Last Updated: April 29, 2026

CLINICAL TRIALS PROFILE FOR ENOXACIN


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All Clinical Trials for ENOXACIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated James Graham Brown Cancer Center Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ENOXACIN

Condition Name

Condition Name for ENOXACIN
Intervention Trials
Disorder Related to Lung Transplantation 1
Dyslipidemias 1
Fibrotic Pulmonary Sequelae Post-COVID19 Infection 1
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Condition MeSH

Condition MeSH for ENOXACIN
Intervention Trials
Atrial Fibrillation 2
Sclerosis 1
Bronchiolitis 1
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Clinical Trial Locations for ENOXACIN

Trials by Country

Trials by Country for ENOXACIN
Location Trials
United States 2
Spain 2
Germany 1
Sweden 1
Brazil 1
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Trials by US State

Trials by US State for ENOXACIN
Location Trials
Utah 1
Kentucky 1
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Clinical Trial Progress for ENOXACIN

Clinical Trial Phase

Clinical Trial Phase for ENOXACIN
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for ENOXACIN
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Terminated 1
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Clinical Trial Sponsors for ENOXACIN

Sponsor Name

Sponsor Name for ENOXACIN
Sponsor Trials
Laboratorios Grossman, S.A. 1
Institut d'Investigació Biomèdica de Bellvitge 1
Apotex Inc. 1
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Sponsor Type

Sponsor Type for ENOXACIN
Sponsor Trials
Other 12
Industry 2
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Clinical Trials Update and Market Outlook for Enoxacin

Last updated: April 27, 2026

What is enoxacin and what is its current development context?

Enoxacin is a fluoroquinolone antibiotic with historical approval in multiple jurisdictions. It has been used for bacterial infections and later faced declining commercial traction due to newer fluoroquinolones, safety scrutiny around the class, and changes in prescribing patterns. Publicly accessible clinical-trial activity for enoxacin is limited, with no broad evidence of late-stage (Phase 3) registrational programs in recent years.

Are there active clinical trials for enoxacin now?

No complete, current, verifiable set of active enoxacin clinical trials (by registry, phase, sponsor, start date, and status) can be produced from the information available in this workspace. The clinical trial landscape for enoxacin is not reliably reconstructible here to an actionable “update” standard.

What is the regulatory pathway status implied by recent activity?

Without a verifiable set of contemporary trials and regulatory milestones, a clean pathway assessment (for example, whether enoxacin is pursuing a new indication, a reformulation, or a line-extension) cannot be stated to the level required for high-stakes planning.

Market analysis: demand drivers, competitive set, and pricing dynamics

Demand drivers

Enoxacin demand is constrained by three structural factors:

  • Class-level prescribing shifts: fluoroquinolone use has faced tightening guidelines and payer controls over time.
  • Resistance and stewardship: bacterial resistance patterns and stewardship policies reduce empiric use.
  • Competitive incumbency: established branded and generic competitors compress margin and slow incentives for new investment in older fluoroquinolones.

Therapeutic adjacency and competitive set

Enoxacin competes within the fluoroquinolone class against agents with stronger contemporary penetration and guideline support (examples in-market by geography include ciprofloxacin and levofloxacin, plus other later entrants depending on country). In antibiotics, market share is driven by:

  • guideline placement (empiric vs culture-directed),
  • local formulary status,
  • and price erosion in generics.

Pricing and commercialization profile

Enoxacin’s commercial economics typically align with an older antibiotic pattern:

  • low pricing power,
  • high substitution risk to same-class alternatives,
  • reliance on generics and narrow use cases.

Market size and forecast

A quantified market forecast requires current sales baselines (e.g., IQVIA/DrugBank/GlobalData-like signals), geography-specific pricing, and current patient share. Those inputs are not available in this workspace to produce a complete and accurate market projection.

Investment and R&D decision implications

Where value would realistically come from

For an older, non-late-stage fluoroquinolone like enoxacin, value capture in R&D would typically depend on one of the following commercial levers:

  • new indication with clear differentiating evidence,
  • novel formulation to address tolerability or dosing,
  • or targeted use cases where resistance/susceptibility profiles support its re-entry.

Where the bottleneck usually is

  • lack of active, recent clinical evidence that supports a new label,
  • limited differentiation versus entrenched fluoroquinolone generics,
  • and regulatory and safety attention that raises development cost per incremental benefit.

Key Takeaways

  • Enoxacin’s current, public clinical-trial activity cannot be verified here to the standard needed for a true “clinical trials update.”
  • A quantified market projection cannot be produced without validated sales and trial baseline inputs.
  • Commercial viability for enoxacin would depend on evidence-led differentiation (new indication or formulation) that changes formulary placement and prescribing behavior.

FAQs

  1. Is enoxacin currently in Phase 3 trials?
    No verifiable Phase 3 status can be stated from the available data in this workspace.

  2. What makes enoxacin difficult to re-commercialize versus newer antibiotics?
    Fluoroquinolone stewardship tightening, strong generic competition, and limited prescribing pull.

  3. Could enoxacin still have a niche market?
    Niche use is plausible, but a measurable outlook cannot be produced here without validated sales and uptake metrics.

  4. What would a successful future pathway look like for enoxacin?
    A registrable new indication or reformulation supported by contemporary clinical evidence and formulary relevance.

  5. How fast would any new enoxacin entrant face price pressure?
    Typically quickly, because antibiotics in mature classes attract generic substitution once supply ramps.


References

[1] ClinicalTrials.gov. Enoxacin (search results and study records). https://clinicaltrials.gov/
[2] FDA (various). Drug approvals and labeling records for fluoroquinolones (search portal). https://www.accessdata.fda.gov/scripts/cder/daf/

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