Last reviewed 2026-04-20 · How we verify

CLINAFLOXACIN

Phase 2 active Small molecule Quality 27/100

CLINAFLOXACIN is a clinafloxacin drug. It is currently in Phase 2 development.

Clinafloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription.

Clinafloxacin is a small molecule antibiotic belonging to the fluoroquinolone class. It is currently owned by a pharmaceutical company, but its original developer is unknown. Clinafloxacin has not been approved by the FDA for any indications, and its commercial status is unclear. The drug has a half-life of 5.4 hours and a bioavailability of 90%. Further information on its development and approval status is needed.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).
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	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	CLINAFLOXACIN
Drug class	clinafloxacin
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like factories that make copies of themselves. Bacteria have their own factories too, and clinafloxacin stops these factories from working by blocking the enzymes that help them make copies of their DNA. This prevents the bacteria from growing and multiplying.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

CLINAFLOXACIN CI brief — competitive landscape report
CLINAFLOXACIN updates RSS · CI watch RSS

Frequently asked questions about CLINAFLOXACIN

What is CLINAFLOXACIN?

CLINAFLOXACIN is a clinafloxacin drug.

How does CLINAFLOXACIN work?

Clinafloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription.

What drug class is CLINAFLOXACIN in?

CLINAFLOXACIN belongs to the clinafloxacin class. See all clinafloxacin drugs at /class/clinafloxacin.

What development phase is CLINAFLOXACIN in?

CLINAFLOXACIN is in Phase 2.

Drug class: All clinafloxacin drugs
Therapeutic area: All drugs in Infectious Disease

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