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NCT00335231 ↗	Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery	Withdrawn	Queen's University	N/A	2006-06-01	Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of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.

Clinical Trial Conditions for Gatifloxacin

Condition Name

Condition Name for Gatifloxacin
Intervention	Trials
Bacterial Conjunctivitis	5
Cataract	3
Tuberculosis	2
Tuberculosis, Multidrug-Resistant	1

Condition MeSH

Condition MeSH for Gatifloxacin
Intervention	Trials
Cataract	7
Conjunctivitis, Bacterial	6
Conjunctivitis	6
Infections	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
South Carolina	1
Kentucky	1
Tennessee	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

Gatifloxacin: Clinical Trials, Market Analysis, and Projections

Introduction to Gatifloxacin

Gatifloxacin is a fourth-generation fluoroquinolone antibiotic, widely used in the treatment of various bacterial infections. It is known for its broad-spectrum activity and is utilized in several therapeutic areas, including ophthalmology, respiratory infections, and urinary tract infections.

Clinical Trials Update

Treatment of Enteric Fever

A significant clinical trial compared gatifloxacin with ceftriaxone in the treatment of enteric fever. This open-label, randomized, controlled trial conducted in Nepal involved patients aged 2-45 years with suspected enteric fever. Patients were randomly assigned to receive either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day) for 7 days.

• The trial revealed that while gatifloxacin showed rapid fever clearance and low relapse burden, it was outperformed by ceftriaxone in culture-confirmed cases. Specifically, 16% of patients treated with gatifloxacin had treatment failure compared to 7% of those treated with ceftriaxone in culture-positive patients[1].
• However, in patients with negative blood cultures, gatifloxacin performed better, with only 3% treatment failure compared to 23% for ceftriaxone[1].

Treatment of Bacterial Conjunctivitis

Another clinical trial focused on the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. This 7-day study involved subjects from birth to 31 days of age and aimed to evaluate the efficacy of gatifloxacin in this age group.

• The study highlighted the potential of gatifloxacin in treating bacterial conjunctivitis, especially in pediatric patients, though detailed outcomes were not specified in the available data[4].

Market Analysis

Current Market Size and Growth

The gatifloxacin market is projected to grow significantly over the next few years. As of 2023, the market size was estimated at USD 315.49 million and is expected to reach USD 331.32 million in 2024. By 2030, the market is forecasted to grow to USD 440.46 million at a Compound Annual Growth Rate (CAGR) of 4.88%[2].

Therapeutic Areas and End Users

Gatifloxacin is used across various therapeutic areas, including ophthalmology, respiratory infections, and urinary tract infections. The major end-use segments include hospitals, clinics, and outpatient care centers. The rising incidence of infectious diseases and growing awareness of antimicrobial resistance are key drivers of market growth[2].

Regional Analysis

The market for gatifloxacin is global, with significant opportunities in emerging markets in Asia-Pacific and Latin America. Companies are advised to form strategic alliances with local pharmaceutical distributors and healthcare providers to capitalize on these opportunities[2].

Competitive Landscape

The global gatifloxacin market involves several key players, including KYORIN PHARMACEUTICAL CO LTD, DR REDDYS LABORATORIES LTD, MYLAN LABORATORIES LTD, and others. These companies are focusing on innovations such as sustained-release formulations and combination therapies to combat antibiotic resistance[5].

Market Projections

Forecasted Market Size

By 2030, the global gatifloxacin market is projected to reach USD 440.46 million, driven by the increasing demand for effective antibiotic therapies and advancements in drug formulation technology[2].

Growth Drivers

• Increasing Prevalence of Infectious Diseases: The rising incidence of bacterial infections is a major driver of the gatifloxacin market.
• Growing Awareness of Antimicrobial Resistance: The need for newer antibiotics due to the growing threat of antibiotic resistance is another significant factor.
• Advancements in Drug Formulation: Innovations in drug delivery systems, such as sustained-release formulations, are expected to enhance the safety and efficacy profiles of gatifloxacin[2].

Challenges and Limitations

• Stringent Regulatory Requirements: Regulatory hurdles can restrict market growth.
• Adverse Effects: Risks such as tendonitis and peripheral neuropathy associated with gatifloxacin use pose challenges for market adoption.
• Antibiotic Resistance: The emergence of fluoroquinolone-resistant strains, as seen in the treatment of enteric fever, is a significant concern[2].

Future Opportunities

Expansion into Emerging Markets

Companies can capitalize on the growing demand for effective antibiotic therapies in Asia-Pacific and Latin America by forming strategic alliances with local distributors and healthcare providers[2].

Research and Development

Collaborative research and development with institutions focusing on antibiotic resistance could yield promising innovations, such as combination therapies that use gatifloxacin alongside other antimicrobial agents[2].

Innovative Drug Delivery Systems

Innovations in drug delivery systems, such as sustained-release formulations, could enhance the safety and efficacy profiles of gatifloxacin, addressing some of the current limitations[2].

Key Takeaways

• Gatifloxacin is a fourth-generation fluoroquinolone antibiotic with broad-spectrum activity.
• Clinical trials have shown mixed results, with gatifloxacin performing well in some cases but being outperformed by ceftriaxone in others.
• The market for gatifloxacin is projected to grow to USD 440.46 million by 2030 at a CAGR of 4.88%.
• Key drivers include the increasing prevalence of infectious diseases and advancements in drug formulation technology.
• Challenges include stringent regulatory requirements, adverse effects, and the growing threat of antibiotic resistance.

FAQs

What is Gatifloxacin used for?

Gatifloxacin is used to treat various bacterial infections, including conjunctivitis, pneumonia, and urinary tract infections.

How does Gatifloxacin compare to Ceftriaxone in treating enteric fever?

In a clinical trial, ceftriaxone outperformed gatifloxacin in culture-confirmed cases of enteric fever, but gatifloxacin performed better in patients with negative blood cultures[1].

What are the major end-use segments for Gatifloxacin?

The major end-use segments include hospitals, clinics, and outpatient care centers[2].

What are the growth drivers for the Gatifloxacin market?

Key drivers include the increasing prevalence of infectious diseases, growing awareness of antimicrobial resistance, and advancements in drug formulation technology[2].

What are the challenges facing the Gatifloxacin market?

Challenges include stringent regulatory requirements, adverse effects associated with gatifloxacin, and the growing threat of antibiotic resistance[2].

Sources

1. The Lancet: "Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in children and adults: a randomised controlled trial"[1].
2. 360iResearch: "Gatifloxacin Market Size & Share 2025-2030"[2].
3. BioSpace: "Bacterial Conjunctivitis Market Size to Reach USD 4.3 Billion by 2034"[3].
4. ClinicalTrials.gov: "A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis"[4].
5. QYResearch: "Global Gatifloxacin API Market Insights, Forecast to 2030"[5].

Last updated: 2025-01-06