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.
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.

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.
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.

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	92
Healthy Volunteers	31
Tuberculosis	23
Healthy Subjects	20

Condition MeSH

Condition MeSH for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Intervention	Trials
Tuberculosis	58
Tuberculosis, Pulmonary	33
Cataract	24
Infections	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	512
South Africa	113
Germany	100
China	89
United Kingdom	60

Trials by US State

Trials by US State for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Location	Trials
Texas	57
California	35
Florida	32
Arizona	31
Maryland	28

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
PHASE4	2
PHASE3	7
PHASE2	4

Clinical Trial Status

Clinical Trial Status for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	365
Recruiting	64
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	476
Industry	442
NIH	16

Moxifloxacin Hydrochloride in Sodium Chloride 0.8% in Plastic Container: Clinical, Market, and Projection Update

Last updated: April 28, 2026

What is the product and how is it positioned clinically?

Moxifloxacin hydrochloride in sodium chloride 0.8% in plastic container is an IV formulation of the fluoroquinolone antibiotic moxifloxacin delivered in a saline vehicle. Clinically, it is positioned for bacterial infections where IV therapy is indicated, typically including:

• Community-acquired pneumonia (CAP)
• Complicated intra-abdominal infections (cIAI)
• Acute bacterial sinusitis and other bacterial respiratory infections
• Skin and skin structure infections (in selected indications)

In market practice, IV moxifloxacin products compete primarily with other IV fluoroquinolones and broad-spectrum IV antibiotics (for example, beta-lactam/beta-lactamase inhibitor regimens, carbapenems, and alternatives depending on local guideline pathways).

Regulatory and labeling context. Moxifloxacin is a well-established antibacterial active; product-level differentiators typically come from formulation and packaging (plastic container), not from the core pharmacology. Clinical trial “updates” for the exact salt-and-vehicle/packaged SKU are often limited because most development activity is tied to the active ingredient’s origin and later life-cycle reformulations.

What clinical trials updates matter for this exact formulation?

A full, SKU-accurate clinical trials update requires product-level mapping to each registration and trial record for the specific presentation (moxifloxacin hydrochloride + sodium chloride 0.8% + plastic container). With only the product description provided, a complete and accurate trial-by-trial update cannot be produced.

How does the broader moxifloxacin clinical evidence translate into current use?

While SKU-specific trial enrollment may be limited, the broader evidence base for IV moxifloxacin informs the current clinical role:

• Fluoroquinolone class exposure is used where clinicians want IV-to-oral switch potential and broad coverage against susceptible gram-positive and gram-negative pathogens.
• Resistance trends influence stewardship; fluoroquinolone restriction policies in hospitals can shift volume toward narrower-spectrum beta-lactams in some settings.
• Packaging and administration format (plastic container) can affect operational preferences, substitution rates, and shortage resilience, but it does not change efficacy relative to labeled moxifloxacin dosing.

Who are the key market competitors for IV moxifloxacin in saline, and where do they win?

The competitive set for an IV moxifloxacin presentation typically includes:

• Other IV fluoroquinolones (same care pathway, different spectrum nuances)
• Broad-spectrum beta-lactams (CAP and cIAI pathways often default to beta-lactams in stewardship-driven formularies)
• Reserve and escalation regimens (carbapenems or combinations in complicated cases)

Key commercial dynamics:

1. Formulary position and stewardship drive quarterly volume more than incremental clinical data.
2. Hospital purchasing contracts favor suppliers with stable supply and predictable packaging formats.
3. Local guideline alignment determines whether IV fluoroquinolone monotherapy is used early or only after beta-lactam alternatives fail.

What market size and growth rates apply to IV moxifloxacin?

A defensible market-size number requires a defined geography, time horizon, and segmentation approach (IV versus oral; moxifloxacin versus all fluoroquinolones; antibiotic class reporting sources). With only the product description, a precise market sizing statement would be incomplete.

What drives pricing, tendering, and margin structure?

For off-patent antibiotic formulations with established actives, typical price formation drivers include:

• Entry of generics and authorized versions that compress net prices
• Tender-based procurement in hospital systems
• Availability and shortage premiums during supply disruptions
• Packaging and container cost impacting landed cost and contract pricing

For an IV saline-plastic container format, packaging cost and container vendor stability matter for margin more than clinical differentiation.

What is the projection outlook for this formulation through the next 3 to 5 years?

A projection requires baseline volume (units or treatments), pricing assumptions, and market share by channel (hospital, clinic infusion, wholesale distribution). Those inputs are not provided, and an accurate projection cannot be produced from the product description alone.

Key risks and levers

Risks

• Stewardship tightening on fluoroquinolones that reduces empirical IV use in some indications
• Switching to alternative IV beta-lactams where local antibiograms support narrower choices
• Price erosion from additional generic entries or reallocation of tenders

Levers

• Formulary re-contracting with stable supply, on-time delivery, and compliant packaging
• Operational fit (plastic container handling, storage, and administration workflows)
• Clinical protocol alignment (CAP or cIAI pathways that continue to include IV moxifloxacin)

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Key Takeaways

• This product is a mature IV antibiotic formulation of moxifloxacin in sodium chloride 0.8% with plastic-container packaging; commercial differentiation typically comes from formulation logistics rather than new pharmacology.
• SKU-specific clinical trial updates cannot be completed from the provided description alone; meaningful trial tracking requires exact product mapping to registrations and trial records.
• Market outlook depends primarily on stewardship, formulary contracting, and tender dynamics, which govern IV antibiotic volume and net pricing in most geographies.
• Projections require baseline market share, pricing, and volume assumptions that are not present in the current input.

FAQs

1. Is moxifloxacin IV still used for CAP and cIAI?
   Yes, but hospital uptake depends on formulary policy and local resistance patterns.

2. What differentiates moxifloxacin in sodium chloride 0.8% plastic container from other presentations?
   The vehicle and container format; clinical efficacy is driven by labeled moxifloxacin dosing and indication.

3. Do clinical trials for moxifloxacin formulations routinely occur after initial approval?
   Often not at SKU level; most post-approval activity relates to logistics, bioequivalence, or life-cycle formulation changes.

4. What most affects revenue for off-patent IV antibiotics?
   Net pricing from tendering and contract share, not new clinical endpoints.

5. How do stewardship policies impact demand?
   They can reduce fluoroquinolone use for empirical therapy, shifting volume to other antibiotic classes depending on guideline and antibiogram alignment.

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References

[1] U.S. Food and Drug Administration. Drug approvals and labeling for moxifloxacin-containing products (accessed via FDA Drugs@FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. Moxifloxacin search results and trial records (accessed via ClinicalTrials.gov). https://clinicaltrials.gov/