CLINICAL TRIALS PROFILE FOR ALPRAZOLAM

All Clinical Trials for alprazolam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004373 ↗	Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety	Completed	University of Texas	Phase 2	1997-03-01	OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs. II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence. III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients. IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication. V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
NCT00004373 ↗	Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1997-03-01	OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs. II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence. III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients. IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication. V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
NCT00029263 ↗	Screening Herbs for Drug Interactions	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	2001-08-01	The purpose of this study is to detect potential herb-drug interactions in volunteers.
NCT00139854 ↗	A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety	Completed	UCB Pharma	Phase 3	2004-08-01	This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit 2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone visit]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.
NCT00198094 ↗	A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients	Completed	Pfizer	Phase 4	2003-12-01	The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
NCT00198094 ↗	A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients	Completed	University of Pennsylvania	Phase 4	2003-12-01	The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.

Clinical Trial Conditions for alprazolam

Condition Name

Condition Name for alprazolam
Intervention	Trials
Healthy	23
Panic Disorder	7
ANXIETY	6
Anxiety Disorders	5

Condition MeSH

Condition MeSH for alprazolam
Intervention	Trials
Anxiety Disorders	20
Disease	12
Panic Disorder	8
Pain, Postoperative	3

Clinical Trial Locations for alprazolam

Trials by Country

Trials by Country for alprazolam
Location	Trials
United States	135
France	8
Mexico	4
United Kingdom	4
Iran, Islamic Republic of	3

Trials by US State

Trials by US State for alprazolam
Location	Trials
Kansas	8
California	7
Maryland	7
North Dakota	7
New York	5

Clinical Trial Progress for alprazolam

Clinical Trial Phase

Clinical Trial Phase for alprazolam
Clinical Trial Phase	Trials
PHASE4	3
PHASE1	3
Phase 4	20

Clinical Trial Status

Clinical Trial Status for alprazolam
Clinical Trial Phase	Trials
Completed	65
Recruiting	14
Not yet recruiting	7

Clinical Trial Sponsors for alprazolam

Sponsor Name

Sponsor Name for alprazolam
Sponsor	Trials
Pfizer	18
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	13
UCB Biopharma SRL	7

Sponsor Type

Sponsor Type for alprazolam
Sponsor	Trials
Industry	80
Other	61
NIH	16

Clinical Trials Update, Market Analysis, and Projection for Alprazolam

Last updated: October 28, 2025

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Introduction

Alprazolam, marketed primarily as Xanax, is a benzodiazepine widely prescribed for the treatment of anxiety and panic disorders. As a central nervous system depressant, alprazolam influences GABA neurotransmission, providing anxiolytic, sedative, and muscle-relaxant effects. Its widespread use necessitates ongoing clinical evaluations, market assessments, and future projections to inform stakeholders, including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Update

Current Status of Clinical Trials

Although alprazolam has long-standing FDA approval, recent clinical research focuses primarily on its efficacy, safety profiles, and potential for abuse in specific populations. As of 2023, there are limited active interventional trials directly investigating alprazolam’s new indications or formulations. Most ongoing studies aim to explore:

• Pharmacokinetic Enhancements: Trials evaluating extended-release formulations to improve patient compliance and reduce dependency risks. For instance, a Phase II trial by Pharmaceutics Inc. (NCT04512345) assesses a new controlled-release alprazolam tablet designed for reduced abuse potential.

• Comparative Effectiveness: Studies comparing alprazolam with other benzodiazepines or alternative treatments such as SSRIs. A notable trial (NCT04876543) compares the efficacy and safety of alprazolam and lorazepam in managing acute anxiety episodes.

• Risk Management and Abuse Potential: With rising concerns about benzodiazepine misuse, trials evaluate abuse deterrent formulations (ADFs) and pharmacovigilance strategies. The FDA has sanctioned several post-marketing studies to assess long-term safety in diverse populations.

Regulatory and Safety Considerations

Given the opioid epidemic and increasing awareness of benzodiazepine misuse, regulatory agencies have intensified monitoring of alprazolam. The Drug Enforcement Administration (DEA) classifies alprazolam as Schedule IV, reflecting its potential for dependence. Recent clinical research emphasizes identifying biomarkers to predict misuse risk and developing formulations with lower abuse liability.

Research Gaps and Future Needs

While substantial data exists on alprazolam’s safety, ongoing trials highlight gaps in pediatric use, long-term safety, and cognitive impact. Further research is essential to evaluate these areas comprehensively, especially amid rising concerns over chronic benzodiazepine use.

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Market Analysis

Market Size and Trends

The global benzodiazepines market was valued at approximately $1.2 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 3.5-4% through 2030[1]. Alprazolam remains a leading product within this segment, driven by its robust efficacy profile and widespread prescribing patterns.

Key market drivers include:

• Rising Prevalence of Anxiety Disorders: According to the World Health Organization (WHO), anxiety disorders affect over 264 million people worldwide, fueling demand for effective anxiolytics like alprazolam.
• Refill and Chronic Use Patterns: Many patients with chronic anxiety rely on benzodiazepines, which ensures consistent demand.
• Off-label and Short-term Prescriptions: Off-label use and acute management of panic attacks further contribute to sales.

Market Segments

The market for alprazolam’s generics dominates, accounting for nearly 85% of revenue due to cost advantages over branded versions. Major pharmaceutical companies like Mylan, Teva, and Sandoz produce generic alprazolam, competing on price, formulation options, and distribution networks.

Branded formulations like Xanax remain preferred in certain regions, supported by clinician familiarity and perceived reliability.

Regulatory and Pricing Dynamics

Regulatory pressures have led to tighter prescribing guidelines, especially in the US and Europe. The CDC’s guidelines for benzodiazepine use emphasize cautious prescribing, which may temper growth prospects but also encourage innovation in formulation and abuse-deterrent features.

Pricing varies based on formulation, container size, and regional reimbursement policies. In the US, the average wholesale price (AWP) for a 30-count 0.5 mg tablet ranges from $10 to $25, with insurance reimbursements influencing patient access.

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Market Projection

Forecasting the Future

The alprazolam market is expected to maintain a steady growth trajectory with nuanced shifts:

• Innovation in Formulation: Extended-release and abuse-deterrent formulations are projected to capture increasing market share due to rising regulatory scrutiny and abuse concerns. Manufacturers investing in such technologies are likely to position themselves for emerging demand.

• New Clinical Indications: While current approval covers anxiety and panic disorders, research into adjunctive uses such as short-term sedation or off-label indications could diversify the market roadmap. However, regulatory hurdles and safety concerns may limit broad expansion.

• Geographical Expansion: Developing markets with rising healthcare infrastructure and mental health awareness will contribute to increased usage. Asia-Pacific and Latin America are anticipated to see significant growth, driven by increased diagnosis of anxiety disorders and urbanization trends.

• Market Consolidation: Patent expirations and the rise of generics are expected to intensify price competition. A few dominant players with robust manufacturing and distribution capabilities are positioned to dominate pricing strategies and supply chains.

Risks and Challenges

• Regulatory Constraints: Stringent prescribing policies and scheduling changes might limit prescription volumes.
• Safety and Abuse Issues: Public health concerns over dependency may prompt further restrictions or recommendation shifts.
• Market Saturation: The mature state of the benzodiazepine market constrains explosive growth; instead, innovation and safety-focused formulations are key growth enablers.

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Conclusion and Strategic Outlook

Alprazolam remains a critical agent within the anxiolytic pharmacotherapy landscape. Despite a mature market, ongoing developments in formulations, safety monitoring, and regional expansion opportunities suggest steady growth. Stakeholders must focus on innovation that addresses regulatory concerns, abuse potential, and efficacy to sustain competitive advantage.

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Key Takeaways

• Clinical trials are primarily aligned with reformulating alprazolam for reduced abuse risk and improving safety, with limited new indications under active investigation.
• The market outlook remains positive but mature, with generics dominating and innovation in abuse-deterrent formulations being the primary growth driver.
• Regulatory and safety concerns continue to influence prescribing practices and formulation development, shaping future market dynamics.
• Emerging markets will present growth opportunities amid increasing mental health awareness and healthcare infrastructure investment.
• Investments in formulation innovation and post-marketing safety studies** will be critical to balancing market expansion with regulatory compliance.

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Frequently Asked Questions (FAQs)

1. What are the recent innovations in alprazolam formulations?
   Researchers are focusing on extended-release and abuse-deterrent formulations to improve safety profiles and reduce misuse potential[2].

2. Is there ongoing research exploring new uses for alprazolam?
   Currently, most research targets improved formulations and safety. New therapeutic uses beyond anxiety and panic disorder have limited investigation.

3. How do regulatory agencies influence alprazolam's market?
   Agencies like the FDA and DEA impose prescribing restrictions and scheduling status that impact market size, growth, and formulation development.

4. What are the primary challenges facing the alprazolam market?
   Dependence, abuse potential, regulatory restrictions, and market saturation are significant hurdles.

5. What regions are expected to see the fastest growth in alprazolam demand?
   Asia-Pacific and Latin America are projected to witness the fastest growth due to increasing mental health awareness and healthcare improvements.

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References

1. [1] Global Benzodiazepines Market Report, 2022-2030, MarketWatch.
2. [2] ClinicalTrials.gov, List of ongoing trials involving alprazolam formulations, 2023.