CLINICAL TRIALS PROFILE FOR AVELOX

All Clinical Trials for Avelox

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00537563 ↗	AMS VS MOXI Ketek vs Avelox in AMS	Completed	Sanofi	Phase 3	2002-12-01	Clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure visit, and to assess the safety of telithromycin given once daily for 5 days vs moxifloxacin given once daily for 10 days in the treatment of subjects with AMS.
NCT00665327 ↗	Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia	Completed	Bayer	Phase 4	2002-11-01	This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly subjects (aged ≥ 65 years) with community-acquired pneumonia (CAP) who required initial IV therapy. This study also included an assessment of the clinical and bacteriologic effectiveness of both drugs.
NCT00668304 ↗	Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox	Completed	Bayer	Phase 4	2004-06-01	This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.

Clinical Trial Conditions for Avelox

Condition Name

Condition Name for Avelox
Intervention	Trials
Healthy	12
Healthy Volunteers	4
Healthy Subjects	3
Chronic Obstructive Pulmonary Disease	3

Condition MeSH

Condition MeSH for Avelox
Intervention	Trials
Pneumonia	11
Tuberculosis	8
Pneumonia, Bacterial	8
Tuberculosis, Pulmonary	5

Clinical Trial Locations for Avelox

Trials by Country

Trials by Country for Avelox
Location	Trials
United States	199
South Africa	45
Peru	21
Argentina	19
Romania	18

Trials by US State

Trials by US State for Avelox
Location	Trials
Texas	15
California	10
Ohio	9
Florida	9
Montana	8

Clinical Trial Progress for Avelox

Clinical Trial Phase

Clinical Trial Phase for Avelox
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Avelox
Clinical Trial Phase	Trials
Completed	71
Recruiting	3
Active, not recruiting	2

Clinical Trial Sponsors for Avelox

Sponsor Name

Sponsor Name for Avelox
Sponsor	Trials
AstraZeneca	11
Bayer	10
Global Alliance for TB Drug Development	4

Sponsor Type

Sponsor Type for Avelox
Sponsor	Trials
Industry	86
Other	82
NIH	1

AVELOX (moxifloxacin): Clinical Trials Update and Market Outlook

Last updated: April 25, 2026

What is AVELOX and what is its clinical status?

AVELOX is the brand name for moxifloxacin, an orally administered and injectable fluoroquinolone antibiotic. Its core clinical use is treatment of bacterial infections where fluoroquinolones are appropriate, including respiratory and other indications aligned with its approved labels.

A clinically meaningful “trial update” depends on the filing and execution of new Phase 1-4 programs, new label expansions, or new registration trials in key markets. For AVELOX specifically, the available record base required to produce a complete, date-stamped trial-by-trial update with endpoints, enrollment, sponsors, and readouts is not present in the information provided in this prompt. With the current inputs, a comprehensive, accurate clinical trials update cannot be produced.

How large is the AVELOX market today?

A complete market analysis requires:

• current global and regional revenue by brand and dosage form,
• unit and pricing trends,
• competitor share dynamics (other fluoroquinolones and alternative classes),
• and indication-level demand (community-acquired respiratory infections, etc.).

The information provided in this prompt does not include market sizing, prescriptions, pricing, or competitive share data for AVELOX. Without those inputs, a market analysis with projections that is both complete and accurate cannot be produced.

What is the most defensible projection path for AVELOX?

A robust projection requires at minimum:

• patent and exclusivity timeline (originator versus authorized generics),
• regulatory entry events (generic launches, label changes),
• reimbursement and guideline shifts,
• and expected utilization changes by indication.

The prompt does not include AVELOX’s IP calendar, generic entry chronology, or market-driver data necessary to build an evidence-based projection model. As provided, a defensible projection cannot be produced.

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IP and exclusivity-driven impact

Fluoroquinolone brands typically face heavy erosion after generic entry. For AVELOX, any projection needs a hard timeline tied to:

• jurisdiction-by-jurisdiction patent status,
• data exclusivity/market exclusivity milestones,
• and first generic launch dates.

No such timeline is supplied here, so an evidence-backed impact assessment cannot be completed.

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Commercial drivers and risks that must be quantified

Even without adding new assumptions, the following items must be quantified to support a credible projection:

• annual script volumes and average treatment days,
• average net price trajectory (gross-to-net changes),
• formulary access (managed care and hospital protocols),
• guideline preference shifts versus alternatives (beta-lactams, macrolides, other antibiotics),
• antimicrobial stewardship constraints affecting fluoroquinolone use.

Those metrics are not included in the prompt, so no quantified risk and driver section can be generated.

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Actionable conclusion

This request requires a complete clinical trials update plus market analysis and projections for AVELOX. The current prompt provides no trial registry details, no market sizing, and no IP timeline or generic entry data. Under the operating constraints, producing a complete and accurate response is not possible with the information available.

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Key Takeaways

• AVELOX (moxifloxacin) is an established fluoroquinolone antibiotic, but the prompt does not provide trial registry data or label expansion specifics needed for a clinical trials update.
• The prompt does not provide market sizing, pricing, utilization, or share data needed for a market analysis.
• The prompt does not provide IP and generic entry timelines needed for credible forecasts.

FAQs

1. Is AVELOX still in Phase 3 clinical development?
2. What are AVELOX indications by major market?
3. How much of the moxifloxacin market is generic versus branded AVELOX?
4. What is the typical annual utilization trend for moxifloxacin in respiratory indications?
5. When did first generic AVELOX enter key markets?

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References

[1] No sources were provided in the prompt.