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.

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
Alcoholism	2
Opioid-Related Disorders	2

Clinical Trial Locations for Hydroxyzine Hydrochloride

Trials by Country

Trials by Country for Hydroxyzine Hydrochloride
Location	Trials
United States	10
France	7
Egypt	2
Netherlands	2
Bulgaria	1

Trials by US State

Trials by US State for Hydroxyzine Hydrochloride
Location	Trials
Virginia	2
Washington	2
North Carolina	1
District of Columbia	1
New York	1

Clinical Trial Progress for Hydroxyzine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Hydroxyzine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	5
Phase 2/Phase 3	2

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
Hospital San Carlos, Madrid	1
Minia University	1

Sponsor Type

Sponsor Type for Hydroxyzine Hydrochloride
Sponsor	Trials
Other	37
Industry	4
NIH	1

Hydroxyzine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Hydroxyzine Hydrochloride

Hydroxyzine hydrochloride is a versatile medication known for its antihistamine, sedative, and anxiolytic properties. It is widely used to treat various health conditions, including anxiety disorders, allergic reactions, and sleep disorders. Here, we will delve into the current state of clinical trials, market analysis, and future projections for hydroxyzine hydrochloride.

Clinical Trials and Safety Concerns

Current Clinical Trials

Hydroxyzine hydrochloride is continuously being evaluated in various clinical trials to assess its efficacy and safety in different indications. For instance, there have been Phase 4 trials examining the efficacy of hydroxyzine versus standard treatments for conditions like panic disorder and anxiety[4].

Safety Concerns and Regulatory Measures

One of the significant safety concerns associated with hydroxyzine is its potential to prolong the QT interval and cause cardiac arrhythmias, such as torsades de pointes. This risk is particularly heightened in patients with pre-existing heart conditions or those taking other medications that affect heart rhythm. To mitigate these risks, the European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have implemented new measures. These include restricting the use of hydroxyzine in high-risk patients and recommending the lowest effective dose for the shortest possible duration[1].

Market Analysis

Global Market Size and Growth

The global hydroxyzine hydrochloride market is experiencing robust growth. As of 2023, the market size was valued at approximately USD 200 million and is projected to reach USD 315 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period[3].

Regional Market Dynamics

North America is currently the largest market for hydroxyzine hydrochloride, driven by factors such as high patient awareness, advanced healthcare infrastructure, and early adoption of new medications. Europe is expected to be the fastest-growing region, with a CAGR of 5.1% during the forecast period[3].

In the Asia-Pacific region, countries like Japan and South Korea are anticipated to witness significant growth due to increasing incidence of allergies and favorable government support. For example, Japan is expected to grow at a CAGR of 7.3%, while South Korea is projected to grow at a CAGR of 8% from 2024 to 2034[5].

Market Drivers

Several factors are driving the growth of the hydroxyzine hydrochloride market:

• Increasing Prevalence of Anxiety Disorders: The rising incidence of anxiety disorders, particularly among the older population, is a significant driver. In the United States alone, around 40 million people experience an anxiety disorder each year[5].
• High Incidence of Allergic Conditions: Allergic diseases such as atopic dermatitis and urticaria are becoming more common due to environmental changes and pollution, leading to a higher demand for antihistamines like hydroxyzine[5].
• Technological Advancements and R&D Investments: Pharmaceutical companies are investing heavily in research and development to enhance hydroxyzine formulations, explore new indications, and develop new delivery methods like extended-release formulations[5].

Market Projections

Future Market Size

By 2034, the global hydroxyzine market is forecast to reach USD 1430 million, growing at a CAGR of 5.6% from 2024 to 2034. This growth is attributed to the increasing demand for antihistamines and anxiolytics, as well as the expanding elderly population and heightened patient awareness about these medications[5].

Competitive Landscape

The competitive landscape in the hydroxyzine market is becoming increasingly fierce. Leading players such as Teva Pharmaceuticals, Pfizer, Inc., and GSK, plc are heavily investing in R&D to enhance formulations and explore new indications. These companies are also navigating the regulatory landscape to maintain compliance and expand their market presence through strategies like mergers, partnerships, and distribution agreements[5].

Product Formulations and Preferences

Tablets are the most preferred form of hydroxyzine hydrochloride due to their convenience, long shelf life, and ease of use. This segment accounted for a significant value share of 38% in 2023. Companies are also focusing on developing new delivery methods to cater to different patient needs[5].

Key Takeaways

• Clinical Trials: Ongoing clinical trials are evaluating the efficacy and safety of hydroxyzine hydrochloride in various indications, with a focus on managing risks associated with cardiac arrhythmias.
• Market Growth: The global hydroxyzine hydrochloride market is projected to grow significantly, driven by increasing prevalence of anxiety and allergic conditions, technological advancements, and R&D investments.
• Regional Dynamics: North America is the largest market, while Europe and the Asia-Pacific region are expected to show robust growth.
• Competitive Landscape: The market is highly competitive, with leading players investing in R&D and strategic partnerships to expand their market share.

FAQs

What are the primary uses of hydroxyzine hydrochloride?

Hydroxyzine hydrochloride is used to treat anxiety disorders, relieve pruritus (itching), serve as premedication before surgery, and manage sleep disorders.

What are the safety concerns associated with hydroxyzine hydrochloride?

The primary safety concern is the potential to prolong the QT interval and cause cardiac arrhythmias, such as torsades de pointes, particularly in high-risk patients.

Which region is expected to be the fastest-growing market for hydroxyzine hydrochloride?

Europe is expected to be the fastest-growing region, with a CAGR of 5.1% during the forecast period.

What drives the growth of the hydroxyzine hydrochloride market?

The growth is driven by the increasing prevalence of anxiety disorders, high incidence of allergic conditions, technological advancements, and significant investments in R&D.

Which companies are major players in the hydroxyzine hydrochloride market?

Leading players include Teva Pharmaceuticals, Pfizer, Inc., and GSK, plc, which are heavily investing in R&D and strategic partnerships.

Sources

1. EMA: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines.
2. Market Research Intellect: Global Hydroxyzine Hydrochloride Market Size, Trends and ...
3. Straits Research: Hydroxyzine Market Size To Surpass at a CAGR of 5.2% by 2032.
4. Patsnap: Hydroxyzine Hydrochloride - Drug Targets, Indications, Patents.
5. Future Market Insights: Hydroxyzine Market Size, Share, Trends & Forecast by 2034 | FMI.