Last reviewed 2026-05-23 · How we verify

Tosulfloxacin (TOSUFLOXACIN)

Phase 2 active Small molecule ✓ Verified May 2026

Tosulfloxacin (generic name: TOSUFLOXACIN) is a tosufloxacin drug. It is currently in Phase 2 development.

Tosulfloxacin works by blocking bacterial enzymes that replicate and transcribe DNA.

Tosulfloxacin is a small molecule antibiotic. Its mechanism of action is not specified in the provided information, but it is classified as a fluoroquinolone antibiotic.

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	TOSUFLOXACIN
Drug class	tosufloxacin
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 their DNA. Bacteria have similar factories, but they're not as precise. Tosulfloxacin stops these bacterial factories from working correctly, which prevents the bacteria from making copies of their DNA and eventually kills them.

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:

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

Frequently asked questions about Tosulfloxacin

What is Tosulfloxacin?

Tosulfloxacin (TOSUFLOXACIN) is a tosufloxacin drug.

How does Tosulfloxacin work?

Tosulfloxacin works by blocking bacterial enzymes that replicate and transcribe DNA.

What is the generic name of Tosulfloxacin?

TOSUFLOXACIN is the generic (nonproprietary) name of Tosulfloxacin.

What drug class is Tosulfloxacin in?

Tosulfloxacin belongs to the tosufloxacin class. See all tosufloxacin drugs at /class/tosufloxacin.

What development phase is Tosulfloxacin in?

Tosulfloxacin is in Phase 2.

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

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