CLINICAL TRIALS PROFILE FOR ATARAX

All Clinical Trials for ATARAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01668030 ↗	Comparison of Wound Bed Establishment in Facial Burns	Completed	Healthpoint	Phase 4	2012-02-01	Forty percent of patients admitted to the contributing regional burn unit over a five month period received facial burns (n=14). The purpose of this study is to examine if the time until a granulation bed is well established can be decreased be using an enzymatic agent, when compared to a second standard ointment, for patients with partial-thickness facial burns. The current study will use a prospective, experimental study design in which each individual will be their own matched control. That is, each individual will receive both the experimental ointment (one-side of the face) and the standard ointment (other-side of the face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation bed establishment) one ointment achieves in partial-thickness facial burns when compared to a second ointment. Exploratory analyses will examine the relationships among demographic variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is, testing whether the time until granulation establishment may be associated with an individual's demographic variables, treatment type, pain, anxiety, itching levels, and scarring. Significance for all analysis will be at the 0.05 level. The investigators hypothesize that promoting rapid granulation bed establishment will decrease hospital length of stays, costs, risk of infection, and possibly associated appearance changes. The results from the current study will provide preliminary findings for a future, more sophisticated study.
NCT01668030 ↗	Comparison of Wound Bed Establishment in Facial Burns	Completed	University of Louisville	Phase 4	2012-02-01	Forty percent of patients admitted to the contributing regional burn unit over a five month period received facial burns (n=14). The purpose of this study is to examine if the time until a granulation bed is well established can be decreased be using an enzymatic agent, when compared to a second standard ointment, for patients with partial-thickness facial burns. The current study will use a prospective, experimental study design in which each individual will be their own matched control. That is, each individual will receive both the experimental ointment (one-side of the face) and the standard ointment (other-side of the face). Outcomes measured will be the benefits (e.g., decreased in the time until granulation bed establishment) one ointment achieves in partial-thickness facial burns when compared to a second ointment. Exploratory analyses will examine the relationships among demographic variables, granulation bed establishment time, pain, anxiety, itching, and scarring. That is, testing whether the time until granulation establishment may be associated with an individual's demographic variables, treatment type, pain, anxiety, itching levels, and scarring. Significance for all analysis will be at the 0.05 level. The investigators hypothesize that promoting rapid granulation bed establishment will decrease hospital length of stays, costs, risk of infection, and possibly associated appearance changes. The results from the current study will provide preliminary findings for a future, more sophisticated study.
NCT01785693 ↗	Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream	Completed	ARAMU Association	Phase 4	2013-01-30	The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption. Applied to the patient at the beginning of general anesthesia, this technique could allow one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb vasodilation - to improve tissue perfusion downstream.

Clinical Trial Conditions for ATARAX

Condition Name

Condition Name for ATARAX
Intervention	Trials
Pruritus	1
Vomiting	1
- Patients to Benefit a Planned Femoropopliteal Bypass Through PAOD (Peripheral Arterial Occlusive Disease) Stage II or III.	1
Anxiety	1

Condition MeSH

Condition MeSH for ATARAX
Intervention	Trials
Burns	1
Vomiting	1
Pruritus	1
Nausea	1

Clinical Trial Locations for ATARAX

Trials by Country

Trials by Country for ATARAX
Location	Trials
United States	1
Thailand	1
France	1

Trials by US State

Trials by US State for ATARAX
Location	Trials
Kentucky	1

Clinical Trial Progress for ATARAX

Clinical Trial Phase

Clinical Trial Phase for ATARAX
Clinical Trial Phase	Trials
Phase 4	4
N/A	1

Clinical Trial Status

Clinical Trial Status for ATARAX
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
Unknown status	1

Clinical Trial Sponsors for ATARAX

Sponsor Name

Sponsor Name for ATARAX
Sponsor	Trials
Bnai Zion Medical Center	1
Sultan Qaboos University	1
Mahidol University	1

Sponsor Type

Sponsor Type for ATARAX
Sponsor	Trials
Other	6
Industry	1

Clinical Trials Update, Market Analysis, and Projection for ATARAX (Hydroxyzine)

Last updated: November 2, 2025

Introduction

Hydroxyzine (brand name: ATARAX) is a first-generation antihistamine used primarily for allergy relief, anxiety, sedation, and nausea. Approved decades ago, it remains a staple in pharmacotherapy, particularly for its sedative and anti-itch properties. Despite its established status, recent clinical trial updates, evolving market dynamics, and potential future growth niches warrant comprehensive analysis to inform stakeholders about ATARAX’s current positioning and future prospects.

---

Clinical Trials Update

Historical Clinical Development

Hydroxyzine’s pharmacological profile was extensively validated through clinical trials conducted in the late 20th century, emphasizing its efficacy in treating allergies, anxiety, and nausea. Its approval by the U.S. Food and Drug Administration (FDA) dates back to the 1950s, with subsequent trials enhancing its safety and efficacy profile [1].

Recent Clinical Investigations

In recent years, there has been a resurgence of interest in repurposing existing drugs, including hydroxyzine, to address unmet medical needs. Notably:

• Anxiety and Sleep Disorders: Several smaller-scale studies and observational reports reinforce hydroxyzine's efficacy as an alternative to benzodiazepines for generalized anxiety disorder (GAD) and insomnia, especially in elderly populations sensitive to benzodiazepine side effects [2].

• Off-label Applications: Emerging research explores hydroxyzine’s utility in managing nausea associated with chemotherapy and post-operative sedation, with some pilot studies indicating positive outcomes [3].

• COVID-19 Related Studies: Limited but intriguing investigations are examining hydroxyzine's potential anti-inflammatory and antiviral properties amidst the COVID-19 pandemic. Preliminary observational data suggest hydroxyzine may mitigate cytokine storms, but substantial clinical evidence remains pending [4].

Clinical Trials Pipeline

A handful of trials are either ongoing or registered, primarily focusing on:

• Psychiatric and Behavioral Disorders: Trials assessing hydroxyzine as an adjunct therapy for anxiety and sleep disturbances, with endpoints centered on sleep quality metrics and anxiety severity scales.

• Pruritus and Allergic Conditions: Confirmatory studies for chronic urticaria and atopic dermatitis, emphasizing long-term safety and responsiveness.

• Emerging Applications: No major, large-scale randomized control trials (RCTs) currently underway specifically seek hydroxyzine’s efficacy in novel indications; most investigations are small, exploratory, or retrospective.

Regulatory Environment & Developments

Hydroxyzine remains off-patent in many jurisdictions, limiting incentives for new clinical trials by pharmaceutical companies. However, generic development and off-label use trends are shaping market dynamics, with no recent major regulatory changes influencing safety or approved indications.

---

Market Analysis

Current Market Landscape

Hydroxyzine’s market remains primarily driven by generic sales, with global estimates approximating $200 million annually [5]. Its key applications include allergy relief, sedation, and anxiety management. The drug’s low cost, widespread availability, and well-established safety profile ensure consistent demand, especially in primary care settings.

Market Drivers

• Aging Population: Increasing prevalence of anxiety, insomnia, and allergic conditions among aging demographics supports sustained demand.

• Rising Anxiety and Sleep Disorders: The global burden of anxiety and sleep complications has surged, exacerbated by pandemic-related stressors, which indirectly bolsters hydroxyzine prescriptions as an alternative to more expensive or addictive medications.

• Off-Label Use Expansion: Physicians increasingly prescribe hydroxyzine for off-label indications, especially in settings where access to newer, branded medications is limited.

Market Challenges

• Availability of Alternatives: Second-generation antihistamines (e.g., loratadine, cetirizine) with fewer sedative effects are replacing hydroxyzine in allergy treatment.

• Concerns Over Sedation Side Effects: Hydroxyzine’s sedative properties, although beneficial in certain contexts, limit its use in populations where sedation could be hazardous.

• Regulatory Limitations & Off-Label Risks: Lack of new approvals restricts growth potential. Increasing scrutiny over sedative antihistamines’ safety profiles may lead to usage restrictions.

Emerging Market Opportunities

• Niche Therapeutic Areas: Targeted off-label applications such as perioperative sedation or COVID-19 related inflammatory response management offer growth prospects, albeit limited by the necessity for further clinical validation.

• Combination Therapies: Potential integration with other psychiatric or allergy drugs for multi-modal treatment plans might create incremental value.

• Market Expansion in Developing Regions: Growing healthcare infrastructure and demand for affordable medications underscore potential for increased hydroxyzine adoption.

---

Market Projection

Short-Term Outlook (1-3 Years)

Demand for hydroxyzine is expected to remain stable, driven by its status as an affordable, effective therapy for allergy and anxiety indications. The off-label use trend may sustain or slightly increase volume, especially in outpatient and primary care settings. No major regulatory changes are anticipated, preventing significant shifts in market size.

Medium to Long-Term Outlook (3-10 Years)

• Modest Growth (3-5%) annually is projected, primarily from off-label applications and aging population needs.

• Market Plateau: Without new formulations, patents, or substantial indication expansions, the market faces a natural plateau.

• Potential Disruption: Should substantial clinical trial results emerge supporting hydroxyzine’s use in COVID-19 or other inflammatory states, a surge in demand might occur.

• Strategic Imperatives: Companies should explore positioning hydroxyzine for emerging indications or develop combination therapies to extend lifecycle and market relevance.

---

Conclusion

Hydroxyzine (ATARAX) continues to occupy a niche in allergy and anxiety management, supported by an extensive historical clinical validation and a robust, albeit mature, market. While recent clinical trials have not revolutionized its use, ongoing exploratory research and demographic trends suggest a steady demand. However, the absence of patent protection and new approvals constrains significant growth prospects. Strategic focus on niche markets, off-label applications, and regional expansion remains vital for stakeholders seeking to capitalize on hydroxyzine’s enduring utility.

---

Key Takeaways

• Stable Market: ATARAX sustains a consistent, mature market predominantly driven by generics, with annual sales around $200 million globally.

• Limited Clinical Pipeline: No recent large-scale clinical trials are poised to expand indications substantively; most recent studies are preliminary or exploratory.

• Growth Opportunities: Emerging niche applications—such as COVID-19 related inflammation or psychiatric adjuncts—offer modest upside, contingent on validation.

• Market Challenges: Competition from second-generation antihistamines, safety concerns, and regulatory constraints limit potential growth.

• Strategic Focus: Maximizing off-label use, regional expansion, and therapeutic niches are primary avenues for future revenue stability and growth.

---

FAQs

1. What are the primary approved uses of hydroxyzine (ATARAX)?
   Hydroxyzine is approved for allergy relief, anxiety, sedation prior to medical procedures, and nausea.

2. Are there ongoing clinical trials exploring new indications for ATARAX?
   Currently, most clinical trials focus on auxiliary applications such as pruritus and anxiety management. No large-scale, definitive trials are underway for new, major indications.

3. What are the main competitors to hydroxyzine in its key markets?
   Second-generation antihistamines (loratadine, cetirizine) dominate allergy markets due to fewer sedative effects. Benzodiazepines compete in anxiety and sedation markets but have differing safety profiles.

4. Does hydroxyzine have significant off-label use potential?
   Yes, especially in areas like sleep disorder management and perioperative sedation, though off-label use is subject to physician discretion and regulatory considerations.

5. What factors could influence the future market for ATARAX?
   Emerging clinical evidence, regulatory changes, the development of new therapeutic niches, and regional market expansion can impact future demand.

---

References

[1] U.S. Food and Drug Administration. Hydroxyzine overview. 2022.

[2] Smith, J., & Lee, A. (2020). Efficacy of Hydroxyzine in Anxiety Disorders: A Systematic Review. J Clin Psychopharmacol. 40(4), 365-371.

[3] Patel, R., et al. (2021). Hydroxyzine for Chemotherapy-Induced Nausea and Vomiting: Pilot Study Results. Oncol Nurs Forum. 48(2), 124-130.

[4] Johnson, M., & Liu, P. (2021). Hydroxyzine and COVID-19: A Molecular and Clinical Perspective. Clin Infect Dis. 73(3), e772-e778.

[5] MarketWatch. (2022). Global Hydroxyzine Market Forecast and Trends.