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PRULIFLOXACIN
PRULIFLOXACIN is a prulifloxacin drug. It is currently in Phase 3 development for Acute exacerbation of chronic bronchitis, Lower urinary tract infectious disease.
Prulifloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication.
Prulifloxacin is a small molecule that inhibits bacterial DNA gyrase, a mechanism consistent with its classification as a third-generation fluoroquinolone. It has been studied for the treatment of various urinary tract infections, including urinary tract infection, acute lower urinary tract infection, and chronic bacterial prostatitis.
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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.
| 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 | PRULIFLOXACIN |
|---|---|
| Drug class | prulifloxacin |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's cells are like factories that make copies of themselves. Bacteria are like tiny factories that make copies of themselves too, but they can be bad for you. Prulifloxacin stops these bacterial factories from making copies of themselves by blocking the machines that help them replicate their DNA.
Approved indications
- Acute exacerbation of chronic bronchitis
- Lower urinary tract infectious disease
Common side effects
Key clinical trials
- Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD (PHASE4)
- Prulifloxacin in Chronic Bacterial Prostatitis (CBP) (PHASE2)
- A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control (PHASE3)
- Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea (PHASE3)
- A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control (PHASE3)
- Treatment of Chronic Bacterial Prostatitis (PHASE4)
- Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin) (PHASE2)
- Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers (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:
- PRULIFLOXACIN CI brief — competitive landscape report
- PRULIFLOXACIN updates RSS · CI watch RSS
Frequently asked questions about PRULIFLOXACIN
What is PRULIFLOXACIN?
How does PRULIFLOXACIN work?
What is PRULIFLOXACIN used for?
What drug class is PRULIFLOXACIN in?
What development phase is PRULIFLOXACIN in?
Related
- Drug class: All prulifloxacin drugs
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute exacerbation of chronic bronchitis
- Indication: Drugs for Lower urinary tract infectious disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing