Last update 01 Dec 2025

Levocetirizine Hydrochloride

Overview

Basic Info

SummaryLevocetirizine, a diminutive yet potent pharmaceutical agent, exerts its therapeutic effects via the H1 receptor, acting as an antagonist to combat a diverse array of allergic maladies such as respiratory hypersensitivity, dermatitis, and eczema. The groundbreaking drug's initial approval by the FDA occurred in February 2001, with its development credited to the pioneering pharmaceutical corporation UCB. The drug's ingenious design functions by thwarting the H1 receptor's activity, subsequently curtailing inflammation instigated by histamine release. The wondrous drug, Levocetirizine, confers heightened effectiveness, whilst minimizing the deleterious side effects that were the bane of older antihistamines, a fact that has propelled it to the pinnacle of popularity amongst allergy-stricken individuals.
Drug Type
Small molecule drug
Synonyms
2-(2-{4-[(R)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid, Airitis, Elzinex
+ [21]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Inactive Indication
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure/Sequence

Molecular FormulaC21H27Cl3N2O3
InChIKeyPGLIUCLTXOYQMV-GHVWMZMZSA-N
CAS Registry130018-87-0

External Link

KEGGWikiATCDrug Bank
D08118-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Hypersensitivity
United States
31 Jan 2017
Hypersensitivity
Japan
31 Oct 2010
Prurigo
Japan
27 Oct 2010
Chronic Urticaria
China
20 Oct 2005
Dermatitis
China
21 Jan 2004
Eczema
China
21 Jan 2004
Pruritus
China
21 Jan 2004
Rhinitis, Allergic
Austria
16 Aug 2001
Rhinitis, Allergic
Belgium
16 Aug 2001
Rhinitis, Allergic
Cyprus
16 Aug 2001
Rhinitis, Allergic
Czechia
16 Aug 2001
Rhinitis, Allergic
Denmark
16 Aug 2001
Rhinitis, Allergic
Estonia
16 Aug 2001
Rhinitis, Allergic
Finland
16 Aug 2001
Rhinitis, Allergic
France
16 Aug 2001
Rhinitis, Allergic
Germany
16 Aug 2001
Rhinitis, Allergic
Greece
16 Aug 2001
Rhinitis, Allergic
Hungary
16 Aug 2001
Rhinitis, Allergic
Ireland
16 Aug 2001
Rhinitis, Allergic
Italy
16 Aug 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnaphylaxisPhase 3-01 Aug 2003
AsthmaPhase 3-20 Mar 2002
Dermatitis, AtopicPhase 3-20 Mar 2002
CoughPhase 2-01 Dec 2001
Pruritis (itchy skin)Phase 1
China
12 Sep 2017
Perennial allergic rhinitis with seasonal variationPhase 1
Japan
02 May 2012
FastingPhase 1
India
01 Dec 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
60
bkejjvbwdr(hwrdmzhsmq): P-Value = 0.007
Positive
01 Nov 2025
Phase 4
18
Placebo Oral Tablet+Levocetirizine Oral Tablet
(Levocetirizin)
wcgkgdxvqa(dauusavnxj) = sogseymofu vdmtxjakqq (fvzeendmgy, 16.4)
-
04 Oct 2019
wcgkgdxvqa(dauusavnxj) = igitvpailx vdmtxjakqq (fvzeendmgy, 35.3)
Phase 1
72
(Part 1: Levocetirizine ODT 5 mg)
cjcenvgced(mjdmrpsufd) = cxwbtkehjb auhqvatbzy (gvouvluuan, qklrwjhpxt - lmpvshptgi)
-
12 Sep 2019
(Part 1: Levocetirizine IRT 5 mg)
cjcenvgced(mjdmrpsufd) = tlhdyvfgik auhqvatbzy (gvouvluuan, wpsiwfkojx - mkfcgadxjf)
Phase 4
62
(Continuous Treatment (CT))
vikbrauybm(hdqcpnhvvc) = hklfrqaawp sheasfjpqg (avnurzgaaz, 0.43)
-
22 Jan 2019
(On Demand Treatment (ODT))
vikbrauybm(hdqcpnhvvc) = jnwubakgfu sheasfjpqg (avnurzgaaz, 0.44)
Phase 3
514
Placebo
(Placebo (PBO))
oqbrxlhjzx(ykvkcixnuz) = jymofeyxfa zcrkfmvbgy (bieydqgish, npejdwzboa - geaycrcdcl)
-
22 Jan 2019
(Levocetirizine (LCTZ))
oqbrxlhjzx(ykvkcixnuz) = wbdjcijprb zcrkfmvbgy (bieydqgish, bmhlczesux - ufvlichszd)
Phase 4
418
Placebo
(Placebo (PBO))
daqxmchzye(tjsecpytne) = pjfsfiicxw dwytcpxxpo (gheiklojlf, 0.49)
-
23 Jul 2018
(Levocetirizine (LCTZ))
daqxmchzye(tjsecpytne) = oeqwdmkenj dwytcpxxpo (gheiklojlf, 0.40)
Phase 2
551
Placebo tablets matching to cetirizine
(Placebo (PBO))
vuyxdswluu(jdwzhygjys) = orcmbitlpe eadzspviaq (qpawamuuej, 0.495)
-
20 Jul 2018
(Levocetirizine (LCTZ) 2.5 mg)
vuyxdswluu(jdwzhygjys) = ftuuwxcqik eadzspviaq (qpawamuuej, 0.406)
Phase 2
47
(Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine))
podcwronmt = bxsflvlypb ftixlzixvu (ywvwstaswi, myddpomrmh - jqzjfdsjmx)
-
13 Feb 2017
(Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine))
szrokgllgz = ikhlvquwxb kqxbfvbruc (dwltceducd, zgeekdsrzd - spllronlee)
Phase 2
36
abtbydydrf(fvzdlzeefe) = jqvzlcrodi xenhvnwypy (smyiqwnivc )
Positive
20 Jan 2015
Phase 4
30
Placebo
(Placebo)
iplsszdgfv(idhncobewk) = xgucojjumt onlncyycjj (ofqilxpplj, 4.58)
-
20 Feb 2014
(Cetirizine)
iplsszdgfv(idhncobewk) = vlimyxooge onlncyycjj (ofqilxpplj, 5.31)
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