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Ofloxacine

Assistance Publique - Hôpitaux de Paris · Phase 3 active Small molecule Under review

Ofloxacine is a Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Abdominal abscess, Acute Moraxella catarrhalis bronchitis, Acute bacterial bronchitis.

Ofloxacine is a small molecule that inhibits bacterial DNA gyrase, a mechanism that is consistent with its classification as an inhibitor. It has been studied in clinical trials for various conditions, including glaucoma, cataract, renal diseases, urolithiasis, and as an antibiotic.

Likelihood of approval
60.3% 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.
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 nameOfloxacine
SponsorAssistance Publique - Hôpitaux de Paris
TargetGamma-aminobutyric acid receptor subunit alpha-2, Histamine H3 receptor, Muscarinic acetylcholine receptor M1
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 3

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Ofloxacine

What is Ofloxacine?

Ofloxacine is a Small molecule drug developed by Assistance Publique - Hôpitaux de Paris, indicated for Abdominal abscess, Acute Moraxella catarrhalis bronchitis, Acute bacterial bronchitis.

What is Ofloxacine used for?

Ofloxacine is indicated for Abdominal abscess, Acute Moraxella catarrhalis bronchitis, Acute bacterial bronchitis, Acute bacterial peritonitis, Acute bacterial sinusitis.

Who makes Ofloxacine?

Ofloxacine is developed by Assistance Publique - Hôpitaux de Paris (see full Assistance Publique - Hôpitaux de Paris pipeline at /company/assistance-publique-h-pitaux-de-paris).

What development phase is Ofloxacine in?

Ofloxacine is in Phase 3.

What does Ofloxacine target?

Ofloxacine targets Gamma-aminobutyric acid receptor subunit alpha-2, Histamine H3 receptor, Muscarinic acetylcholine receptor M1.

Related

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