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Last Updated: July 8, 2025

CLINICAL TRIALS PROFILE FOR CETIRIZINE HYDROCHLORIDE HIVES RELIEF


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

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.
OTC NCT02865018 ↗ Neuromyelitis Optica (NMO) & Cetirizine Completed Icahn School of Medicine at Mount Sinai 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 Relief

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.
NCT00257582 ↗ Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics Completed GlaxoSmithKline Phase 3 2005-08-01 To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cetirizine Hydrochloride Hives Relief

Condition Name

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

Trials by Country

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

Trials by US State for Cetirizine Hydrochloride Hives Relief
Location Trials
Texas 9
Massachusetts 4
Maryland 4
Ohio 3
Indiana 3
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Clinical Trial Progress for Cetirizine Hydrochloride Hives Relief

Clinical Trial Phase

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

Sponsor Name

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

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

Last updated: January 1, 2025

Introduction

Cetirizine hydrochloride is a widely used antihistamine that belongs to the second-generation class of antihistamines. It is renowned for its efficacy in treating various allergic conditions, including allergic rhinitis, allergic conjunctivitis, and hives. This article delves into the recent clinical trials, market analysis, and future projections for cetirizine hydrochloride, particularly focusing on its use in relieving hives and other allergic symptoms.

Clinical Trials and Efficacy

Allergic Rhinitis and Asthma

Clinical trials have consistently demonstrated the efficacy of cetirizine hydrochloride in treating allergic rhinitis and mild to moderate asthma. In a six-week, placebo-controlled study involving 186 patients, cetirizine hydrochloride at a dose of 10 mg once daily significantly improved rhinitis symptoms without altering pulmonary function[1].

Pediatric Patients

In pediatric patients, cetirizine hydrochloride has shown safety and efficacy. A four-week clinical trial in pediatric patients aged 6 to 11 years found that doses of 5 or 10 mg did not increase the QTc interval compared to placebo. Similar safety was observed in younger children, with studies involving patients aged 6 to 11 months and 12 to 24 months showing no significant ECG abnormalities or QTc interval increases[1].

Acute Urticaria

A phase 3 clinical trial comparing intravenous (IV) cetirizine with IV diphenhydramine for the treatment of acute urticaria revealed that IV cetirizine had comparable efficacy in reducing pruritus severity. Notably, IV cetirizine caused fewer adverse effects, particularly less sedation, compared to IV diphenhydramine[3].

Safety Profile

QTc Interval

Extensive studies have evaluated the effect of cetirizine hydrochloride on the QTc interval. In healthy adult males, doses up to 60 mg per day (six times the maximum clinical dose) did not result in significant QTc prolongation. However, when combined with ketoconazole, a mean increase in QTc of 9.1 msec was observed, although this is still within clinically acceptable limits[1].

Side Effects

While generally well-tolerated, cetirizine hydrochloride can induce side effects such as insomnia, hyperactivity, uneven heartbeat, nausea, constipation, and headache. These side effects, although common, are typically mild to moderate and do not significantly hinder its use[5].

Market Analysis

Global Market Size

The global market for cetirizine hydrochloride was valued at US$ 839.2 million in 2023 and is projected 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].

Key Players

The market is dominated by several major pharmaceutical companies, including J & J, UCB Pharma, GSK, Teva, HUAPONT Pharm, Sun Pharma, and others. These companies play a crucial role in the production, distribution, and marketing of cetirizine hydrochloride products[2].

Regional Market

North America holds a dominant position in the global cetirizine hydrochloride market due to the high prevalence of allergic conditions such as hay fever and allergic conjunctivitis. The region's market growth is further driven by the significant economic burden caused by these allergic diseases[5].

Market Projections

Growth Drivers

The increasing incidence of allergic conditions, including allergic rhinitis, allergic conjunctivitis, and eczema, is expected to drive the growth of the cetirizine hydrochloride market. According to the American Academy of Allergy Asthma and Immunology, allergic rhinitis affects around 10% to 30% of the global population, with higher prevalence rates in North America[5].

Dosage Forms

The market is segmented by dosage forms, including tablets, capsules, and solutions. The solution form, particularly the oral solution, is gaining popularity due to its ease of administration, especially in pediatric patients[5].

Economic Impact

The economic burden of allergic diseases is substantial, with allergies being the sixth leading cause of chronic illness in the U.S. and resulting in an annual expenditure of over US$ 18 billion. The use of cetirizine hydrochloride can help reduce this burden by providing effective relief from allergic symptoms[5].

Budget Impact Analysis

Emergency Department Costs

A budget impact analysis comparing IV cetirizine with IV diphenhydramine for the treatment of acute urticaria in the emergency department setting showed that IV cetirizine could lead to lower total annual costs due to reduced need for return visits and lower drug costs. This analysis supports the inclusion of IV cetirizine in hospital formularies for treating acute urticaria[3].

Conclusion

Cetirizine hydrochloride remains a cornerstone in the treatment of various allergic conditions, including hives, allergic rhinitis, and acute urticaria. The drug's safety and efficacy have been well-documented in numerous clinical trials, and its market is expected to grow driven by the increasing prevalence of allergic diseases.

Key Takeaways

  • Efficacy: Cetirizine hydrochloride is effective in treating allergic rhinitis, asthma, and acute urticaria.
  • Safety: The drug has a favorable safety profile, with minimal impact on the QTc interval and fewer side effects compared to first-generation antihistamines.
  • Market Size: The global market for cetirizine hydrochloride is projected to reach US$ 945.6 million by 2030.
  • Growth Drivers: Increasing incidence of allergic conditions and the economic burden of these diseases drive market growth.
  • Regional Dominance: North America dominates the market due to high prevalence rates of allergic conditions.

FAQs

What are the common uses of cetirizine hydrochloride?

Cetirizine hydrochloride is commonly used to treat allergic rhinitis, allergic conjunctivitis, hives, and acute urticaria.

What is the typical dosage of cetirizine hydrochloride?

The typical dosage for adults is 10 mg once daily, while pediatric dosages vary based on age and weight.

Is cetirizine hydrochloride safe for pediatric patients?

Yes, cetirizine hydrochloride has been shown to be safe in pediatric patients, including those as young as 6 months old, in various clinical trials.

What are the potential side effects of cetirizine hydrochloride?

Common side effects include insomnia, hyperactivity, uneven heartbeat, nausea, constipation, and headache.

How does the market for cetirizine hydrochloride project to grow in the future?

The market is expected to grow at a CAGR of 1.7% from 2024 to 2030, driven by the increasing incidence of allergic conditions and the economic burden of these diseases.

Sources

  1. Drugs.com: Cetirizine Oral Solution: Package Insert / Prescribing Info.
  2. Valuates Reports: Cetirizine Hydrochloride - Market Size.
  3. AHDB Online: Budget Impact of Intravenous Cetirizine Hydrochloride for the Treatment of Acute Urticaria in the Emergency Department Setting.
  4. Synapse: Cetirizine Hydrochloride - Drug Targets, Indications, Patents.
  5. Coherent Market Insights: Cetirizine Hydrochloride Market Size And Forecast To 2026.

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