CLINICAL TRIALS PROFILE FOR CORVERT

All Clinical Trials for CORVERT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02513940 ↗	Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes	Completed	American Heart Association	Phase 4	2016-05-01	Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for drug-induced TdP in men, possibly due to declining serum testosterone concentrations. Available evidence shows an inverse relationship between QTc intervals and serum testosterone concentrations. In addition, experimental data, including those from the investigators' laboratory, suggest that both exogenous testosterone or progesterone administration may be protective against prolongation of ventricular repolarization and TdP. Specific Aim: Establish the influence of transdermal testosterone administration and oral progesterone administration as preventive methods by which to diminish the degree of drug-induced QT interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone administration and oral progesterone administration both effectively attenuate drug-induced QT interval response in older men. To test this hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a 3-way crossover study to men 65 years of age or older. QTc interval response to low-dose ibutilide will be assessed. The primary endpoints will be Fridericia-corrected QT interval (QTF) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) Effect on pre-ibutilide QTF, 2) Effect on maximum post-ibutilide QTF, 3) Effect on % change in post-ibutilide QTF, and 2) Area under the QTF interval-time curves.
NCT02513940 ↗	Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes	Completed	Purdue University	Phase 4	2016-05-01	Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for drug-induced TdP in men, possibly due to declining serum testosterone concentrations. Available evidence shows an inverse relationship between QTc intervals and serum testosterone concentrations. In addition, experimental data, including those from the investigators' laboratory, suggest that both exogenous testosterone or progesterone administration may be protective against prolongation of ventricular repolarization and TdP. Specific Aim: Establish the influence of transdermal testosterone administration and oral progesterone administration as preventive methods by which to diminish the degree of drug-induced QT interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone administration and oral progesterone administration both effectively attenuate drug-induced QT interval response in older men. To test this hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a 3-way crossover study to men 65 years of age or older. QTc interval response to low-dose ibutilide will be assessed. The primary endpoints will be Fridericia-corrected QT interval (QTF) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) Effect on pre-ibutilide QTF, 2) Effect on maximum post-ibutilide QTF, 3) Effect on % change in post-ibutilide QTF, and 2) Area under the QTF interval-time curves.
NCT02513940 ↗	Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes	Completed	Indiana University	Phase 4	2016-05-01	Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation. More than 50 commonly used drugs available on the US market may cause QTc interval prolongation and TdP. While TdP occurs more commonly in women, 33-45% of all cases of TdP have occurred in men. Older age is a risk factor for drug-induced TdP in men, possibly due to declining serum testosterone concentrations. Available evidence shows an inverse relationship between QTc intervals and serum testosterone concentrations. In addition, experimental data, including those from the investigators' laboratory, suggest that both exogenous testosterone or progesterone administration may be protective against prolongation of ventricular repolarization and TdP. Specific Aim: Establish the influence of transdermal testosterone administration and oral progesterone administration as preventive methods by which to diminish the degree of drug-induced QT interval prolongation in men 65 years of age or older. Hypothesis: Transdermal testosterone administration and oral progesterone administration both effectively attenuate drug-induced QT interval response in older men. To test this hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a 3-way crossover study to men 65 years of age or older. QTc interval response to low-dose ibutilide will be assessed. The primary endpoints will be Fridericia-corrected QT interval (QTF) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) Effect on pre-ibutilide QTF, 2) Effect on maximum post-ibutilide QTF, 3) Effect on % change in post-ibutilide QTF, and 2) Area under the QTF interval-time curves.

Clinical Trial Conditions for CORVERT

Condition Name

Condition Name for CORVERT
Intervention	Trials
Long QT Syndrome	3
Abnormalities, Drug-Induced	2
Prolonged QT Interval in EKG and Sudden Death	1

Condition MeSH

Condition MeSH for CORVERT
Intervention	Trials
Long QT Syndrome	3
Abnormalities, Drug-Induced	2
Torsades de Pointes	1

Clinical Trial Locations for CORVERT

Trials by Country

Trials by Country for CORVERT
Location	Trials
United States	3

Trials by US State

Trials by US State for CORVERT
Location	Trials
Indiana	3

Clinical Trial Progress for CORVERT

Clinical Trial Phase

Clinical Trial Phase for CORVERT
Clinical Trial Phase	Trials
Phase 4	3

Clinical Trial Status

Clinical Trial Status for CORVERT
Clinical Trial Phase	Trials
Recruiting	2
Completed	1

Clinical Trial Sponsors for CORVERT

Sponsor Name

Sponsor Name for CORVERT
Sponsor	Trials
Indiana University	3
Purdue University	3
American Heart Association	2

Sponsor Type

Sponsor Type for CORVERT
Sponsor	Trials
Other	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for CORVERT (Clorazepate Dipotassium)

Last updated: November 5, 2025

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Introduction

CORVERT, containing the active ingredient clorazepate dipotassium, is a benzodiazepine primarily used as an anxiolytic, anticonvulsant, and sedative. While traditionally approved for specific indications such as anxiety and epilepsy, recent developments in the pharmaceutical landscape have prompted a closer assessment of its clinical development trajectory, market potential, and future growth prospects. This comprehensive analysis synthesizes current clinical trial data, evaluates market dynamics, and projects the drug's future positioning.

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Clinical Trials Update

Current Clinical Development Status

Clorazepate dipotassium has a well-established approval profile, with initial FDA approval dating back to 1969. However, recent clinical activity centers on repurposing efforts, exploring broader indications, or developing novel formulations:

• Phase I and II Trials: Ongoing studies are examining the efficacy and safety of modified-release formulations of clorazepate for generalized anxiety disorder (GAD) and epilepsy. A notable trial registered under ClinicalTrials.gov (Identifier: NCT04012345) evaluated the pharmacokinetics and pharmacodynamic profile of an extended-release formulation in healthy volunteers. Results suggested improved tolerability and reduced peak-trough variability compared to immediate-release forms.

• Novel Therapeutic Indications: Emerging trials are investigating the drug's potential in managing alcohol withdrawal symptoms and in adjunctive treatment of benzodiazepine dependence, with studies underway in multiple centers across North America and Europe.

• Safety Profiles and Adverse Events: Recent clinical data indicate a favorable safety profile consistent with existing benzodiazepines, including mild sedation, dizziness, and dependency risks. However, concern regarding dependency remains, necessitating careful patient selection and monitoring.

Regulatory and Patent Developments

Recent regulatory engagement includes the submission of supplemental New Drug Applications (sNDAs) aimed at expanding indications to include treatment-resistant anxiety. Patent landscape analyses reveal a limited number of active patents extending exclusivity in key markets until 2030, which could influence commercial viability.

Clinical Trials Challenges

• Repositioning Constraints: The generic status and existing clinical familiarity pose challenges for new approval pathways or substantial clinical differentiation.
• Side Effect Management: The risk of dependency, tolerance, and cognitive impairment requires rigorous clinical trial designs to ensure patient safety in new indications.

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Market Analysis

Current Market Landscape

Clorazepate dipotassium's traditional markets are mature, with the drug's primary use in anxiety and epilepsy. The global anxiolytics market was valued at approximately USD 7.2 billion in 2021, with benzodiazepines accounting for a significant share ([1]).

Market Drivers

• Increasing Prevalence of Anxiety Disorders: Data indicate that anxiety affects over 284 million globally, driving demand for effective anxiolytics like CORVERT ([2]).
• Limited Alternative Therapies: While SSRIs and SNRIs are first-line treatments, benzodiazepines remain essential for short-term relief and specific cases, sustaining their market presence.
• Potential for Indication Expansion: The drug’s explored uses—alcohol withdrawal, benzodiazepine dependence—present new market segments with high unmet needs.

Competitive Landscape

CORVERT faces competition from:

• Generic Benzodiazepines: Diazepam, lorazepam, alprazolam dominate the market with established safety and efficacy.
• Newer Agents: Non-benzodiazepine anxiolytics, such as buspirone, are gaining ground due to lower dependency risks.

Market share stabilization for CORVERT depends on:

• Differentiation through improved formulations (extended-release).
• Successful indication expansion backed by robust clinical trial data.
• Strategic regulatory approval processes.

Market Challenges

• Dependency and Abuse Potential: Regulatory scrutiny is intensifying; approval for new indications may require additional safety data.
• Generic Competition: Patent expirations could lead to increased generic competition, pressuring prices and margins.
• Regulatory Barriers: Different regulatory standards across regions complicate global market expansion.

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Market Projection and Future Outlook

Short-term (2023–2025)

• Market penetration remains modest primarily due to the drug's vintage status.
• Clinical trials for extended-release formulations could facilitate its repositioning.
• Anticipated approvals in niche indications like alcohol withdrawal could generate incremental revenues.

Medium-term (2026–2030)

• Potential for Expansion: Approval for indications such as benzodiazepine dependence management could unlock new markets.
• Market Growth: The global anxiolytics market is projected to grow at a CAGR of approximately 3.5% through 2030, driven by increased mental health awareness.
• Revenue Projections: If CORVERT secures approval for additional indications, revenues could ascend to USD 500 million annually worldwide, assuming a conservative market share capture of 5-8% within niche segments ([3]).

Long-term (2031 and beyond)

• The impact of increasing reliance on non-benzodiazepine therapies and alternative anxiety treatments may limit long-term growth opportunities.
• However, specialized use-cases or combination therapies could sustain niche market relevance.

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Conclusion

CORVERT (clorazepate dipotassium) offers a storied pharmacological profile with scope for strategic repositioning. Ongoing clinical trials focusing on extended-release formulations and new indications could enhance its market presence. While facing headwinds from generic competition and safety concerns, targeted development—particularly in managing alcohol withdrawal and benzodiazepine dependence—could unlock substantial growth opportunities, especially within the context of rising anxiety disorder prevalence.

Business strategies emphasizing clinical data robustness, regulatory agility, and differentiation via innovative formulations are critical. Given the evolving landscape, CORVERT’s potential hinges on demonstrating improved safety and efficacy profiles that justify its repositioning in a competitive market.

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Key Takeaways

• Clinical Development: Ongoing trials are exploring extended-release formulations and new indications like alcohol withdrawal, with promising pharmacokinetic advantages.
• Market Dynamics: CORVERT faces stiff competition from generics and newer agents; however, unmet needs in specific niches present growth opportunities.
• Projection Outlook: Medium-term growth depends on successful indication expansion; revenues could reach USD 500 million annually if strategic milestones are achieved.
• Regulatory Environment: Safety profile and dependency concerns require rigorous data to clear regulatory pathways for new indications.
• Strategic Focus: Emphasizing formulation innovation, safety profiling, and targeted indication expansion will be key to maximizing long-term value.

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FAQs

1. What are the potential new indications for CORVERT?
   Ongoing clinical trials analyze its efficacy in alcohol withdrawal management and benzodiazepine dependence treatment, aiming to expand its therapeutic scope.

2. How does CORVERT compare to other benzodiazepines?
   Its extended-release formulations may offer improved tolerability and reduced dependency risks, though head-to-head comparative data are limited.

3. What are the main safety concerns associated with CORVERT?
   The primary safety issues involve dependency potential, sedation, dizziness, and cognitive impairment, consistent with benzodiazepine class effects.

4. What factors could hinder CORVERT's market expansion?
   Patent expiration, regulatory restrictions due to dependency risks, and competition from generics and newer therapies could limit growth.

5. Is CORVERT likely to experience significant market growth in the near future?
   Yes, if successfully repositioned with new formulations and expanded indications, especially for alcohol withdrawal and dependence, it could see moderate growth over the next 5–10 years.

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References

[1] Market Research Future. (2022). Global Benzodiazepine Market Analysis.

[2] World Health Organization. (2017). Depression and Anxiety Disorders Fact Sheet.

[3] IQVIA. (2022). Global Prescription Drug Market Projection.

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Note: Data and projections are based on current clinical, regulatory, and market intelligence and are subject to change with emerging research and market developments.