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NCT00335231 ↗	Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery	Withdrawn	Queen's University	N/A	2006-06-01	Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of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
Hypoglycemia	1

Condition MeSH

Condition MeSH for Gatifloxacin
Intervention	Trials
Cataract	7
Conjunctivitis, Bacterial	6
Conjunctivitis	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
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 Market Analysis and Financial Projection

Last updated: April 28, 2026

Gatifloxacin: Clinical Trials Update and Market Analysis With Forward Projections

Gatifloxacin is a fluoroquinolone antibiotic with active clinical programs historically centered on ophthalmology and select anti-infective formulations. Commercially, the molecule’s global market is mature and down-cycle in most regions due to stewardship-driven restriction, competitive class dynamics, and safety-driven preference shifts within fluoroquinolones. Pricing and demand remain formulation- and indication-dependent, with ophthalmic products typically carrying more stable pull than systemic use in many markets.

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What is the current clinical-trials landscape for gatifloxacin?

How the trial base is structured

Publicly disclosed gatifloxacin development is not dominated by large Phase 3 registration programs in recent years. Instead, trial activity concentrates in:

• Ophthalmic indications (clinical studies tied to bacterial conjunctivitis and post-procedural prophylaxis)
• Formulation and dosing refinements (bioequivalence, pharmacokinetic/pharmacodynamic bridging, and study endpoints aligned to regulator frameworks)

The practical read-through for portfolio planning is that late-stage, label-expanding programs are limited, while lifecycle work and indication-specific studies still appear where local regulator or payer systems require new evidence.

Typical endpoints and regulatory framing

Where trials appear, they tend to use:

• Microbiological eradication and/or clinical cure endpoints
• Time-to-resolution of signs and symptoms (for ocular surface infections)
• Safety monitoring for class effects (e.g., neurologic and glucose-related risk signals)

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What is the market size profile for gatifloxacin today?

Market maturity

Gatifloxacin’s market position is mature. In many geographies, systemic fluoroquinolone demand has stabilized or declined relative to peak years due to:

• Stewardship restrictions (restriction of fluoroquinolones for non-severe infections in multiple markets)
• Safety preference shifts within class (regulators and formularies reduced use where signals were judged higher)
• Competition from other fluoroquinolones with stronger contemporary guideline alignment in some settings

Where demand persists

Demand persists most consistently in:

• Ophthalmic antibacterials, where local bacterial coverage and established clinical practice maintain utilization
• Hospital formularies for specific procedural or infection scenarios, typically where branded formulations have entrenched usage

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What is the commercial outlook: 3- to 5-year projection?

Base-case market trajectory

Given the molecule’s mature status and the lack of widespread new Phase 3 label expansion activity, the most actionable projection is:

• Low single-digit global volume growth where ophthalmic use continues and generics remain stable
• Flat to low declining revenue growth if pricing pressure and formulary substitution persist

A practical projection range for global revenue (not individual country share) is:

• Near-term (0 to 2 years): flat to modest decline
• Mid-term (2 to 5 years): low growth in volume, offset by net price pressure

Key drivers that swing the numbers

The projection is most sensitive to four variables:

1. Ophthalmic penetration and SKU mix (single- vs multi-dose, preservative systems, and manufacturer share)
2. Formulary position in key procurement systems (especially hospital and managed-care formularies)
3. Generic competition and pricing resets in major markets
4. Any new safety or guideline signal specific to gatifloxacin products

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Competitive dynamics: why gatifloxacin performs as a mature class player

Class substitution risk

Within fluoroquinolones, prescribers and institutions substitute based on:

• perceived safety profile
• local guideline endorsements
• availability and price

That substitution risk typically limits upside unless gatifloxacin retains a protected niche (often tied to formulation availability or established clinical practice).

Ophthalmic vs systemic split

• Ophthalmic: more durable demand due to localized treatment patterns and procedural prophylaxis protocols.
• Systemic: greater demand volatility due to stewardship and guideline shifts.

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Clinical pipeline implication for business decisions

What an investor or pharma planner should infer

With limited late-stage expansions apparent in public disclosures, the most likely commercial strategy patterns are:

• Lifecycle stewardship of existing ophthalmic assets
• Geographic relaunches through local licensing and distribution where formulations still hold market access
• Quality and regulatory maintenance to preserve tender eligibility and formulary status

What is unlikely

• Large step-change label growth driven by new Phase 3 programs
• Material market share gains against class incumbents unless access and pricing align to displace entrenched competitors

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Scenario framework for projections (revenue impact logic)

Base case

• Ophthalmic volume holds; pricing remains pressured
• Revenue tracks near-flat to modestly negative over a 3- to 5-year window

Bull case

• Ophthalmic share gains via procurement and improved SKU availability
• Pricing stabilizes in priority markets
• Revenue shows low-to-mid single-digit growth on a sustained basis

Bear case

• Further formulary restriction, stronger substitution, or accelerated price erosion in generics
• Revenue declines in line with class contraction or tender resets

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Key Takeaways

• Gatifloxacin is a mature fluoroquinolone with most active emphasis historically in ophthalmic antibacterial use rather than new broad systemic label expansion.
• Clinical trial activity is best characterized as lifecycle and indication-specific work rather than dominant late-stage registration programs.
• Market outlook points to flat-to-modest revenue erosion with low volume growth potential, primarily supported by ophthalmic persistence and constrained by stewardship and class competition.
• The most material swings in projection come from ophthalmic SKU mix, formulary/tender position, and generic pricing pressure.

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FAQs

1. Is gatifloxacin currently in major Phase 3 registration trials for new indications?
   Development activity is not dominated by large-scale late-stage label-expanding Phase 3 programs; emphasis tends toward ophthalmic and lifecycle studies.

2. Which segment drives gatifloxacin’s most stable demand?
   Ophthalmic antibacterial use typically provides more stable utilization than systemic use in mature markets.

3. How do fluoroquinolone stewardship policies affect gatifloxacin projections?
   Stewardship restrictions reduce systemic use and limit upside unless ophthalmic demand offsets broader class softness.

4. What is the main economic risk for gatifloxacin revenue?
   Generic competition and tender-driven pricing erosion compress revenue even when volume holds.

5. What would most likely change the outlook materially?
   A meaningful label expansion supported by late-stage data, or a reversal of formulary restriction that increases institutional preference.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Search results for gatifloxacin (accessed 2026-04-28). https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Drug Safety Communications and labeling for fluoroquinolones and gatifloxacin-containing products (accessed 2026-04-28). https://www.fda.gov/