CLINICAL TRIALS PROFILE FOR MOXIFLOXACIN HYDROCHLORIDE

505(b)(2) Clinical Trials for MOXIFLOXACIN HYDROCHLORIDE

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.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Jyväskylä 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.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Kuopio University 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.
New Indication	NCT03257423 ↗	Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects	Enrolling by invitation	Oulu University 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

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.
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.
NCT00140309 ↗	TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment	Completed	Centers for Disease Control and Prevention	Phase 2	2003-07-01	This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.
NCT00144417 ↗	TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment	Completed	Bayer	Phase 2	2006-02-01	This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.

Clinical Trial Conditions for MOXIFLOXACIN HYDROCHLORIDE

Condition Name

Condition Name for MOXIFLOXACIN HYDROCHLORIDE
Intervention	Trials
Healthy	92
Healthy Volunteers	30
Tuberculosis	22
Healthy Subjects	20

Condition MeSH

Condition MeSH for MOXIFLOXACIN HYDROCHLORIDE
Intervention	Trials
Tuberculosis	57
Tuberculosis, Pulmonary	32
Cataract	24
Infections	23

Clinical Trial Locations for MOXIFLOXACIN HYDROCHLORIDE

Trials by Country

Trials by Country for MOXIFLOXACIN HYDROCHLORIDE
Location	Trials
United States	511
South Africa	113
Germany	100
China	88
United Kingdom	60

Trials by US State

Trials by US State for MOXIFLOXACIN HYDROCHLORIDE
Location	Trials
Texas	57
California	34
Florida	32
Arizona	31
Maryland	28

Clinical Trial Progress for MOXIFLOXACIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for MOXIFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for MOXIFLOXACIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	365
Recruiting	63
Not yet recruiting	28

Clinical Trial Sponsors for MOXIFLOXACIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for MOXIFLOXACIN HYDROCHLORIDE
Sponsor	Trials
Bayer	34
GlaxoSmithKline	20
Pfizer	18

Sponsor Type

Sponsor Type for MOXIFLOXACIN HYDROCHLORIDE
Sponsor	Trials
Other	473
Industry	438
NIH	16

Moxifloxacin Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Moxifloxacin hydrochloride, a broad-spectrum fluoroquinolone antibiotic, remains a key player in the treatment of various bacterial infections, including respiratory, intra-abdominal, and skin infections. Its unique pharmacokinetic profile, coupled with its efficacy, has sustained its relevance in both clinical practice and pharmaceutical pipelines. This analysis aims to synthesize recent developments in clinical trials, assess current market dynamics, and project future growth trajectories for moxifloxacin hydrochloride within the global pharmaceutical landscape.

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Clinical Trials Update

Recent years have seen an intensified focus on optimizing moxifloxacin's therapeutic applications, mitigating resistance, and developing novel formulations. The majority of ongoing clinical trials aim to enhance safety profiles, evaluate combination therapies, and expand indications.

Ongoing and Completed Trials

• Respiratory Infections: Multiple phase III trials continue to assess moxifloxacin's efficacy against multi-drug resistant Streptococcus pneumoniae and Haemophilus influenzae. Notably, the ORBIT-2 trial (ClinicalTrials.gov Identifier: NCT01579590) evaluated moxifloxacin in acute exacerbations of chronic bronchitis, demonstrating superior efficacy and tolerability compared to comparator antibiotics.

• COVID-19 and Postviral Infections: While initial interest was limited, exploratory trials investigated moxifloxacin as adjunct therapy in viral-bacterial co-infections common in COVID-19 cases. These studies (e.g., NCT04596416) indicated limited benefit, emphasizing antibiotic stewardship.

• Novel Formulations: Several phase I and II studies focus on liposomal or inhaled formulations intended to enhance pulmonary delivery and reduce systemic side effects. For example, a trial (NCT04264715) evaluates inhaled moxifloxacin in ventilator-associated pneumonia, showing promising pharmacokinetic profiles.

Resistance and Safety Studies

Ongoing surveillance studies are tracking resistance patterns associated with moxifloxacin use. The emergence of moxifloxacin-resistant Mycobacterium tuberculosis strains has prompted adjustments in both clinical guidelines and patent strategies.

Furthermore, post-market surveillance continues to monitor rare adverse events, notably tendinopathy and QT prolongation, influencing prescribing practices and prompting development of safer analogs or formulations.

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Market Analysis

Current Market Landscape

Moxifloxacin hydrochloride's market remains robust, driven by its extensive approved indications, branding by major pharmaceutical firms (e.g., Bayer’s Avelox), and generic proliferation following patent expirations.

• Global Sales Figures: In 2021, the global fluoroquinolone market was valued at approximately USD 3.5 billion, with moxifloxacin accounting for roughly 25% of this segment, corresponding to market revenues approaching USD 875 million (source: GlobalData).

• Regional Markets: North America, Europe, and Asia-Pacific dominate the moxifloxacin market. North America held the largest share (~40%) owing to high prevalence of respiratory infections and established healthcare infrastructure. The Asia-Pacific region is emerging rapidly, fueled by rising bacterial infection rates, increased antibiotic access, and growing healthcare expenditures.

• Market Penetration and Competition: Patent protections for branded formulations have kept market entry limited, but the rise of generic manufacturers has intensified price competition, shrinking profit margins. Several generics, including Ciprofloxacin and Levofloxacin, act as substitutes, impacting moxifloxacin's market share.

Regulatory and Patent Dynamics

Patent expirations in key markets (e.g., the US in 2015) facilitated generic entry, reducing costs and expanding accessibility but also increasing market saturation. Recent patent litigations and data exclusivity periods influence the pace of new formulations and usage indications.

Emerging Therapeutic Trends

• Combination Therapy: The combination of moxifloxacin with other antibiotics, such as beta-lactams, is increasingly studied for resistant infections, opening pathway for co-formulations and combination patents.

• Shift Towards Resistance Management: Regulatory agencies emphasizing antibiotic stewardship are impacting prescribing patterns, with some regions limiting moxifloxacin's use to specific indications.

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Future Market Projections

Growth Drivers

• Expanding Indications: Emerging evidence supports moxifloxacin's use in neglected areas such as intra-abdominal infections and tuberculosis, especially in multidrug-resistant scenarios, potentially broadening its market.

• Innovation in Formulations: Inhaled and liposomal formulations are poised to increase therapeutic efficacy and reduce systemic toxicity, opening new markets.

• Global Health Initiatives: Efforts to combat bacterial resistance and improve diagnostics are likely to catalyze targeted use, reinforcing demand.

Challenges

• Antibiotic Resistance: Rising resistance could curtail moxifloxacin's efficacy, leading to decreased clinical utility and market shrinkage.

• Regulatory Scrutiny: Tighter regulations regarding safety and stewardship could restrict prescribing, especially if adverse event profiles intensify.

• Competition: Introduction of newer fluoroquinolones with improved safety or targeted approaches may capture market share.

Forecast Outlook

Industry analysts project a compound annual growth rate (CAGR) of approximately 3-5% through 2030 for the moxifloxacin segment, contingent upon successful expansion into new indications and formulations. The Asia-Pacific market, in particular, is expected to account for over 50% of growth due to demographic shifts and healthcare expansion.

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Strategic Implications for Stakeholders

• Pharmaceutical Developers: Investing in novel formulations and combination therapies could extend lifecycle and capture unmet needs.

• Regulatory Bodies: Emphasizing post-marketing surveillance and stewardship programs will be critical to maintaining moxifloxacin's utility.

• Healthcare Providers: Judicious use aligned with resistance patterns and guidelines will sustain moxifloxacin’s relevance.

• Investors: Monitoring pipeline developments and regional market dynamics will guide strategic investment decisions.

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Key Takeaways

1. Clinical advances in inhaled and combination formulations bolster moxifloxacin's therapeutic profile, yet resistance surveillance remains a priority to ensure long-term efficacy.

2. Market growth is supported by expanding indications, geographic expansion, and innovation, with Asia-Pacific poised as a key growth driver.

3. Patent expirations have increased generic competition, eroding margins but also expanding access and overall volume sales.

4. Resistance challenges necessitate adaptive prescribing practices and continued research into novel formulations or analogs.

5. Strategic focus should prioritize innovation, stewardship, and regional market penetration to sustain revenue streams amid evolving healthcare landscapes.

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FAQs

1. What are the primary clinical indications for moxifloxacin hydrochloride?
Moxifloxacin is primarily indicated for respiratory tract infections (e.g., pneumonia, bronchitis), skin and soft tissue infections, intra-abdominal infections, and certain sexually transmitted infections, guided by regulatory approvals across different regions.

2. How does resistance impact moxifloxacin’s market potential?
Emerging resistance, especially in Mycobacterium tuberculosis and Streptococcus pneumoniae, challenges its efficacy, leading to more restrictive use and prompting the development of new formulations. Resistance trends significantly influence prescribing guidelines and market size.

3. Are there new forms of moxifloxacin in development?
Yes. Several studies are exploring inhalable, liposomal, and combination formulations aimed at improving delivery, reducing systemic side effects, and expanding therapeutic indications.

4. What are the key competitors to moxifloxacin in the antibiotic market?
Other fluoroquinolones like levofloxacin, ciprofloxacin, and newer agents such as delafloxacin compete in overlapping indications. Macrolides and cephalosporins also serve as alternatives, especially with resistance concerns.

5. How do regulatory and safety considerations affect moxifloxacin’s use?
Concerns over adverse events like tendinopathy and QT prolongation lead to restricted prescribing, boxed warnings, and heightened post-market surveillance, influencing market dynamics and clinical guidelines.

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References

[1] GlobalData, “Fluoroquinolone Market Analysis,” 2022.

[2] ClinicalTrials.gov, Database of clinical trials involving moxifloxacin, 2023.

[3] U.S. Food and Drug Administration (FDA), “Avelox (moxifloxacin) prescribing information,” 2021.

[4] World Health Organization, “Global antimicrobial resistance surveillance,” 2022.

[5] Statista, “Pharmaceutical sales of moxifloxacin by region,” 2022.

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In summary, moxifloxacin hydrochloride’s clinical and market landscapes are evolving amid resistance challenges and innovation pursuits. Strategic investments in research, formulations, and stewardship will determine its role in future infection management paradigms.