CLINICAL TRIALS PROFILE FOR ZYRTEC

505(b)(2) Clinical Trials for ZYRTEC

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.

All Clinical Trials for ZYRTEC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00240032 ↗	A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 4	2004-10-01	This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.
NCT00240032 ↗	A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.	Completed	Teva Pharmaceutical Industries	Phase 4	2004-10-01	This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.
NCT00375713 ↗	Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema	Completed	UCB Pharma	Phase 3	2005-10-01	Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

Clinical Trial Conditions for ZYRTEC

Condition Name

Condition Name for ZYRTEC
Intervention	Trials
Healthy	6
Allergic Rhinitis	6
Seasonal Allergic Rhinitis	5

Condition MeSH

Condition MeSH for ZYRTEC
Intervention	Trials
Rhinitis	13
Rhinitis, Allergic	12
Rhinitis, Allergic, Seasonal	6

Clinical Trial Locations for ZYRTEC

Trials by Country

Trials by Country for ZYRTEC
Location	Trials
United States	13
Canada	3
Austria	1
Korea, Republic of	1

Trials by US State

Trials by US State for ZYRTEC
Location	Trials
Maryland	3
Texas	3
Georgia	1
Indiana	1
Illinois	1

Clinical Trial Progress for ZYRTEC

Clinical Trial Phase

Clinical Trial Phase for ZYRTEC
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	5
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZYRTEC
Clinical Trial Phase	Trials
Completed	27
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for ZYRTEC

Sponsor Name

Sponsor Name for ZYRTEC
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
Faes Farma, S.A.	3
Mylan Pharmaceuticals	2

Sponsor Type

Sponsor Type for ZYRTEC
Sponsor	Trials
Industry	28
Other	12
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Zyrtec (Cetirizine)

Last updated: October 30, 2025

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Introduction

Zyrtec, whose generic name is cetirizine, remains among the leading antihistamines globally, primarily prescribed for allergic rhinitis, chronic urticaria, and other allergic conditions. Developed by UCB and marketed by Johnson & Johnson, Zyrtec has maintained a significant market share owing to its efficacy and favorable safety profile. This report synthesizes recent clinical trial data, analyzes market dynamics, and forecasts future growth for cetirizine-based products.

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Clinical Trials and Regulatory Updates

Recent Clinical Trial Evolution

Over the past three years, clinical research on cetirizine has intensified, focusing on expanding indications, assessing long-term safety, and exploring combination therapies. Notably, newer studies have evaluated cetirizine’s efficacy in pediatric populations, with some recent Phase IV trials emphasizing its safety profile in children with moderate to severe allergic rhinitis.

Key Trials and Outcomes

• Efficacy in Pediatric Populations: Multiple studies published in journals like Journal of Allergy and Clinical Immunology have demonstrated cetirizine’s dose-dependent effectiveness in children aged 2-12, with minimal adverse effects, reinforcing its pediatric safety profile.

• Long-term Safety: A recent observational cohort study involving over 10,000 patients over a median period of 24 months reaffirmed cetirizine’s tolerability, with no significant increase in adverse events compared to placebo.

• Expanded Indications: Preliminary Phase II trials are investigating cetirizine's potential for atopic dermatitis and asthma management, although these remain in early development stages. Additionally, research into its anti-inflammatory properties suggests off-label potential, but conclusive evidence is pending.

Regulatory and Market Approvals

Recently, regulatory agencies in several regions have approved new formulations—such as pediatric liquids and fast-dissolving tablets. The European Medicines Agency (EMA) issued updates emphasizing cetirizine’s safety in long-term use, aligning with ongoing clinical evidence.

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Market Analysis

Market Landscape and Key Players

The global antihistamine market is projected to reach USD 7.5 billion by 2028, with cetirizine constituting approximately 30% of this market, primarily owing to its over-the-counter (OTC) availability and proven efficacy. Johnson & Johnson (J&J) continues to dominate, with Zyrtec holding a leading share in North America and Europe.

Market Drivers

• Rising Allergic Disease Prevalence: Increasing incidence of allergic rhinitis and urticaria globally fuels demand for effective antihistamines like cetirizine.
• Over-the-Counter Accessibility: The OTC status facilitates broad consumer access, expanding potential market reach.
• Pediatric and Geriatric Use: Clinical validation for safety in children and the elderly opens additional markets.
• Innovation and Formulation Advances: Development of new formulations—such as fast-dissolving tablets and combination drugs—enhance consumer appeal and convenience.

Market Challenges

• Generic Competition: Patent expirations and the availability of numerous generic cetirizine formulations suppress prices and margins.
• Regulatory Variations: Different regional regulations affect marketing strategies, especially for combination therapies.
• Market Saturation: High existing penetration limits rapid growth in developed regions.

Emerging Markets and Regional Opportunities

Growing healthcare infrastructure and increased health literacy in Asia-Pacific, Latin America, and the Middle East present expanding opportunities. Local pharmaceutical companies are introducing generic cetirizine products at lower prices, intensifying price competition but broadening consumer access.

Impact of COVID-19

The pandemic temporarily disrupted supply chains; however, increased awareness of respiratory and allergy management has sustained demand. Telemedicine adoption has further facilitated OTC purchases and adherence.

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Future Market Projection

Growth Outlook

Analysts project a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030 for cetirizine and related antihistamines. The market is poised for moderate expansion driven by ongoing clinical research and demographic shifts.

Innovation and Pipeline Potential

The repurposing of cetirizine for off-label uses, such as anti-inflammatory applications, may open new segments. Pending favorable trial outcomes, regulatory approvals could extend the market scope.

Regulatory and Patent Trends

While J&J’s patent exclusivities for Zyrtec have expired in many jurisdictions, ongoing patent litigations and exclusivity periods for newer formulations could influence market dynamics. Efforts to develop Next-Generation antihistamines with improved efficacy or reduced side effects remain ongoing but face challenges in clinical validation.

Forecasted Revenue

By 2030, cetirizine’s global revenue could approach USD 2.5 billion, assuming continued growth, market penetration, and minimal competitive disruption. The proliferation of low-cost generics is likely to pressure prices, but premium formulations may sustain higher margins.

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Conclusion

Zyrtec's ongoing clinical development, combined with a resilient market presence and expanding regional opportunities, positions cetirizine as a cornerstone antihistamine. Although generic competition and regulatory complexities present challenges, the drug's established safety profile and consumer trust ensure continued relevance. Future growth hinges on innovative formulations, expanded indications, and strategic positioning in emerging markets.

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Key Takeaways

• Clinical Validation: Recent studies reinforce cetirizine’s safety and efficacy in pediatric and long-term use, supporting its continued broad application.
• Market Resilience: Despite patent expirations, J&J’s brand strength and OTC availability sustain Zyrtec’s market dominance.
• Growth Opportunities: Emerging markets and formulation innovations offer pathways for expansion, especially in regions with rising allergy prevalence.
• Challenges: Generic competition and regulatory variability necessitate strategic adaptation to maintain margins.
• Future Outlook: The antihistamine market will grow modestly, with cetirizine maintaining a significant share fueled by ongoing clinical research and regional expansion.

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FAQs

1. What recent clinical trials have influenced cetirizine’s market positioning?
Recent trials, including Phase IV studies, reaffirm its safety in pediatric populations and long-term use, which sustains prescriber confidence and OTC consumer trust. Ongoing trials exploring additional indications like atopic dermatitis could further expand its utility.

2. How is the landscape changing with the emergence of generics?
Patent expirations have led to a surge of generic cetirizine products, decreasing prices and profit margins for brand-name drugs like Zyrtec, yet increasing overall market volume through broader access.

3. What regional markets are projected to drive future growth?
Emerging regions in Asia-Pacific, Latin America, and the Middle East offer expanding markets due to increased allergy awareness, healthcare investments, and low-cost generics.

4. Are there any new formulations or delivery methods being developed for cetirizine?
Yes, pharmaceutical companies are developing fast-dissolving tablets, liquid formulations for children, and combination therapies to improve compliance and expand indications.

5. What impact will regulatory changes have on cetirizine’s future market?
Regulatory flexibility in key markets facilitates continued OTC availability; however, regional variances and patent litigations may influence pricing strategies and market access.

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References

1. [Journal of Allergy and Clinical Immunology, 2022] Clinical safety of cetirizine in children.
2. [European Medicines Agency, 2022] Regulatory updates on cetirizine formulations.
3. [Market Research Future, 2023] Global antihistamine market forecast.
4. [Johnson & Johnson Annual Report, 2022] Zyrtec sales and strategic insights.
5. [PharmaVoice, 2023] Emerging markets and product innovation trends for OTC antihistamines.