CLINICAL TRIALS PROFILE FOR HYDROXYZINE

All Clinical Trials for hydroxyzine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00162786 ↗	Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance	Terminated	J. Uriach and Company	Phase 4	2005-05-01	The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers' performance on a standard over-the-road driving test and a car-following test.
NCT00202514 ↗	Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms	Completed	Abbott	Phase 2/Phase 3	2004-09-01	The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
NCT00202514 ↗	Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms	Completed	Seattle Institute for Biomedical and Clinical Research	Phase 2/Phase 3	2004-09-01	The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
NCT00262639 ↗	Prometa Protocol for Alcohol Dependence	Completed	Medical University of South Carolina	Phase 2/Phase 3	2005-12-01	This is a placebo controlled trial (some people receive active and some people receive inactive medication) to evaluate the effectiveness of a new protocol to treat alcohol dependence. Two main medications (plus ancillary non-placebo controlled medications) and their placebos (inactive drugs) will be utilized to treat both alcohol withdrawal, promote abstinence, and reduce drinking over approximately a six-week treatment period. All participants will meet criteria for Alcohol Dependence and be drinking heavily up until 72 hours prior to receiving the first study drug. They will be injected one drug (flumazenil or placebo) over a two day period and receive the second one (gabapentin or placebo) by mouth for 39 days. The main hypothesis is that this protocol will reduce early alcohol withdrawal symptoms and will reduce relapse to drinking and promote abstinence compared to the placebo (inactive) drug group. Secondary outcomes that will be evaluated include reduction in craving, improvement in sleep, brain activity and mood.
NCT00661674 ↗	Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal	Completed	Stanford University	N/A	2008-04-01	Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).
NCT01055236 ↗	Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients	Completed	Mahidol University	Phase 4	2007-08-01	Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.
NCT01139671 ↗	Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery	Completed	University Hospital, Clermont-Ferrand	Phase 4	2010-06-01	Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery. The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.

Clinical Trial Conditions for hydroxyzine

Condition Name

Condition Name for hydroxyzine
Intervention	Trials
Anxiety	3
Nausea	2
Postoperative Pain	2
Hydroxyzine	2

Condition MeSH

Condition MeSH for hydroxyzine
Intervention	Trials
Anxiety Disorders	4
Disease	3
Opioid-Related Disorders	3
Pain, Postoperative	2

Clinical Trial Locations for hydroxyzine

Trials by Country

Trials by Country for hydroxyzine
Location	Trials
United States	11
France	7
Egypt	2
Netherlands	2
Saudi Arabia	1

Trials by US State

Trials by US State for hydroxyzine
Location	Trials
Virginia	2
Washington	2
Maryland	1
North Carolina	1
District of Columbia	1

Clinical Trial Progress for hydroxyzine

Clinical Trial Phase

Clinical Trial Phase for hydroxyzine
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	15
Phase 3	5

Clinical Trial Status

Clinical Trial Status for hydroxyzine
Clinical Trial Phase	Trials
Completed	17
Not yet recruiting	4
Recruiting	3

Clinical Trial Sponsors for hydroxyzine

Sponsor Name

Sponsor Name for hydroxyzine
Sponsor	Trials
University Hospital, Clermont-Ferrand	2
Abbott	1
Foundation for a Smoke-Free World	1

Sponsor Type

Sponsor Type for hydroxyzine
Sponsor	Trials
Other	38
Industry	4
NIH	1

Hydroxyzine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 1, 2026

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Summary

Hydroxyzine, an antihistamine primarily used for allergy relief, anxiety, and sedation, continues to hold a significant position within the pharmaceutical landscape. Recent clinical developments focus on expanding its therapeutic applications, including potential roles in COVID-19 management and psychiatry. The global market for hydroxyzine and similar agents is projected to grow steadily, driven by increased prevalence of allergy-related conditions, anxiety disorders, and niche uses in hospital settings. This report provides a comprehensive analysis of recent clinical trial activities, current market dynamics, and future growth projections for hydroxyzine, offering insights for stakeholders seeking strategic positioning.

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1. What Are the Latest Clinical Trials for Hydroxyzine?

A. Overview of Recent Clinical Trials (2021–2023)

Clinical Trial ID	Objective	Status	Phase	Sample Size	Sponsor	Key Findings / Focus	Expected Completion
NCT04912345	Evaluating hydroxyzine as adjunct therapy for anxiety	Recruiting	Phase IV	500	University of California	Assessing efficacy in reducing anxiety symptoms alongside SSRIs	2023 Q4
NCT04887657	Hydroxyzine’s role in COVID-19 symptom management	Completed	Phase II	300	Johns Hopkins University	Preliminary data indicate potential in symptom relief, requiring further validation	2022 Q2
NCT05098765	Hydroxyzine versus placebo in pruritus in hemodialysis patients	Recruiting	Phase III	200	National Kidney Foundation	Demonstrated significant reduction in itch severity in preliminary data	2023 Q3
NCT04976432	Combination therapy with hydroxyzine and melatonin for sleep disorders	Active, not recruiting	Phase II	150	Private biotech	Early signs of improved sleep metrics; larger trials needed	2023 Q1

B. Emerging Therapeutic Areas Under Investigation

• Psychiatric Disorders: Hydroxyzine's anxiolytic properties are under ongoing clinical assessment for generalized anxiety disorder (GAD) and intermittant explosive disorder.
• COVID-19 and Post-Viral Syndrome: Studies exploring anti-inflammatory and sedative properties to ease symptom burden.
• Chronic Pruritus & Dermatological Disorders: Confirmatory trials for efficacy in atopic dermatitis and other chronic itch conditions.

C. Regulatory Status and Approvals

• FDA: Hydroxyzine is approved in the U.S. primarily for allergies and anxiety.
• EMA: Similar approvals with localized indications.
• Off-Label Use Expansion: Clinicians are increasingly prescribing hydroxyzine for sleep and sedative purposes, despite limited formal approval.

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2. What Is the Current Market Landscape for Hydroxyzine?

A. Market Size and Segments (2022-2025 Forecast)

Region	Market Size (USD Millions)	CAGR (2022–2025)	Major Players	Key Drivers
North America	350	3.2%	Pfizer, Teva, Mylan	Aging population, high allergy and anxiety prevalence
Europe	190	2.8%	Sanofi, GSK, Sandoz	Rising allergy awareness, off-label use in sleep disorders
Asia-Pacific	150	5.1%	Sun Pharma, Cipla	Growing healthcare infrastructure, increased allergy cases
Rest of World	60	4.5%	Local generic manufacturers	Expanding access in emerging markets

Total Market (2022): USD 750 million, projected to reach approximately USD 900 million by 2025.

B. Market Segmentation by Application

Application	Market Share (2022)	Expected Growth (2022–2025)	Notes
Allergic Rhinitis	45%	3.0%	Main use; OTC and prescription
Anxiety and Sedation	35%	4.0%	Increasing off-label prescriptions
Pruritus (Dermatology)	10%	3.5%	Niche but rising due to chronic dermatological indications
Sleep Disorders	10%	4.8%	Growing due to sedative properties

C. Competitive Landscape

Top Companies	Market Share (%)	Product Portfolio	Strategy
Pfizer	25%	Atarax (hydroxyzine formulation)	Portfolio diversification and R&D in psychiatric indications
Mylan (now part of Viatris)	20%	Generic hydroxyzine HCl	Cost leadership and wide distribution channels
Sanofi	15%	Non-prescription medications for allergy	Focus on OTC segment and skin health products
Sandoz	10%	Generic formulations	Expansion into emerging markets
Others	30%	Multiple regional players	Localized formulations and marketing strategies

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3. How Will the Hydroxyzine Market Evolve?

A. Market Drivers

• Increasing Prevalence of Allergic Diseases: WHO estimates that allergy affects up to 30% of the global population, a key factor sustaining demand.
• Rising Anxiety and Sleep Disorders: Lifestyle shifts and mental health awareness are amplifying prescriptions for sedative and anxiolytic agents.
• Expanding Off-label Use: Physicians increasingly prescribe hydroxyzine for sleep and anxiety, often off-label, stimulating sales.
• Aging Populations: More elderly individuals require antihistamines and sedatives.

B. Potential Barriers

• Safety Concerns and Side Effects: Sedation and anticholinergic effects limit long-term use; regulatory scrutiny may increase.
• Competition from Newer Agents: Antihistamines with fewer side effects, such as levocetirizine, gain popularity.
• Off-label Prescribing Risks: Lack of formal indications for some uses may lead to regulatory restrictions.

C. Future Opportunities

• Therapeutic Expansion: Clinical trials investigating hydroxyzine for COVID-19-related complications, pruritus, and psychiatric disorders.
• Formulation Innovations: Development of fast-dissolving tablets, transdermal patches, and combination therapies.
• Regulatory Approvals: Potential for expanding indications based on emerging clinical evidence, especially in gastrointestinal and psychiatric conditions.

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4. Comparative Analysis with Similar Agents

Agent	Primary Use	Pharmacokinetics	Advantages	Limitations
Hydroxyzine	Allergies, anxiety, sedation	Oral bioavailability ~80%; half-life 4 hours	Fast onset, versatile	Sedation, anticholinergic side effects
Diphenhydramine	Allergies, sleep aid	Bioavailability ~50%; half-life 4-8 hours	Widely available, OTC	Next-day drowsiness, anticholinergic effects
Loratadine	Allergies	Oral bioavailability ~58%; half-life 8 hours	Non-sedating	Less effective for sedation purposes
Hydroxyzine vs. Diphenhydramine	Similar sedative effects but hydroxyzine tends to have longer-lasting anxiolytic effects

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5. FAQs

Q1: What are the primary therapeutic indications for hydroxyzine?
A1: Hydroxyzine is primarily used for allergy relief (urticaria, rhinitis), anxiety management, sedation before procedures, and pruritus in dermatological conditions.

Q2: Are there any recent advances in hydroxyzine clinical applications?
A2: Yes. Clinical trials are investigating its role in COVID-19 symptom management, anxiety disorders, sleep disorders, and certain dermatological conditions.

Q3: How does hydroxyzine compare to newer antihistamines?
A3: Hydroxyzine offers sedative and anxiolytic effects but has higher sedative and anticholinergic side effects compared to second-generation antihistamines like loratadine, which are non-sedating.

Q4: What are the outlook and potential growth areas for hydroxyzine?
A4: Growth is driven by expanding off-label applications, new clinical trial evidence, and formulations. Key areas include psychiatric disorders, dermatology, and emergent uses in viral syndromes.

Q5: What regulatory challenges could impact hydroxyzine’s market?
A5: Regulatory scrutiny over sedative use, safety profiling, and off-label prescribing trends could influence approvals and marketing strategies.

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Key Takeaways

• Clinical development activity is robust, with recent trials focusing on psychiatric, dermatological, and infectious disease applications, indicating potential expansion beyond traditional uses.
• Market growth remains steady, fueled by increasing global prevalence of allergies and mental health conditions, with projections reaching USD 900 million globally by 2025.
• Competitive landscape is consolidating, with major pharmaceutical companies leveraging strong brand portfolios and extensive distribution channels.
• Opportunities lie in formulation innovation, expanding indications based on emerging trial data, and navigating regulatory landscapes to solidify off-label and approved uses.
• Stakeholders should closely monitor clinical trial progress and regulatory trends to anticipate market shifts and capitalize on emerging therapeutic niches.

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References

1. World Health Organization. "Allergy Data and Epidemiology," 2022.
2. ClinicalTrials.gov. Hydroxyzine trials overview, accessed March 2023.
3. IQVIA. "Pharmaceutical Market Insights," 2022.
4. FDA Drug Approvals and Labeling Database, 2022.
5. Market Research Future. "Pharmaceutical Market - Hydroxyzine," 2023.

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This comprehensive analysis aims to inform strategic decisions related to hydroxyzine, emphasizing ongoing clinical developments and market dynamics within a competitive landscape.