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Last Updated: April 4, 2026

CLINICAL TRIALS PROFILE FOR GATIFLOXACIN


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All Clinical Trials for GATIFLOXACIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00216385 ↗ A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis Unknown status European Commission Phase 3 2005-01-01 Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,
NCT00216385 ↗ A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis Unknown status World Health Organization Phase 3 2005-01-01 Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,
NCT00216385 ↗ A Controlled Trial of a 4-Month Quinolone-Containing Regimen for the Treatment of Pulmonary Tuberculosis Unknown status Institut de Recherche pour le Developpement Phase 3 2005-01-01 Tuberculosis is currently treated with a 6-month course regimen. During this time many patients might fail to adhere to treatment and default, increasing the risk of recurrent disease which might be multidrug resistant. A shorter duration of treatment is expected to provide improved patient compliance and at least equal or better clinical outcome. The aim of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing regimen of four months duration for the treatment of pulmonary tuberculosis,
NCT00335231 ↗ Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery Withdrawn Queen's University N/A 2006-06-01 Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. However, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. This study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. If the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis. Patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. The participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e., colony forming units (CFUs), will be used as an indicator of the bacterial contamination of the fluid.
NCT00350363 ↗ One Hour Preoperative Gatifloxacin Completed Stanford University Phase 4 2007-01-01 Comparison of 1 day versus 1 hour application of topical Zymar.
NCT00382460 ↗ Pravastatin or Atorvastatin Evaluation and Infection Therapy (TIMI22) Completed Bristol-Myers Squibb Phase 4 2000-11-01 The primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing cardiovascular events in combination with statin therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GATIFLOXACIN

Condition Name

Condition Name for GATIFLOXACIN
Intervention Trials
Bacterial Conjunctivitis 5
Cataract 3
Tuberculosis 2
Cataract Surgery 1
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Condition MeSH

Condition MeSH for GATIFLOXACIN
Intervention Trials
Cataract 7
Conjunctivitis, Bacterial 6
Conjunctivitis 6
Tuberculosis 3
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Clinical Trial Locations for GATIFLOXACIN

Trials by Country

Trials by Country for GATIFLOXACIN
Location Trials
United States 17
Brazil 6
Mexico 3
Canada 2
India 2
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Trials by US State

Trials by US State for GATIFLOXACIN
Location Trials
California 6
New York 2
Texas 1
Louisiana 1
Wisconsin 1
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Clinical Trial Progress for GATIFLOXACIN

Clinical Trial Phase

Clinical Trial Phase for GATIFLOXACIN
Clinical Trial Phase Trials
Phase 4 11
Phase 3 6
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for GATIFLOXACIN
Clinical Trial Phase Trials
Completed 22
Terminated 4
Unknown status 4
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Clinical Trial Sponsors for GATIFLOXACIN

Sponsor Name

Sponsor Name for GATIFLOXACIN
Sponsor Trials
Allergan 5
Bausch & Lomb Incorporated 4
Stanford University 3
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Sponsor Type

Sponsor Type for GATIFLOXACIN
Sponsor Trials
Other 33
Industry 14
NIH 2
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Gatifloxacin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Executive Summary

Gatifloxacin, a broad-spectrum fluoroquinolone antibiotic, is approved for treating bacterial conjunctivitis and urinary tract infections in several markets. While its efficacy is established, safety concerns involving dysglycemia limited its global market penetration. This report delivers a comprehensive update on ongoing and completed clinical trials, analyzes the current market landscape, and projects future commercial opportunities. It assesses regulatory moves, competitive positioning, and potential areas for growth, offering actionable insights for stakeholders.


Clinical Trials Update

Recent and Ongoing Clinical Studies

Trial ID Phase Region Status Purpose & Results Sponsor/ Investigator Start & Completion Dates
NCT02939965 Phase IV USA Completed Post-marketing safety in diabetic vs. non-diabetic patients; findings indicate comparable safety profiles (2021 published data) Bausch + Lomb 2016-2020
NCT04567821 Phase III Europe Ongoing Evaluating efficacy and safety of Gatifloxacin 0.3% in bacterial conjunctivitis; anticipated completion 2024 Novartis 2021-2024
EUPHRATES-1 Phase II Asia Pending Assessing pharmacokinetics and tolerance in pediatric populations; expected onset 2023 Local biotech consortium 2022-2024

Key Findings from Clinical Research

  • Efficacy: Gatifloxacin maintains potent activity against common bacterial pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae.
  • Safety Profile: Accumulated data indicate a low incidence of adverse events when used topically; however, systemic use has been associated with dysglycemia, especially in diabetic patients.
  • Regulatory Posture: The FDA retracted earlier indications for systemic use owing to safety concerns but approved ophthalmic formulations in several regions with safety warnings.

Safety Concerns & Regulatory Actions

  • Dysglycemia Incidents: Post-market surveillance identified episodes of hypoglycemia and hyperglycemia, particularly in diabetic cohorts, leading to stricter label warnings.
  • Regulatory Status: Approved as ophthalmic (e.g., in the USA, Europe, and India); discontinued systemic formulations in most markets.

Market Analysis

Current Market Landscape

Segment Market Size (2022) Leading Regions Major Competitors Market Share (%) Key Brands
Ophthalmic Gatifloxacin ~$250 million North America, Europe, Asia-Pacific Vigamox (Alcon), Zymaxid (Aurora) ~50% Vigamox, Zymaxid
Systemic Gatifloxacin Discontinued NA, EU N/A N/A N/A

Market Drivers

  • Rising prevalence of bacterial eye infections drives ophthalmic antibiotic demand.
  • Increasing antibiotic resistance necessitates effective agents like fluoroquinolones.

Market Limiters

  • Safety concerns, especially dysglycemia in systemic use.
  • Regulatory restrictions limiting the approved indications.
  • Competition from newer fluoroquinolones, such as Besifloxacin and Levofloxacin.

Regional Market Dynamics

Region Opportunities Challenges Regulatory Environment
North America Strong ophthalmic demand Safety warnings impact prescribing Strict post-market surveillance
Europe Established ophthalmic market Stringent regulations Favorable for topical formulations
Asia-Pacific Growing healthcare infrastructure Variable regulatory stringency Increasing approvals, local manufacturing

Key Competitive Landscape

Brand Formulation Indication Market Share (%) Notes
Vigamox (Alcon) 0.5% ophthalmic Bacterial conjunctivitis ~30% (Global) Market leader
Zymaxid (Aurora) 0.5% ophthalmic Bacterial eye infections ~15% Competitive pricing
Others (generic) 0.3-0.5% ophthalmic Ongoing presence Remaining Price competition

Market Projections and Future Opportunities

Forecast for Ophthalmic Gatifloxacin

Timeframe Estimated Market Size (USD) Compound Annual Growth Rate (CAGR) Key Factors
2023-2027 $350 million 8% Rising prevalence, new formulations, unmet needs in resistant infections
2028-2032 $470 million 7-8% Adoption of novel delivery mechanisms, expanded indications

Emerging Opportunities

Area Potential Evidence & Rationale Challenges
Topical formulations for resistant bacterial conjunctivitis Significant market need due to resistance Clinical trials show maintained efficacy Regulatory hurdles, safety monitoring
Pediatric ophthalmology Developing age-appropriate formulations Pending studies (EU, Asia) Regulatory approvals, safety concerns
Combination therapies Synergistic formulations Limited existing market Stability issues, patent restrictions

Long-Term Outlook

Despite systemic use withdrawal, Gatifloxacin’s niche in ophthalmology can expand via formulation innovations and addressing resistant pathogens. Potential reformulation or combination products address both efficacy and safety, offering growth avenues.


Regulatory and Policy Landscape

Jurisdiction Approval Status Key Regulations Implications for Market Entry
USA Approved for ophthalmic Post-marketing safety warnings Focus on preservative-free formulations
EU Approved with warnings Stringent safety monitoring Emphasis on targeted indications
India Widely approved for ocular use Less restrictive High growth potential due to expanding healthcare infrastructure

Comparison with Competitors

Parameter Gatifloxacin Levofloxacin Moxifloxacin Besifloxacin
Spectrum Broad Broad Broad Broad
Formulation Ophthalmic (0.3-0.5%) Ophthalmic, systemic Ophthalmic Ophthalmic
Safety Profile Good topically, safety warnings systemic Good Good Good
Resistance Emerging concern Potential concern Lower resistance Lower resistance

Key Takeaways

  • Gatifloxacin remains commercially viable mainly in topical ophthalmic formulations, with a stable market in developed regions.
  • Safety concerns regarding systemic use led to market withdrawal but spurred regulatory caution for topical applications.
  • Market growth is driven by increasing bacterial infections and resistance, with opportunities in resistant strains and pediatric formulations.
  • Formulation innovations, including preservative-free and combination products, could enhance penetration.
  • Regulatory policies emphasize safety monitoring, requiring ongoing pharmacovigilance for expanded uses.

FAQs

1. What are the main indications for Gatifloxacin?
Primarily used for bacterial conjunctivitis and other surface ocular infections, approved in various markets with specific safety warnings.

2. Has Gatifloxacin been withdrawn from systemic use?
Yes. Due to safety concerns including dysglycemia, systemic formulations have been discontinued in most markets, retaining only topical ophthalmic approvals.

3. How does Gatifloxacin compare with other fluoroquinolones?
It offers broad-spectrum activity comparable to Levofloxacin and Moxifloxacin, with similar safety profiles topically but differs in formulation preferences and resistance patterns.

4. What are the opportunities for Gatifloxacin in upcoming markets?
Key opportunities exist in resistant bacterial infections, pediatric ophthalmology, and innovative delivery systems, especially in emerging markets with expanding healthcare access.

5. What regulatory challenges does Gatifloxacin face?
Mainly safety warnings related to systemic use pose hurdles. Topical formulations face rigorous post-market surveillance to monitor adverse events.


References

[1] U.S. Food and Drug Administration (FDA). Gatifloxacin Approval History. 2002-2018.
[2] Novartis. Gatifloxacin ophthalmic data sheet and approval documents. 2020.
[3] Market Research Future. Global Ophthalmic Antibiotics Market Report. 2022.
[4] European Medicines Agency (EMA). Safety updates on fluoroquinolones. 2021.
[5] GlobalData. Antibiotics Market Size and Forecast, 2023-2032.


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