Last reviewed 2026-05-31 · How we verify

Nifurfolin (NIFURFOLINE)

Phase 2 active Small molecule ✓ Verified May 2026

Nifurfolin (generic name: NIFURFOLINE) is a nifurfoline drug. It is currently in Phase 2 development.

Nifurfoline is thought to work by inhibiting a specific target, although this target is currently unknown.

Nifurfolin is a small molecule. It is also known by the synonyms NIFURFOLINA and NIFURFOLINE.

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	NIFURFOLINE
Drug class	nifurfoline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and the target is the key that fits into those locks. Nifurfoline is like a key that blocks the target from working properly, which can help treat certain conditions. However, without knowing the target, it's difficult to fully understand how nifurfoline works.

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:

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

Frequently asked questions about Nifurfolin

What is Nifurfolin?

Nifurfolin (NIFURFOLINE) is a nifurfoline drug.

How does Nifurfolin work?

Nifurfoline is thought to work by inhibiting a specific target, although this target is currently unknown.

What is the generic name of Nifurfolin?

NIFURFOLINE is the generic (nonproprietary) name of Nifurfolin.

What drug class is Nifurfolin in?

Nifurfolin belongs to the nifurfoline class. See all nifurfoline drugs at /class/nifurfoline.

What development phase is Nifurfolin in?

Nifurfolin is in Phase 2.

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

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