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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR BISOPROLOL FUMARATE


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All Clinical Trials for Bisoprolol Fumarate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00702156 ↗ Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease Terminated NHS Greater Glasgow and Clyde Phase 2 2005-03-01 The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.
NCT01741623 ↗ Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition Completed IPCA Laboratories Ltd. Phase 1 2012-08-01 This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult human subjects.
NCT01744873 ↗ Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition Completed IPCA Laboratories Ltd. Phase 1 2012-08-01 This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult human subjects.
NCT03299452 ↗ Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor Unknown status Alphacait, LLC Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗ Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor Unknown status Haining Health-Coming Biotech Co., Ltd. Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bisoprolol Fumarate

Condition Name

Condition Name for Bisoprolol Fumarate
Intervention Trials
Type 2 Diabetes 1
Acute Coronary Syndrome 1
Cardiomyopathy, Dilated 1
Chronic Obstructive Pulmonary Disease 1
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Condition MeSH

Condition MeSH for Bisoprolol Fumarate
Intervention Trials
Hypertension 1
Neoplasm Metastasis 1
Essential Hypertension 1
Malnutrition 1
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Clinical Trial Locations for Bisoprolol Fumarate

Trials by Country

Trials by Country for Bisoprolol Fumarate
Location Trials
China 2
India 2
Russian Federation 2
Egypt 1
United Kingdom 1
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Clinical Trial Progress for Bisoprolol Fumarate

Clinical Trial Phase

Clinical Trial Phase for Bisoprolol Fumarate
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Bisoprolol Fumarate
Clinical Trial Phase Trials
Completed 4
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Bisoprolol Fumarate

Sponsor Name

Sponsor Name for Bisoprolol Fumarate
Sponsor Trials
IPCA Laboratories Ltd. 2
Alphacait, LLC 1
Haining Health-Coming Biotech Co., Ltd. 1
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Sponsor Type

Sponsor Type for Bisoprolol Fumarate
Sponsor Trials
Other 10
Industry 3
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Bisoprolol Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction to Bisoprolol Fumarate

Bisoprolol fumarate is a selective beta-1 adrenergic antagonist widely used in the treatment of hypertension and heart failure. It works by reducing heart rate and the workload on the heart, thereby lowering blood pressure and improving heart function.

Clinical Trials and Pharmacokinetics

Pharmacokinetic Profile

Bisoprolol fumarate has a well-defined pharmacokinetic profile. It is absorbed quickly, with peak plasma concentrations occurring within 2-4 hours of dosing. The drug has a plasma elimination half-life of 9-12 hours, slightly longer in elderly patients due to decreased renal function. Steady state is achieved within 5 days of once-daily dosing, with low plasma accumulation[1].

Clinical Trials

Several clinical trials have been conducted to evaluate the efficacy and safety of bisoprolol fumarate. These trials have shown that bisoprolol fumarate is effective in reducing resting and exercise heart rate, cardiac output, and blood pressure. It has also demonstrated a negative chronotropic effect and a reduction in exercise- and isoproterenol-induced tachycardia[1].

A specific clinical trial registered in the European Union Clinical Trials Register (EudraCT) with the number 2019-000751-13 was completed, focusing on the efficacy of bisoprolol fumarate. However, the details of this trial do not include pharmacokinetic, pharmacodynamic, or bioequivalence studies[4].

Market Analysis

Current Market Size and Growth

The bisoprolol fumarate market is experiencing significant growth driven by the increasing global demand for effective treatments for cardiovascular diseases. The market size is projected to grow from $1.84 billion in 2023 to $2 billion in 2024 and is expected to reach $2.8 billion by 2028 at a compound annual growth rate (CAGR) of 8.7%[3].

Regional Market Trends

The market is expanding particularly in emerging markets such as Asia-Pacific, Latin America, and parts of Africa. These regions are facing rising healthcare challenges due to lifestyle changes, urbanization, and aging populations, leading to a surge in demand for affordable and effective cardiovascular treatments. Governments in these regions are prioritizing healthcare reforms, which include the widespread availability of heart disease treatments, further bolstering the market for bisoprolol fumarate[2].

Key Drivers and Trends

  • Increasing Demand for Cardiovascular Treatments: The rise in lifestyle-related diseases and improved access to patient support programs are key drivers of the market growth.
  • Innovations in Drug Delivery Systems: Developments in long-acting formulations and new dosage forms, such as liquid formulations for patients with swallowing difficulties, are enhancing patient compliance and therapeutic efficacy[2].
  • Combination Therapies: The trend toward using bisoprolol fumarate in combination with other cardiovascular drugs, such as ACE inhibitors and diuretics, is improving patient outcomes and contributing to market growth[2].
  • Generic Versions: The expiration of patents has led to the entry of generic bisoprolol fumarate into the market, making the drug more affordable and accessible to patients in developing and low-income countries[2].

Market Projections

Future Demand and Revenue Growth

The bisoprolol fumarate market is projected to experience significant growth during the forecast period. The US and Canada market, Europe market, and China market are all expected to increase substantially, driven by the growing demand for cardiovascular treatments and advancements in drug formulations[5].

Investment Opportunities

The increasing need for effective cardiovascular treatments presents ample investment opportunities in the bisoprolol fumarate market. Pharmaceutical companies that produce bisoprolol fumarate are well-positioned to benefit from this growth. Investments in research and development (R&D) focused on improving drug formulations and expanding distribution networks in emerging markets will drive further growth[2].

Strategic Partnerships and Innovations

Several pharmaceutical companies are entering into strategic partnerships with healthcare providers, non-governmental organizations (NGOs), and governments to enhance the availability and affordability of bisoprolol fumarate globally. These partnerships facilitate the development of new formulations and delivery methods, ensuring bisoprolol fumarate remains relevant in the evolving cardiovascular market[2].

Competitive Landscape

The bisoprolol fumarate market is characterized by intense competition among key players. Companies are continuously improving their products and strategies to stay competitive. The market report includes in-depth examinations of industry chain structures, raw material suppliers, market trends, overall income, trading prices, and manufacturing cost structures[5].

Key Takeaways

  • Growing Market Size: The bisoprolol fumarate market is expected to grow significantly, driven by global demand for cardiovascular treatments.
  • Regional Expansion: Emerging markets are driving growth due to increasing healthcare challenges and government reforms.
  • Innovations and Combination Therapies: Advances in drug delivery systems and the use of bisoprolol fumarate in combination therapies are enhancing patient outcomes.
  • Generic Versions and Affordability: The availability of generic bisoprolol fumarate has made the drug more accessible to a broader patient population.
  • Investment Opportunities: The market presents significant investment opportunities, particularly in R&D and distribution networks.

FAQs

What is the primary use of bisoprolol fumarate?

Bisoprolol fumarate is primarily used to treat high blood pressure (hypertension) and heart failure by reducing heart rate and the workload on the heart.

How does bisoprolol fumarate work?

Bisoprolol fumarate works by blocking certain receptors in the heart, leading to a reduction in heart rate and the workload on the heart, which results in lower blood pressure and improved heart function.

What are the key drivers of the bisoprolol fumarate market growth?

Key drivers include the increasing global demand for cardiovascular treatments, innovations in drug delivery systems, the trend toward combination therapies, and the availability of generic versions.

Which regions are driving the growth of the bisoprolol fumarate market?

Emerging markets such as Asia-Pacific, Latin America, and parts of Africa are driving the growth due to rising healthcare challenges and government healthcare reforms.

What are the future projections for the bisoprolol fumarate market?

The market is projected to grow to $2.8 billion by 2028 at a CAGR of 8.7%, driven by increasing demand and advancements in drug formulations.

Sources

  1. FDA Label for ZIAC (Bisoprolol Fumarate and Hydrochlorothiazide) Tablets - [Access Data FDA][1]
  2. The Future of Cardiovascular Treatment: Bisoprolol Fumarate Market Shows Strong Growth - [Market Research Intellect][2]
  3. Bisoprolol Global Market Report 2024 - [GII Research][3]
  4. EU Clinical Trials Register: Bisoprolol Fumarate - [EU Clinical Trials Register][4]
  5. Bisoprolol Fumarate Market 2024: Future Demand, Top Players, and Revenue Growth till 2032 - [News Channel Nebraska][5]

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