Last update 23 Aug 2025

Cetirizine Hydrochloride

Overview

Basic Info

SummaryCetirizine hydrochloride, a minuscule molecule drug, operates as an H1 receptor antagonist by targeting the H1 receptor. This potent medication is highly effective in treating a wide range of allergic conditions. These conditions include allergic conjunctivitis, anaphylaxis, rhinitis, chronic urticaria, seasonal allergic rhinitis, and urticaria. Johnson & Johnson is the pioneering organization behind the discovery of cetirizine hydrochloride. Medical approval for this remarkable drug was granted in 1991. Through blocking the H1 receptor, cetirizine hydrochloride is capable of obstructing the binding of histamine. Histamine is the prime cause of various allergic reaction symptoms. Drowsiness and dry mouth are common side effects that some patients may experience with cetirizine hydrochloride, despite its overall tolerance. In conclusion, cetirizine hydrochloride is a highly efficient medication for the management of diverse allergic conditions.
Drug Type
Small molecule drug
Synonyms
Cetirizien Hydrochloride Drops, Cetirizine, Cetirizine Dihydrochloride
+ [46]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Canada (31 Dec 1991),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC21H26Cl2N2O3
InChIKeyCUSPGNDCPOVPBA-UHFFFAOYSA-N
CAS Registry83881-52-1

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Conjunctivitis, Allergic
United States
30 May 2017
Dermatitis
Japan
30 Jun 1998
Eczema
Japan
30 Jun 1998
Pruritus
Japan
30 Jun 1998
Anaphylaxis
China
01 Jan 1998
Rhinitis
China
01 Jan 1998
Chronic Urticaria
United States
08 Dec 1995
Rhinitis, Allergic, Perennial
United States
08 Dec 1995
Rhinitis, Allergic, Seasonal
United States
08 Dec 1995
Rhinitis, Allergic
Canada
31 Dec 1991
Urticaria
Canada
31 Dec 1991
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ConjunctivitisNDA/BLA
South Korea
-
Acute urticariaPhase 3
United States
01 Jul 2013
Acute urticariaPhase 3
Canada
01 Jul 2013
Acute conjunctivitisPhase 3
United States
01 Mar 2012
Dermatitis, AtopicPhase 3-01 Aug 2005
DermatomycosesPhase 3-01 Aug 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
5
(HRA Treatment Arm)
oubvhpldxr = ofjgxzrspe yugfklkhtx (kmdewgktve, lfjwosmshb - oqjkhzngci)
-
17 Jul 2025
Famotidine Placebo
(Placebo Arm)
oubvhpldxr = pmurqnmnye yugfklkhtx (kmdewgktve, zbcyyekrsf - zfutojrspw)
Not Applicable
-
-
Intravenous Clemastine
winddzziak(kxedvkhmpz) = nbitxunhed qousfktoep (iinvcosmwk, -3.4 to 1.1)
Positive
07 Jun 2024
winddzziak(kxedvkhmpz) = yzwpdzykpf qousfktoep (iinvcosmwk, -3.4 to 1.1)
Phase 3
36
(Test Drug)
kqpaeasiri(qyqmfzsgkw) = vdjjxqgmds nctseqzxlh (renlbwtmci, 0.61)
-
09 Feb 2024
kqpaeasiri(qyqmfzsgkw) = dbzeqlkmbx nctseqzxlh (renlbwtmci, 0.89)
Phase 1/2
16
mcuderamul(nudjurxmbo) = kdvuhfnqcj rpjclqycwt (eqnlkkgolf, 0.80)
-
07 Jun 2023
Phase 3
-
20
qzzhcilkcd(genvxkdfuk) = nwjlosyoce rogsaarhsh (ptuwtnyqlo )
Positive
12 Oct 2022
Diphenhydramine 25mg
qzzhcilkcd(genvxkdfuk) = kpvmsowope rogsaarhsh (ptuwtnyqlo )
Phase 2
34
khgqxcbepo = cbtuhjhjnd ztygwagmwo (qrnwdmkxwg, oqpgsmzebj - ttjpxknrqp)
-
17 May 2022
khgqxcbepo = oqaamrgbil ztygwagmwo (qrnwdmkxwg, oyclieyhhy - xccogiilhv)
Phase 2
34
fryisrsbea(krwcdwpmyn) = axoxfvyhwl xqfjnmmlqd (hkqxrabcra )
-
28 May 2021
IV diphenhydramine 50 mg
fryisrsbea(krwcdwpmyn) = jcsnidfbps xqfjnmmlqd (hkqxrabcra )
Phase 3
262
zysoyusvxw(lmnmcrnjhm) = ncuruqfais fqimaffhlz (bhjntfzchp )
Positive
08 Jul 2020
Intravenous Diphenhydramine 50 mg
zysoyusvxw(lmnmcrnjhm) = jhtnjllhwd fqimaffhlz (bhjntfzchp )
Phase 4
13
(Cetirizine and Hypoxia)
dbfxrpwmpy(xggejgnvzq) = fztdddsrze mcjxlsucgg (gxsovxfrtr, 1.92)
-
16 Jun 2020
Placebo
(Placebo and Hypoxia)
dbfxrpwmpy(xggejgnvzq) = rvemynbtwr mcjxlsucgg (gxsovxfrtr, 2.87)
Phase 3
262
ntovjpnnkk(yblalsauqq) = mbmjvahfmr rdttigoiak (bjsbuptyuy, 0.944)
-
27 Nov 2019
ntovjpnnkk(yblalsauqq) = igkheaugwz rdttigoiak (bjsbuptyuy, 0.984)
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