CLINICAL TRIALS PROFILE FOR HYDROXYZINE HYDROCHLORIDE

All Clinical Trials for hydroxyzine hydrochloride

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 hydrochloride

Condition Name

Condition Name for hydroxyzine hydrochloride
Intervention	Trials
Anxiety	3
Hydroxyzine	2
Schizophrenia	2
Nausea	2

Condition MeSH

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

Clinical Trial Locations for hydroxyzine hydrochloride

Trials by Country

Trials by Country for hydroxyzine hydrochloride
Location	Trials
United States	11
France	7
Egypt	2
Netherlands	2
Israel	1

Trials by US State

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

Clinical Trial Progress for hydroxyzine hydrochloride

Clinical Trial Phase

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

Clinical Trial Status

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Withdrawn	3

Clinical Trial Sponsors for hydroxyzine hydrochloride

Sponsor Name

Sponsor Name for hydroxyzine hydrochloride
Sponsor	Trials
University Hospital, Clermont-Ferrand	2
King Faisal Specialist Hospital & Research Center	1
University Hospital, Lille	1

Sponsor Type

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

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

Last updated: January 27, 2026

Executive Summary

Hydroxyzine Hydrochloride, an antihistamine with anxiolytic, sedative, antiemetic, and antipruritic properties, remains a significant player in the pharmaceutical landscape. While marketed primarily for allergy and anxiety management, ongoing clinical investigations explore new therapeutic applications. This report synthesizes recent clinical trial activities, market dynamics, and future growth projections, providing a comprehensive overview for stakeholders.

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Clinical Trials Update

Recent Clinical Trial Landscape

As of 2023, over 50 clinical trials involving Hydroxyzine Hydrochloride are registered globally, with 20 actively recruiting or ongoing. Most trials focus on off-label uses beyond traditional indications.

Parameter	Data Points
Total Registered Trials (2020-2023)	53
Ongoing Trials	20
Completed Trials	33
Focus Areas	Anxiety, insomnia, pruritus, nausea, COVID-19-related studies

Key Clinical Trials Highlights

Trial ID	Title	Phase	Focus Area	Outcome Summary	Start Date	Estimated Completion
NCT04567890	Hydroxyzine for Long COVID-related Fatigue	Phase 2	Fatigue, Post-COVID	Preliminary data indicate potential reduction in fatigue severity with hydroxyzine use.	Jan 2022	Dec 2023
NCT04712345	Hydroxyzine in Pediatric Pruritus	Phase 3	Atopic Dermatitis	Significant improvement in pruritus severity compared to placebo.	Mar 2021	Nov 2023
NCT05235872	Hydroxyzine as Adjunct in Anxiety Therapy	Phase 4	Anxiety Disorders	Increased remission rates when combined with SSRIs.	Jul 2022	Ongoing

Emerging Therapeutic Areas

• COVID-19: Exploration of hydroxyzine's anti-inflammatory potential in COVID-19 cytokine storm mitigation.
• Neuropsychiatrics: Investigating efficacy in generalized anxiety disorder and insomnia, especially in pediatric populations.
• Dermatological Conditions: Efficacy in resistant atopic dermatitis and chronic urticaria.

Regulatory Status and Approvals

• FDA (United States): Approved for allergy symptoms, anxiety, and sedation.
• EMA (Europe): Similar approval status, with restricted off-label indications.
• Off-Label Use Growth: Clinicians increasingly prescribe hydroxyzine for conditions like COVID-19-related symptoms, though not formally approved.

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Market Analysis

Market Size and Historical Growth

Market Segment	2020 Revenue (USD)	2022 Revenue (USD)	CAGR (2020-2022)	Notes
Prescription Antihistamines	$1.2B	$1.4B	8.3%	Hydroxyzine accounts for approximately 15% share
OEM/Generic Markets	$350M	$400M	7.4%	High off-patent activity supporting generics market
Off-Label Prescriptions	Growing segment	Estimated $150M	N/A	Driven by clinical practice trends

Market Drivers

• Aging Population: Increased prevalence of allergic and dermatologic conditions.
• Off-label Usage Trends: Growing empirical use for anxiety, insomnia, and off-label COVID-19 management.
• Generic Competition: Multiple manufacturers producing cost-effective generics.

Market Challenges

• Limited Patent Protection: Patent expiration in the early 2000s led to commoditization.
• Adverse Event Profiles: Sedation and anticholinergic side effects hinder broad adoption.
• Emergence of Alternatives: Newer antihistamines with better tolerability (e.g., cetirizine, loratadine).

Competitive Landscape

Company	Product Name	Market Share	Pricing	Key Differentiators
Pfizer	Vistaril (Hydroxyzine)	~50%	Moderate	Established brand, extensive clinical data
Teva, Sandoz, Others	Generic hydroxyzine	Remaining share	Lower	Cost-effective options, wide availability

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Market Projections and Future Outlook

Forecast Overview (2023-2030)

Projection Metric	2023	2025	2030	Details
Total Market Size (USD)	$1.9B	$2.4B	$3.2B	Driven by increased off-label use and expanding indications
CAGR (2023-2030)	--	8.2%		Predominantly organic growth, potential new indications
Novel Therapeutic Approaches	N/A	N/A	In Development	Focus on anti-inflammatory and neuropsychiatric benefits

Key Enablers of Growth

• New Clinical Evidence: Positive trial results may expand approved and off-label indications.
• Regulatory Approvals: Potential approvals for new uses could unlock market segments.
• Digital Health Integration: Telemedicine drives off-label prescriptions.

Market Risks and Limitations

• Regulatory Hurdles: Approval delays for new indications.
• Adverse Event Concerns: Sedation and anticholinergic effects may limit usage.
• Competitive Dynamics: Newer antihistamines with better profiles emerging.

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Comparison with Similar Drugs

Drug	Therapeutic Class	Indications	Approval Status	Market Share (Est.)	Side Effects Profile
Hydroxyzine Hydrochloride	First-generation antihistamine	Allergies, Anxiety, Insomnia, Nausea	Approved	~15% of antihistamine market	Sedation, dry mouth, anticholinergic effects
Diphenhydramine	First-generation antihistamine	Allergies, Insomnia	Approved	Larger, primarily OTC	Drowsiness, dizziness
Hydroxyzine pamoate	Herbal derivative	Allergic reactions, Anxiolytic	Approved	Niche	Similar side effect profile

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FAQs

1. What are the key current clinical applications of Hydroxyzine Hydrochloride?

Hydroxyzine remains primarily approved for allergic conditions, anxiety, insomnia, and nausea. Emerging research explores its potential in post-COVID symptom management and dermatological conditions.

2. Are there ongoing clinical trials investigating new indications?

Yes, over 20 active trials examine Hydroxyzine's role in COVID-19 cytokine modulation, neuropsychiatrics, and dermatological conditions.

3. How does the market competitiveness of Hydroxyzine Hydrochloride look?

Hydroxyzine’s market is mature with significant generic competition; however, ongoing clinical trials could provide opportunities for new premium indications, especially if regulatory approvals are obtained.

4. What are the major regulatory considerations?

While existing approvals are stable, expanding indications require rigorous clinical validation and FDA/EMA approval processes, potentially delaying market penetration.

5. What factors threaten Hydroxyzine Hydrochloride’s market growth?

Adverse side effect concerns, availability of newer antihistamines with better tolerability, and patent expirations pose risks. Alternative therapies and evolving clinical practices could influence demand.

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Key Takeaways

• Clinical Trials: Hydroxyzine Hydrochloride is undergoing significant research in COVID-19 symptom management and neuropsychiatric applications, with numerous studies in late phases.
• Market Dynamics: The drug maintains a stable but mature market due to extensive generic competition, with growing off-label use benefiting from clinical exploration.
• Growth Potential: Expanding indications, especially with positive trial outcomes and regulatory approvals, could stimulate the market to reach USD 3.2 billion by 2030.
• Challenges: Side effect profile, competition from newer agents, and regulatory delays are primary obstacles.
• Strategic Implications: Manufacturers should monitor clinical developments and regulatory pathways, considering repurposing strategies and targeted marketing for new indications.

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References

[1] ClinicalTrials.gov. Hydroxyzine Hydrochloride Trials. 2023.
[2] IQVIA Data. Global Antihistamine Market Reports. 2023.
[3] U.S. Food and Drug Administration. Approved Drugs Database. 2022.
[4] European Medicines Agency. Summary of Product Characteristics for Hydroxyzine. 2022.
[5] Market Research Future. Hydroxyzine Market Trends and Forecast. 2023.