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NCT00335231 ↗	Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery	Withdrawn	Queen's University	N/A	2006-06-01	Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of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, 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
India	2
Pakistan	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 update, market analysis and projected outlook (2026)

Last updated: July 28, 2026

Gatifloxacin remains a legacy fluoroquinolone approved in multiple markets historically, but it is not established as a commercially active, late-stage development program globally. Current “clinical trials update” is best framed as: (1) residual efficacy/safety evidence and pharmacovigilance follow-through from prior eras, (2) next-generation fluoroquinolone competition, and (3) limited likelihood of new pivotal trials for gatifloxacin specifically, absent a clear pathway to US market re-entry or a differentiated formulation/indication strategy. Market projections are therefore driven more by historical sales decay, regional availability, and competitive substitution than by new late-stage pipeline catalysts.

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What clinical trials exist for gatifloxacin, and what is the latest update?

Answer: No current, clearly identified gatifloxacin-led late-stage efficacy/safety trials drive a new regulatory label expansion. The clinical evidence base is predominantly from prior registrations and older comparative studies in acute bacterial infections, including ophthalmic and otic uses, and from safety work tied to fluoroquinolone class risks.

Which conditions were gatifloxacin studied for historically?

Common historical clinical-development themes for gatifloxacin include:

• Bacterial conjunctivitis/ocular infections (ophthalmic formulations)
• Otitis externa/media (otic formulations in some jurisdictions)
• Respiratory and skin/soft tissue infections (systemic formulations in historical approvals)
• Enteric and other bacterial infections where fluoroquinolones are used as alternatives

What safety signals shaped the clinical record?

Gatifloxacin’s clinical program is strongly associated with:

• Dysglycemia risk (both hyperglycemia and hypoglycemia) that affected risk-benefit framing in some regulators’ decisions for systemic use in the past.
• Class fluoroquinolone adverse-event considerations that remain part of modern prescribing context (tendinopathy, QT prolongation, CNS effects), though gatifloxacin’s dysglycemia emphasis is the standout differentiator in the historical narrative.

Does gatifloxacin have any active registrational trial activity now?

No late-stage registrational readouts are identifiable from the current clinical-trials landscape in a way that would materially change expected market dynamics for gatifloxacin specifically. Any ongoing studies tend to be:

• Pharmacovigilance-oriented
• Post-marketing observational work
• Non-pivotal comparative or local clinical studies with limited global impact

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What is the Orange Book status of gatifloxacin in the US, and can generics launch?

Answer: Gatifloxacin is an older, legacy small-molecule antibiotic. US exclusivity would have largely run out for original formulations by now. The practical US question is not “what exclusivities exist today,” but “whether any listed patents still control any specific approved formulation strength, dosage form, or reference product,” and whether those products remain market-authorized.

How to think about US patent control for a legacy antibiotic

For older fluoroquinolones, modern generic risk often hinges on:

• Whether there is a currently marketed FDA-approved reference listed drug (RLD) still active for a given dosage form.
• Whether there are remaining Orange Book listings tied to that RLD for formulation, polymorph, manufacturing, or method-of-use claims.

If the product is not actively marketed or the listings have expired, the generic pathway becomes low-friction and entry is typically limited by supply chain economics rather than patent law.

Practical implication for projection

Even without active late-stage trials, pricing and access still matter. For a legacy molecule, the dominant market forces are:

• Generic availability and substitution
• Provider familiarity
• Regional reimbursement and formulary positioning
• Scarcity premium when supply is constrained

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What patents protect gatifloxacin, and how strong is the patent estate today?

Answer: The patent estate for gatifloxacin-era formulations and methods largely matured long ago, so current “strength” is usually low for any remaining assets, unless specific, newer reformulations exist in a given jurisdiction.

What patent types were historically relevant?

For fluoroquinolone antibiotics, patent families typically include:

• Chemical composition / active ingredient
• Crystalline form and polymorph
• Formulation (solubility, excipients, viscosity, ocular penetration enhancers)
• Manufacturing processes
• Use claims (indications, dosing regimens, therapeutic protocols)

How does this affect licensing and litigation risk?

When patent coverage is expired or narrow, the pathway shifts from “litigation as gatekeeping” to “commercial gating”:

• Ability to source API economically
• Stability, sterility, and manufacturing compliance for ocular/otic products
• Meeting label-specific bioequivalence requirements for generics

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When does gatifloxacin lose exclusivity, and what does that mean for generics?

Answer: Any original gatifloxacin exclusivity and associated brand exclusivity from early approvals have largely elapsed. For projection purposes, generic launch risk is more about whether the product remains FDA/EMA-authorized in a way that supports market access.

Generic entry scenarios that historically play out for legacy fluoroquinolones

• No remaining patent barriers: generics enter quickly once manufacturing capacity exists.
• Supply-side bottlenecks: fewer competitors can preserve higher pricing briefly.
• Formulary inertia: clinicians may shift to alternative fluoroquinolones with stronger local availability.

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How does gatifloxacin compare with newer fluoroquinolones on efficacy and safety, and who wins prescribing?

Answer: Newer or better-positioned fluoroquinolones and competitive antibiotic classes have largely captured the mainstream share where fluoroquinolone therapy is used, while gatifloxacin faces legacy safety framing and substitution effects.

What drives switching away from gatifloxacin?

• Dysglycemia history influenced risk-benefit perception for systemic use.
• Broader prescriber adoption of other fluoroquinolones with more favorable local guidance or simpler risk framing.
• Antibiotic stewardship trends that shift use toward narrower agents based on resistance patterns and guideline updates.

Who are typical competitors in the same treatment settings?

Common competitive substitutes in bacterial infection categories include:

• Other fluoroquinolones (systemic)
• Beta-lactams and other broad-spectrum agents depending on indication
• Ophthalmic/otic alternatives for eye and ear infections

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What formulations are protected by patents for gatifloxacin (ophthalmic, otic, systemic)?

Answer: For projection, formulation-specific IP matters only if a particular dosage form remains tightly controlled by current listings. Historically, ocular and otic formulations have meaningful formulation-science IP, but that coverage typically matures quickly.

Formulation-specific considerations

• Ophthalmic: sterility assurance, corneal penetration, preservative systems
• Otic: stability in ear-use conditions, viscosity, drop formulation uniformity
• Systemic: solid-state, dissolution, and manufacturability constraints for generics

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What patent litigation affects gatifloxacin, and are there active settlements?

Answer: There is no clearly identifiable, ongoing, high-impact gatifloxacin-specific patent litigation that would change generic timing in the near term.

Why litigation is usually muted for legacy antibiotics

• Patent term expiry
• Fewer remaining enforceable claims
• Lower RLD commercial value compared with newer specialty drugs

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What is the biosimilar risk for gatifloxacin?

Answer: None. Gatifloxacin is a small-molecule antibiotic, not a biologic.

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What regulatory pathway governs gatifloxacin generics and reformulations?

Answer: Generic entry for legacy small molecules typically uses standard abbreviated pathways (e.g., ANDA in the US), with formulation-specific bioequivalence considerations and CMC compliance.

What regulators typically care about now

• Stability and shelf-life under real-world storage conditions
• Bioequivalence for systemic forms
• Sterility and preservative system justification for ophthalmic products
• Local tolerance data if formulation changes are material

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Market analysis: current demand drivers and constraints for gatifloxacin

Answer: The market is dominated by legacy uptake and generic substitution rather than new demand from new indications or new evidence.

Key demand drivers

• Established use patterns where fluoroquinolones are standard of care
• Hospital and clinic formulary persistence in some regions
• Availability and pricing of generics

Key constraints

• Prescriber risk perception tied to prior dysglycemia concerns for systemic use
• Competitive pressure from other antibiotics with stronger guideline positioning
• Supply availability and regulatory status changes by country

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Revenue and volume projection for gatifloxacin (2026-2030)

Answer: Expect continued decline or flat-to-low single-digit value growth at best, driven by:

• continued generic availability and price compression
• lack of new label expansion catalysts
• potential regional product discontinuations

Projection framework (directional)

• Base case (most likely): declining sales volume with stabilized revenue in low-growth markets due to generics.
• Downside case: continued substitutions and supply interruptions compress revenue further.
• Upside case: narrow resurgence if a specific dosage form remains essential in particular regional formularies, but that requires availability and competitive pricing rather than new clinical adoption.

What to watch for in 2026-2030

• Country-level regulatory status (renewals, discontinuations, withdrawals)
• Generic supply additions or exits
• Formulary changes at major institutions

(No quantified global revenue dataset is provided here because the request is for “hard data and actionable insights,” and the necessary market/sales figures and licensing/regulatory statuses are not supplied in the input context.)

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Geographic outlook: where gatifloxacin is most likely to persist

Answer: Persistence is most plausible in markets where legacy fluoroquinolone generics remain embedded in formularies and where regulatory renewals keep approved products on shelves.

How to map risk by geography

• Higher risk: regions with aggressive antimicrobial stewardship and switch to narrower agents
• Lower risk: regions with robust generic supply continuity and entrenched clinical workflows

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Key takeaways

• Clinical trials: gatifloxacin does not present an identifiable, active late-stage registrational development story; the evidence base is historical.
• Exclusivity and generics: original exclusivity has largely elapsed; remaining barriers, if any, are formulation/product-specific and typically narrow.
• Market: outlook depends on generic availability and regional regulatory status more than on new efficacy or safety milestones.
• Competitive dynamics: substitution by other fluoroquinolones and alternative antibiotic classes is the dominant force shaping demand.

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FAQs

1. Why is gatifloxacin less favored compared with other fluoroquinolones?
2. What manufacturing or CMC factors matter most for generic gatifloxacin ocular/otic products?
3. How do dysglycemia-related risk perceptions affect formulary placement for systemic gatifloxacin?
4. What would trigger a resurgence in gatifloxacin use (new indication, new formulation, or guideline change)?
5. Which markets are most sensitive to antibiotic stewardship in fluoroquinolone prescribing?

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References

No sources were provided in the prompt for clinical-trial listings, Orange Book entries, patent filings, litigation dockets, or sales datasets, so no citations can be generated without introducing uncited external claims.