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Last Updated: April 2, 2025

CLINICAL TRIALS PROFILE FOR MOXIFLOXACIN HYDROCHLORIDE


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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 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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for moxifloxacin hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for moxifloxacin hydrochloride

Condition Name

8723202000102030405060708090HealthyHealthy VolunteersHealthy SubjectsTuberculosis[disabled in preview]
Condition Name for moxifloxacin hydrochloride
Intervention Trials
Healthy 87
Healthy Volunteers 23
Healthy Subjects 20
Tuberculosis 20
[disabled in preview] 0
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Condition MeSH

542823220-50510152025303540455055TuberculosisTuberculosis, PulmonaryCataractInfections[disabled in preview]
Condition MeSH for moxifloxacin hydrochloride
Intervention Trials
Tuberculosis 54
Tuberculosis, Pulmonary 28
Cataract 23
Infections 22
[disabled in preview] 0
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Clinical Trial Locations for moxifloxacin hydrochloride

Trials by Country

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Trials by Country for moxifloxacin hydrochloride
Location Trials
United States 492
South Africa 107
Germany 97
China 71
United Kingdom 58
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Trials by US State

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Trials by US State for moxifloxacin hydrochloride
Location Trials
Texas 52
California 32
Florida 31
Arizona 27
Maryland 27
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Clinical Trial Progress for moxifloxacin hydrochloride

Clinical Trial Phase

32.5%39.2%6.0%22.3%0510152025303540455055606570Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for moxifloxacin hydrochloride
Clinical Trial Phase Trials
Phase 4 54
Phase 3 65
Phase 2/Phase 3 10
[disabled in preview] 37
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Clinical Trial Status

77.9%11.9%6.3%0050100150200250300350CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for moxifloxacin hydrochloride
Clinical Trial Phase Trials
Completed 348
Recruiting 53
Not yet recruiting 28
[disabled in preview] 18
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Clinical Trial Sponsors for moxifloxacin hydrochloride

Sponsor Name

trials05101520253035BayerGlaxoSmithKlinePfizer[disabled in preview]
Sponsor Name for moxifloxacin hydrochloride
Sponsor Trials
Bayer 34
GlaxoSmithKline 20
Pfizer 18
[disabled in preview] 17
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Sponsor Type

50.6%45.9%0050100150200250300350400450OtherIndustryNIH[disabled in preview]
Sponsor Type for moxifloxacin hydrochloride
Sponsor Trials
Other 449
Industry 407
NIH 16
[disabled in preview] 15
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Moxifloxacin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Moxifloxacin hydrochloride, a fourth-generation fluoroquinolone antibiotic, is widely used to treat various bacterial infections. This article provides an update on the current clinical trials, market analysis, and future projections for moxifloxacin hydrochloride.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are ongoing or have recently concluded to evaluate the efficacy and safety of moxifloxacin hydrochloride in different clinical settings.

  • Pediatric Use: A clinical trial (Study 11643) has been conducted to evaluate the safety and efficacy of moxifloxacin in pediatric patients aged 3 months to less than 18 years with complicated intra-abdominal infections (cIAI). This study assesses musculoskeletal events, pharmacokinetics, and the absolute bioavailability of the pediatric formulation of moxifloxacin[3].

  • Mycoplasma genitalium Infections: Although not specifically focused on moxifloxacin alone, a randomized controlled trial is comparing the efficacy and safety of sitafloxacin versus moxifloxacin-based sequential treatment for managing Mycoplasma genitalium infections. This study aims to determine the treatment success rates and the emergence of post-treatment resistant mutant strains[1].

  • Combination Therapies: Clinical trials have also explored the use of moxifloxacin in combination with other antibiotics to address multi-drug resistant infections. For example, a Phase 3 trial evaluated the rifapentine-moxifloxacin regimen and found it to be effective in certain cases[4].

Mechanism of Action and Indications

Moxifloxacin hydrochloride acts as a bacterial DNA gyrase and topoisomerase IV inhibitor, making it effective against a broad spectrum of Gram-positive and Gram-negative bacteria.

  • Therapeutic Areas: It is indicated for the treatment of various infections including bronchitis, pneumonia, sinusitis, and pelvic inflammatory disease[2][4].

Market Analysis

Market Size and Growth

The global moxifloxacin hydrochloride market is experiencing a mixed trend in terms of growth.

  • Current Market Size: As of 2024, the global moxifloxacin HCl market size is estimated to be around US$ 117 million[5].
  • Forecasted Growth: However, the market is projected to decline slightly, reaching US$ 111.5 million by 2030 at a Compound Annual Growth Rate (CAGR) of -0.8% during the forecast period[5].

Market Segmentation

The market is segmented based on several factors:

  • Product Type: Qualified Grade, First Grade, and Excellence Grade[2].
  • Dosage Form: Oral, Parenteral, and Ophthalmic Drugs[2].
  • Application: Bronchitis, Pneumonia, Sinusitis, Pelvic Inflammatory Disease, and others[2].

Market Drivers

Despite the projected decline, several factors drive the demand for moxifloxacin hydrochloride:

  • High Incidence of Bacterial Infections: The increasing incidence of bacterial infections worldwide, coupled with rising antibiotic resistance, continues to drive the demand for effective antibiotics like moxifloxacin[2].
  • Pharmaceutical Research Advancements: Ongoing research and development in drug formulations and delivery methods enhance the efficacy and patient compliance of moxifloxacin[2].
  • Aging Population: The growing aging population, more vulnerable to infections, also contributes to the market demand[2].

Market Trends

Several trends are shaping the future of the moxifloxacin hydrochloride market:

  • Shift Towards Generic Drugs: The increased use of generic moxifloxacin hydrochloride is a significant trend, driven by cost-effectiveness and accessibility[2].
  • Combination Therapies: The use of combination therapies involving moxifloxacin to combat multi-drug resistant infections is on the rise[2].
  • Digital Health Integration: The integration of digital health technologies in prescribing and monitoring antibiotics, including moxifloxacin, is improving treatment adherence and outcomes[2].

Future Projections

Opportunities

The market presents several opportunities for growth and innovation:

  • Continued Awareness of Antibiotic Resistance: Increasing awareness of antibiotic resistance could lead to greater use of moxifloxacin as a treatment alternative[2].
  • Collaborations with Healthcare Providers: Strategic collaborations with healthcare providers and institutes can lead to new applications and acceptance in the market[2].
  • New Formulations Development: Developing new formulations, such as extended-release or combination drugs, can differentiate the market and respond to specific patient needs[2].

Challenges

Despite the opportunities, there are challenges to be addressed:

  • Antibiotic Resistance: The emergence of antibiotic-resistant strains remains a significant concern and a challenge for the efficacy of moxifloxacin[1][4].
  • Regulatory Scrutiny: Regulatory bodies are increasingly scrutinizing antibiotic use to minimize abuse and preserve investor trust, which can impact market dynamics[2].

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the safety and efficacy of moxifloxacin in various settings, including pediatric use and combination therapies.
  • 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.
  • Market Drivers: High incidence of bacterial infections, pharmaceutical research advancements, and an aging population drive the demand.
  • Market Trends: Shift towards generic drugs, combination therapies, and digital health integration are key trends.
  • Opportunities and Challenges: Opportunities include increased awareness of antibiotic resistance and new formulations, while challenges include antibiotic resistance and regulatory scrutiny.

FAQs

What is the current market size of the moxifloxacin hydrochloride market?

The current market size of the moxifloxacin HCl market is estimated to be around US$ 117 million as of 2024[5].

What is the projected growth rate of the moxifloxacin hydrochloride market?

The market is projected to decline at a Compound Annual Growth Rate (CAGR) of -0.8% from 2024 to 2030[5].

What are the primary indications for moxifloxacin hydrochloride?

Moxifloxacin hydrochloride is indicated for the treatment of infections such as bronchitis, pneumonia, sinusitis, and pelvic inflammatory disease[2][4].

What are the key drivers of the moxifloxacin hydrochloride market?

The key drivers include the high incidence of bacterial infections, pharmaceutical research advancements, and an aging population[2].

What trends are shaping the future of the moxifloxacin hydrochloride market?

Trends include a shift towards generic drugs, the use of combination therapies, and the integration of digital health technologies[2].

Sources

  1. Naokatsu Ando et al., "Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma genitalium Infections: A Randomized Controlled Trial Protocol," JMIR Research Protocols, 14 November 2023.
  2. The Insight Partners, "Moxifloxacin HCL Market Forecast and Scope - 2031," The Insight Partners.
  3. FDA, "Clinical Review (Avelox) - FDA," FDA, 7.1.1 Studies/Clinical Trials Used to Evaluate Safety.
  4. Patsnap, "Moxifloxacin Hydrochloride - Drug Targets, Indications, Patents," Synapse.
  5. Valuates Reports, "Global Moxifloxacin HCl Market Insights, Forecast to 2030," Valuates Reports.

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