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Last Updated: January 8, 2025

CLINICAL TRIALS PROFILE FOR LEVOCETIRIZINE HYDROCHLORIDE


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All Clinical Trials for LEVOCETIRIZINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00150761 ↗ Facial Thermography Study of Levocetirizine Versus Cetirizine Completed UCB Pharma Phase 4 2004-07-01 Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.
NCT00152412 ↗ Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis Completed UCB Pharma Phase 2 2004-06-01 4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years) suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy of the treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each of the 4 individual rhinitis symptom scores
NCT00152464 ↗ 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 Pharma Phase 3 2002-03-20 The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.
NCT00152464 ↗ 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 Pharma SA Phase 3 2002-03-20 The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for LEVOCETIRIZINE HYDROCHLORIDE

Condition Name

Condition Name for LEVOCETIRIZINE HYDROCHLORIDE
Intervention Trials
Allergic Rhinitis 13
Rhinitis 7
Rhinitis, Allergic, Seasonal 6
Urticaria 5
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Condition MeSH

Condition MeSH for LEVOCETIRIZINE HYDROCHLORIDE
Intervention Trials
Rhinitis 37
Rhinitis, Allergic 33
Urticaria 13
Chronic Urticaria 12
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Clinical Trial Locations for LEVOCETIRIZINE HYDROCHLORIDE

Trials by Country

Trials by Country for LEVOCETIRIZINE HYDROCHLORIDE
Location Trials
United States 71
Spain 7
Germany 6
India 5
France 5
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Trials by US State

Trials by US State for LEVOCETIRIZINE HYDROCHLORIDE
Location Trials
Texas 5
Missouri 4
Tennessee 4
Oklahoma 4
Georgia 4
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Clinical Trial Progress for LEVOCETIRIZINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for LEVOCETIRIZINE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 29
Phase 3 19
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for LEVOCETIRIZINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 57
Unknown status 3
Recruiting 3
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Clinical Trial Sponsors for LEVOCETIRIZINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for LEVOCETIRIZINE HYDROCHLORIDE
Sponsor Trials
UCB Pharma 30
GlaxoSmithKline 5
Hanmi Pharmaceutical Company Limited 3
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Sponsor Type

Sponsor Type for LEVOCETIRIZINE HYDROCHLORIDE
Sponsor Trials
Industry 60
Other 29
NIH 1
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LEVOCETIRIZINE HYDROCHLORIDE Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Levocetirizine Hydrochloride

Introduction

Levocetirizine Hydrochloride, a second-generation antihistamine, has been a cornerstone in the treatment of various allergic conditions, including respiratory hypersensitivity, dermatitis, and eczema. Here, we delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy and Safety Comparisons

A recent multicenter, double-blind, double-dummy, non-inferiority phase III trial compared the efficacy and safety of bilastine versus levocetirizine in Chinese patients. Although the primary focus was on bilastine, this study provides valuable insights into the performance of levocetirizine. The trial involved 28-day treatment with either bilastine 20 mg or levocetirizine 5 mg daily. The primary endpoint was the Total Symptom Score (TSS) for itching, wheals number, and size. Secondary endpoints included detailed TSS analysis, Urticaria Composite Score (UCS), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS), and Global Clinical Impression (GCI). The study found that both drugs had similar efficacy profiles, with levocetirizine showing a slightly higher rate of treatment-emergent adverse events (TEAEs) at 34.0% compared to bilastine at 30.2%[1].

Gender Differences in Pharmacokinetics

Another significant study investigated gender differences in the pharmacokinetics and pharmacodynamics of levocetirizine. This clinical trial, approved by the Ministry of Food and Drug Safety in Korea, analyzed plasma concentration values over time following the oral administration of levocetirizine 5 mg tablets. The results indicated that while there were differences in pharmacokinetic parameters between genders, such as higher maximum concentration and shorter half-life in females, these differences were not significant enough to warrant different dosage regimens for males and females in the absence of special disease factors like renal dysfunction[3].

Market Analysis

Market Size and Growth

The Levocetirizine Hydrochloride market has experienced substantial growth in recent years. As of 2023, the market size was valued at several billion USD and is projected to continue growing at a robust rate until 2031. The market is segmented by type (oral liquid, tablet) and application (hospitals, drugstores, others), with geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa contributing to its expansion[2].

Regional Consumption

North America is currently the largest consumer of Levocetirizine Hydrochloride globally. This region's high demand is driven by the prevalence of allergic conditions and the preference for second-generation antihistamines due to their efficacy and minimal side effects[5].

Market Dynamics

The market dynamics are influenced by several factors, including drivers such as increasing prevalence of allergic diseases, advancements in pharmaceutical technology, and growing healthcare expenditure. However, restraints like competition from other antihistamines and potential side effects also play a role. The market report provides a comprehensive analysis using Porter's 5 Forces Framework, macroeconomic evaluation, and a thorough pricing analysis to understand these dynamics[2].

Market Projections

Volume and Value Growth

The global Levocetirizine Dihydrochloride market volume was approximately 4 thousand tonnes in 2023 and is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 10.45% until 2034. This growth is expected to be driven by increasing demand for effective antihistamines and expanding healthcare infrastructure in emerging markets[5].

Competitive Landscape

The market is characterized by the presence of both established and emerging players. Prominent companies are profiled in market reports, including details on their product offerings and market-related factors. The competitive landscape is expected to remain dynamic, with companies focusing on product innovation, pricing strategies, and market penetration[2].

Key Takeaways

  • Clinical Efficacy: Levocetirizine Hydrochloride has been shown to be effective in treating allergic conditions, with comparable efficacy to other second-generation antihistamines.
  • Pharmacokinetics: Gender differences in pharmacokinetics are present but not significant enough to alter dosage regimens in most cases.
  • Market Growth: The market is expected to grow substantially until 2031, driven by increasing demand and healthcare expenditure.
  • Regional Dominance: North America is the largest consumer of Levocetirizine Hydrochloride, with other regions also showing significant growth.
  • Competitive Dynamics: The market is competitive, with both established and emerging players vying for market share through innovation and strategic pricing.

FAQs

Q1: What was the global market volume of Levocetirizine Dihydrochloride in 2023?

The global market volume of Levocetirizine Dihydrochloride was approximately 4 thousand tonnes in 2023[5].

Q2: Which region is the largest consumer of Levocetirizine Dihydrochloride?

North America is the largest consumer of Levocetirizine Dihydrochloride globally[5].

Q3: Are there significant gender differences in the pharmacokinetics of Levocetirizine Hydrochloride?

While there are differences in pharmacokinetic parameters between genders, they are not significant enough to warrant different dosage regimens in most cases[3].

Q4: What is the projected growth rate of the Levocetirizine Dihydrochloride market until 2034?

The market is anticipated to grow at a CAGR of 10.45% until 2034[5].

Q5: What are the primary drivers of the Levocetirizine Hydrochloride market growth?

The primary drivers include increasing prevalence of allergic diseases, advancements in pharmaceutical technology, and growing healthcare expenditure[2].

Sources

  1. Efficacy and safety of bilastine vs. levocetirizine for the treatment of... - Journal of Clinical Medicine.
  2. Levocetirizine Hydrochloride Market Size, Scope And Forecast Report - Market Research Intellect.
  3. Is Gender an Important Factor in the Precision Medicine Approach to ... - MDPI.
  4. Levocetirizine Hydrochloride - Drug Targets, Indications, Patents - Synapse.
  5. Levocetirizine Dihydrochloride Market Size, Share & Forecast 2034 - ChemAnalyst.

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