Last reviewed 2026-05-28 · How we verify

Nifuraden (NIFURADENE)

Phase 2 active Small molecule ✓ Verified May 2026

Nifuraden (generic name: NIFURADENE) is a nifuradene drug. It is currently in Phase 2 development.

Nifuradene is thought to work by inhibiting the growth of microorganisms through its antimicrobial properties.

Nifuraden is a small molecule with the synonyms NF-246, NIFURADENE, NIFURADENO, NSC-6470, and OXAFURADENE.

Likelihood of approval

15.3% 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).

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	NIFURADENE
Drug class	nifuradene
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body is a garden, and microorganisms are weeds. Nifuradene is like a weed killer that helps prevent the weeds from growing and spreading. It does this by interfering with the way the microorganisms make energy, ultimately killing them or preventing them from 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:

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

Frequently asked questions about Nifuraden

What is Nifuraden?

Nifuraden (NIFURADENE) is a nifuradene drug.

How does Nifuraden work?

Nifuradene is thought to work by inhibiting the growth of microorganisms through its antimicrobial properties.

What is the generic name of Nifuraden?

NIFURADENE is the generic (nonproprietary) name of Nifuraden.

What drug class is Nifuraden in?

Nifuraden belongs to the nifuradene class. See all nifuradene drugs at /class/nifuradene.

What development phase is Nifuraden in?

Nifuraden is in Phase 2.

Drug class: All nifuradene drugs
Therapeutic area: All drugs in Other

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