upsher-Smith LaboratoriesFor profitMKTGOct 12, 2018
Warner ChilcottFor profitMKTG—
Watson PharmaceuticalsFor profitMKTGJul 1, 1986
X Gen PharmaceuticalsFor profitSYNOct 29, 2013
X Gen PharmaceuticalsFor profitMKTGOct 29, 2013
Yung Shin Pharm. Ind. Co., Ltd.For profitMKTGJun 13, 2013
Zydus Discovery DMCCFor profitMKTGFeb 20, 2014