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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR BIAXIN


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All Clinical Trials for Biaxin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00006219 ↗ Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma Completed National Cancer Institute (NCI) Phase 2 2000-08-01 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.
NCT00006219 ↗ Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma Completed Mayo Clinic Phase 2 2000-08-01 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.
NCT00151203 ↗ Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma Completed Celgene Corporation Phase 2 2004-12-01 PRIMARY STUDY OBJECTIVES - To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). - To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES - To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide. - To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
NCT00151203 ↗ Phase II Study of Biaxin, Revlimid, and Dexamethasone for Untreated Multiple Myeloma Completed Weill Medical College of Cornell University Phase 2 2004-12-01 PRIMARY STUDY OBJECTIVES - To evaluate the efficacy of the combination of clarithromycin (Biaxin®), lenalidomide (Revlimid™), and dexamethasone (Decadron®) as an induction therapy for patients with newly diagnosed multiple myeloma (MM). - To evaluate the safety of the combination of clarithromycin, lenalidomide, and dexamethasone as an induction therapy for patients with newly diagnosed MM. SECONDARY STUDY OBJECTIVES - To examine the role of clarithromycin on the pharmacokinetic properties of dexamethasone and lenalidomide. - To examine the angiogenesis profile in untreated patients and in patients receiving induction therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Biaxin

Condition Name

Condition Name for Biaxin
Intervention Trials
Healthy 13
Multiple Myeloma 10
Idiopathic Hypersomnia 2
Infection 2
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Condition MeSH

Condition MeSH for Biaxin
Intervention Trials
Neoplasms, Plasma Cell 15
Multiple Myeloma 15
Pneumonia 3
Aggressive Periodontitis 2
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Clinical Trial Locations for Biaxin

Trials by Country

Trials by Country for Biaxin
Location Trials
United States 97
China 24
Canada 19
Korea, Republic of 4
India 3
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Trials by US State

Trials by US State for Biaxin
Location Trials
New York 9
Arizona 7
Missouri 6
Washington 6
Texas 5
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Clinical Trial Progress for Biaxin

Clinical Trial Phase

Clinical Trial Phase for Biaxin
Clinical Trial Phase Trials
Phase 4 2
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Biaxin
Clinical Trial Phase Trials
Completed 37
Recruiting 4
Active, not recruiting 4
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Clinical Trial Sponsors for Biaxin

Sponsor Name

Sponsor Name for Biaxin
Sponsor Trials
Abbott 6
Ranbaxy Laboratories Limited 5
Weill Medical College of Cornell University 5
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Sponsor Type

Sponsor Type for Biaxin
Sponsor Trials
Industry 43
Other 40
NIH 6
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Clarithromycin (Biaxin): Clinical Trials, Market Analysis, and Projections

Introduction

Clarithromycin, marketed under the brand name Biaxin, is a macrolide antibiotic widely used for treating various bacterial infections. This article provides an update on recent clinical trials, market analysis, and future projections for clarithromycin.

Clinical Trials Update

Cardiovascular Risks

A significant update in the clinical use of clarithromycin came from the FDA in 2018. The FDA warned clinicians about the risks associated with prescribing clarithromycin to patients with heart disease, based on data from the CLARICOR clinical trial. This trial showed an increased risk of cardiac and cerebrovascular events, and even death, in patients with stable coronary heart disease who were treated with clarithromycin[1].

COVID-19 Treatment

In the context of the COVID-19 pandemic, clarithromycin has been investigated for its potential in treating mild COVID-19 pneumonia. The CAME COVID study, initiated in May 2021, is an exploratory, multicentre, open-label, randomised controlled trial that aims to evaluate the efficacy of clarithromycin in patients who do not require oxygen administration. The study compares different doses of clarithromycin against standard treatment without the antibiotic. Preliminary findings suggest that clarithromycin is well-tolerated and may have benefits in suppressing inflammatory cytokines and alleviating symptoms[3].

Multiple Myeloma Treatment

Another clinical trial of interest involves the use of clarithromycin in combination with other drugs for treating multiple myeloma. The D-ClaPd study assesses the tolerability and safety of a combination therapy including daratumumab, pomalidomide, dexamethasone, and clarithromycin in patients with relapsed or refractory multiple myeloma. This study aims to determine if the addition of daratumumab to the standard combination treatment enhances response rates and safety profiles[4].

Market Analysis

Global Market Size and Growth

The global clarithromycin market is experiencing steady growth driven by increasing incidences of bacterial infections and the rising adoption of combination therapies. As of 2024, the global clarithromycin market was estimated to be worth approximately USD 2142.6 million. It is projected to grow to USD 4526.5 million by 2032, with a compound annual growth rate (CAGR) of 9.80% during the forecast period[5].

Market Drivers

Several factors are driving the growth of the clarithromycin market:

  • Increasing Prevalence of Bacterial Infections: The rising incidence of respiratory and other bacterial infections, particularly among aging populations and individuals with chronic illnesses, is a significant driver.
  • Combination Therapies: Clarithromycin’s use in combination therapies, such as with proton pump inhibitors for the eradication of Helicobacter pylori, has strengthened its position in the market.
  • Advanced Formulations: Innovations like extended-release formulations introduced by major pharmaceutical companies are improving patient compliance and driving market growth[5].

Competitive Landscape

The clarithromycin market is highly competitive, with major players including AbbVie Inc., Abbott Laboratories, and Teva Pharmaceutical Industries Ltd. These companies collectively hold a significant market share and are investing heavily in research and development to enhance product efficacy and create advanced formulations. As of 2024, AbbVie Inc. leads with approximately 15% of the market, followed by Abbott Laboratories at 12% and Teva Pharmaceutical Industries Ltd. at 11%[5].

Market Projections

Future Growth

The global clarithromycin market is anticipated to expand significantly over the next few years. The market value is projected to reach USD 4526.5 million by 2032, driven by ongoing advancements in pharmaceutical research and the rising demand for effective treatments against bacterial infections. The CAGR of 9.80% during the forecast period indicates a robust growth trajectory[5].

Emerging Markets

Emerging markets such as Asia-Pacific and Latin America are expected to play a crucial role in the future growth of the clarithromycin market. These regions are experiencing an increase in the incidence of bacterial infections and have a growing demand for effective antibiotic treatments[5].

Product Enhancements

The introduction of advanced formulations, such as extended-release technologies, is expected to continue driving market growth. These innovations aim to improve patient compliance and efficacy, making clarithromycin a more attractive option for both patients and healthcare providers[5].

Regulatory Considerations

FDA Warnings

The FDA's warning regarding the use of clarithromycin in patients with heart disease is a critical regulatory consideration. Clinicians are advised to consider alternative antibiotics for these patients, and the drug labels have been updated to reflect this increased risk[1].

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the efficacy and safety of clarithromycin in treating COVID-19 and multiple myeloma.
  • Market Growth: The global clarithromycin market is projected to grow significantly, driven by increasing bacterial infections and the adoption of combination therapies.
  • Competitive Landscape: Major pharmaceutical companies are investing in research and development to enhance product efficacy and compliance.
  • Regulatory Considerations: The FDA has issued warnings regarding the use of clarithromycin in patients with heart disease.

FAQs

What are the current clinical trials focusing on clarithromycin?

Current clinical trials are focusing on the use of clarithromycin in treating mild COVID-19 pneumonia and its combination with other drugs for treating multiple myeloma.

What are the risks associated with clarithromycin use in patients with heart disease?

The FDA has warned about the increased risk of cardiac and cerebrovascular events, and even death, in patients with heart disease who are treated with clarithromycin.

How is the global clarithromycin market expected to grow?

The global clarithromycin market is projected to grow to USD 4526.5 million by 2032, with a CAGR of 9.80% during the forecast period.

Which companies are leading the clarithromycin market?

AbbVie Inc., Abbott Laboratories, and Teva Pharmaceutical Industries Ltd. are the top players in the clarithromycin market.

What are the key drivers of the clarithromycin market growth?

The key drivers include the increasing prevalence of bacterial infections, the adoption of combination therapies, and the introduction of advanced formulations.

Sources

  1. FDA: Clarithromycin Risky for Patients With Heart Disease - AAFP
  2. Global Antibiotics Market Size, Share & Industry Growth Analysis - BCC Research
  3. Efficacy of clarithromycin in patients with mild COVID-19 pneumonia - BMJ Open
  4. A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide, and Dexamethasone (D-ClaPd) in Multiple Myeloma Patients Previously Exposed to Daratumumab - Weill Cornell Medicine
  5. Clarithromycin Market Trends and Future Opportunities - Cognitive Market Research

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