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
Alcohol Dependence	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
Germany	1
China	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	4
Not yet recruiting	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

Last updated: July 27, 2026

OXAZEPAM Clinical Trials Update, Market Analysis, and Exclusivity Outlook

Oxazepam is an oral benzodiazepine indicated for anxiety and related conditions in multiple markets. Public clinical-trial activity and near-term market prospects depend on whether a given jurisdiction’s marketed product is still under active regulatory exclusivity and whether local generics have already entered. No complete, source-grounded dataset is available here to support an accurate, date-stamped “clinical trials update” (trial IDs, status by phase, enrollment/completion dates, sponsor, endpoints) and a quantified market projection (current sales, CAGR drivers, generic penetration, pricing trajectory, forecast horizon).

What clinical trials are ongoing for oxazepam and what are the latest results?

A source-backed update requires trial registries (e.g., ClinicalTrials.gov, EU CTR, WHO ICTRP) with the specific “oxazepam” entries, including NCT numbers, protocol titles, sponsors, status dates, and results postings. Without that dataset, a precise “latest results” summary cannot be produced without risking factual error.

Which phases (Phase 1, 2, 3) involve oxazepam in recent years?

A complete phase-by-phase view requires registry extraction by year, including study status and primary endpoints (anxiety scales, sedation, pharmacokinetics, safety).

Are there oxazepam reformulation or new-dose studies?

Reformulation studies (e.g., extended-release, bioequivalence, taste-masked solids) and pharmacokinetic studies often dominate for older benzodiazepines. A reliable inventory requires protocol identifiers and publication links.

How big is the oxazepam market and what is the base case forecast?

A quantified market analysis requires: (1) current annual sales by geography and product form, (2) volume and pricing trends, (3) payer mix where relevant, and (4) forecast assumptions tied to regulatory entry and generic erosion. With no sourced sales dataset and no geography scope, no defensible projection can be stated.

What drives oxazepam demand: guideline use, indications, or prescribing trends?

Demand for benzodiazepines is driven by physician prescribing patterns, substitutability with SSRIs/SNRIs and other anxiolytics, and safety restrictions (falls, dependence). A market model needs jurisdiction-specific prescribing and policy data to produce an accurate forecast.

What is the generic penetration risk for oxazepam?

Generic penetration is typically high for legacy benzodiazepines, but the exact timing and residual brand share depend on local approvals, Orange Book or equivalent listings, and patent/market exclusivity records by country.

When does oxazepam lose exclusivity and can generics launch immediately?

Exclusivity timing must be tied to jurisdiction-specific regulatory status: FDA Orange Book listings for US brands (if any), EU/UK SPCs where applicable, and other national data protection or market exclusivity regimes. Without Orange Book or equivalent listings for the specific marketed product, exclusivity dates cannot be stated accurately.

What is the Orange Book status of oxazepam?

Orange Book status requires identifying the specific NDA/ANDA or listed drug product and then reading listed patents, expiration dates, and exclusivity codes.

What patents protect oxazepam in key markets?

Patent protection for oxazepam is often dominated by old basic composition or process claims and may have expired in many jurisdictions. A defensible answer requires a country-by-country patent harvest linked to the listed drug product, with numbers, assignees, and expiration dates.

How strong is the patent estate for oxazepam formulations and methods of use?

Patent strength depends on claim scope and remaining term, not just the existence of any filing. A useful analysis requires: claim categories (composition, process, formulation, method-of-use), grant status, prosecution history, and litigation record.

What formulations are protected for oxazepam (if any)?

Formulation patents would cover specific excipient systems, dosage forms, and release profiles. These must be mapped to the commercial product’s dosage strength and form.

Are there method-of-use patents for oxazepam (e.g., specific anxiety disorders)?

Method-of-use protections require a clear linkage to the FDA labeling or the local label and proof of claim relevance to the marketed claim.

What patent litigation affects oxazepam and its generic entry?

Patent litigation requires docket-level facts: parties, asserted patents, filings (e.g., Paragraph IV notices), courts, injunction outcomes, and settlement terms. Without sourced litigation records for oxazepam (by jurisdiction and asserted patents), no credible statement is possible.

Which companies are challenging oxazepam?

A challenge list requires identifying ANDA/HANDA filers and the patents asserted in each notice.

Did settlements occur and what were the terms?

Settlement agreements require published or docket-attached details: design-arounds, entry dates, royalty/licensing payments, and carve-outs.

How does oxazepam compare with competing benzodiazepines for market outlook?

Competitive comparisons require current labeling, safety constraints, and real-world prescribing patterns by country. Benzodiazepine competition often includes lorazepam, diazepam, alprazolam, clonazepam, and non-benzodiazepine anxiolytics depending on market and guideline positioning.

Which alternative drugs substitute for oxazepam?

Substitution depends on onset, half-life, elimination route (important for hepatic impairment), and clinician preference.

How do safety policies affect benzodiazepine sales?

Policy levers include prescribing caps, class warnings, and clinician risk management programs. These can shift share among agents.

Key Takeaways

• A precise clinical trials update for oxazepam requires trial registry extraction with identifiers and status dates; that sourced dataset is not present in the available information here.
• A quantified market analysis and projection needs current sales and forecast modeling inputs by geography and product; those inputs are not available in this context.
• Exclusivity, patent strength, and generic-launch timing must be tied to jurisdiction-specific regulatory and patent listings; without those listings for the specific marketed product(s), actionable dates cannot be stated.

FAQs

1. Are there any new Phase 2 or Phase 3 oxazepam trials registered in the last 12 months?
2. Which oxazepam dosage forms have the most recent bioequivalence filings in the US and EU?
3. Does oxazepam have any FDA Orange Book listed patents for currently marketed products?
4. Have any ANDA Paragraph IV challenges been filed for oxazepam, and what settlement terms were reached?
5. How does oxazepam’s hepatic clearance profile affect its competitive positioning versus lorazepam and diazepam?

References

No sources were cited because the requested dataset (trial registry records, regulatory exclusivity/patent listings, litigation dockets, and market sales figures) is not provided in the available information.