CLINICAL TRIALS PROFILE FOR CETIRIZINE HYDROCHLORIDE HIVES

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.

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.

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

Condition MeSH

Condition MeSH for CETIRIZINE HYDROCHLORIDE HIVES
Intervention	Trials
Rhinitis, Allergic	34
Rhinitis	34
Rhinitis, Allergic, Seasonal	15
Urticaria	12

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
France	3
Japan	3

Trials by US State

Trials by US State for CETIRIZINE HYDROCHLORIDE HIVES
Location	Trials
Texas	9
Massachusetts	4
Maryland	4
Indiana	3
California	3

Clinical Trial Progress for CETIRIZINE HYDROCHLORIDE HIVES

Clinical Trial Phase

Clinical Trial Phase for CETIRIZINE HYDROCHLORIDE HIVES
Clinical Trial Phase	Trials
PHASE3	2
Phase 4	24
Phase 3	21

Clinical Trial Status

Clinical Trial Status for CETIRIZINE HYDROCHLORIDE HIVES
Clinical Trial Phase	Trials
Completed	70
RECRUITING	12
Unknown status	4

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

Sponsor Type

Sponsor Type for CETIRIZINE HYDROCHLORIDE HIVES
Sponsor	Trials
Industry	70
Other	51
NIH	2

CETIRIZINE HYDROCHLORIDE HIVES Clinical Trials Update, Market Analysis, and 2026+ Forecast

Last updated: May 21, 2026

Cetirizine hydrochloride for hives (urticaria/inducible urticaria) is a well-established, off-patent oral antihistamine in most markets. No active, company-defining late-stage development programs were identified in the provided context, and no reliable trial-by-trial update set can be generated to support a credible clinical-trials “update” narrative.

Market outlook for cetirizine in urticaria

• Commercial positioning: Broad OTC and prescription penetration; drug is widely used for chronic urticaria symptom control.
• Competitive set: Other second-generation antihistamines (loratadine, fexofenadine, levocetirizine, desloratadine) and newer agents for refractory chronic spontaneous urticaria (CSU) such as omalizumab and investigational biologics, which do not typically displace first-line oral antihistamines but compete for patients with inadequate response.
• Pricing and share drivers: Generic entry is the primary determinant in most countries; brands compete on label positioning (sleep/non-sleep claims, dosing convenience) and contracting.
• Projection logic: For established generics, near-term growth is dominated by (1) population growth, (2) OTC mix shifts, and (3) periodic guideline-driven prescribing. Durable market share gains are typically limited absent a new delivery system, superior tolerance profile at equal dosing, or a differentiated indication expansion.

Because the prompt does not include a jurisdiction, time horizon, competitor set, target patient type (acute vs chronic spontaneous urticaria vs inducible urticaria), or a specific commercial dataset, a complete and accurate, metrics-based market projection cannot be produced.

What clinical trials are updating cetirizine hydrochloride for hives (urticaria)?

Featured snippet answer: No specific current, late-stage, or label-expanding cetirizine hives trials can be listed from the information provided.

Are there phase 3 or phase 4 trials for cetirizine in chronic spontaneous urticaria?

• A credible “phase 3/4 update” requires trial registry-linked identifiers, sites, endpoints, and status dates. The supplied context contains none of these.

Do new formulations of cetirizine for urticaria have active studies?

• Formulation work (e.g., faster onset, pediatric or special packaging) would need trial IDs and sponsor details to be listed accurately. Not available.

Does cetirizine have ongoing trials for inducible urticaria (e.g., cold/pressure/sunlight)

• Inducible urticaria studies need registry and endpoint data. Not available.

How big is the market for cetirizine hydrochloride in hives/urticaria, and what drives demand?

Featured snippet answer: The urticaria segment is demand-stable but growth-constrained by generic competition and symptom-based dosing.

Demand drivers

• Guideline fit: Oral second-generation antihistamines remain standard first-line therapy for CSU symptom control.
• OTC availability: OTC distribution supports baseline volume.
• Dosing patterns: Standard dosing supports predictable consumption; escalation to higher antihistamine doses depends on clinician and label frameworks in each country.
• Patient behavior: Many patients self-manage mild episodes and only seek clinician care when symptoms persist.

Supply and pricing constraints

• Generic saturation: In most markets, multiple ANDA-equivalent or local generic products cap price.
• Promotional intensity: OTC brands compete on spend; net growth often tracks consumer and distributor category dynamics rather than new-to-market penetration.

Competitive displacement risk

• Second-generation antihistamine class competition: Switching among loratadine/fexofenadine/levocetirizine/desloratadine is common at pharmacy level.
• Biologics for refractory CSU: Omalizumab and other advanced therapies compete only after inadequate response to antihistamines; they reduce incremental upside for oral products at the severe end rather than in the broad first-line base.

When does cetirizine hydrochloride lose exclusivity for hives in major markets?

Featured snippet answer: Cetirizine hydrochloride is broadly off-patent; exclusivity is not a credible constraint for a 2026+ forecast based on the prompt’s content.

Patent estate gating (what would matter)

A forward-looking exclusivity map requires:

• reference product patent numbers,
• jurisdiction-specific filing and expiration,
• regulatory exclusivities (if any),
• formulation/process patents,
• and any Orange Book-type listings. No such dataset is provided in the prompt.

Which patents protect cetirizine hydrochloride for hives, and how strong is the patent estate?

Featured snippet answer: A strength assessment cannot be produced without the relevant patent list by jurisdiction, claim scope, and expiry dates.

What patent types usually exist for cetirizine in urticaria

• polymorph/formulation,
• method of treating urticaria with specific dosing,
• and pediatric-use formulations. A defensible count and expiry schedule require actual document retrieval.

What generic entry risks exist for cetirizine hydrochloride hives products?

Featured snippet answer: Generic entry risk is not a meaningful forecast variable for a mature, widely generic oral antihistamine in most geographies.

Paragraph IV / ANDA litigation scenario

• Paragraph IV frameworks apply primarily when reference product exclusivity exists. For cetirizine hives, a litigation-driven launch catalyst is not supported by the provided context.

How does cetirizine compare with loratadine, fexofenadine, and levocetirizine for urticaria efficacy and safety?

Featured snippet answer: Class effects dominate. Cetirizine and levocetirizine typically offer strong symptom relief; tolerability differentiators are mainly sedation risk and individual patient response.

Typical clinical differentiation in practice

• sedation is a key trade-off versus agents considered less sedating (e.g., fexofenadine),
• onset and perceived control drive preference,
• pediatric dosing formulations influence uptake.

Commercial implication

• switching happens at the margin through pharmacy access, formulary tiering, and OTC promotions, not through persistent label advantage.

What is the regulatory status of cetirizine hydrochloride for hives (FDA/EMA), and does it affect market growth?

Featured snippet answer: Regulatory status alone is unlikely to be growth-limiting for a long-established OTC/prescription product without a new indication expansion.

FDA label scope

• A label-based growth thesis requires current label language, pediatric sub-populations, and any recent label supplements. Not provided.

EMA/UK status

• A European segmentation requires product-specific authorization status, SmPC/PL updates, and whether any new product lines are targeting inducible urticaria. Not available.

Market forecast: revenue projection scenarios for cetirizine in urticaria

Featured snippet answer: A reliable numerical forecast cannot be generated from the prompt’s content. A projection framework can be stated, but not quantified, without market sizing inputs.

What a credible forecast model would include

• Geography: US, EU5, UK, Canada, GCC, LatAm, APAC splits.
• Channel: OTC versus Rx and formulary penetration.
• Mix: acute urticaria versus chronic spontaneous urticaria; pediatric share.
• Price: weighted average net price by channel and generic erosion rate.
• Share shifts: competitive antihistamines; severe CSU migration to biologics.

Scenario levers

• faster generic erosion (downside),
• OTC expansion and pediatric uptake (upside),
• increased penetration of advanced therapies among refractory CSU (downside for severe segment).

Key Takeaways

• Cetirizine hydrochloride for hives is a mature, widely available antihistamine; growth is constrained by generic competition in most markets.
• A clinical-trials “update” with identifiable trial milestones cannot be produced from the provided prompt content.
• A market projection cannot be quantified without market sizing, geography, and competitive pricing inputs.

FAQs

1. Is cetirizine effective for chronic spontaneous urticaria compared with antihistamines like fexofenadine?
2. Does cetirizine help inducible urticaria, and how do outcomes differ by subtype?
3. What OTC dosing patterns for urticaria drive unit and revenue in mature markets?
4. How do biologics for refractory CSU affect long-term demand for oral antihistamines?
5. What product differentiators (formulation, pediatric presentation, sedation claims) most influence switching among second-generation antihistamines for hives?

References

No sources were provided in the prompt.