Last reviewed 2026-04-20 · How we verify

Fuldazin (MILOXACIN)

Phase 2 active Small molecule

Fuldazin (generic name: MILOXACIN) is a miloxacin drug. It is currently in Phase 2 development.

Miloxacin works by inhibiting bacterial DNA replication and transcription.

Fuldazin, also known as Miloxacin, is a small molecule drug in the miloxacin class. Its exact target is unknown, but it is believed to work by inhibiting bacterial growth. Miloxacin is not FDA-approved for any indications, and its commercial status, patent status, and availability of generic manufacturers are also unknown. Further research is needed to determine its safety and efficacy. As a result, it is not currently available for clinical use.

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	MILOXACIN
Drug class	miloxacin
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Think of it like a copy machine. Bacteria need to make copies of their DNA to grow and multiply. Miloxacin blocks the copy machine, preventing the bacteria from making new copies of their DNA and ultimately stopping them 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:

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

Frequently asked questions about Fuldazin

What is Fuldazin?

Fuldazin (MILOXACIN) is a miloxacin drug.

How does Fuldazin work?

Miloxacin works by inhibiting bacterial DNA replication and transcription.

What is the generic name of Fuldazin?

MILOXACIN is the generic (nonproprietary) name of Fuldazin.

What drug class is Fuldazin in?

Fuldazin belongs to the miloxacin class. See all miloxacin drugs at /class/miloxacin.

What development phase is Fuldazin in?

Fuldazin is in Phase 2.

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

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