CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

cetirizine

Trade name: zyrtec

Small moleculeapproved

Approved

Dec 8, 1995

Cetirizine, a human metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of peripheral H1 receptors. It is indicated for the relief of nasal and non-nasal symptoms associated with seasonal or perennial allergic rhinitis, hay fever and chronic idiopathic urticaria. Commonly reported adverse reactions of cetirizine include headache, dry mouth and drowsiness or fatigue. Pharmacokinetic interaction studies with Cetirizine in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin. No interactions were observed. — NCATS

Clinical trial activity

94 trials · 79 clinical orgs · 52 marketing orgs

Phase 1
23
Phase 2
38
Phase 3
25
Phase 4
26

Earliest trial started Apr 1, 2000 (NCT00322907)

Timeline

1990s

  1. Dec 8, 1995

    Earliest FDA Approval

  2. Dec 8, 1995

    Johnson and Johnson — NDA Secondary Org

  3. Sep 27, 1996

    Johnson and Johnson — First NDA Organization

  4. Sep 27, 1996

    Johnson and Johnson — NDA Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2002

    Mylan — Earliest Phase 1 Sponsor(trial)

  4. Nov 1, 2006

    Ranbaxy — Marketing Organization

  5. Dec 27, 2007

    Apotex — Marketing Organization

  6. Dec 27, 2007

    Contract Pharmacal — Marketing Organization

  7. Dec 27, 2007

    Mylan — Marketing Organization

  8. Dec 27, 2007

    Perrigo — Marketing Organization

  9. Dec 27, 2007

    PL Developments — Marketing Organization

  10. Dec 28, 2007

    Glenmark Pharmaceuticals — Marketing Organization

  11. Dec 28, 2007

    Actavis — Marketing Organization

  12. Dec 28, 2007

    Wockhardt — Marketing Organization

  13. Dec 28, 2007

    Heritage Pharma — Marketing Organization

  14. Jan 15, 2008

    Dr. Reddy's Laboratories — Marketing Organization

  15. Feb 14, 2008

    Sandoz — Marketing Organization

  16. Feb 14, 2008

    Novartis — Marketing Organization

  17. Apr 22, 2008

    Taro Pharmaceuticals — Marketing Organization

  18. Apr 22, 2008

    Pharmaceutical Associates — Marketing Organization

  19. May 27, 2008

    Teva — Marketing Organization

  20. Jun 17, 2008

    Padagis Us — Marketing Organization

  21. Oct 6, 2008

    Esteve Labs — Marketing Organization

  22. Oct 6, 2008

    Bionpharma Inc — Marketing Organization

  23. Oct 10, 2008

    Cypress Pharmaceutical — Marketing Organization

  24. Feb 19, 2009

    Orbion Pharms — Marketing Organization

  25. Feb 19, 2009

    Orchid Pharma — Marketing Organization

  26. Mar 30, 2009

    Torrent Pharmaceuticals Limited — Marketing Organization

  27. Jun 26, 2009

    Unichem — Marketing Organization

  28. Jul 23, 2009

    Bionpharma Inc — NDA Secondary Org

  29. Aug 26, 2009

    Unique Pharmaceuticals Ltd, India — Marketing Organization

  30. Aug 28, 2009

    Atlantide Pharmaceuticals — Marketing Organization

  31. Sep 25, 2009

    Lannett Company, Inc. — Marketing Organization

  32. Oct 7, 2009

    Amneal Pharmaceuticals — Marketing Organization

  33. Nov 12, 2009

    Saptalis Pharmaceuticals — Marketing Organization

  34. Nov 12, 2009

    Micro Labs Ltd India — Marketing Organization

  35. Nov 12, 2009

    Department of Veteran Affairs — Marketing Organization

2010s

  1. Feb 2, 2010

    Aurobindo Pharma — Marketing Organization

  2. Jun 15, 2010

    Marksans Pharma — Marketing Organization

  3. Apr 22, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  4. Aug 30, 2011

    Sun Pharmaceuticals — Marketing Organization

  5. Oct 17, 2011

    Apnar Pharma — Marketing Organization

  6. Oct 17, 2011

    Athem — Marketing Organization

  7. Nov 16, 2012

    Tris Pharma, Inc. — Marketing Organization

  8. Jul 25, 2013

    Cipla — Marketing Organization

  9. Mar 11, 2014

    IPCA Laboratories Ltd. — Marketing Organization

  10. Feb 19, 2015

    Jubilant Innovation Ltd. — Marketing Organization

  11. Mar 8, 2016

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  12. May 30, 2017

    Eyevance — NDA Secondary Org

  13. Jul 21, 2017

    Strides Pharma Science — Marketing Organization

  14. Dec 22, 2017

    Granules India — Marketing Organization

  15. Mar 13, 2019

    Hetero Labs Ltd — Marketing Organization

  16. May 16, 2019

    Quagen Pharma — Marketing Organization

  17. Oct 4, 2019

    JDP Therapeutics, Inc. — Marketing Organization

  18. Oct 4, 2019

    Jdp — Marketing Organization

  19. Oct 4, 2019

    Jdp — NDA Secondary Org

2020s

  1. Sep 21, 2020

    Catalent — Marketing Organization

  2. Sep 21, 2020

    Micron Technologies — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 8, 1995

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Mol. weight
388.9 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Over the Counter

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • allacan
  • allertek
  • becoallergy
  • cetec
  • ceterizine
  • cetirizin
  • cetirizin
  • cetirizina
  • cetirizina
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine
  • cetirizine di hcl
  • cetirizine dihydrochloride
  • cetirizine hcl
  • cetirizine hcl
  • cetirizine hcl
  • cetirizine hydrochloride
  • cetirizine hydrochloride
  • cetirizine hydrochloride
  • cetirizine hydrochloride
  • cetirizine hydrochloride
  • cetirizinum
  • cetirizinum
  • cetirocol
  • cotrifazid
  • cotrifazid
  • p-071
  • p-071
  • piriteze
  • pollenshield
  • ziralton
  • zirtek
  • zirtek
  • zynor
  • zyrtec
  • zyrtec
  • zyrtec
  • zyrtec

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07236372N/ANov 30, 2025University of Phayao
NCT06890260N/AApr 11, 2025Zhejiang University
NCT06819774Phase 3Apr 22, 2024Shandong New Time Pharmaceutical Co., LTD
NCT05946551Phase 3Jan 31, 2024Emory University
NCT06126991Phase 1/Phase 2 (Phase 2)Nov 1, 2023Jiao Tong University
NCT06121518Phase 3Jul 31, 2023Chong Kun Dang Pharmaceutical, Hanyang University
NCT05931224Phase 3Jun 28, 2023Chong Kun Dang Pharmaceutical, Seoul National University
NCT05526703Phase 3Sep 28, 2022Chong Kun Dang Pharmaceutical
NCT05476679Phase 1/Phase 2 (Phase 2)Sep 25, 2022Raziel Therapeutics Ltd.
NCT05540912Phase 1Sep 15, 2022Chong Kun Dang Pharmaceutical
NCT04836806Phase 4Aug 31, 2021Emory University
NCT05095311Phase 4May 19, 2021Indiana University
NCT06754410Phase 3Mar 1, 2021South Valley University
NCT04293822Phase 4Jun 30, 2020Assiut University
NCT04237090Phase 3Feb 29, 2020Ciusss de L'Est de l'Île de Montréal
NCT04189588Phase 2Feb 29, 2020JDP Therapeutics, Inc., Tersera Theraps Llc
NCT04481412Phase 2/Phase 3 (Phase 3)Feb 16, 2020Cairo University
NCT04071821Phase 1Oct 1, 2019Frontage Laboratories, Inc., Seattle Gummy Company
NCT03772158Phase 1Dec 11, 2018Algorithme Pharma Inc, Johnson and Johnson
NCT03590912Phase 4Aug 31, 2018Lumbini Medical College
Showing 20 of 94 trials
Page 1 / 5

Organizations

Research & Development (79)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit121152005
MerckFor profit101022001
Chong Kun Dang PharmaceuticalFor profit4422022
JDP Therapeutics, Inc.For profit4432011
Faes Farma, S.A.For profit3322004
GenzymeFor profit3332014
Johnson and JohnsonFor profit3322001
Medical University of LodzAcademic/Hospital3122004
SanofiFor profit3032014
AAIPharmaFor profit2012006
ActavisFor profit2212006
Algorithme Pharma IncFor profit2012011
Dr. Reddy's LaboratoriesFor profit2212006
Emory UniversityAcademic/Hospital2222021
Hoosier Cancer Research NetworkAcademic/Hospital2212002
Indiana UniversityAcademic/Hospital2212017
Lambda Therapeutic Research LtdFor profit2012006
McNeilFor profit2122011
MylanFor profit2212002
Novum Pharmaceutical Research ServicesFor profit2012002
79 organizations
Page 1 / 4

Marketing (70)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGDec 28, 2007
ActavisFor profitSYNMay 9, 2008
Amneal PharmaceuticalsFor profitMKTGOct 7, 2009
Amneal PharmaceuticalsFor profitSYNJan 21, 2010
Apnar PharmaFor profitMKTGOct 17, 2011
ApotexFor profitSYNAug 12, 2016
ApotexFor profitMKTGDec 27, 2007
AthemFor profitMKTGOct 17, 2011
Atlantide PharmaceuticalsFor profitMKTGAug 28, 2009
Aurobindo PharmaFor profitMKTGFeb 2, 2010
Aurobindo PharmaFor profitSYNDec 16, 2009
Bionpharma IncFor profitNDA2Jul 23, 2009
Bionpharma IncFor profitMKTGOct 6, 2008
CatalentFor profitMKTGSep 21, 2020
Chartwell PharmaceuticalsFor profitMKTGApr 22, 2011
Chartwell PharmaceuticalsFor profitSYNMay 9, 2008
CiplaFor profitMKTGJul 25, 2013
Contract PharmacalFor profitMKTGDec 27, 2007
Cypress PharmaceuticalFor profitMKTGOct 10, 2008
Department of Veteran AffairsGovernmentMKTGNov 12, 2009
Dr. Reddy's LaboratoriesFor profitMKTGJan 15, 2008
Esteve LabsFor profitMKTGOct 6, 2008
Esteve LabsFor profitSYNOct 6, 2008
EyevanceFor profitNDA2May 30, 2017
Glenmark PharmaceuticalsFor profitMKTGDec 28, 2007
Granules IndiaFor profitSYNDec 22, 2017
Granules IndiaFor profitMKTGDec 22, 2017
Heritage PharmaFor profitMKTGDec 28, 2007
Hetero Labs LtdFor profitMKTGMar 13, 2019
IPCA Laboratories Ltd.For profitMKTGMar 11, 2014
JDP Therapeutics, Inc.For profitMKTGOct 4, 2019
JdpFor profitMKTGOct 4, 2019
JdpFor profitNDA2Oct 4, 2019
Johnson and JohnsonFor profitNDASep 27, 1996
Johnson and JohnsonFor profitNDA2Dec 8, 1995
Jubilant Innovation Ltd.For profitMKTGFeb 19, 2015
Lannett Company, Inc.For profitMKTGSep 25, 2009
Marksans PharmaFor profitMKTGJun 15, 2010
Micro Labs Ltd IndiaFor profitMKTGNov 12, 2009
Micron TechnologiesFor profitMKTGSep 21, 2020
MylanFor profitMKTGDec 27, 2007
MylanFor profitSYNNov 12, 2009
NovartisFor profitMKTGFeb 14, 2008
Novel Anti-Infective Technologies, LLCFor profitMKTGMar 8, 2016
Orbion PharmsFor profitMKTGFeb 19, 2009
Orchid PharmaFor profitMKTGFeb 19, 2009
PL DevelopmentsFor profitMKTGDec 27, 2007
Padagis UsFor profitMKTGJun 17, 2008
PerrigoFor profitMKTGDec 27, 2007
PerrigoFor profitSYNJun 17, 2008
Pharmaceutical AssociatesFor profitMKTGApr 22, 2008
Quagen PharmaFor profitMKTGMay 16, 2019
RanbaxyFor profitMKTGNov 1, 2006
SandozFor profitMKTGFeb 14, 2008
Saptalis PharmaceuticalsFor profitMKTGNov 12, 2009
Strides Pharma ScienceFor profitMKTGJul 21, 2017
Sun PharmaceuticalsFor profitSYNAug 30, 2011
Sun PharmaceuticalsFor profitMKTGAug 30, 2011
Sun PharmaceuticalsFor profitSYNDec 27, 2007
Sun PharmaceuticalsFor profitSYNDec 27, 2007
Taro PharmaceuticalsFor profitMKTGApr 22, 2008
TevaFor profitSYNFeb 25, 2008
TevaFor profitMKTGMay 27, 2008
Torrent Pharmaceuticals LimitedFor profitMKTGMar 30, 2009
Torrent Pharmaceuticals LimitedFor profitSYNApr 15, 2010
Tris Pharma, Inc.For profitMKTGNov 16, 2012
UnichemFor profitMKTGJun 26, 2009
Unique Pharmaceuticals Ltd, IndiaFor profitMKTGAug 26, 2009
Unique Pharmaceuticals Ltd, IndiaFor profitSYNAug 26, 2009
WockhardtFor profitMKTGDec 28, 2007