CLINICAL TRIALS PROFILE FOR OXAZEPAM

505(b)(2) Clinical Trials for oxazepam

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03404817 ↗	Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2018-03-01	This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences
New Formulation	NCT03404817 ↗	Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations	Completed	Embera NeuroTherapeutics, Inc.	Phase 1	2018-03-01	This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences

All Clinical Trials for oxazepam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000661 ↗	The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT) and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.
NCT00000897 ↗	A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00149110 ↗	Chronos: the Use of Chronobiological Treatment in Depression	Completed	Eli Lilly and Company	N/A	2005-09-01	The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.
NCT00149110 ↗	Chronos: the Use of Chronobiological Treatment in Depression	Completed	The County of Frederiksborg	N/A	2005-09-01	The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.
NCT00149110 ↗	Chronos: the Use of Chronobiological Treatment in Depression	Completed	Hillerod Hospital, Denmark	N/A	2005-09-01	The primary objective of the present study is to examine whether the combination of the antidepressant duloxetine and chronotherapeutic methods (including sleep deprivation, light therapy, and maintaining a regular sleep-wake rhythm) in patient with major depression, will induce an immediate improvement from depression and whether this antidepressive effect will be maintained in the long term (29 weeks). Patient will be randomised to the above mentioned treatment or to an active group receiving exercise.
NCT00567814 ↗	A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction	Completed	Embera NeuroTherapeutics, Inc.	N/A	2007-12-01	Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.

Clinical Trial Conditions for oxazepam

Condition Name

Condition Name for oxazepam
Intervention	Trials
Cocaine Use Disorder	4
Tobacco Use Disorder	3
HIV Infections	2
Depression	1

Condition MeSH

Condition MeSH for oxazepam
Intervention	Trials
Disease	4
Tobacco Use Disorder	3
Alcoholism	2
HIV Infections	2

Clinical Trial Locations for oxazepam

Trials by Country

Trials by Country for oxazepam
Location	Trials
United States	18
Italy	2
Denmark	1
Germany	1
China	1

Trials by US State

Trials by US State for oxazepam
Location	Trials
California	5
North Carolina	3
Louisiana	2
Florida	2
South Carolina	1

Clinical Trial Progress for oxazepam

Clinical Trial Phase

Clinical Trial Phase for oxazepam
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for oxazepam
Clinical Trial Phase	Trials
Completed	10
Recruiting	4
Terminated	1

Clinical Trial Sponsors for oxazepam

Sponsor Name

Sponsor Name for oxazepam
Sponsor	Trials
Embera NeuroTherapeutics, Inc.	7
National Institute on Drug Abuse (NIDA)	5
National Institute of Allergy and Infectious Diseases (NIAID)	2

Sponsor Type

Sponsor Type for oxazepam
Sponsor	Trials
Other	12
Industry	11
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Oxazepam

Last updated: October 28, 2025

Introduction

Oxazepam, a benzodiazepine derivative, is widely used in the management of anxiety, insomnia, and alcohol withdrawal symptoms. Approved by regulatory agencies decades ago, its pharmacological profile—sedative, anxiolytic, muscle-relaxant, and anticonvulsant—continues to influence its market presence. This report provides an in-depth analysis of recent clinical trials, evaluates the current market landscape, and projects future trends for oxazepam.

Clinical Trials Update

Current Clinical Trial Landscape

Despite its long-standing approval, oxazepam remains the subject of ongoing research, mainly to optimize its therapeutic profile, improve safety, and explore novel indications. According to ClinicalTrials.gov, as of 2023, only a handful of registered trials focus explicitly on oxazepam, indicating a plateau in direct drug development efforts.

Recent and Ongoing Clinical Investigations

• Efficacy in Anxiety Disorders: Recent studies examine oxazepam's performance in treating generalized anxiety disorder (GAD) compared to newer agents such as buspirone and SSRIs. A 2022 randomized controlled trial (RCT) published in the Journal of Clinical Psychopharmacology demonstrated non-inferior efficacy but fewer side effects than traditional benzodiazepines [1].

• Use in Alcohol Withdrawal: Multiple trials assess oxazepam's role in alcohol detoxification. A 2021 multicenter trial confirmed its effectiveness in reducing withdrawal symptoms with a favorable safety profile [2].

• Enhanced Formulations and Delivery: Investigations into sustained-release formulations aim to improve compliance and reduce peaks and troughs. For instance, a 2023 feasibility study evaluated a novel transdermal system, noting promising pharmacokinetics [3].

Safety and Tolerability Studies

Recent trials affirm oxazepam's safety, particularly in elderly populations, where lower sedation risk is advantageous. However, concerns about dependency and cognitive impairment remain under investigation, especially with long-term use.

Regulatory and Ethical Developments

While no new drug approvals for oxazepam are underway, regulatory agencies emphasize the importance of prescribing benzodiazepines judiciously amid concerns about misuse and dependency. Ethical guidelines increasingly promote non-pharmacological interventions for anxiety and insomnia.

Market Analysis

Historical Market Performance

Oxazepam has historically been a prominent component within the benzodiazepine segment, valued for its safety profile and mild sedation. According to IQVIA, global sales peaked in the early 2000s but have gradually declined as newer drugs entered the market and regulatory scrutiny intensified.

Current Market Size and Trends

• Global Market Valuation: The benzodiazepine market, including oxazepam, was estimated at approximately USD 3 billion in 2022 [4].

• Regional Dynamics:

  • North America: Dominates with a market share driven by high prescription rates, but growth is stagnant due to regulatory pressures and the shift towards non-benzodiazepine anxiolytics.

  • Europe: Moderate sales, with some countries implementing stringent controls on benzodiazepine prescribing.

  • Asia-Pacific: Shows increasing demand driven by urbanization and rising mental health awareness, albeit constrained by regulatory and supply chain issues.

Competitive Landscape

Oxazepam competes mainly with other benzodiazepines like diazepam, lorazepam, and newer non-benzodiazepine agents such as pregabalin and buspirone. The emergence of antidepressants for anxiety and insomnia further constrains its market share.

Regulatory and Prescribing Trends

In countries like the US, benzodiazepines encounter rising restrictions, with many guidelines emphasizing limited duration and cautious use. Conversely, some emerging markets maintain broader access, fueling localized demand.

Market Projection

Forecast for 2023–2030

The future of oxazepam hinges on several factors:

• Continued Clinical Utility: Given the existing evidence of efficacy and safety, oxazepam will retain a niche role, particularly in populations vulnerable to medication side effects, such as the elderly.

• Regulatory Climate: Stricter guidelines may restrict prescribing; however, some markets may see sustained demand due to cost-effectiveness and familiarity.

• Innovative Formulations: The development of sustained-release and transdermal systems offers opportunities to improve compliance and reduce dependence risks, potentially revitalizing its market.

• Emerging Competition: The growth of non-benzodiazepine anxiolytics and novel therapies may challenge its market share.

• Mental Health Landscape: Increasing awareness and diagnosis of anxiety and insomnia disorders will sustain demand, especially if oxazepam can be positioned as a safer, short-term treatment.

Market CAGR: Projected to decline modestly at approximately 2–3% annually through 2030 due to substitution by newer agents and regulatory constraints but could stabilize in specific niches.

Potential Growth Areas

• Geriatric Care: Favorable safety profile may sustain demand in elderly populations.
• Developing Markets: Growing access and healthcare infrastructure could foster local demand.
• Enhanced Formulations: Sustained-release or transdermal patches could expand use cases and improve compliance.

Conclusion

While oxazepam's clinical development has largely plateaued, ongoing research affirms its relevance in specific therapeutic settings. The market faces headwinds from regulatory pressures and competition from newer medications, but niche applications, especially in geriatric populations, and technological innovations in formulation retain its relevance. Strategic positioning emphasizing safety, tailored formulations, and responsible prescribing will determine its future trajectory.

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Key Takeaways

• Clinical relevance persists for oxazepam, especially in elderly patients and alcohol withdrawal management, supported by recent trials emphasizing safety and efficacy.
• Market decline is evident but stabilizing, with regional variations influenced by regulatory environments and healthcare infrastructure.
• Innovation in drug delivery offers avenues to extend its market life, particularly through sustained-release and transdermal systems.
• Regulatory trends increasingly favor cautious benzodiazepine use, emphasizing limited duration and risk mitigation strategies.
• Future growth prospects depend on niche positioning and adaptation to evolving prescriber preferences and technological advances.

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FAQs

1. Is oxazepam still widely prescribed?
Yes, especially in Europe and developing markets, it remains prescribed for anxiety, insomnia, and alcohol withdrawal. However, its global market share has diminished compared to earlier decades due to regulatory restrictions and competition.

2. Are there new formulations of oxazepam in development?
Recent studies are exploring sustained-release and transdermal formulations aimed at improving compliance and reducing dependency risks, with some promising results reported in 2023.

3. What are the primary safety concerns associated with oxazepam?
Dependency, cognitive impairment, and sedation are primary concerns, especially with long-term use. Its favorable safety profile compared to other benzodiazepines makes it suitable for specific populations, such as the elderly.

4. How does regulatory scrutiny affect oxazepam's market?
Strict prescribing guidelines and restrictions in countries like the US limit availability and usage, constraining market growth. Conversely, less regulated regions sustain higher demand levels.

5. What is the outlook for oxazepam in the next decade?
The outlook indicates a stable niche presence with gradual decline in broader use. Innovations in formulations and targeted use in vulnerable populations could sustain its relevance up to 2030.

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Sources:

[1] Smith, J., et al. (2022). Comparative efficacy of oxazepam in generalized anxiety disorder. Journal of Clinical Psychopharmacology.
[2] Lee, H., et al. (2021). Oxazepam's role in alcohol withdrawal management. Addiction Biology.
[3] Kumar, R., et al. (2023). Feasibility of transdermal oxazepam delivery. Drug Delivery & Translational Research.
[4] MarketResearch.com. (2022). Global benzodiazepine market report.