CLINICAL TRIALS PROFILE FOR MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	AIDS Clinical Trials Group	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Helsinki University Central Hospital	N/A	2017-04-04	Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.

All Clinical Trials for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00062231 ↗	Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer	Terminated	European Organisation for Research and Treatment of Cancer - EORTC	N/A	2002-04-01	RATIONALE: Antibiotics such as amoxicillin, ciprofloxacin, and moxifloxacin may be effective in preventing or controlling fever and neutropenia in patients with cancer. It is not yet known whether moxifloxacin alone is more effective than amoxicillin combined with ciprofloxacin in treating neutropenia and fever. PURPOSE: This randomized clinical trial is studying how well moxifloxacin works and compares it to ciprofloxacin together with amoxicillin in treating neutropenia and fever in patients with cancer.

Clinical Trial Conditions for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Condition Name

Condition Name for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Intervention	Trials
Healthy	87
Healthy Volunteers	23
Healthy Subjects	20

Condition MeSH

Condition MeSH for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Intervention	Trials
Tuberculosis	54
Tuberculosis, Pulmonary	28
Cataract	23

Clinical Trial Locations for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Trials by Country

Trials by Country for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Location	Trials
United States	492
South Africa	107
Germany	97
China	71
United Kingdom	58

Trials by US State

Trials by US State for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Location	Trials
Texas	52
California	32
Florida	31
Arizona	27
Maryland	27

Clinical Trial Progress for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	54
Phase 3	65
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Clinical Trial Phase	Trials
Completed	348
Recruiting	53
Not yet recruiting	28

Clinical Trial Sponsors for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container

Sponsor Name

Sponsor Name for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Sponsor	Trials
Bayer	34
GlaxoSmithKline	20
Pfizer	18

Sponsor Type

Sponsor Type for Moxifloxacin Hydrochloride In Sodium Chloride 0.8% In Plastic Container
Sponsor	Trials
Other	449
Industry	407
NIH	16

Moxifloxacin Hydrochloride in Sodium Chloride 0.8%: Clinical Trials, Market Analysis, and Projections

Introduction

Moxifloxacin hydrochloride, a broad-spectrum fluoroquinolone antibiotic, is widely used to treat various bacterial infections. This article provides an update on the clinical trials, market analysis, and future projections for moxifloxacin hydrochloride, particularly in its formulation with sodium chloride 0.8% in a plastic container.

Clinical Trials Update

Hepatic Safety Profile

A significant clinical trial (Study 14705) is underway to evaluate the hepatic safety profile of moxifloxacin. This retrospective cohort study with nested case-control analysis aims to assess the rate of noninfectious acute liver injury among new users of moxifloxacin compared to other antimicrobials such as amoxicillin, cefuroxime, and levofloxacin. The study is conducted within the HealthCore Integrated Research Database (HIRD) and includes adults aged 18 years and older with continuous enrollment for at least 6 months before their first prescription claim for a study antimicrobial. Patients with chronic alcoholism, cirrhosis, infectious hepatitis, HIV/AIDS, or pregnant women are excluded from the study[1].

Tuberculosis Treatment

Another notable clinical trial involves the use of moxifloxacin in a 4-month regimen for the treatment of drug-susceptible pulmonary tuberculosis. This regimen, which includes rifapentine, moxifloxacin, isoniazid, and pyrazinamide, has been shown to be as effective as the standard 6-month regimen. The CDC recommends this 4-month regimen as a treatment option for U.S. patients aged 12 years and older with drug-susceptible pulmonary TB, emphasizing the importance of microbiological, laboratory, and clinical assessments before and during treatment[4].

Pharmacokinetics and Formulation

Moxifloxacin hydrochloride, when administered as an oral tablet or intravenous infusion, exhibits high bioavailability. The absolute bioavailability of moxifloxacin is approximately 90%, and plasma concentrations increase proportionately with the dose. The mean elimination half-life from plasma is about 12 hours, with steady-state concentrations achieved after at least three days of a 400 mg once-daily regimen. The formulation in sodium chloride 0.8% solution does not affect the product's stability, and the solution contains inactive ingredients such as sodium chloride, water for injection, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment[3].

Market Analysis

Global Market Size and Growth

The global moxifloxacin HCl market is expected to experience moderate growth, although at a declining rate. As of 2024, the market size is projected to be around US$ 117 million, with a forecasted size of US$ 111.5 million by 2030, reflecting a Compound Annual Growth Rate (CAGR) of -0.8% during the forecast period. This decline is attributed to various challenges, including the emergence of antibiotic-resistant bacterial strains and strict regulatory requirements[5].

Regional Market Trends

North America and Europe are significant markets due to their well-established healthcare systems and high investments in research and development. However, the Asia-Pacific region is expected to witness rapid growth driven by increasing healthcare awareness, rising cases of infections, and expanding pharmaceutical manufacturing capabilities[2].

Key Players

Prominent companies in the moxifloxacin HCl market include Bayer AG, Aurobindo Pharma, Cipla, Actavis (now part of Teva Pharmaceutical Industries), and Mylan N.V. These companies are actively involved in the development, manufacturing, and distribution of moxifloxacin HCl[2].

Challenges and Limitations

Antibiotic Resistance

One of the major challenges facing the moxifloxacin HCl market is the emergence of antibiotic-resistant bacterial strains. This resistance can significantly limit the effectiveness of moxifloxacin and other antibiotics, necessitating the development of new treatment options[2].

Regulatory Requirements

Strict regulatory requirements pose another challenge. The development and approval process for antibiotics is rigorous, involving extensive clinical trials and safety evaluations, which can be costly and time-consuming[2].

Side Effects

Moxifloxacin is associated with potential side effects such as tendon rupture and QT prolongation, which may limit its usage in certain patient populations. These side effects require careful monitoring and management to ensure patient safety[2].

Future Projections

Market Strategies

To navigate the challenges and capitalize on growth opportunities, companies in the moxifloxacin HCl market are focusing on strategic research and development. This includes investing in new formulations, exploring different therapeutic applications, and enhancing manufacturing capabilities to meet growing demand, especially in the Asia-Pacific region[2].

Technological Advancements

Advancements in pharmaceutical technology, such as improved drug delivery systems and personalized medicine approaches, are expected to play a crucial role in the future of moxifloxacin HCl. These innovations could enhance the drug's efficacy and safety profile, potentially expanding its market share[5].

Key Takeaways

• Clinical Trials: Ongoing studies are evaluating the hepatic safety profile of moxifloxacin and its efficacy in shorter treatment regimens for tuberculosis.
• Market Size: The global moxifloxacin HCl market is projected to decline slightly from US$ 117 million in 2024 to US$ 111.5 million by 2030.
• Regional Trends: North America and Europe remain significant markets, while the Asia-Pacific region is expected to grow rapidly.
• Challenges: Antibiotic resistance, strict regulatory requirements, and potential side effects are key challenges.
• Future Projections: Strategic R&D, technological advancements, and expanded manufacturing capabilities are crucial for market growth.

FAQs

What is the primary use of moxifloxacin hydrochloride?

Moxifloxacin hydrochloride is primarily used to treat various bacterial infections, including respiratory tract infections, intra-abdominal infections, and pelvic inflammatory disease.

What is the significance of the 4-month rifapentine-moxifloxacin regimen?

The 4-month regimen, which includes rifapentine, moxifloxacin, isoniazid, and pyrazinamide, has been shown to be as effective as the standard 6-month regimen for treating drug-susceptible pulmonary tuberculosis.

What are the major challenges facing the moxifloxacin HCl market?

The major challenges include the emergence of antibiotic-resistant bacterial strains, strict regulatory requirements, and potential side effects such as tendon rupture and QT prolongation.

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

North America and Europe are significant markets, but the Asia-Pacific region is expected to witness rapid growth due to increasing healthcare awareness and expanding pharmaceutical manufacturing capabilities.

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

The global moxifloxacin HCl market is projected to be around US$ 111.5 million by 2030, reflecting a CAGR of -0.8% from 2024 to 2030.

Sources

1. ClinicalTrials.bayer.com: Drug-Induced Liver Injury | Study 14705
2. OpenPR.com: Moxifloxacin HCl Market Size, Growth, Trends & Forecast to 2033
3. FDA.gov: Avelox - Moxifloxacin Hydrochloride
4. CDC.gov: Interim Guidance: 4-Month Rifapentine-Moxifloxacin Regimen for the Treatment of Drug-Susceptible Pulmonary Tuberculosis — United States, 2022
5. Valuates.com: Global Moxifloxacin HCl Market Insights, Forecast to 2030