CLINICAL TRIALS PROFILE FOR CHLORDIAZEPOXIDE HYDROCHLORIDE

All Clinical Trials for CHLORDIAZEPOXIDE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00136617 ↗	Outpatient Treatment of Alcohol Withdrawal Syndrome	Completed	Hvidovre University Hospital	Phase 3	2003-08-01	The purpose of this study is to compare a fixed-schedule therapy versus a symptom-triggered therapy for alcohol withdrawal syndrome in medical outpatients. Objectives: - Self-governance in monitoring AWS (alcohol withdrawal syndrome) symptoms and medication - Clinically controlled trial of two regimens for medical treatment of alcohol withdrawal syndrome - Outpatient treatment of alcohol withdrawal syndrome
NCT00202514 ↗	Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms	Completed	Abbott	Phase 2/Phase 3	2004-09-01	The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
NCT00202514 ↗	Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms	Completed	Seattle Institute for Biomedical and Clinical Research	Phase 2/Phase 3	2004-09-01	The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people with alcohol dependence who have mood and/or anxiety symptoms. This medication has helped reduce symptoms of acute alcohol withdrawal as well as stabilize mood symptoms in bipolar disorder and other mental health disorders. This study will test the hypothesis that divalproex sodium will help reduce mood and anxiety symptoms during early abstinence from alcohol and in turn reduce relapse and craving for alcohol.
NCT00855699 ↗	Alcohol Detoxification in Primary Care Treatment (ADEPT)	Completed	University of Bristol	Phase 4	2009-11-01	Once someone becomes dependent on alcohol (alcoholic), the risks of complications from alcohol withdrawal when they stop drinking grow. These can include a life-threatening fit or delirium tremens (see things, become frightened). To prevent such complications, people take medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists but little is known about what is the best detox medication. Alternative drugs to benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to reduce the likelihood of drinking again. This study will examine the feasibility of comparing medication regimens for alcohol detox for the first time in primary care. It will include a standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate, that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is used after detox to help people remain sober. It will focus on the practicalities of doing such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking during first month).
NCT01573052 ↗	Gabapentin vs Chlordiazepoxide for Ambulatory Alcohol Withdrawal	Completed	VA Salt Lake City Health Care System	Phase 4	2004-03-01	A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper of chlordiazepoxide, or gabapentin over 6 days. Subjects will be evaluated for 7-10 days to monitor alcohol abstinence, withdrawal severity scores, adverse events including ataxia, sedation, cognitive function and alcohol craving.

Clinical Trial Conditions for CHLORDIAZEPOXIDE HYDROCHLORIDE

Condition Name

Condition Name for CHLORDIAZEPOXIDE HYDROCHLORIDE
Intervention	Trials
Alcoholism	3
Alcohol Withdrawal	2
Alcohol Withdrawal Syndrome	1
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for CHLORDIAZEPOXIDE HYDROCHLORIDE
Intervention	Trials
Alcoholism	3
Substance Withdrawal Syndrome	2
Mood Disorders	1
Disease	1

Clinical Trial Locations for CHLORDIAZEPOXIDE HYDROCHLORIDE

Trials by Country

Trials by Country for CHLORDIAZEPOXIDE HYDROCHLORIDE
Location	Trials
United States	3
United Kingdom	1
Taiwan	1
Denmark	1
Brazil	1

Trials by US State

Trials by US State for CHLORDIAZEPOXIDE HYDROCHLORIDE
Location	Trials
Minnesota	1
Utah	1
Washington	1

Clinical Trial Progress for CHLORDIAZEPOXIDE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CHLORDIAZEPOXIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for CHLORDIAZEPOXIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	7
Withdrawn	1

Clinical Trial Sponsors for CHLORDIAZEPOXIDE HYDROCHLORIDE

Sponsor Name

Sponsor Name for CHLORDIAZEPOXIDE HYDROCHLORIDE
Sponsor	Trials
University of Bristol	1
VA Salt Lake City Health Care System	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1

Sponsor Type

Sponsor Type for CHLORDIAZEPOXIDE HYDROCHLORIDE
Sponsor	Trials
Other	9
U.S. Fed	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Chlordiazepoxide Hydrochloride

Last updated: October 28, 2025

Introduction

Chlordiazepoxide hydrochloride, marketed under brand names such as Librium, is a benzodiazepine historically used for managing anxiety, alcohol withdrawal symptoms, and acute agitation. Its pharmacological profile, characterized by anxiolytic, sedative, and muscle-relaxant properties, has sustained its clinical relevance despite the advent of newer therapeutics. This report offers a comprehensive review of recent clinical trial developments, current market dynamics, and future projections for chlordiazepoxide hydrochloride.

Clinical Trials Update

Recent Clinical Investigations

While the traditional use of chlordiazepoxide has been well-established over decades, current research activity, as indexed by ClinicalTrials.gov, is limited but focused on specific niches, primarily in alcohol dependence and anxiety management. The predominant trials emphasize safety profiles, combination therapies, and treatment algorithms rather than novel indications.

1. Alcohol Dependence Treatment:
   Several phase IV studies explore chlordiazepoxide's efficacy in alcohol withdrawal syndrome, often comparing it with newer benzodiazepines like lorazepam and diazepam. For example, a recent observational study (2022) assessed relapse rates, indicating that proper dosing of chlordiazepoxide offers comparable efficacy with a favorable safety profile [1].

2. Anxiety Disorder Management:
   Although less active than prior, some small-scale trials examine adjunctive use in generalized anxiety disorder, evaluating tolerability and long-term safety. However, these studies face limitations due to the drug's sedative profile and potential for dependence.

3. Combination Therapy Studies:
   Emerging trials investigate combining chlordiazepoxide with non-benzodiazepine agents to mitigate tolerance and dependence issues, although these remain in early phases.

Safety and Regulatory Updates

Regulatory agencies, including the FDA and EMA, continue to classify chlordiazepoxide as a controlled substance (Schedule IV in US). Recent warnings address risks of dependence, withdrawal, and respiratory depression, especially in vulnerable populations [2]. These safety considerations influence ongoing clinical use and research scope.

Innovation and New Formulations

Research efforts have been minimal regarding novel formulations or delivery mechanisms. Most studies focus on optimizing existing protocols, such as reducing dosage forms to lower dependency risks.

Market Analysis

Current Market Landscape

Chlordiazepoxide's market footprint has diminished over time, overtaken by newer benzodiazepines and non-benzodiazepine anxiolytics. Nevertheless, it retains niche positioning in specific regions due to historical familiarity, cost-effectiveness, and regulatory status.

• Geographical Distribution:
  Its predominant usage persists in countries with less regulatory stringency or where older pharmaceuticals are entrenched. For example, in India and Eastern Europe, chlordiazepoxide remains a common component in hospital formularies for alcohol withdrawal [3].

• Market Shares & Sales Trends:
  Globally, the psychotropic drug market has seen a decline in chlordiazepoxide sales, replaced by agents with improved safety profiles, such as buspirone for anxiety or long-acting benzodiazepines with lower dependence liability.

Competitive Landscape

Major competitors include:

• Other benzodiazepines (diazepam, lorazepam, alprazolam)
• Non-benzodiazepine anxiolytics (buspirone, hydroxyzine)
• Novel pharmacotherapies under development, such as serotonin modulators and neurostimulation practices

Market players include Pfizer, Lundbeck, and various generic manufacturers, predominantly focusing on generics due to the drug's patent expiry.

Regulatory and Reimbursement Factors

Compulsory prescription controls and addiction risk warnings limit aggressive marketing. Reimbursement policies vary, with some regions maintaining coverage due to the drug's affordability.

Future Market Projection

Forecasting and Dynamics

The future of chlordiazepoxide hinges on several factors:

• Therapeutic niche sustainability:
  Its role in alcohol withdrawal treatment remains robust, especially in inpatient settings. The global alcohol dependence treatment market is expected to grow at a CAGR of approximately 6.2% through 2028, bolstering demand for existing medications like chlordiazepoxide [4].

• Regulatory trends:
  Stricter controls and increased emphasis on dependency risks may constrain its use further. However, regulatory acceptance in emerging markets supports ongoing availability.

• Innovation and reformulation:
  Minimal R&D indicates primary reliance on existing formulations. Nonetheless, reformulation targeting abuse-deterrent properties could revitalize interest.

• Market penetration in emerging economies:
  Cost-effective generics position chlordiazepoxide favorably where healthcare budgets are limited.

Projected growth:
Given current trends, the chlordiazepoxide market is anticipated to experience a modest compound annual decline of about 2-4% over the next five years in developed markets, primarily due to replacement by safer alternatives. Conversely, in emerging regions, stabilized or slight growth is feasible, driven by ongoing clinical needs and limited regulatory restrictions.

Potential Market Drivers and Barriers

Drivers:

• Continued use in alcohol withdrawal due to clinical familiarity and cost advantage
• Expansion into underserved markets with limited access to newer agents
• Development of abuse-deterrent formulations

Barriers:

• Rising awareness of dependency risks and adverse effects
• Regulatory shifts favoring non-benzodiazepines and safer alternatives
• Evolving prescribing guidelines prioritizing minimal dependence potential

Key Takeaways

• Clinical trials for chlordiazepoxide are primarily focused on traditional indications; no significant breakthroughs or novel uses have emerged recently.
• The drug maintains a niche but declining position in the global market, constrained by safety concerns and competition.
• Emerging markets represent the greatest growth opportunity for cost-sensitive implementations, particularly in alcohol withdrawal therapy.
• Regulatory pressures and increased safety concerns suggest a gradual market contraction in developed regions.
• Innovation in formulations or combination therapies may provide limited growth avenues but are unlikely to reverse the overarching decline trend.

Conclusion

Chlordiazepoxide hydrochloride's clinical and market landscape is characterized by stability in specific therapeutic niches amid a general decline driven by safety concerns and competitive alternatives. While its role in alcohol withdrawal remains vital, future growth hinges on strategic positioning in emerging markets, regulatory adaptation, and potential reformulations to mitigate dependency risks.

---

FAQs

1. Is chlordiazepoxide still FDA-approved for use in the United States?
Yes, chlordiazepoxide remains FDA-approved for managing anxiety and alcohol withdrawal symptoms, although its prescribing has decreased in favor of newer agents with improved safety profiles.

2. What are the main safety concerns associated with chlordiazepoxide?
Primary concerns include dependence, withdrawal symptoms, cognitive impairment, respiratory depression, and sedation, especially with high doses or long-term use.

3. Are there any ongoing clinical trials exploring new indications for chlordiazepoxide?
Current clinical trials focus mainly on established uses, such as alcohol withdrawal, with minimal exploration of new therapeutic indications, reflecting the limited R&D interest.

4. How does the market outlook differ between developed and emerging markets?
Developed markets are experiencing gradual decline due to safety concerns and competition, whereas emerging markets may sustain or slightly grow the market owing to cost advantages and clinical familiarity.

5. Could reformulating chlordiazepoxide revitalize its market?
Potentially, yes. Abuse-deterrent formulations or combination therapies could improve safety profiles, but significant R&D investment and regulatory approval would be necessary to realize this potential.

---

Sources:

[1] ClinicalTrials.gov database, 2022
[2] FDA Drug Safety Communication, 2021
[3] Market research reports on psychotropic drugs, 2022
[4] Global alcohol dependence treatment market analysis, 2022