Last reviewed 2026-04-23 · How we verify

nebulized levofloxacin

University of Rochester · Phase 3 active Small molecule

nebulized levofloxacin is a fluoroquinolone antibiotic Small molecule drug developed by University of Rochester. It is currently in Phase 3 development for Community-acquired pneumonia, Chronic bacterial prostatitis, Acute bacterial sinusitis.

Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial DNA replication and transcription.

Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial DNA replication and transcription. Used for Community-acquired pneumonia, Chronic bacterial prostatitis, Acute bacterial sinusitis.

Likelihood of approval

63.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
Big-pharma sponsor +3.0pp
University of Rochester is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	nebulized levofloxacin
Sponsor	University of Rochester
Drug class	fluoroquinolone antibiotic
Target	DNA gyrase and topoisomerase IV
Modality	Small molecule
Therapeutic area	Infectious diseases
Phase	Phase 3

Mechanism of action

This inhibition ultimately leads to the death of bacterial cells. Levofloxacin is a fluoroquinolone antibiotic that targets both Gram-positive and Gram-negative bacteria.

Approved indications

Community-acquired pneumonia
Chronic bacterial prostatitis
Acute bacterial sinusitis

Common side effects

Nausea
Headache
Diarrhea
Vomiting
Dizziness
Insomnia

Key clinical trials

Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

nebulized levofloxacin CI brief — competitive landscape report
nebulized levofloxacin updates RSS · CI watch RSS
University of Rochester portfolio CI

Frequently asked questions about nebulized levofloxacin

What is nebulized levofloxacin?

nebulized levofloxacin is a fluoroquinolone antibiotic drug developed by University of Rochester, indicated for Community-acquired pneumonia, Chronic bacterial prostatitis, Acute bacterial sinusitis.

How does nebulized levofloxacin work?

Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial DNA replication and transcription.

What is nebulized levofloxacin used for?

nebulized levofloxacin is indicated for Community-acquired pneumonia, Chronic bacterial prostatitis, Acute bacterial sinusitis.

Who makes nebulized levofloxacin?

nebulized levofloxacin is developed by University of Rochester (see full University of Rochester pipeline at /company/university-of-rochester).

What drug class is nebulized levofloxacin in?

nebulized levofloxacin belongs to the fluoroquinolone antibiotic class. See all fluoroquinolone antibiotic drugs at /class/fluoroquinolone-antibiotic.

What development phase is nebulized levofloxacin in?

nebulized levofloxacin is in Phase 3.

What are the side effects of nebulized levofloxacin?

Common side effects of nebulized levofloxacin include Nausea, Headache, Diarrhea, Vomiting, Dizziness, Insomnia.

What does nebulized levofloxacin target?

nebulized levofloxacin targets DNA gyrase and topoisomerase IV and is a fluoroquinolone antibiotic.

Drug class: All fluoroquinolone antibiotic drugs
Target: All drugs targeting DNA gyrase and topoisomerase IV
Manufacturer: University of Rochester — full pipeline
Therapeutic area: All drugs in Infectious diseases
Indication: Drugs for Community-acquired pneumonia
Indication: Drugs for Chronic bacterial prostatitis
Indication: Drugs for Acute bacterial sinusitis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing