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Fluoroquinolone
Fluoroquinolone is a Small molecule drug developed by Haiphong University of Medicine and Pharmacy. It is currently in Phase 2 development. Also known as: ciprofloxacin, levofloxacin, and moxifloxacin, OFLOCIN.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Fluoroquinolone |
|---|---|
| Also known as | ciprofloxacin, levofloxacin, and moxifloxacin, OFLOCIN |
| Sponsor | Haiphong University of Medicine and Pharmacy |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot (PHASE4)
- Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (PHASE2, PHASE3)
- APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) (PHASE2)
- Shortened Regimen for Drug-susceptible TB in Children (PHASE3)
- CARNIVAL Study: Gut Flora Dependent Metabolism of Dietary CARNItine and Phosphatidylcholine and cardioVAscuLar Disease (EARLY_PHASE1)
- Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia (PHASE4)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Study to Evaluate the Effect of BMS-986278 on Cardiac Repolarization in Healthy Participants (PHASE1)
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:
- Fluoroquinolone CI brief — competitive landscape report
- Fluoroquinolone updates RSS · CI watch RSS
- Haiphong University of Medicine and Pharmacy portfolio CI
Frequently asked questions about Fluoroquinolone
What is Fluoroquinolone?
Who makes Fluoroquinolone?
Is Fluoroquinolone also known as anything else?
What development phase is Fluoroquinolone in?
Related
- Manufacturer: Haiphong University of Medicine and Pharmacy — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: ciprofloxacin, levofloxacin, and moxifloxacin, OFLOCIN
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing