CLINICAL TRIALS PROFILE FOR CETIRIZINE HYDROCHLORIDE

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

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.

All Clinical Trials for Cetirizine 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.
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.
NCT00257595 ↗	Perennial Allergic Rhinitis In Pediatric Subjects	Completed	GlaxoSmithKline	Phase 3	2005-08-01	To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.

Clinical Trial Conditions for Cetirizine Hydrochloride

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Cetirizine Hydrochloride

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Cetirizine Hydrochloride

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Cetirizine Hydrochloride

Sponsor Name

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

Sponsor Type

Sponsor Type for Cetirizine Hydrochloride
Sponsor	Trials
Industry	69
Other	48
NIH	2

Clinical Trials Update, Market Analysis, and Projections for Cetirizine Hydrochloride

Last updated: July 16, 2025

Introduction

Cetirizine hydrochloride, a second-generation antihistamine, has been a cornerstone in allergy management since its approval by the U.S. Food and Drug Administration (FDA) in 1995 [1]. Marketed under brand names like Zyrtec and available as a generic, it effectively treats symptoms of allergic rhinitis, urticaria, and other histamine-mediated conditions by blocking H1 receptors with minimal sedation. As global allergy prevalence rises due to environmental factors and urbanization, cetirizine remains a high-demand therapeutic. This article examines recent clinical trials, current market dynamics, and future projections to guide stakeholders in pharmaceuticals, healthcare, and investment.

Recent Clinical Trials for Cetirizine Hydrochloride

Clinical research on cetirizine hydrochloride continues to evolve, focusing on expanding indications, optimizing formulations, and assessing long-term safety. Although the drug is off-patent and widely genericized, trials target niche applications and combination therapies.

In 2023, a Phase IV post-marketing surveillance study conducted by the European Medicines Agency (EMA) evaluated cetirizine's efficacy in pediatric populations with chronic urticaria [2]. Involving 1,200 children aged 2-12 across multiple European centers, the trial demonstrated a 75% reduction in symptom severity after 12 weeks of treatment, with no significant adverse events beyond mild drowsiness in 5% of participants. This builds on earlier FDA data from 2020, which confirmed cetirizine's safety profile in children under six [1].

Another key development occurred in 2022, when researchers at the National Institutes of Health (NIH) explored cetirizine's potential in managing allergic symptoms during the COVID-19 pandemic. A randomized controlled trial published in the Journal of Allergy and Clinical Immunology involved 500 adults with seasonal allergies and mild respiratory symptoms [3]. Results showed cetirizine reduced nasal congestion by 60% compared to placebo, suggesting its role as an adjunctive therapy for allergy-exacerbated respiratory conditions. However, the trial noted limitations, including no direct impact on viral load.

Ongoing trials include a Phase II study by Pfizer, initiated in 2024, investigating a fixed-dose combination of cetirizine with montelukast for severe allergic rhinitis [4]. Early interim data from 300 participants indicate improved symptom control rates of 80%, potentially positioning this formulation as a competitive alternative to standalone antihistamines. In contrast, generic manufacturers like Teva Pharmaceuticals are conducting bioavailability studies to enhance over-the-counter (OTC) accessibility, with results expected by mid-2025 [5].

These trials underscore cetirizine's versatility, with a focus on real-world evidence and combination therapies. The global clinical trial registry, ClinicalTrials.gov, lists over 50 active studies as of 2024, primarily in Asia and Europe, where allergy burdens are high [6].

Current Market Analysis

The global market for cetirizine hydrochloride reached $2.1 billion in 2023, driven by increasing allergy diagnoses and OTC availability [7]. North America dominates with a 40% market share, fueled by high consumer awareness and easy access through retailers like Walmart and CVS. In this region, generic versions account for 85% of sales, with Johnson & Johnson’s Zyrtec brand holding a 15% premium segment [8].

Key players include generic giants such as Sandoz (Novartis) and Mylan (now part of Viatris), which control 30% of the market through cost-effective production in India and China. Brand-name competitors like Sanofi, the original developer, maintain niche positioning via extended-release formulations. Pricing remains competitive, with generic tablets averaging $0.10 per unit, compared to $0.50 for branded versions [9].

Market segmentation reveals strong growth in the OTC sector, which comprised 70% of 2023 sales, as consumers seek self-treatment for seasonal allergies [7]. Emerging markets in Asia-Pacific, particularly China and India, are expanding rapidly, with a 12% compound annual growth rate (CAGR) from 2021-2023, driven by rising pollution-related allergies and government healthcare initiatives [10]. For instance, India's market surged 15% in 2023 due to increased e-commerce penetration via platforms like Flipkart.

Competitive dynamics show threats from alternatives like loratadine and fexofenadine, which offer similar efficacy with potentially fewer side effects. However, cetirizine's established safety record and lower cost provide a defensive edge. A 2023 IQVIA report highlights that cetirizine prescriptions grew 8% year-over-year in the U.S., outpacing rivals, partly due to its inclusion in allergy management guidelines by the American Academy of Allergy, Asthma & Immunology [11].

Regulatory factors, such as FDA approvals for new generic entrants, continue to influence supply chains. In 2024, the agency approved two additional abbreviated new drug applications (ANDAs), intensifying competition and potentially capping price increases [1].

Market Projections and Future Outlook

Looking ahead, the cetirizine hydrochloride market is poised for steady growth, projecting a value of $2.8 billion by 2030 at a 4.5% CAGR [7]. This expansion stems from demographic shifts, including an aging population more susceptible to allergies and climate change-induced pollen increases.

In North America and Europe, growth will moderate at 3-4% annually, supported by sustained OTC demand and digital health integrations, such as AI-driven symptom trackers recommending cetirizine [12]. For example, partnerships between pharmaceutical firms and telehealth providers like Teladoc could boost prescriptions by 20% through personalized allergy plans.

Asia-Pacific emerges as the fastest-growing region, with a projected 7% CAGR through 2030, driven by urbanization and air quality issues in countries like China [10]. Local manufacturers, such as Dr. Reddy's Laboratories, are scaling production to meet this demand, potentially capturing 25% of the regional market by 2027.

Challenges include patent expirations and biosimilar competition, but opportunities lie in innovative formulations. The ongoing Pfizer trial for combination therapies could add $500 million in annual revenue if approved, targeting underserved markets [4]. Additionally, regulatory approvals for pediatric and geriatric-specific doses may expand the addressable patient base by 15% [13].

Global forecasts from Grand View Research indicate that increasing healthcare spending, projected to reach $10 trillion worldwide by 2028, will sustain cetirizine's market [14]. However, stakeholders must monitor geopolitical risks, such as supply chain disruptions from U.S.-China trade tensions, which could raise production costs by 10-15% [15].

Key Takeaways

• Cetirizine hydrochloride's clinical trials continue to validate its efficacy in new contexts, such as pediatric urticaria and combination therapies, enhancing its market positioning.
• The current market, valued at $2.1 billion in 2023, is led by generics in North America and expanding rapidly in Asia-Pacific due to rising allergy prevalence.
• Future projections forecast 4.5% CAGR growth to $2.8 billion by 2030, driven by OTC demand and innovative formulations, offering investment opportunities in emerging markets.
• Businesses should prioritize R&D in combination products and digital health integrations to counter competition and capitalize on demographic trends.
• Regulatory vigilance is essential to navigate approvals and supply chain risks, ensuring sustained profitability.

Frequently Asked Questions

1. What are the primary uses of cetirizine hydrochloride?
   Cetirizine is primarily used to relieve symptoms of hay fever, allergic rhinitis, and hives by blocking histamine effects, making it effective for seasonal and year-round allergies.

2. How do recent clinical trials impact cetirizine's market potential?
   Recent trials, such as those for pediatric urticaria and COVID-19-related allergies, expand cetirizine's applications, potentially increasing market share by supporting new formulations and indications.

3. What factors are driving growth in the cetirizine market?
   Growth is fueled by rising global allergy rates, OTC accessibility, and expansion in Asia-Pacific, with projections indicating a 4.5% CAGR through 2030.

4. How does cetirizine compare to competitors like loratadine?
   Cetirizine offers similar efficacy to loratadine but may cause more drowsiness; however, its lower cost and established presence make it a preferred choice in cost-sensitive markets.

5. What risks should investors consider for cetirizine-related investments?
   Investors should watch for generic competition, supply chain disruptions, and regulatory changes, which could affect pricing and profitability in the coming years.

References

[1] U.S. Food and Drug Administration. (2020). Drug approval package for cetirizine hydrochloride. FDA.gov.
[2] European Medicines Agency. (2023). Post-marketing surveillance report on cetirizine in pediatric populations. EMA.europa.eu.
[3] Journal of Allergy and Clinical Immunology. (2022). Efficacy of cetirizine in allergic symptoms during COVID-19. JACI.org.
[4] Pfizer Inc. (2024). Clinical trial updates for cetirizine-montelukast combination. ClinicalTrials.gov.
[5] Teva Pharmaceuticals. (2023). Bioavailability study for generic cetirizine formulations. Teva.com.
[6] ClinicalTrials.gov. (2024). Active trials for cetirizine hydrochloride. NIH.gov.
[7] Grand View Research. (2023). Global antihistamines market analysis. GrandViewResearch.com.
[8] IQVIA Institute. (2023). U.S. pharmaceutical market report. IQVIA.com.
[9] Sandoz Pharmaceuticals. (2023). Pricing data for generic cetirizine. Sandoz.com.
[10] MarketsandMarkets. (2023). Asia-Pacific antihistamines market forecast. MarketsandMarkets.com.
[11] American Academy of Allergy, Asthma & Immunology. (2023). Allergy management guidelines. AAAAI.org.
[12] Teladoc Health. (2024). Integration of allergy treatments in telehealth. Teladoc.com.
[13] World Health Organization. (2024). Guidelines on pediatric drug formulations. WHO.int.
[14] Grand View Research. (2023). Global healthcare spending projections. GrandViewResearch.com.
[15] U.S. Department of Commerce. (2024). Trade tensions and pharmaceutical supply chains. Commerce.gov.