Xyzal

(levocetirizine)

ApprovedSmall molecule

Xyzal is a small molecule that works as a Histamine H1 Receptor Antagonist.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Xyzal is one of 160 small molecule programs targeting Allergic Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

159

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Allergic DiseaseActive, not recruiting

AsthmaApproved

RhinitisApproved

Vasomotor RhinitisApproved

Rhinitis, Allergic, PerennialApproved

Eczematoid DermatitisApproved

Colorectal NeoplasmApproved

Atopic EczemaApproved

UrticariaCompleted

Seasonal Allergic RhinitisCompleted

Allergic DiseaseApproved

Active, not recruiting

AsthmaApproved

Approved

RhinitisApproved

Approved

Vasomotor RhinitisApproved

Approved

Rhinitis, Allergic, PerennialApproved

Approved

Eczematoid DermatitisApproved

Approved

Colorectal NeoplasmApproved

Approved

Atopic EczemaApproved

Approved

UrticariaApproved

Completed

Seasonal Allergic RhinitisApproved

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Xyzal

CChattem

Approved

41 2

Celexa

AbbVie

Preclinical

1 3

Arcoxia

Novartis

Preclinical

—4

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 5

DUPIXENT

Regeneron

Preclinical

1 6

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 7

Paracetamol

GSK

Preclinical

1 8

Aclidinium Bromide

AstraZeneca

Preclinical

—9

Lexapro

SShirley Ryan AbilityLab

Preclinical

1 10

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Kidney Disease

NCT05638880

Q1 2032

N/ARecruiting

Rhinitis

NCT05348148

Clinical

Trials by Indication[1]

Allergic Rhinitis11 trials

Anti-inflammatory H1 Antihistamines Allergic Rhinitis

Completed·IIuliu Hatieganu University of Medicine and Pharmacy·Phase 4·NCT02507635·115 enrolled

Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis

Completed·IInstitut für Atemwegsforschung GmbH·Phase 4·NCT00355771·100 enrolled

LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

Completed· UCB logo

UCB·Phase 4·NCT00160589·729 enrolled

Show 8 more trials

Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis

Completed·IInstitut für Atemwegsforschung GmbH·Phase 4·NCT00439712·60 enrolled

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin

Completed· UCB logo

UCB·Phase 3·NCT00619801·173 enrolled

Completed· UCB logo

UCB·Phase 4·NCT00160537·200 enrolled

Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 3·NCT01640535·283 enrolled

ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

Completed· UCB logo

UCB·Phase 4·NCT00160680·62 enrolled

Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis

Completed·—·Phase 4·NCT00894231·30 enrolled

Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis

Completed· UCB logo

UCB·Phase 2·NCT00152412·30 enrolled

To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

Completed·BBrian J Lipworth·Phase 4·NCT00679250·25 enrolled

Urticaria4 trials

CUTE (Chronic Urticaria Treatment Evaluation)

Completed· UCB logo

UCB·Phase 4·NCT00264303·886 enrolled

Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Levocetirizine Alone in High Doses

Completed·AAssociation Asthma, Bulgaria·Phase 4·NCT01250652·24 enrolled

COrticosteroids in acUte uRticAria in emerGency dEpartment

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT03545464·137 enrolled

Show 1 more trial

Treatment Options for Chronic Urticaria

Not yet recruiting·SSheikh Zayed Medical College·Phase 2·NCT06816784·72 enrolled

Atopic Dermatitis2 trials

Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)

Completed· UCB logo

UCB·Phase 3·NCT00152464·514 enrolled

Prevention of Asthma With Levocetirizine (36 Month Treatment) in Young Children Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and House Dust Mite and Having Completed the Previous EPAAC Trial (NCT00152464)

Terminated· UCB logo

UCB·Phase 3·NCT00160563·207 enrolled

Seasonal Allergic Rhinitis2 trials

Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

Completed· UCB logo

UCB·Phase 4·NCT00295022·418 enrolled

A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

Completed· UCB logo

UCB·Phase 2·NCT00291642·551 enrolled

ESS2 trials

Is Levocetirizine Less Sedating Than Cetirizine?

Completed·VVanderbilt University·Phase 4·NCT00826943·30 enrolled

The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

Completed·OOrganon and Co·Phase 4·NCT00359138·36 enrolled

17 more indications

Dermatitis1 trial

Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

Completed· UCB logo

UCB·Phase 3·NCT00375713·466 enrolled

Kidney Disease1 trial

Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease

Recruiting·MMostafa Bahaa·Phase 2·NCT05638880·60 enrolled

Pediatrics1 trial

Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics

Completed· GSK logo

GSK·Phase 3·NCT01563081·60 enrolled

Chronic Idiopathic Urticaria1 trial

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Completed·FFaes Farma, S.A.·Phase 3·NCT00421109·522 enrolled

Motor Function1 trial

Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving

Completed·UUtrecht Institute for Pharmaceutical Sciences·Phase 4·NCT01496911·24 enrolled

Phase 11 trial

Phase 1 Study of Levocetirizine

Completed· GSK logo

GSK·Phase 1·NCT02447393·20 enrolled

ART1 trial

A Phase I Study of LY3471851 in Healthy Participants

Completed·NNektar Therapeutics·Phase 1·NCT05565729·41 enrolled

Interaction1 trial

A Drug Interaction Study of Montelukast and Levocetirizine

Completed· Hanmi Pharmaceutical Company Limited logo

Hanmi Pharmaceutical Company Limited·Phase 1·NCT01491503·30 enrolled

Drug1 trial

Drug Use Investigation for XYZAL®

Completed· GSK logo

GSK··NCT01445262·10,728 enrolled

Montelukast1 trial

Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

Completed· UCB logo

UCB·Phase 3·NCT00315523·403 enrolled

Nasal Obstruction1 trial

The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)

Completed·OOrganon and Co·Phase 3·NCT00789152·81 enrolled

Oral1 trial

Pharmacokinetic Study of Levocetirizine Oral Solution

Completed· GSK logo

GSK·Phase 1·NCT01622283·20 enrolled

Colorectal Cancer1 trial

Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT01722162·47 enrolled

Children1 trial

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months

Completed· UCB logo

UCB·Phase 3·NCT00628108·69 enrolled

Rhinitis1 trial

Comparison of the Effects for Lightening the Shiners Among Different Treatments for Rhinitis

Recruiting·—·N/A·NCT05348148·450 enrolled

Acute Lymphoblastic Leukemia1 trial

Wheal and Flare Reaction During 24 Hours in Allergic Volunteers.

Completed· UCB logo

UCB·Phase 1·NCT00521170

Unspecified4 trials

3-D Visualization of the Anti-Obstructive Effect of Levocetirizine

Completed·CClinical Research International Limited·Phase 3·NCT01000792·1 enrolled

Omnaris Versus Levocetirizine Phase 4 Study

Completed·HHandok Inc.·Phase 4·NCT01430260·349 enrolled

Facial Thermography Study of Levocetirizine Versus Cetirizine

Completed· UCB logo

UCB·Phase 4·NCT00150761·60 enrolled

Show 1 more trial

Safety Study of Levocetirizine and Fexofenadine

Completed·—·Phase 4·NCT01586091·18 enrolled

Regulatory

FDA Approval Timeline[4]

May 25, 2007

XYZAL

NDA NDA022064

Jan 28, 2008

XYZAL

NDA NDA022157

Jan 31, 2017

XYZAL ALLERGY 24HR

NDA NDA209090

Jan 31, 2017

XYZAL ALLERGY 24HR

NDA NDA209089

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for levocetirizine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — levocetirizine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for levocetirizine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209090). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xyzal. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Chattem company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histamine H1 Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CChattem

Patent Landscape[5]

Patent Cliff

Oct 16, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8633194Oct 16, 2027

Xyzal

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2032

Trials by Indication[1]

Allergic Rhinitis11 trials

Urticaria4 trials

Atopic Dermatitis2 trials

Seasonal Allergic Rhinitis2 trials

ESS2 trials

Dermatitis1 trial

Kidney Disease1 trial

Pediatrics1 trial

Chronic Idiopathic Urticaria1 trial

Motor Function1 trial

Phase 11 trial

ART1 trial

Interaction1 trial

Drug1 trial

Montelukast1 trial

Nasal Obstruction1 trial

Oral1 trial

Colorectal Cancer1 trial

Children1 trial

Rhinitis1 trial

Acute Lymphoblastic Leukemia1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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