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.

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
Austria	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	3
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
Industry	11
Other	11
NIH	7

Oxazepam: Clinical Trials, Market Analysis, and Projections

Introduction to Oxazepam

Oxazepam is a benzodiazepine used primarily for the treatment of anxiety and insomnia, as well as for managing alcohol withdrawal symptoms. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Comparative Studies

Clinical studies have compared oxazepam with other benzodiazepines and placebo to assess its efficacy and safety. A notable study compared oxazepam with midazolam and placebo in treating insomnia. The results showed that both oxazepam and midazolam significantly shortened sleep onset latency, reduced the number of awakenings, and improved sleep quality compared to placebo. Midazolam induced sleep more rapidly and was rated more favorably by patients, but both drugs were well-tolerated with minimal side effects[1].

Long-Term Use and Dependence

A 5-year follow-up study on benzodiazepine users found that patients starting with oxazepam had a higher risk of dose escalation compared to those starting with diazepam. This study highlighted that despite oxazepam being considered to have a lower liability for dependence, it still posed significant risks for long-term users, particularly in terms of dose escalation and the development of dependence[5].

Market Analysis

Current Market Trends

The oxazepam market is driven by several key factors, including the increasing prevalence of mental health conditions, growing awareness about mental health, and the rising geriatric population. Oxazepam's effectiveness in managing alcohol withdrawal symptoms and its milder sedative effects compared to other benzodiazepines contribute to its market demand[3].

Global Market Report

The global oxazepam market report for 2024 provides a comprehensive overview of the market size, share, growth, CAGR, and forecast until 2031. The report includes competitor analysis, regional and country analysis, segment analysis, market trends, drivers, opportunities, and restraints. It also covers ESG analysis, Porter's Five Forces analysis, PESTEL analysis, and SWOT analysis, providing a thorough understanding of the market dynamics[2].

Manufacturing and Project Economics

The oxazepam manufacturing plant project report details the project economics, including capital investments, project funding, operating expenses, and income. This report is crucial for understanding the financial viability and operational aspects of producing oxazepam, highlighting the significant role of regulatory approvals and guidelines in shaping the market[3].

Market Projections

Growth Drivers

The oxazepam market is expected to grow steadily due to several drivers:

• Increasing Prevalence of Mental Health Conditions: The rising awareness and diagnosis of mental health issues are driving the demand for medications like oxazepam.
• Growing Geriatric Population: The elderly often require medications with milder sedative effects, making oxazepam a preferred choice.
• Regulatory Approvals: Strict guidelines ensure the responsible use of benzodiazepines, including oxazepam, which helps in maintaining market stability[3].

Forecast and CAGR

The global oxazepam market is forecasted to grow from 2025 to 2031, with a significant CAGR. The market size and revenue are expected to increase, driven by the factors mentioned above. The report provides detailed forecasts and segment analysis to help stakeholders understand the future market landscape[2].

Challenges and Restraints

Dependence and Dose Escalation

Despite its benefits, oxazepam faces challenges related to dependence and dose escalation. Studies have shown that long-term use can lead to increased risk of dose escalation, which can be a significant restraint on the market growth[5].

Regulatory Scrutiny

Benzodiazepines, including oxazepam, are under regulatory scrutiny due to their potential for abuse and dependence. This scrutiny can impact market growth and necessitate careful management and compliance with regulatory guidelines[3].

Conclusion

Oxazepam remains a vital medication in the treatment of anxiety, insomnia, and alcohol withdrawal symptoms. While clinical trials highlight its efficacy and safety, long-term use studies caution against the risks of dependence and dose escalation. The market analysis indicates a steady growth trajectory driven by increasing mental health awareness and the needs of the geriatric population. However, regulatory scrutiny and the potential for dependence are critical factors that need to be managed to ensure sustainable market growth.

Key Takeaways

• Efficacy and Safety: Oxazepam is effective in treating insomnia and anxiety, with a favorable safety profile compared to other benzodiazepines.
• Market Growth: The market is expected to grow due to increasing mental health awareness and the needs of the geriatric population.
• Regulatory Scrutiny: Strict regulatory guidelines are in place to ensure the responsible use of oxazepam.
• Dependence Risks: Long-term use poses risks of dependence and dose escalation.
• Market Forecast: The global oxazepam market is forecasted to grow with a significant CAGR from 2025 to 2031.

FAQs

What are the primary uses of oxazepam?

Oxazepam is primarily used for the treatment of anxiety, insomnia, and managing alcohol withdrawal symptoms.

How does oxazepam compare to midazolam in treating insomnia?

Both oxazepam and midazolam are effective in treating insomnia, but midazolam induces sleep more rapidly and is rated more favorably by patients[1].

What are the risks associated with long-term use of oxazepam?

Long-term use of oxazepam can lead to increased risks of dose escalation and dependence[5].

What drives the growth of the oxazepam market?

The market growth is driven by increasing mental health awareness, the growing geriatric population, and the effectiveness of oxazepam in managing alcohol withdrawal symptoms[3].

What are the regulatory considerations for oxazepam?

Oxazepam is subject to strict regulatory guidelines to ensure its responsible use and minimize the risks of abuse and dependence[3].

Sources

1. Comparative clinical studies with midazolam, oxazepam and placebo - PubMed
2. Global Oxazepam Market Report 2024 Edition - Cognitive Market Research
3. Oxazepam Manufacturing Plant Project Report 2023 - IMARC Group
4. Otsuka Pharmaceutical Development & Commercialization, Inc. - ClinicalTrials.gov
5. A 5-year follow-up study of users of benzodiazepine: starting with oxazepam or diazepam - British Journal of General Practice