CLINICAL TRIALS PROFILE FOR AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

All Clinical Trials for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00492024 ↗	BAY12-8039: 5 Days for Sinusitis vs Placebo	Completed	Bayer	Phase 3	2005-01-01	The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.
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.

Clinical Trial Conditions for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Condition Name

Condition Name for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Healthy	12
Healthy Volunteers	4
Healthy Subjects	3
Chronic Obstructive Pulmonary Disease	3

Condition MeSH

Condition MeSH for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Pneumonia	11
Tuberculosis	8
Pneumonia, Bacterial	8
Tuberculosis, Pulmonary	5

Clinical Trial Locations for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
United States	199
South Africa	45
Peru	21
Argentina	19
Romania	18

Trials by US State

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Trials by US State for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
Texas	15
California	10
Florida	9
Ohio	9
Montana	8

Clinical Trial Progress for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	71
Recruiting	3
Unknown status	2

Clinical Trial Sponsors for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor	Trials
AstraZeneca	11
Bayer	10
GlaxoSmithKline	4

Sponsor Type

Sponsor Type for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Sponsor	Trials
Industry	86
Other	82
U.S. Fed	1

Moxifloxacin HCl: Clinical Trials, Market Analysis, and Projections

Introduction to Moxifloxacin HCl

Moxifloxacin HCl, marketed under the brand name Avelox, is a fluoroquinolone antibiotic used to treat various bacterial infections. This article will delve into the current clinical trials, market analysis, and future projections for Moxifloxacin HCl.

Clinical Trials Overview

Ongoing and Recent Studies

Several clinical trials have been conducted to assess the efficacy and safety of Moxifloxacin HCl in various indications.

• Secondary Infection in Chronic Respiratory Disease: A local prospective and observational study is underway to evaluate the efficacy and safety of Avelox tablets in treating secondary infections in patients with chronic respiratory diseases. This study aims to enroll 500 patients and assess their response during the treatment period[1].

• Comparison with Delafloxacin: A Phase 3 study compared the efficacy and safety of delafloxacin with moxifloxacin in adults with community-acquired bacterial pneumonia (CABP). The study found that both drugs had similar early clinical response rates and success rates at the test of cure, with moxifloxacin demonstrating non-inferiority to delafloxacin[4].

Efficacy and Safety

Clinical Efficacy

Moxifloxacin HCl has been studied in various clinical trials for its efficacy in treating bacterial infections such as skin and skin structure infections, respiratory tract infections, and other bacterial diseases.

• Community-Acquired Bacterial Pneumonia (CABP): In the Phase 3 study comparing delafloxacin and moxifloxacin, both drugs showed high early clinical response rates, with moxifloxacin achieving an 89.0% response rate[4].

• Complicated Skin and Skin Structure Infections: Clinical trials have shown that moxifloxacin is effective in treating complicated skin and skin structure infections, with treatment durations up to 21 days[3].

Safety Profile

While moxifloxacin is generally well-tolerated, it does come with some potential side effects.

• Common Adverse Events: Treatment-emergent adverse events related to moxifloxacin were reported in 12.6% of patients in the CABP study, with common events including gastrointestinal issues and central nervous system effects[4].

• Serious Side Effects: Moxifloxacin can cause serious side effects such as tendon rupture and QT prolongation, which may limit its usage in certain patient populations[5].

Market Analysis

Current Market Size and Forecast

The global Moxifloxacin HCl market is experiencing a mixed trend in terms of growth.

• Market Size: As of 2024, the global Moxifloxacin HCl market size is estimated to be around US$ 117 million. However, it is projected to decline slightly to US$ 111.5 million by 2030, with a Compound Annual Growth Rate (CAGR) of -0.8% during the forecast period[2].

• Regional Segmentation: The market is segmented by region, with North America and Europe being significant markets due to well-established healthcare systems and high R&D investments. The Asia-Pacific region is expected to witness rapid growth due to increasing healthcare awareness and expanding pharmaceutical manufacturing capabilities[5].

Key Players

Several pharmaceutical companies are actively involved in the development, manufacturing, and distribution of Moxifloxacin HCl.

• Prominent Companies: Key players include Bayer AG, Aurobindo Pharma, Actavis (now part of Teva Pharmaceutical Industries), MERCK, and Mylan N.V., among others[5].

Market Segmentation

The market is segmented based on type, application, and region.

• Types-Based Segmentation: The market is segmented into different purity levels such as 98.0%-99.5%, 99.5-99.9%, and above 99.9%[5].

• End-User Segmentation: Moxifloxacin HCl is used in various forms including oral tablets, injections, and ophthalmic drugs[5].

Challenges and Opportunities

Challenges

The Moxifloxacin HCl market faces several challenges:

• Antibiotic Resistance: The emergence of antibiotic-resistant bacterial strains is a significant challenge for the market[5].

• Regulatory Requirements: Strict regulatory requirements and high costs associated with drug development are other challenges[5].

• Side Effects: Potential side effects such as tendon rupture and QT prolongation may limit the usage of Moxifloxacin HCl[5].

Opportunities

Despite the challenges, there are opportunities for growth:

• Increasing Healthcare Awareness: Rising healthcare awareness, especially in the Asia-Pacific region, is expected to drive market growth[5].

• Expanding Pharmaceutical Manufacturing: The expansion of pharmaceutical manufacturing capabilities in emerging markets presents opportunities for market expansion[5].

Future Projections

Market Growth

The global Moxifloxacin HCl market is expected to experience moderate growth, albeit with some decline in the near future.

• CAGR and Market Size: The market is projected to decline slightly from US$ 117 million in 2024 to US$ 111.5 million by 2030, with a CAGR of -0.8% during the forecast period[2].

Regional Growth

• Asia-Pacific Region: This region is expected to witness rapid growth due to increasing healthcare awareness and expanding pharmaceutical manufacturing capabilities[5].

Key Takeaways

• Clinical Efficacy: Moxifloxacin HCl has shown efficacy in treating various bacterial infections, including CABP and complicated skin and skin structure infections.
• Safety Profile: While generally well-tolerated, moxifloxacin can cause serious side effects such as tendon rupture and QT prolongation.
• Market Size and Forecast: The global market is projected to decline slightly from US$ 117 million in 2024 to US$ 111.5 million by 2030.
• Regional Segmentation: The Asia-Pacific region is expected to drive market growth due to increasing healthcare awareness and expanding pharmaceutical manufacturing capabilities.
• Challenges and Opportunities: The market faces challenges such as antibiotic resistance and strict regulatory requirements, but also has opportunities for growth in emerging markets.

FAQs

What is the current market size of Moxifloxacin HCl?

The current market size of Moxifloxacin HCl is estimated to be around US$ 117 million as of 2024[2].

What is the projected market size of Moxifloxacin HCl by 2030?

The market is projected to decline slightly to US$ 111.5 million by 2030, with a CAGR of -0.8% during the forecast period[2].

What are the common side effects of Moxifloxacin HCl?

Common side effects include gastrointestinal issues and central nervous system effects. Serious side effects can include tendon rupture and QT prolongation[4][5].

Which regions are expected to drive the growth of the Moxifloxacin HCl market?

The Asia-Pacific region is expected to drive market growth due to increasing healthcare awareness and expanding pharmaceutical manufacturing capabilities[5].

Who are the key players in the Moxifloxacin HCl market?

Key players include Bayer AG, Aurobindo Pharma, Actavis (now part of Teva Pharmaceutical Industries), MERCK, and Mylan N.V., among others[5].

Sources

1. Bayer Clinical Trials Explorer: Study 16515 - Special Drug Use Investigation - Assessment of efficacy and safety in treating secondary infection of chronic respiratory disease.
2. Valuates Reports: Global Moxifloxacin HCl Market Insights, Forecast to 2030.
3. NIH: Avelox 400 mg film-coated tablets and Avelox 400 mg solution for infusion.
4. Oxford Academic: Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia.
5. OpenPR: Moxifloxacin HCl Market Size, Growth, Trends & Forecast to 2033.