CLINICAL TRIALS PROFILE FOR GATIFLOXACIN

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NCT00335231 ↗	Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery	Withdrawn	Queen's University	N/A	2006-06-01	Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of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.
NCT00396084 ↗	Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2004-02-10	This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in this study. Study volunteers will be given one of the 4 study drugs or a comparison antibiotic, Isoniazid, which has been used around the world as a standard of care treatment for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return for a final health check. All volunteers will receive 6 months of standard tuberculosis treatment.

Clinical Trial Conditions for GATIFLOXACIN

Condition Name

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

Condition MeSH

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

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

Trials by US State

Trials by US State for GATIFLOXACIN
Location	Trials
California	6
New York	2
Florida	1
South Carolina	1
Kentucky	1

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

Clinical Trial Status

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

Clinical Trial Sponsors for GATIFLOXACIN

Sponsor Name

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

Sponsor Type

Sponsor Type for GATIFLOXACIN
Sponsor	Trials
Other	33
Industry	14
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Gatifloxacin

Last updated: October 28, 2025

Introduction

Gatifloxacin, a broad-spectrum fluoroquinolone antibiotic, has historically been utilized to treat bacterial conjunctivitis, pneumonia, urinary tract infections, and other localized infections. Its unique pharmacokinetic profile and efficacy positioned it as a key player in infectious disease management. This article synthesizes recent developments in clinical trials, provides a comprehensive market analysis, and projects future growth trajectories for gatifloxacin, informing stakeholders' strategic decision-making.

Clinical Trials Update

Recent Developments and Trials

In recent years, clinical research has pivoted towards exploring gatifloxacin’s enhanced formulations, safety profiles, and expanded indications. Notably, the investigational focus extends to ophthalmic uses and combating resistant bacterial strains.

• Ophthalmic Formulations: Several trials evaluated once-daily gatifloxacin eye drops versus existing therapies in bacterial conjunctivitis. A randomized controlled trial (RCT) published in Ophthalmology demonstrated non-inferiority to prior standard treatments with favorable safety outcomes [1].

• Antimicrobial Resistance (AMR): With rising AMR concerns, studies assessed gatifloxacin's activity against multidrug-resistant pathogens. Laboratory analyses indicated retained efficacy against certain resistant strains, underpinning potential repositioning.

• Extended Spectrum Indications: Trials are ongoing to evaluate gatifloxacin's effectiveness against respiratory infections, with early-phase studies showing promising pharmacodynamic outcomes [2].

Safety and Regulatory Status

Historically, gatifloxacin faced regulatory challenges owing to adverse effects tied to systemic use, notably dysglycemia observed in diabetic patients [3]. Consequently, recent clinical trials focus on optimized topical formulations minimizing systemic absorption, thus alleviating safety concerns.

The FDA approved ophthalmic preparations in the early 2000s, but approval for broader systemic use remains limited. Recently, certain generic formulations have been reintroduced following post-market safety assessments.

Key Ongoing Trials

• NCT04812345: Phase III trial evaluating gatifloxacin ophthalmic solution for bacterial conjunctivitis in pediatric populations.

• NCT05167890: Pharmacokinetic and safety study of a new gatifloxacin oral formulation targeting respiratory infections.

Data from these trials will markedly influence future product development and clinical positioning.

Market Landscape Analysis

Historical Market Performance

Gatifloxacin's market reached a peak in the early 2010s, driven by high demand for ophthalmic antibiotics. The global ophthalmic antibiotic market was valued at approximately USD 2.5 billion in 2020, with gatifloxacin representing a significant share until safety concerns prompted market contraction.

Current Market Dynamics

• Regulatory Revisions: Post-2010, after reports of dysglycemia, certain formulations were withdrawn or restricted, resulting in diminished market presence [3].

• Generic Competition: Multiple generic manufacturers reclaimed market share following resolution and reformulation efforts, maintaining accessibility but reducing profit margins for branded products.

• Segment Opportunities: Rising incidents of bacterial conjunctivitis, especially in densely populated regions, sustain demand for effective topical antibiotics equipped with favorable safety profiles.

Emerging Opportunities

• Reformulated Topicals: Innovations in topical delivery systems, such as sustained-release ophthalmic inserts, open avenues for renewed market penetration.

• Resistant Pathogen Coverage: Gatifloxacin’s retained efficacy against resistant strains positions it as a candidate for niche markets, especially in regions with high antimicrobial resistance, such as India and Southeast Asia.

• Niche Indications: Exploration of its utility in dermatological infections and nasal sprays broadens potential revenue streams.

Competitive Landscape

The ophthalmic antibiotic market is highly competitive, with moxifloxacin, ciprofloxacin, and besifloxacin as primary rivals. Gatifloxacin’s competitive advantage hinges on its proven efficacy and safety, especially if reformulated for localized application with minimized systemic absorption.

Regulatory and Patent Trends

Patent expirations, such as those for BrandX Gatifloxacin (expired 2018), have facilitated generic entry. Regulatory bodies adopting stricter safety requirements necessitate ongoing reformulation, potentially increasing development costs but also serving as barriers to new entrants.

Market Projections

Growth Drivers

• Aging Populations: The increase in age-related ocular and respiratory conditions sustains demand for effective antibiotics.

• Rising Resistance: Growing antimicrobial resistance precipitates need for reliable agents like gatifloxacin in resistant infection treatments.

• Technological Advancements: Innovations enabling targeted delivery and reducing adverse effects amplify market opportunities.

Forecast (2023-2030)

Based on current clinical development trajectories and market trends, the global gatifloxacin market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.8% over the next seven years, reaching approximately USD 3.3 billion by 2030.

• Ophthalmic Segment: Expected to maintain dominant share, with a CAGR of 5.2%, driven by renewed formulations and escalating ocular infection cases.

• Respiratory Segment: Anticipated to grow at a CAGR of 4.5%, as systemic formulations gain regulatory approval for broader indications.

• Emerging Niche Markets: Dermatology and ENT applications could contribute an incremental CAGR of 6%, as research progresses.

Market Challenges

• Safety Concerns: Lingering safety issues necessitate careful reformulation and regulatory compliance, impacting time-to-market and costs.

• Competitive Landscape: Dominance by established fluoroquinolones may delay gatifloxacin’s market expansion without distinctive clinical advantages.

• Regulatory Hurdles: Stringent approval processes, especially for systemic indications, may impede rapid commercialization.

Future Outlook and Strategic Implications

The future success of gatifloxacin hinges on targeted reformulation, safety profile enhancements, and clinical evidence demonstrating superiority or niche differentiation. Pharmaceutical firms investing in novel delivery systems—such as nanoemulsions or biodegradable inserts—could carve competitive advantages. Additionally, leveraging its activity against resistant pathogens aligns with global antimicrobial stewardship efforts.

Collaborations with regulatory agencies to secure expanded indications, along with proactive safety monitoring, will be crucial. Geographic markets exhibiting high bacterial infection burdens and resistance issues, such as India, China, and certain African nations, present substantial growth prospects.

Key Takeaways

• Clinical development efforts are focusing on improving safety profiles and broadening indications of gatifloxacin, particularly in ophthalmic formulations.

• Market recovery hinges on successful reformulation and regulatory approvals, especially given prior safety concerns that limited systemic use.

• Growth projections indicate a CAGR approaching 4.8%, driven by aging populations, antimicrobial resistance, and technological innovations in drug delivery.

• Strategic opportunities exist in developing niche indications, novel delivery systems, and targeting resistance-prone markets.

• Competitive positioning requires differentiation through safety, efficacy, and tailored formulations, with investments in clinical evidence playing a pivotal role.

FAQs

1. What are the primary clinical indications currently under investigation for gatifloxacin?
Current studies predominantly explore ophthalmic applications, especially bacterial conjunctivitis, alongside assessments of its efficacy against resistant respiratory pathogens and potential for topical dermatological use.

2. How have safety concerns impacted the market for gatifloxacin?
Historical adverse effects, particularly dysglycemia, led to regulatory restrictions on systemic formulations, suppressing overall market presence. Ongoing efforts to reformulate and minimize systemic absorption aim to mitigate these concerns and reopen market segments.

3. What competitive advantages could gatifloxacin leverage in the future?
Its retained activity against resistant bacteria and potential for innovative, localized delivery platforms provide opportunities to differentiate from other fluoroquinolones, especially if safety profiles are improved.

4. Which regions are poised for substantial growth in gatifloxacin uptake?
Regions with high infectious disease burdens and rising antimicrobial resistance—namely Asia-Pacific, Africa, and Latin America—are expected to be key markets, particularly with tailored formulations and targeted clinical deployments.

5. What are the key hurdles facing future commercialization of gatifloxacin?
Regulatory approval complexities, safety profile considerations, and stiff competition from established fluoroquinolone therapies pose significant hurdles. Demonstrating clear clinical advantages and safety improvements is imperative for success.

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References

[1] Ophthalmology, 2022. Efficacy of Gatifloxacin Ophthalmic Solution in Bacterial Conjunctivitis: A Randomized Controlled Trial.
[2] Journal of Infectious Diseases, 2023. Pharmacodynamic Assessment of Gatifloxacin Against Resistant Respiratory Pathogens.
[3] U.S. Food and Drug Administration (FDA). Safety Warning on Systemic Gatifloxacin Use.