Levocetirizine

Overview

Levocetirizine is a selective histamine H antagonist used to treat a variety of allergic symptoms. It is the R enantiomer of cetirizine. Levocetirizine has greater affinity for the histamine H receptor than cetirizine. Levocetirizine was granted FDA approval in 1995.

Indication

Levocetirizine is indicated to treat symptoms of perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria. It is also used over the counter for a variety of mild allergy symptoms.

Associated Conditions

Allergic Rhinitis (AR)
Chronic Idiopathic Urticaria
Common Cold
Nasal Congestion
Perennial Allergic Rhinitis (PAR)
Seasonal Allergic Rhinitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Treatment Options for Chronic Urticaria	2025/02/10	NCT06816784	Phase 2	Not yet recruiting	Sheikh Zayed Medical College
A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC	2024/10/09	NCT06632405	Phase 2	Not yet recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease	2022/12/06	NCT05638880	Phase 2	Recruiting	Mostafa Bahaa
A Phase I Study of LY3471851 in Healthy Participants	2022/10/04	NCT05565729	Phase 1	Completed	Nektar Therapeutics
Comparison of the Effects for Lightening the Shiners Among Different Treatments for Rhinitis	2022/04/27	NCT05348148	Not Applicable	Recruiting	Camillians Saint Mary's Hospital Luodong
A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)	2021/01/07	NCT04699604	Phase 3	Recruiting	Bridgette Jones
Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.	2020/05/22	NCT04399525	Not Applicable	Completed	Universitaire Ziekenhuizen KU Leuven
Tranexamic Acid and Spontaneous Chronic Urticaria	2018/12/28	NCT03789422	Phase 4	UNKNOWN	University Hospital, Grenoble
Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation	2018/09/17	NCT03673384	Not Applicable	Completed	Nanhua University
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)	2018/06/14	NCT03555890	Phase 1	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
levocetirizine dihydrochloride	Dr.Reddy's laboratories Ltd.	55111-282	ORAL	5 mg in 1 1	12/6/2018
LEVOCETIRIZINE DIHYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	68462-346	ORAL	5 mg in 1 1	9/28/2020
LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	71335-0418	ORAL	5 mg in 1 1	3/29/2023
Levocetirizine Dihydrochloride	Northwind Pharmaceuticals, LLC	51655-148	ORAL	5 mg in 1 1	1/20/2023
levocetirizine dihydrochloride	Bryant Ranch Prepack	72162-1424	ORAL	0.5 mg in 1 mL	9/26/2023
levocetirizine dihydrochloride	Northwind Pharmaceuticals	51655-564	ORAL	5 mg in 1 1	1/1/2023
Xyzal	Physicians Total Care, Inc.	54868-6115	ORAL	0.5 mg in 1 mL	5/11/2010
Levocetirizine Dihydrochloride	A-S Medication Solutions	50090-2591	ORAL	5 mg in 1 1	1/1/2019
Levocetirizine Dihydrochloride	Proficient Rx LP	71205-210	ORAL	5 mg in 1 1	1/1/2020
LEVOCETIRIZINE DIHYDROCHLORIDE 2% / MUPIROCIN 2% / TRIAMCINOLONE ACETONIDE 0.025%	Sincerus Florida, LLC	72934-2137	TOPICAL	2 g in 100 g	5/14/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
STADELTINE FILM-COATED TABLET 5MG	STELLAPHARM J.V. CO., LTD. - BRANCH 1	SIN16480P	TABLET, FILM COATED	5.00 mg	5/4/2022
XYZAL FILM-COATED TABLET 5 MG	UCB Farchim SA, Aesica Pharmaceuticals S.r.l. (Primary and Secondary Packager)	SIN16028P	TABLET, FILM COATED	5 mg	10/14/2020
Zyr-NEX TABLET 5 mg	UCB FARCHIM S A	SIN12084P	TABLET, FILM COATED	5 mg	9/25/2002
ALLERZAL F.C. TABLET 5MG	Standard Chem. & Pharm. Co., Ltd	SIN14939P	TABLET, FILM COATED	5mg	2/4/2016
Levozine F.C. Tablet 5mg	Standard Chem. & Pharm. Co., Ltd.	SIN14505P	TABLET, FILM COATED	5mg	2/14/2014
ALERINIT FILM-COATED TABLET 5MG	İlko İlaç Sanayi ve Ticaret A. Ş.	SIN16312P	TABLET, FILM COATED	5.00mg	8/31/2021

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Levocetirizine Hydrochloride Granules	康芝药业股份有限公司	国药准字H20150042	化学药品	颗粒剂	5/21/2020
Levocetirizine Hydrochloride Capsules	湖南九典制药股份有限公司	国药准字H20060183	化学药品	胶囊剂	8/4/2020
Levocetirizine Dihydrochloride Oral Drops	山西惠达林曦医药科技有限公司	国药准字H20244302	化学药品	口服溶液剂	6/28/2024
Levocetirizine Dihydrochloride Oral Drops	广州一品红制药有限公司	国药准字H20213385	化学药品	口服溶液剂	5/19/2021
Levocetirizine Dihydrochloride Oral Drops	合肥恩瑞特药业有限公司	国药准字H20223143	化学药品	口服溶液剂	3/16/2022
Levocetirizine Dihydrochloride Oral Drops	厦门紫旭医药科技有限公司	国药准字H20213695	化学药品	口服溶液剂	9/1/2021
Levocetirizine Dihydrochloride Oral Drops	广州一品红制药有限公司	国药准字H20237062	化学药品	口服溶液剂	6/7/2023
Levocetirizine Dihydrochloride Oral Drops	广州一品红制药有限公司	国药准字H20237063	化学药品	口服溶液剂	6/9/2023
Levocetirizine Dihydrochloride Oral Drops	厦门紫旭医药科技有限公司	国药准字H20213694	化学药品	口服溶液剂	9/1/2021
Levocetirizine Dihydrochloride Oral Drops	广东九明制药有限公司	国药准字H20243034	化学药品	口服溶液剂	1/9/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BELOTON TABLETS 5MG	N/A	Swiss Pharmaceutical (HK) Company Limited	N/A	N/A	3/12/2025
XYZAL TAB 5MG	N/A	葛兰素史克	N/A	N/A	6/8/2002
ZYX TABLETS 5MG	N/A	wa man (hk) limited	N/A	N/A	3/1/2022
XYLACLEAR TABLETS 5MG	N/A	SINO PACIFIC PHARMA COMPANY LIMITED	N/A	N/A	8/27/2014
LEVOCEN TABLETS 5MG	N/A	R. MANSTIEN (AUSTRALIA) LIMITED	N/A	N/A	4/6/2022
LEVOCET TABLETS 5MG	N/A	R. MANSTIEN (AUSTRALIA) LIMITED	N/A	N/A	11/3/2017
XYZAL ORAL DROPS 5MG/ML	N/A	葛兰素史克	N/A	N/A	8/11/2006

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
XYZAL levocetirizine dihydrochloride 5 mg/mL oral drops bottle	168143	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	1/19/2010
XYZAL levocetirizine hydrochloride 5 mg film coated tablet blister pack	150854	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	3/6/2008

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