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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR CETIRIZINE HYDROCHLORIDE HIVES


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505(b)(2) Clinical Trials for Cetirizine Hydrochloride Hives

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02024152 ↗ Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg Completed Algorithme Pharma Inc Phase 1 2011-03-01 This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.
OTC NCT02024152 ↗ Safety, Tolerability and Pharmacokinetics Trial of JDP-205 Injection 10 mg Completed JDP Therapeutics, Inc. Phase 1 2011-03-01 This study is to investigate the pharmacokinetics (PK) together with the safety and tolerability of JDP-205 at 5 mg and 10 mg intravenous doses and 10 mg intramuscular dose, in comparison to the marketed cetirizine oral product Zyrtec® 10 mg tablets (an OTC product) in healthy male and female volunteers after a single dose administration.
OTC NCT02865018 ↗ Neuromyelitis Optica (NMO) & Cetirizine Completed Guthy Jackson Charitable Foundation Phase 1/Phase 2 2014-04-01 Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system. Patients have relapses (also known as attacks) which are often quite severe and leave them with significant disability. Without treatment, within 5 years 50% of NMO patients are blind in one or both eyes or require walking assistance (cane, walker or wheelchair). NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system. This ultimately leads to disability, some of which is permanent. Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody. However, recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell. Specifically, researchers have noted the importance of a specific cell type, eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular over-the-counter allergy medicine. Cetirizine is already known to be safe and well-tolerated in the general population. In this study, the researchers plan to add cetirizine on to patients' current NMO treatment. The researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment. The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid.
OTC NCT02865018 ↗ Neuromyelitis Optica (NMO) & Cetirizine Completed Guthy Jackson Foundation Phase 1/Phase 2 2014-04-01 Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system. Patients have relapses (also known as attacks) which are often quite severe and leave them with significant disability. Without treatment, within 5 years 50% of NMO patients are blind in one or both eyes or require walking assistance (cane, walker or wheelchair). NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system. This ultimately leads to disability, some of which is permanent. Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody. However, recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell. Specifically, researchers have noted the importance of a specific cell type, eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular over-the-counter allergy medicine. Cetirizine is already known to be safe and well-tolerated in the general population. In this study, the researchers plan to add cetirizine on to patients' current NMO treatment. The researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment. The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cetirizine Hydrochloride Hives

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.
NCT00189397 ↗ Azathioprine Versus Corticosteroids in Parthenium Dermatitis Completed All India Institute of Medical Sciences, New Delhi N/A 2003-02-01 The dermatitis caused by the substances which come in contact with the skin is known as contact dermatitis. When such a reaction is caused by the agents suspended in the air, it is called air-borne contact dermatitis (ABCD). Parthenium hysterophorus at present is the commonest cause of ABCD in India though in some cases other plants have also been found to cause ABCD. Parthenium dermatitis is one of the major health problems in dermatology in our country. Though it has very little mortality, the disease normally continues to persist with variable remissions and relapses causing great distress and morbidity. Corticosteroids, topical and systemic have been the mainstay of the treatment so far. Therefore, the patients with ABCD who have to take corticosteroids for long periods of time tend to develop severe and sometimes irreversible side effects of the therapy. Azathioprine is an immunosuppressive drug which acts by inhibiting the T lymphocytes. In our previous studies we have been able to induce remissions in these patients with azathioprine used as daily as well as monthly bolus dose, without having to use systemic corticosteroids. The side effect with azathioprine in these studies were almost absent. We have therefore planned to study the therapeutic efficacy of azathioprine weekly pulse doses versus daily azathioprine in achieving remissions in patients having Parthenium dermatitis and to monitor the side effects of both the regimens.
NCT00253058 ↗ Study Of Perennial Allergic Rhinitis In Pediatrics Completed GlaxoSmithKline Phase 3 2005-07-01 To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period
NCT00257569 ↗ Study Of Atopic Dermatitis In Pediatrics Completed GlaxoSmithKline Phase 3 2005-08-01 To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cetirizine Hydrochloride Hives

Condition Name

Condition Name for Cetirizine Hydrochloride Hives
Intervention Trials
Allergic Rhinitis 11
Healthy 9
Seasonal Allergic Rhinitis 9
Urticaria 6
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Condition MeSH

Condition MeSH for Cetirizine Hydrochloride Hives
Intervention Trials
Rhinitis 34
Rhinitis, Allergic 33
Rhinitis, Allergic, Seasonal 15
Urticaria 12
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Clinical Trial Locations for Cetirizine Hydrochloride Hives

Trials by Country

Trials by Country for Cetirizine Hydrochloride Hives
Location Trials
United States 56
Canada 13
Germany 5
Italy 3
France 3
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Trials by US State

Trials by US State for Cetirizine Hydrochloride Hives
Location Trials
Texas 9
Massachusetts 4
Maryland 4
New York 3
Pennsylvania 3
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Clinical Trial Progress for Cetirizine Hydrochloride Hives

Clinical Trial Phase

Clinical Trial Phase for Cetirizine Hydrochloride Hives
Clinical Trial Phase Trials
Phase 4 24
Phase 3 21
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Cetirizine Hydrochloride Hives
Clinical Trial Phase Trials
Completed 69
Recruiting 10
Unknown status 4
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Clinical Trial Sponsors for Cetirizine Hydrochloride Hives

Sponsor Name

Sponsor Name for Cetirizine Hydrochloride Hives
Sponsor Trials
GlaxoSmithKline 12
UCB Pharma 6
Merck Sharp & Dohme Corp. 5
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Sponsor Type

Sponsor Type for Cetirizine Hydrochloride Hives
Sponsor Trials
Industry 69
Other 48
NIH 2
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Cetirizine Hydrochloride: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Cetirizine Hydrochloride

Cetirizine hydrochloride is a widely used second-generation antihistamine, marketed under brands such as Zyrtec and Aller-Tec. It is primarily used to treat various allergic conditions, including allergic rhinitis, allergic conjunctivitis, and hives. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Mechanism of Action and Therapeutic Uses

Cetirizine hydrochloride functions as an H1 receptor antagonist, reducing the effects of histamine in the body. This mechanism helps alleviate symptoms such as sneezing, watery eyes, runny nose, and itching associated with allergies and hives[1][5].

Clinical Trials Update

Several clinical trials have been conducted to assess the efficacy and safety of cetirizine hydrochloride. Here are some key updates:

  • Efficacy and Safety Studies: A multi-center, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of cetirizine hydrochloride in patients with seasonal allergic rhinitis and concomitant mild to moderate asthma. This study, involving the combination of cetirizine and pseudoephedrine, aimed to assess the drug's effectiveness in managing symptoms of both conditions[4].

  • Pediatric and Adult Populations: Clinical trials have included a wide range of populations, from infants to adults, to ensure the drug's safety and efficacy across different age groups. For instance, studies have been conducted on children and adolescents to evaluate the drug's performance in treating allergic rhinitis and other allergic conditions[4].

Market Analysis

The global market for cetirizine hydrochloride is substantial and continues to grow due to several factors.

Market Size and Growth

  • As of 2023, the global market for cetirizine hydrochloride was estimated to be worth US$ 839.2 million. It is forecasted to reach US$ 945.6 million by 2030, with a Compound Annual Growth Rate (CAGR) of 1.7% during the forecast period of 2024-2030[2].

  • Another report indicates that the market was valued at US$ 6.3 billion in 2024 and is projected to grow at a CAGR of 2.6% to reach US$ 8.0 billion by 2034[3].

Key Drivers

  • Increasing Prevalence of Allergic Conditions: The rise in allergic diseases such as eczema, food allergies, and allergic rhinitis is a significant driver. For example, according to the CDC, more than 1 in 4 American children and over 1 in 3 American adults reported having a food allergy, eczema, or seasonal allergy in 2021[3].

  • Public Awareness and Education: Growing public awareness of allergies and available treatments is another key driver. Increased awareness prompts more people to seek professional diagnoses and treatments, boosting demand for cetirizine hydrochloride[3].

Market Segmentation

  • By Type: The market is segmented into tablets, capsules, and solutions. These various forms cater to different patient needs and preferences[2].

  • By Application: The primary applications include hospitals, drug stores, and other retail outlets. The drug's availability over-the-counter (OTC) in pharmacies and supermarkets has significantly expanded its reach[5].

  • By Region: North America holds a dominant position due to the high prevalence of hay fever and allergic conjunctivitis. The Asia Pacific region is expected to witness the fastest growth due to an aging population, increased disposable income, and rising allergy awareness[3][5].

Key Players

The market is competitive, with several major players including Johnson & Johnson, UCB Pharma, GSK, Teva, HUAPONT Pharm, Sun Pharma, Mylan, Apotex, Jubilant Life Sciences, and HAILISHENG. These companies are focused on new product launches and expanding their market share[2][5].

Projections and Future Outlook

Market Growth Projections

  • The cetirizine hydrochloride market is expected to continue growing, driven by the increasing incidence of allergic conditions. By 2030, the market is projected to reach US$ 945.6 million, and by 2034, it is expected to reach US$ 8.0 billion[2][3].

Challenges and Restraints

  • Regulatory Challenges: Stringent regulations and the potential development of new medications could slow the growth rate of cetirizine hydrochloride. However, its established safety profile and effectiveness are expected to maintain its market position[3].

  • Side Effects: The drug can induce side effects such as insomnia, hyperactivity, and headache, which may limit its adoption in some cases. However, these side effects are generally mild to moderate and do not significantly hinder the market growth[5].

Regional Insights

  • North America: This region is expected to maintain a significant market share due to the high incidence of allergic rhinitis and urticaria. The economic burden of allergic diseases on the population also contributes to the market growth[3].

  • Asia Pacific: This region is anticipated to witness the fastest growth due to an aging population, greater disposable income, and increasing allergy awareness. Developing nations in this region offer considerable market potential[3].

  • Europe: The European market is expanding steadily, driven by an aging population and the rise in allergy prevalence among senior citizens[3].

  • Latin America and Middle East & Africa: These regions are emerging markets with growing healthcare spending, particularly due to an expanding middle class, which could propel the market for cetirizine hydrochloride[3].

Key Takeaways

  • Cetirizine hydrochloride is a widely used antihistamine for treating various allergic conditions.
  • The global market for cetirizine hydrochloride is projected to grow significantly, driven by the increasing prevalence of allergic diseases.
  • Key players are focusing on new product launches and expanding their market share.
  • The drug's availability in various forms and its OTC status have increased its accessibility.
  • Regulatory challenges and the development of new medications are potential restraints, but the drug's established safety profile is expected to maintain its market position.

FAQs

What is the primary mechanism of action of cetirizine hydrochloride?

Cetirizine hydrochloride functions as an H1 receptor antagonist, reducing the effects of histamine in the body to alleviate allergic symptoms.

What are the main therapeutic uses of cetirizine hydrochloride?

The drug is used to treat allergic rhinitis, allergic conjunctivitis, hives, and other allergic conditions.

What is the projected market size of cetirizine hydrochloride by 2030?

The global market for cetirizine hydrochloride is forecasted to reach US$ 945.6 million by 2030, with a CAGR of 1.7% during the forecast period of 2024-2030[2].

Which regions are expected to drive the growth of the cetirizine hydrochloride market?

North America is expected to maintain a significant market share, while the Asia Pacific region is anticipated to witness the fastest growth due to an aging population and increasing allergy awareness[3].

What are the potential restraints on the growth of the cetirizine hydrochloride market?

Stringent regulations and the potential development of new medications could slow the growth rate. Additionally, side effects such as insomnia and hyperactivity may limit adoption in some cases[3][5].

Sources

  1. Synapse: Cetirizine Hydrochloride - Drug Targets, Indications, Patents.
  2. Valuates Reports: Cetirizine Hydrochloride - Market Size.
  3. Prophecy Market Insights: Global Cetirizine Hydrochloride Market By Overview.
  4. EU Clinical Trials Register: A multi-center, randomized, double blind, placebo controlled study of the efficacy and safety of Zyrtex-D 12 hour.
  5. Coherent Market Insights: Global Cetirizine Hydrochloride Market Size And Forecast To 2026.

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