CLINICAL TRIALS PROFILE FOR AVELOX

All Clinical Trials for Avelox

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00082173 ↗	Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis	Completed	Johns Hopkins University	Phase 2	2004-10-01	Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
NCT00158093 ↗	A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo	Completed	Mylan Bertek Pharmaceuticals	Phase 1	2003-06-01	Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
NCT00280514 ↗	Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration	Completed	Medical University of Vienna	Phase 4	2006-01-01	Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested. Patients with an abscess scheduled for drainage will receive study drugs (single or multiple dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be determined using a pharmacokinetic model.

Clinical Trial Conditions for Avelox

Condition Name

Condition Name for Avelox
Intervention	Trials
Healthy	12
Healthy Volunteers	4
Tuberculosis	3

Condition MeSH

Condition MeSH for Avelox
Intervention	Trials
Pneumonia	11
Tuberculosis	8
Pneumonia, Bacterial	8

Clinical Trial Locations for Avelox

Trials by Country

Trials by Country for Avelox
Location	Trials
United States	199
South Africa	45
Peru	21
Argentina	19
Romania	18

Trials by US State

Trials by US State for Avelox
Location	Trials
Texas	15
California	10
Ohio	9
Florida	9
Montana	8

Clinical Trial Progress for Avelox

Clinical Trial Phase

Clinical Trial Phase for Avelox
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Avelox
Clinical Trial Phase	Trials
Completed	71
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for Avelox

Sponsor Name

Sponsor Name for Avelox
Sponsor	Trials
AstraZeneca	11
Bayer	10
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for Avelox
Sponsor	Trials
Industry	86
Other	82
NIH	1

AVELOX (Moxifloxacin): Clinical Trials Update, Market Analysis, and Projections

Introduction to AVELOX (Moxifloxacin)

AVELOX, known generically as moxifloxacin, is a broad-spectrum antibiotic used to treat various bacterial infections, including community-acquired pneumonia (CABP), skin and skin structure infections, and other respiratory tract infections. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Studies

A significant recent study involving moxifloxacin is the LEAP trials, which compared moxifloxacin with lefamulin in treating CABP. The study found that patients treated with moxifloxacin had a comparable time to clinical response and clinical stability compared to those treated with lefamulin. The median time to clinical response was 4 days for both groups, indicating that moxifloxacin remains an effective option for empiric treatment of CABP[3].

Ongoing and Future Trials

There are no major ongoing or upcoming clinical trials specifically focused on moxifloxacin that have been highlighted in recent pharmaceutical reports. However, the drug continues to be used in various clinical settings based on its established efficacy and safety profile.

Market Analysis

Global Market

The global moxifloxacin market is experiencing a mixed trend. As of 2024, the market size is estimated at US$ 117 million, but it is projected to decline to US$ 111.5 million by 2030, reflecting a Compound Annual Growth Rate (CAGR) of -0.8% during the forecast period. This decline is partly due to increased competition and pricing pressures[2].

Chinese Market

In China, the moxifloxacin market has faced significant challenges, particularly due to the COVID-19 pandemic and subsequent government-led price reductions. The sales value of moxifloxacin in China declined by a CAGR of -3.76% from 2016 to 2020. However, with the easing of the pandemic, the market is expected to recover, driven by the drug's broad antibacterial spectrum and strong curative effects. The entry of new manufacturers is likely to increase competition, leading to lower prices but potentially higher sales volumes[5].

Competitive Landscape

The moxifloxacin market is highly competitive, with several key players including Actavis UK, MERCK, Cayman, Allergan, Tecoland, BOC Sciences, Aurobindo, and NIVIKA Chemo Pharma. These top five players hold approximately 60% of the market share, indicating a concentrated market with significant competition[2].

Market Projections

Forecasted Market Size

By 2030, the global moxifloxacin market is expected to reach US$ 111.5 million, down from US$ 117 million in 2024. This decline is attributed to the competitive landscape and pricing pressures[2].

Growth Drivers and Challenges

• Growth Drivers: The broad antibacterial spectrum and strong curative effects of moxifloxacin are significant advantages. Additionally, the recovery from the COVID-19 pandemic is expected to boost sales.
• Challenges: Increased competition, government-led price reductions, and the entry of new manufacturers are likely to keep prices low, affecting overall market value[5].

Regional Trends

In China, the market is expected to grow in terms of sales volume despite declining prices. The competitive landscape, with 19 pharmaceutical companies involved, suggests that while prices may drop, the overall sales volume could increase[5].

Applications and Types

Applications

Moxifloxacin is used in various forms, including oral tablets, injections, and ophthalmic drugs. Its broad application range contributes to its market presence despite the competitive environment[2].

Types

The drug is available in different purity levels, such as 98.0%-99.5%, 99.5-99.9%, and more than or equal to 99.9%. These variations cater to different clinical and research needs[2].

Conclusion

AVELOX (moxifloxacin) remains a vital antibiotic in the treatment of bacterial infections, particularly CABP. While the global market is projected to decline slightly due to competition and pricing pressures, the drug's efficacy and broad antibacterial spectrum ensure its continued relevance. In regions like China, the market is expected to recover post-pandemic, driven by increased sales volumes despite lower prices.

Key Takeaways

• Clinical Efficacy: Moxifloxacin has been shown to have comparable efficacy to other antibiotics like lefamulin in treating CABP.
• Market Trends: The global market is projected to decline slightly by 2030, but regional markets like China are expected to see growth in sales volume.
• Competitive Landscape: The market is highly competitive with several major players holding significant market share.
• Applications: Moxifloxacin is used in various forms, including oral tablets, injections, and ophthalmic drugs.
• Future Outlook: Despite pricing pressures, the drug's strong curative effects and broad antibacterial spectrum will continue to drive its use.

FAQs

What is the current global market size for moxifloxacin?

The current global market size for moxifloxacin is estimated at US$ 117 million as of 2024[2].

What is the projected market size for moxifloxacin by 2030?

The global moxifloxacin market is projected to reach US$ 111.5 million by 2030[2].

How does moxifloxacin compare to other antibiotics in clinical trials?

Moxifloxacin has been shown to have comparable efficacy to lefamulin in treating CABP, with similar times to clinical response and stability[3].

What are the main drivers and challenges for the moxifloxacin market?

The main drivers include the drug's broad antibacterial spectrum and strong curative effects, while challenges include increased competition and government-led price reductions[5].

Which companies are the major players in the moxifloxacin market?

Major players include Actavis UK, MERCK, Cayman, Allergan, Tecoland, BOC Sciences, Aurobindo, and NIVIKA Chemo Pharma[2].

Sources

1. GSK Pipeline Assets and Clinical Trials Appendix - Q2 2024 - GSK
2. Global Moxifloxacin HCl Market Insights, Forecast to 2030 - Valuates Reports
3. Post Hoc Assessment of Time to Clinical Response Among Adults with CABP - Open Forum Infectious Diseases
4. Clinical Trials Appendix - AstraZeneca H1 2024 Results Update - AstraZeneca
5. China Moxifloxacin Markets, 2016-2020 & 2021-2025 - ResearchAndMarkets.com