CLINICAL TRIALS PROFILE FOR VISTARIL

All Clinical Trials for VISTARIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).
NCT01971853 ↗	Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry	Terminated	University of Colorado, Denver	N/A	2013-10-01	All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.
NCT05737511 ↗	Efficacy of Hydroxyzine for Patients With Panic Disorder	Not yet recruiting	Sultan Qaboos University	Phase 4	2023-12-30	The aim of this study is to evaluate the efficacy of hydroxyzine compared to treatment as usual (TAU) for patients with panic disorder. By conducting a pilot study, we hope to provide initial data on the feasibility and potential impact of hydroxyzine for this population. This will inform the design and power calculations of a larger, more comprehensive study in the future. Objectives: To assess the feasibility of conducting a randomized controlled trial (RCT) of hydroxyzine for panic disorder. To evaluate the effectiveness of hydroxyzine compared to TAU in reducing panic symptoms in patients with panic disorder. To explore the potential side effects and tolerability of hydroxyzine in this population. Methods: This will be a single-center, open-label, randomized pilot study. A total of 30 patients with a primary diagnosis of panic disorder will be recruited from a psychiatric outpatient clinic. Participants will be randomly assigned to receive either hydroxyzine or TAU for 8 weeks. The primary outcome measure will be the change in panic symptoms as assessed by the Panic Disorder Severity Scale (PDSS). Secondary outcome measures will include the Hamilton Anxiety Rating Scale (HAM-A) and the Clinical Global Impression-Severity (CGI-S) scale. Participants will be assessed at baseline, 4 weeks, and 8 weeks. Adverse events will be monitored throughout the study. Expected Results: This pilot study is expected to provide preliminary data on the feasibility and potential efficacy of hydroxyzine for panic disorder. The results will inform the design of a larger RCT to further evaluate the efficacy of hydroxyzine for this population. Significance: There is a need for effective and well-tolerated treatments for panic disorder. If found to be effective, hydroxyzine could provide a new option for patients with this condition, potentially improving their quality of life and functioning. The results of this pilot study will inform the design of future studies and contribute to the development of evidence-based treatments for panic disorder.

Clinical Trial Conditions for VISTARIL

Condition Name

Condition Name for VISTARIL
Intervention	Trials
Substance-Related Disorders	1
Pain	1
Panic Disorder	1

Condition MeSH

Condition MeSH for VISTARIL
Intervention	Trials
Panic Disorder	1
Substance-Related Disorders	1

Clinical Trial Locations for VISTARIL

Trials by Country

Trials by Country for VISTARIL
Location	Trials
United States	2

Trials by US State

Trials by US State for VISTARIL
Location	Trials
Colorado	1
California	1

Clinical Trial Progress for VISTARIL

Clinical Trial Phase

Clinical Trial Phase for VISTARIL
Clinical Trial Phase	Trials
Phase 4	1
N/A	2

Clinical Trial Status

Clinical Trial Status for VISTARIL
Clinical Trial Phase	Trials
Not yet recruiting	1
Terminated	1
Completed	1

Clinical Trial Sponsors for VISTARIL

Sponsor Name

Sponsor Name for VISTARIL
Sponsor	Trials
Stanford University	1
University of Colorado, Denver	1
Sultan Qaboos University	1

Sponsor Type

Sponsor Type for VISTARIL
Sponsor	Trials
Other	3

VISTARIL Market Analysis and Financial Projection

Last updated: February 5, 2026

What is the current status of clinical trials for VISTARIL (hydroxyzine)?

VISTARIL (hydroxyzine) has not been the focus of recent clinical trial updates. The drug, primarily used for anxiety, nausea, and allergy symptoms, held traditional approval statuses. The last detailed clinical trial data from major databases like ClinicalTrials.gov dates back several years, with no new phase 3 or late-phase trials registered since 2019. Historically, hydroxyzine was approved in the 1950s and 1960s for allergy treatment; more recent research focused on its off-label applications.

What is VISTARIL's market position and recent sales figures?

Hydroxyzine, sold under VISTARIL and other brand names such as Atarax, remains a niche medication primarily prescribed in the U.S., Europe, and some Asian markets. Its sales have declined gradually with the emergence of newer medications like second-generation antihistamines (e.g., loratadine, cetirizine) which do not cause sedation.

• U.S. Market: Estimated retail sales less than $100 million annually, primarily driven by chronic allergy management and short-term anxiety therapy.
• Key Prescriber Segments: Allergists, psychiatrists, and general practitioners.
• Market Share: Hydroxyzine occupies approximately 3–5% of the antihistamine market, with sales declining at roughly 2% annually in the absence of new formulations or indications.

What insights inform future market projections?

Hydroxyzine’s market outlook hinges on patent status, regulatory environment, and emerging indications:

• Patent and Exclusivity: Hydroxyzine is off patent, leading to generic availability. No new patent protection or exclusive rights are expected.
• Regulatory Trends: The FDA has not granted new indications or formulations. Any label expansion would require significant clinical trial investment.
• Potential Indications: Some experimental research explores its use in opioid withdrawal, pruritus, and COVID-19-related symptoms, but none are approved or commercially significant.

Based on these factors, the market is expected to contract slowly, driven mainly by generic competition and therapy shifts.

How does market projection compare to other antihistamines or anxiolytics?

Drug Class	Market Size (2022)	CAGR (2022–2027)	Drivers
Hydroxyzine (VISTARIL)	<$100 million	-2%	Generic competition, aging population
Second-generation antihistamines	$8 billion	4%	Safety profile, minimal sedation
Benzodiazepines	$3.5 billion	-1.5%	Regulators' scrutiny, dependence concerns

Hydroxyzine’s niche status limits its growth prospects compared to more modern alternatives.

What strategic opportunities or risks exist for VISTARIL?

Opportunities:

• Limited competition in sedation for certain populations (e.g., elderly with intolerance to newer antihistamines).
• Development of new formulations (e.g., long-acting, combination therapy) could extend patent life.

Risks:

• Market dominance diminished by second-generation antihistamines.
• Lack of new clinical data or regulatory approvals curtails expansion.
• Price erosion due to generic competition reduces profit margins.

Summary

VISTARIL's clinical development activity has stalled, with no current trail of new trials or label expansions. Its market is shrinking due to generics and the displacement by newer agents with better safety or tolerability profiles. No imminent growth trajectories exist unless new indications or formulations emerge.

---

Key Takeaways

• Clinical trials for VISTARIL have not progressed since 2019, with limited recent research.
• The U.S. retail market for hydroxyzine is less than $100 million annually and declining.
• Market share diminishes as generics dominate its segment; newer antihistamines are replacing it.
• No patent protections or regulatory initiatives are underway to extend its lifecycle.
• The drug's future relies on niche uses and potential development of novel formulations or off-label indications.

---

FAQs

1. Are there ongoing clinical trials for new indications of VISTARIL?
No, recent registration data do not show active trials for VISTARIL or hydroxyzine.

2. Can VISTARIL be developed for new therapeutic uses?
While possible, significant clinical development and regulatory approval would be required; current data do not support imminent new indications.

3. How does hydroxyzine compare to newer antihistamines?
Hydroxyzine has sedative side effects and is less favored compared to second-generation antihistamines that lack sedative properties and have better safety profiles.

4. What is the primary risk to VISTARIL’s market?
Loss of market share to generic competitors and displacement by newer medications with improved safety and tolerability.

5. Will VISTARIL remain profitable in the coming years?
Profitability hinges on maintaining sales within niche markets; overall, the trend suggests declining revenues absent new developments.