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Last Updated: February 9, 2025

CLINICAL TRIALS PROFILE FOR ZYRTEC HIVES RELIEF


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505(b)(2) Clinical Trials for Zyrtec 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 Zyrtec Hives Relief

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
NCT00420082 ↗ A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Completed Faes Farma, S.A. Phase 2 2006-10-01 This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
NCT00504933 ↗ Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis Completed Faes Farma, S.A. Phase 3 2005-05-01 The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zyrtec Hives Relief

Condition Name

Condition Name for Zyrtec Hives Relief
Intervention Trials
Healthy 6
Allergic Rhinitis 6
Seasonal Allergic Rhinitis 5
Perennial Allergic Rhinitis 4
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Condition MeSH

Condition MeSH for Zyrtec Hives Relief
Intervention Trials
Rhinitis 13
Rhinitis, Allergic 12
Rhinitis, Allergic, Seasonal 6
Rhinitis, Allergic, Perennial 4
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Clinical Trial Locations for Zyrtec Hives Relief

Trials by Country

Trials by Country for Zyrtec Hives Relief
Location Trials
United States 13
Canada 3
Austria 1
Korea, Republic of 1
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Trials by US State

Trials by US State for Zyrtec Hives Relief
Location Trials
Maryland 3
Texas 3
Georgia 1
Indiana 1
Illinois 1
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Clinical Trial Progress for Zyrtec Hives Relief

Clinical Trial Phase

Clinical Trial Phase for Zyrtec Hives Relief
Clinical Trial Phase Trials
Phase 4 12
Phase 3 5
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Zyrtec Hives Relief
Clinical Trial Phase Trials
Completed 27
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Zyrtec Hives Relief

Sponsor Name

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

Sponsor Type for Zyrtec Hives Relief
Sponsor Trials
Industry 28
Other 12
NIH 2
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Zyrtec Hives Relief: Clinical Trials, Market Analysis, and Projections

Introduction to Zyrtec Hives Relief

Zyrtec, known generically as cetirizine hydrochloride, is a widely used antihistamine for treating various allergic conditions, including hives. Here, we will delve into the clinical trials, market analysis, and projections for Zyrtec in the context of hives relief.

Clinical Trials and Efficacy

Mechanism of Action

Cetirizine hydrochloride belongs to the antihistamine drug class, which works by reducing the natural chemical histamine in the body. Histamine is responsible for symptoms such as itching, sneezing, and runny nose, making cetirizine an effective treatment for hives and other allergic reactions[5].

Clinical Studies

While specific clinical trials focused solely on Zyrtec for hives relief might not be as extensive as those for other conditions like allergic rhinitis, the drug's efficacy in treating hives is well-established. Studies on antihistamines, including cetirizine, have shown significant relief from itching and hives. For instance, H1-antihistamines like cetirizine are the first-line pharmacological intervention for chronic hives due to their demonstrable efficacy and favorable safety profile[3].

Market Analysis

Global Market Size and Growth

The global cetirizine hydrochloride market was valued at US$ 1,100 million in 2017 and is expected to exhibit a robust Compound Annual Growth Rate (CAGR) of 3.2% over the forecast period from 2018 to 2026. This growth is driven by the increasing incidence of allergic conditions such as allergic rhinitis, allergic conjunctivitis, and eczema[5].

Regional Dominance

North America holds a dominant position in the global cetirizine hydrochloride market due to the high prevalence of hay fever and allergic conjunctivitis in the U.S. The economic burden caused by allergic diseases also contributes to the market growth in this region[5].

Market Drivers

  • Increasing Incidence of Allergic Conditions: The high prevalence of allergic rhinitis, allergic conjunctivitis, and other allergic conditions drives the demand for cetirizine hydrochloride.
  • Financial Support and Research: Increased financial support for researchers to develop novel interventions and growing awareness in developing countries about infections and diseases further accelerate market growth[2][5].

Market Challenges

Despite the favorable market conditions, the cetirizine hydrochloride market faces challenges such as:

  • Side Effects: The drug can induce severe to moderate side effects, including insomnia, hyperactivity, uneven heartbeat, nausea, constipation, and headache, which can limit its adoption[5].

Market Projections

Forecast Period

The global cetirizine hydrochloride market is expected to continue growing over the forecast period from 2018 to 2026. Here are some key projections:

  • Market Size: The market is expected to grow from US$ 1,100 million in 2017 to a higher value by 2026, driven by the increasing incidence of allergic conditions and the drug's efficacy in treating these conditions[5].
  • Regional Growth: North America is expected to maintain its dominance, while the Asia-Pacific region is anticipated to witness high growth due to the increase in research projects and growing awareness about allergic diseases[2][5].

Competitive Landscape

Other Treatment Options

The hives treatment market is competitive, with various treatment options available, including:

  • H2 Antagonists: These drugs are used in combination with H1-antihistamines for more severe cases.
  • Tricyclic Antidepressants: Used in some cases of chronic urticaria.
  • Immunotherapies: Drugs like XOLAIR (omalizumab) are used for patients who do not respond to antihistamines[3][4].

Emerging Treatments

New treatments like remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, are being investigated for chronic spontaneous urticaria (CSU). These emerging treatments may offer alternative options for patients who do not respond to traditional antihistamines like cetirizine[1].

Patient Epidemiology

Prevalence of Hives

Hives, or urticarial, affect a significant portion of the global population. The increase in the number of people suffering from hives is a major factor driving the growth of the hives treatment market. Chronic spontaneous urticaria, in particular, has a significant impact on patients' quality of life, necessitating effective and long-term treatment options[2][3].

Conclusion

Zyrtec Hives Relief, through its active ingredient cetirizine hydrochloride, remains a cornerstone in the treatment of hives due to its efficacy and safety profile. The market for cetirizine hydrochloride is expected to grow, driven by the increasing incidence of allergic conditions and the drug's established role in treating these conditions.

Key Takeaways

  • Efficacy: Cetirizine hydrochloride is effective in treating hives and other allergic reactions.
  • Market Growth: The global cetirizine hydrochloride market is projected to grow at a CAGR of 3.2% from 2018 to 2026.
  • Regional Dominance: North America dominates the market due to high prevalence of allergic conditions.
  • Emerging Treatments: New treatments like remibrutinib are being investigated, offering alternative options for patients.

FAQs

Q: What is the primary mechanism of action of Zyrtec in treating hives? A: Zyrtec works by reducing the natural chemical histamine in the body, which is responsible for symptoms such as itching and hives.

Q: What is the expected growth rate of the global cetirizine hydrochloride market? A: The global cetirizine hydrochloride market is expected to exhibit a robust CAGR of 3.2% over the forecast period from 2018 to 2026.

Q: Which region dominates the global cetirizine hydrochloride market? A: North America holds a dominant position in the global cetirizine hydrochloride market due to the high prevalence of hay fever and allergic conjunctivitis.

Q: What are some common side effects of cetirizine hydrochloride? A: Common side effects include insomnia, hyperactivity, uneven heartbeat, nausea, constipation, and headache.

Q: Are there emerging treatments for chronic spontaneous urticaria? A: Yes, new treatments like remibrutinib, a highly selective BTK inhibitor, are being investigated for chronic spontaneous urticaria.

Sources

  1. Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria. Novartis.
  2. Global Hives Treatment Market - Industry Trends and Forecast to 2028. Data Bridge Market Research.
  3. Chronic Spontaneous Urticaria Market - Trends, Size, Share .... Coherent Market Insights.
  4. XOLAIR® (omalizumab) Clinical Results For Chronic Hives & Itching. XOLAIR.
  5. Cetirizine Hydrochloride Market Size And Forecast To 2026. Coherent Market Insights.

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