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chlorhexidine

Trade name: hibitane

Small moleculeapproved

Approved

Jun 1, 1954

Chlorhexidine is a broad-spectrum biocide effective against Gram-positive bacteria, Gram-negative bacteria and fungi. It is used primarily as its salts (e.g., the dihydrochloride, diacetate, and digluconate). Chlorhexidine inactivates microorganisms with a broader spectrum than other antimicrobials (e.g. antibiotics) and has a quicker kill rate than other antimicrobials (e.g. povidone-iodine). It has both bacteriostatic (inhibits bacterial growth) and bactericidal (kills bacteria) mechanisms of action, depending on its concentration. Chlorhexidine kills by disrupting the cell membrane. The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception; 4) toothache; 5) upper respiratory tract infection; and 6) headache. — NCATS

Clinical trial activity

565 trials · 460 clinical orgs · 30 marketing orgs

Phase 1
40
Phase 2
155
Phase 3
104
Phase 4
123

Earliest trial started May 1, 1998 (NCT00004640)

Timeline

1950s

  1. Jun 1, 1954

    Imperial Chemical Industries — Earliest FDA Approval

  2. Jun 1, 1954

    Imperial Chemical Industries — NDA Organization

1970s

  1. Sep 17, 1976

    Molnlycke Health Care AB — NDA Secondary Org

1980s

  1. Dec 24, 1984

    Xttrium Laboratories — NDA Secondary Org

  2. Jul 22, 1986

    Ecolab — NDA Secondary Org

  3. Jul 24, 1986

    Matrix Pharmaceutical — Marketing Organization

  4. Aug 13, 1986

    3M — NDA Secondary Org

  5. Dec 17, 1987

    Soapco — Marketing Organization

  6. Dec 2, 1988

    CareFusion — NDA Secondary Org

  7. Mar 31, 1989

    K. W. GRIFFEN CO — NDA Secondary Org

1990s

  1. Feb 28, 1991

    Johnson and Johnson — Marketing Organization

  2. Jan 14, 1994

    Colgate Palmolive — Marketing Organization

  3. Dec 15, 1995

    Teva — Marketing Organization

  4. Dec 15, 1995

    Pharmaceutical Associates — Marketing Organization

  5. Dec 28, 1995

    Lyne Laboratories — Marketing Organization

  6. May 7, 1996

    Saptalis Pharmaceuticals — Marketing Organization

  7. May 7, 1996

    Hi Tech Pharmaceuticals — Marketing Organization

  8. May 7, 1996

    Akorn, Inc. — Marketing Organization

  9. May 7, 1996

    Sciegen Pharmaceticals — Marketing Organization

  10. Sep 11, 1997

    Department of Veteran Affairs — NDA Secondary Org

  11. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  12. May 15, 1998

    Dexcel Pharma Technologies Ltd. — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jul 14, 2000

    Becton Dickinson — Marketing Organization

  3. Jul 14, 2000

    Becton Dickinson — NDA Secondary Org

  4. Nov 14, 2000

    Department of Veteran Affairs — Marketing Organization

  5. Mar 3, 2004

    Wockhardt — Marketing Organization

  6. Mar 3, 2004

    Chartwell Pharmaceuticals — Marketing Organization

  7. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  8. Apr 25, 2005

    Sage Products, Inc. — NDA Secondary Org

  9. Jun 3, 2005

    PDI Healthcare — Marketing Organization

  10. Jun 3, 2005

    PDI Healthcare — NDA Secondary Org

  11. Nov 29, 2005

    Sunstar — Marketing Organization

  12. Jun 18, 2009

    Xttrium Laboratories — Marketing Organization

  13. Jun 18, 2009

    PHARMOBEDIENT — Marketing Organization

2010s

  1. Aug 8, 2018

    Bausch Health Companies — NDA Secondary Org

  2. Nov 20, 2018

    Medline Industries — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • Cell membraneINHIBITOR

    Cell membrane inhibitor

    Disrupts cell membrane

Combination products

  • avagar

    with ethanol

  • chloraprep one-step

    with isopropyl alcohol

    Also known as chloraprep one-step frepp, chloraprep one-step sepp, chloraprep single swabstick, chloraprep triple swabstick, chloraprep with tint, prevantics maxi swabstick, prevantics swab, prevantics swabstick

Approval history

  • approvedJun 1, 1954

Chemistry & pharmacology

Loading structure…

SMILES

ClC1=CC=C(NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC2=CC=C(Cl)C=C2)C=C1
Mol. weight
505.447 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 1,1'-hbcb
  • 1,1'-hexamethylenebis-(5-(ethylhexyl)biguanide)
  • 1,1'-hexamethylene bis(5-(p-chlorophenyl)biguanide)
  • 1,1'-hexamethylene bis(5-(p-chlorophenyl)biguanide)
  • acriflex
  • aerocide 1
  • alcoholic chlorhexidine
  • avagard
  • avagard
  • avagard
  • bacticlens
  • bioscrub
  • bioscrub
  • brian care
  • brian care
  • cepton
  • cetriclens
  • cetriclens fte
  • chg scrub
  • chlohexidine gluconate
  • chlohexidine gluconate
  • chloraprep
  • chloraprep
  • chlorexidine
  • chlorhexamed
  • chlorhex glucon
  • chlorhex hcl
  • chlorhexidin
  • chlorhexidin
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine
  • chlorhexidine acetate
  • chlorhexidine acetate
  • chlorhexidine bigluconate
  • chlorhexidine digluconate
  • chlorhexidine digluconate
  • chlorhexidine digluconate
  • chlorhexidine gluconate
  • chlorhexidine gluconate
  • chlorhexidine gluconate
  • chlorhexidine gluconate
  • chlorhexidine gluconate
  • chlorhexidine gluconate
  • chlorhexidine gluconate mixture with isopropyl alcohol
  • chlorhexidine hcl
  • chlorhexidine hcl
  • chlorhexidine hydrochloride
  • chlorhexidine hydrochloride
  • chlorhexidine hydrochloride
  • chlorhexidine hydrochloride
  • chlorhexidine hydrochloride
  • chlorhexidine hydrochloride
  • chlorhexidinum
  • chlorhexidinum
  • chlorohex
  • chlorohexidine
  • chlorohexidine
  • chlorohexidine
  • chlorohexidine gluconate
  • cida-stat
  • cida-stat
  • clinivex
  • cloresidina
  • cloresidina
  • clorhexidina
  • clorhexidina
  • clorhexidine
  • corsodyl
  • corsodyl
  • corsodyl daily
  • corsodyl daily defence
  • corsodyl ici
  • curasept
  • curasept
  • curasept ads 220
  • cx 1
  • cyteal
  • dispray 1
  • dispray 2
  • dyna-hex
  • dyna-hex
  • dyna-hex
  • eczmol
  • eludril
  • exidine
  • exidine
  • e-z scrub
  • gibitan
  • gppe soln
  • gppe tinct
  • gppe wsh
  • habitant
  • hexidine
  • hibclens
  • hibi
  • hibicet
  • hibiclens
  • hibiclens
  • hibiclens
  • hibident
  • hibidil
  • hibidil
  • hibiscrub
  • hibiscrub
  • hibiscrub
  • hibisol
  • hibispray
  • hibispray
  • hibistat
  • hibistat
  • hibitane
  • hibitane plus
  • hydrex
  • microderm
  • microderm
  • n,n'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide
  • n,n'-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide
  • peridex
  • peridex
  • peridex
  • periochip
  • periochip
  • perio chip
  • periogard
  • periogard
  • perio-kin
  • pharmaseal scrub care
  • pharmaseal scrub care
  • phiso-med
  • phiso-med
  • prevacare
  • prevacare
  • prevacare r
  • prevacare r
  • primahex
  • rotersept
  • rotersept
  • rotersept
  • savloclens
  • savloclens
  • savlodil
  • savlon hc
  • savlon jnr
  • sterets tisept
  • sterets uniscrub
  • sterets unisept
  • sterexidine
  • steri-stat
  • steri-stat
  • tarodent
  • tisept
  • uriflex-c

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07200063N/AJan 31, 2026Cairo University
NCT07311512N/AJan 23, 2026Imperial College London, Loughborough University, Temple University, University of Portsmouth
NCT07191262N/ADec 31, 2025University of Alabama, Birmingham
NCT07239219N/ADec 31, 2025Irrimax Corporation, Ohio State University
NCT07307716N/ADec 31, 2025Riyadh Elm University
NCT07215156N/AOct 6, 2025Kafrelsheikh University
NCT07196618N/ASep 30, 2025Al Azhar University
NCT07124650Phase 4Sep 15, 2025Saint-Petersburg State Medical University
NCT07016659Phase 3Sep 1, 2025Cairo University
NCT07058727N/AAug 1, 2025Cukurova University
NCT07119840N/AAug 1, 2025Khyber Medical University Peshawar, Khyber Medical University Peshawer, Saidu College of Dentistry
NCT07069166N/AJul 30, 2025University of Pavia
NCT07115784N/AJul 21, 2025Khyber Medical University Peshawar
NCT07252258N/AJul 15, 2025College of Physicians and Surgeons Pakistan
NCT07073092Phase 2Jul 15, 2025Ain Shams University
NCT07031388N/AJul 1, 2025Kurdistan Board for Medical Specialist
NCT07059572N/AMay 27, 2025Bangladesh Medical University
NCT07198919Phase 1/Phase 2 (Phase 2)May 20, 2025Altamash Institute of Dental Medicine
NCT07180498N/AApr 15, 2025Harran University
NCT06900881Phase 2/Phase 3 (Phase 3)Apr 6, 2025Al-Mustansiriyah University
Showing 20 of 565 trials
Page 1 / 29

Organizations

Research & Development (460)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cairo UniversityAcademic/Hospital272752016
3MFor profit141142007
Johns Hopkins UniversityAcademic/Hospital121142004
Bio-Science LaboratoriesFor profit9042013
Medline IndustriesFor profit9932014
University of PaviaAcademic/Hospital9912021
Zurex Pharma, Inc.For profit9932014
Centers for Disease Control and Prevention (CDC)Government8142004
Colgate PalmoliveFor profit8531998
University of MilanAcademic/Hospital8832011
Washington University in St. LouisAcademic/Hospital8542007
Department of Veteran AffairsGovernment7442001
National Institute of Dental and Craniofacial Research (NIDCR)Government7041998
Sage Products, Inc.For profit7032005
University of Santiago de CompostelaAcademic/Hospital7732010
Ain Shams UniversityAcademic/Hospital6632014
CareFusionFor profit6532007
Fundação de Amparo à Pesquisa do Estado de São PauloAcademic/Hospital6032005
MicroBioTestFor profit6032011
Rush UniversityAcademic/Hospital6342005
460 organizations
Page 1 / 23

Marketing (37)

OrganizationOrg typeRelationshipDate
3MFor profitNDA2Aug 13, 1986
3MFor profitSYNAug 8, 2018
Akorn, Inc.For profitMKTGMay 7, 1996
Bausch Health CompaniesFor profitNDA2Aug 8, 2018
Becton DickinsonFor profitSYNOct 24, 1989
Becton DickinsonFor profitMKTGJul 14, 2000
Becton DickinsonFor profitNDA2Jul 14, 2000
CareFusionFor profitNDA2Dec 2, 1988
Chartwell PharmaceuticalsFor profitMKTGMar 3, 2004
Colgate PalmoliveFor profitMKTGJan 14, 1994
Colgate PalmoliveFor profitSYNJan 28, 2016
Department of Veteran AffairsGovernmentMKTGNov 14, 2000
Department of Veteran AffairsGovernmentNDA2Sep 11, 1997
Dexcel Pharma Technologies Ltd.For profitNDA2May 15, 1998
EcolabFor profitNDA2Jul 22, 1986
Hi Tech PharmaceuticalsFor profitMKTGMay 7, 1996
Imperial Chemical IndustriesFor profitNDAJun 1, 1954
Johnson and JohnsonFor profitMKTGFeb 28, 1991
K. W. GRIFFEN COFor profitNDA2Mar 31, 1989
Kendall McGaw LaboratoriesFor profitNDA2—
Lyne LaboratoriesFor profitMKTGDec 28, 1995
Matrix PharmaceuticalFor profitMKTGJul 24, 1986
Medline IndustriesFor profitNDA2Nov 20, 2018
Molnlycke Health Care ABFor profitNDA2Sep 17, 1976
PDI HealthcareFor profitMKTGJun 3, 2005
PDI HealthcareFor profitNDA2Jun 3, 2005
PHARMOBEDIENTFor profitMKTGJun 18, 2009
Pharmaceutical AssociatesFor profitMKTGDec 15, 1995
Sage Products, Inc.For profitNDA2Apr 25, 2005
Saptalis PharmaceuticalsFor profitMKTGMay 7, 1996
Sciegen PharmaceticalsFor profitMKTGMay 7, 1996
SoapcoAcademic/HospitalMKTGDec 17, 1987
SunstarFor profitMKTGNov 29, 2005
TevaFor profitMKTGDec 15, 1995
WockhardtFor profitMKTGMar 3, 2004
Xttrium LaboratoriesFor profitNDA2Dec 24, 1984
Xttrium LaboratoriesFor profitMKTGJun 18, 2009