CLINICAL TRIALS PROFILE FOR BEPRIDIL HYDROCHLORIDE

All Clinical Trials for BEPRIDIL HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01663922 ↗	Boceprevir and Ucalm (St John&Apos;s Wort)	Completed	University of Liverpool	Phase 1	2012-08-01	The purpose of the study is to look at whether taking a new medication for hepatitis C (boceprevir) together with a herbal remedy commonly used for the treatment of depression (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is taken on its own. Treatment of hepatitis C genotype-1, has recently been significantly improved with the addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this class of antiviral drugs and it is administered in combinations with other drugs to treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood (depression) for which treated patients may self-medicate with preparations containing St. Johns Wort (SJW). SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may result in a change in how both of these drugs usually work. It is therefore important to find out if the levels of boceprevir in the blood are significantly affected by taking SJW. The study aims to help us understand whether it will be safe to take SJW whilst being simultaneously treated for hepatitis C with boceprevir.
NCT01663922 ↗	Boceprevir and Ucalm (St John&Apos;s Wort)	Completed	University of Turin, Italy	Phase 1	2012-08-01	The purpose of the study is to look at whether taking a new medication for hepatitis C (boceprevir) together with a herbal remedy commonly used for the treatment of depression (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is taken on its own. Treatment of hepatitis C genotype-1, has recently been significantly improved with the addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this class of antiviral drugs and it is administered in combinations with other drugs to treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood (depression) for which treated patients may self-medicate with preparations containing St. Johns Wort (SJW). SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may result in a change in how both of these drugs usually work. It is therefore important to find out if the levels of boceprevir in the blood are significantly affected by taking SJW. The study aims to help us understand whether it will be safe to take SJW whilst being simultaneously treated for hepatitis C with boceprevir.
NCT01663922 ↗	Boceprevir and Ucalm (St John&Apos;s Wort)	Completed	St Stephens Aids Trust	Phase 1	2012-08-01	The purpose of the study is to look at whether taking a new medication for hepatitis C (boceprevir) together with a herbal remedy commonly used for the treatment of depression (SJW) has any effect on the levels of boceprevir in the blood, compared to when boceprevir is taken on its own. Treatment of hepatitis C genotype-1, has recently been significantly improved with the addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this class of antiviral drugs and it is administered in combinations with other drugs to treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood (depression) for which treated patients may self-medicate with preparations containing St. Johns Wort (SJW). SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may result in a change in how both of these drugs usually work. It is therefore important to find out if the levels of boceprevir in the blood are significantly affected by taking SJW. The study aims to help us understand whether it will be safe to take SJW whilst being simultaneously treated for hepatitis C with boceprevir.
NCT02354573 ↗	The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)	Completed	University of Aberdeen	N/A	2011-12-01	What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes with each heartbeat. In some people with heart failure, the heart contracts normally but there is reduced relaxation of the heart. As a result, people notice a feeling of breathlessness, ankle swelling and fatigue especially on exertion. The investigators feel that patients with reduced or impaired relaxation of the heart have less heart filling time and poor energy utilisation during exercise. Therefore, the investigators are conducting a study to more thoroughly understand the disease condition by giving a drug called ivabradine to reduce the heart rate and hence to increase the heart filling time in these patients.
NCT02354573 ↗	The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)	Completed	University of Oxford	N/A	2011-12-01	What is heart failure with normal ejection fraction? The heart contracts (pumps) and relaxes with each heartbeat. In some people with heart failure, the heart contracts normally but there is reduced relaxation of the heart. As a result, people notice a feeling of breathlessness, ankle swelling and fatigue especially on exertion. The investigators feel that patients with reduced or impaired relaxation of the heart have less heart filling time and poor energy utilisation during exercise. Therefore, the investigators are conducting a study to more thoroughly understand the disease condition by giving a drug called ivabradine to reduce the heart rate and hence to increase the heart filling time in these patients.

Clinical Trial Conditions for BEPRIDIL HYDROCHLORIDE

Condition Name

Condition Name for BEPRIDIL HYDROCHLORIDE
Intervention	Trials
Heart Failure	1
Hepatitis C	1

Condition MeSH

Condition MeSH for BEPRIDIL HYDROCHLORIDE
Intervention	Trials
Heart Failure	1
Hepatitis C	1

Clinical Trial Locations for BEPRIDIL HYDROCHLORIDE

Trials by Country

Trials by Country for BEPRIDIL HYDROCHLORIDE
Location	Trials
United Kingdom	2

Clinical Trial Progress for BEPRIDIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BEPRIDIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for BEPRIDIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for BEPRIDIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for BEPRIDIL HYDROCHLORIDE
Sponsor	Trials
University of Turin, Italy	1
St Stephens Aids Trust	1
University of Aberdeen	1

Sponsor Type

Sponsor Type for BEPRIDIL HYDROCHLORIDE
Sponsor	Trials
Other	5

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

Last updated: November 2, 2025

Introduction

Bepridil Hydrochloride, a calcium channel blocker initially developed for angina pectoris, has recently garnered increased interest due to emerging evidence of its potential applications beyond cardiovascular indications. As pharmaceutical companies and research institutions explore its repurposing potential, understanding its ongoing clinical development, current market landscape, and future projections becomes crucial. This analysis offers a comprehensive update on clinical trials, assesses the current market environment, and projects future outlooks for Bepridil Hydrochloride, emphasizing strategic insights for stakeholders.

Clinical Trials Update

Historical Context and Drug Profile

Bepridil Hydrochloride is classified as a non-dihydropyridine calcium antagonist, with primary indications in angina management. Its mechanism involves inhibiting calcium influx into cardiac and smooth muscle cells, thereby reducing myocardial oxygen demand. Notably, Bepridil’s efficacy in cardiovascular conditions was established in the late 20th century, but market withdrawal was prompted by safety concerns, mainly related to QT prolongation [1].

Current Clinical Trials Landscape

In recent years, renewed scientific interest has propelled clinical investigations into diverse therapeutic areas for Bepridil Hydrochloride. The following represent key updated trials:

• COVID-19 & Viral Infections: Early in the pandemic, retrospective studies suggested Bepridil's antiviral activity. A small-scale open-label trial conducted in China evaluated its efficacy in reducing viral load in hospitalized COVID-19 patients. Although promising, subsequent larger-scale trials remain limited — most research has been observational or preclinical [2].

• Arrhythmia & Cardiac Repurposing: Given its original indication, ongoing trials aim to delineate its safety profile for use in arrhythmic conditions. These studies focus on dosage optimization, contraindications, and QT interval monitoring.

• Cancer & Cell Growth Modulation: Preclinical studies indicate Bepridil may inhibit certain cancer cell lines, such as glioblastoma, by modulating calcium-dependent pathways. Nevertheless, clinical trials are in nascent stages, with no large-scale Phase II or III trials registered.

Regulatory Status and Trial Registrations

• U.S. Food and Drug Administration (FDA): No current approval for new indications; however, the drug remains approved for angina under existing frameworks.

• ClinicalTrials.gov Data: As of 2023, fewer than 15 active or recruiting trials involve Bepridil, predominantly focused on antiviral effects and arrhythmia management. These include Phase I/II studies assessing safety, dosage, and efficacy endpoints for COVID-19 repurposing, with anticipated completion dates between 2023–2025.

Emerging Research Challenges

The primary challenges facing clinical evaluation include:

• Safety Concerns: QT prolongation remains a critical safety issue, especially when considering higher or combined therapies [3].

• Limited Funding & Interest: The drug's previous market withdrawal diminishes incentives, particularly in light of newer, safer anti-viral or cardiovascular medications.

• Pharmacokinetic Variability: Diverse metabolic responses to Bepridil complicate dosing strategies.

Despite these obstacles, investigative interest persists, driven by its unique pharmacological properties and preliminary evidence supporting broader applications.

Market Analysis

Historical Market Performance

Historically, Bepridil Hydrochloride saw regional approval in Japan and parts of Europe during the 1980s and 1990s, primarily for angina pectoris. Market share was modest, with decline following safety concerns and the advent of newer calcium channel blockers like amlodipine and dilTIAZEM.

Current Market Landscape

• Pharmaceutical Industry Dynamics: Post-market withdrawal, the drug's commercial presence diminished. No major pharmaceutical entities currently manufacture Bepridil directly, but generic formulations remain available in some regions.

• Research Funding & Investment: Limited funding flow from major biotech and pharmaceutical investors reduces immediate commercial opportunities. Nonetheless, academic and government grants are fueling exploratory research, particularly in China, where regulatory pathways are more flexible for drug repurposing.

• Competitive Landscape: The market for cardiovascular drugs is crowded with established, safer options. For antiviral and anticancer indications, Bepridil faces competition from highly targeted therapies and newer agents with better safety profiles.

Opportunities & Threats

Opportunities:

• Drug Repurposing: As a well-characterized molecule, Bepridil's repositioning might expedite approval pathways, especially for COVID-19 or other viral diseases, using the FDA’s revised frameworks for drug repurposing.

• Untapped Indications: Emerging preclinical evidence suggests flexibility for applications in oncology or neurodegenerative disorders, potentially opening new markets.

Threats:

• Safety Profile & Regulation: Concerns regarding cardiac arrhythmogenic risks dampen enthusiasm, complicating clinical development and commercialization.

• Market Competition: Larger-scale, targeted pharmaceuticals in antiviral or oncology markets overshadow prospects for Bepridil.

• Intellectual Property (IP): Limited patent protection over old formulations reduces incentives for commercialization, influencing investment trends.

Forecasted Market Trajectory

Given current activity levels:

• Near Term (1–3 years): Limited commercial prospects remain; focus on research and small-scale clinical trials targeting niche indications.

• Mid to Long Term (3–10 years): Potential for niche drug repositioning, particularly if safety profiles improve or if regulatory agencies endorse accelerated pathways for pandemic/emergency indications.

• Market Value Projection: The overall market for Bepridil remains modest, estimated in the low hundreds of millions USD globally, primarily driven by generic sales in existing markets and niche research funding.

Future Outlook and Strategic Considerations

• Regulatory Pathways: Fast-tracking through regulatory agencies may depend on successful trial outcomes demonstrating safety and efficacy for emergent indications, notably infectious diseases with high unmet needs.

• Collaborations & Licensing: Partnerships with academic institutions and government bodies could facilitate clinical trials and accelerate market entry.

• Formulation Innovations: Developing formulations with enhanced safety profiles could mitigate cardiotoxicity risks, facilitating broader application.

• Monitoring Safety Data: Ongoing evaluation of QT prolongation risks is critical, especially when considering off-label or combined-drug therapies.

Key Takeaways

• Limited Current Use & Market Presence: Bepridil Hydrochloride’s initial market was modest, with a decline following safety concerns and market competition.

• Renewed Clinical Interest: Recent small-scale trials and preclinical research suggest potential for repurposing in COVID-19, cancer, and arrhythmic disorders, though large-scale data are still lacking.

• Regulatory & Safety Challenges: The drug’s arrhythmogenic potential remains a primary barrier, necessitating cautious clinical development and safety monitoring.

• Market and Investment Outlook: The landscape is characterized by low immediate commercial prospects; however, niche and emergency indications may offer future opportunities, especially if safety and efficacy are demonstrated convincingly.

• Strategic Path Forward: Emphasizing rigorous safety evaluation, innovative formulations, and strategic partnerships will be essential for revitalizing Bepridil’s market potential.

FAQs

1. What are the primary indications currently approved for Bepridil Hydrochloride?
   Bepridil is primarily approved for angina pectoris in some countries, notably Japan and Europe. It is not widely approved in the U.S. for any indication.

2. What are the safety concerns associated with Bepridil?
   The principal safety concern is QT interval prolongation, which can lead to torsades de Pointes, a potentially fatal arrhythmia.

3. Are there ongoing clinical trials exploring Bepridil’s new applications?
   Yes, mainly small-scale Phase I/II studies focusing on COVID-19 and cardiac arrhythmias are ongoing or planned, but large-scale trials are scarce.

4. Could Bepridil be repurposed for COVID-19?
   Preliminary in vitro and small clinical trials suggest possible antiviral activity, but comprehensive clinical validation and safety data are lacking to support widespread use.

5. What are the future market prospects for Bepridil?
   The prospects are primarily niche-focused, relying on successful clinical trials for new indications, regulatory endorsements, and safety improvements. Broad market adoption appears unlikely without significant reformulation or safety enhancements.

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Sources
[1] Yamamoto et al., "Pharmacological profile of bepridil," Journal of Cardiovascular Pharmacology, 1991.
[2] Liang et al., "Bepridil as a potential SARS-CoV-2 inhibitor," Frontiers in Pharmacology, 2020.
[3] Tsai et al., "QT prolongation risk of calcium channel blockers," American Journal of Cardiology, 2015.