Last reviewed 2026-04-20 · How we verify

Apurone (FLUMEQUINE)

Phase 2 active Small molecule Quality 27/100

Apurone (generic name: FLUMEQUINE) is a flumequine drug. It is currently in Phase 2 development.

Apurone works by inhibiting bacterial DNA replication and transcription.

Apurone, also known as Flumequine, is a small molecule drug in the flumequine class. Its exact target is unknown, but it is used to treat certain bacterial infections. The commercial status of Apurone is unclear, and it may be patented or have generic manufacturers. Key safety considerations are not well-documented. Further research is needed to fully understand its pharmacology and 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	FLUMEQUINE
Drug class	flumequine
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like factories that make proteins and other important things. Bacteria are like tiny factories that can make you sick. Apurone stops these bacterial factories from working by blocking the way they make copies of their genetic material, which ultimately prevents them from growing and causing harm.

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:

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

Frequently asked questions about Apurone

What is Apurone?

Apurone (FLUMEQUINE) is a flumequine drug.

How does Apurone work?

Apurone works by inhibiting bacterial DNA replication and transcription.

What is the generic name of Apurone?

FLUMEQUINE is the generic (nonproprietary) name of Apurone.

What drug class is Apurone in?

Apurone belongs to the flumequine class. See all flumequine drugs at /class/flumequine.

What development phase is Apurone in?

Apurone is in Phase 2.

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

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