Last reviewed 2026-05-19 · How we verify

Urfadine (NIFURTOINOL)

Phase 2 active Small molecule ✓ Verified May 2026

Urfadine (generic name: NIFURTOINOL) is a nifurtoinol drug. It is currently in Phase 2 development for Urinary tract infectious disease.

Urfadine works by inhibiting the growth and replication of bacteria in the urinary tract.

Urfadine (NIFURTOINOL) is a small molecule drug in the nifurtoinol class, used to treat urinary tract infectious diseases. Its exact target is unknown, but it is believed to work by inhibiting bacterial growth and replication. Urfadine's commercial status is unclear, and it may be patented or available as a generic medication. Key safety considerations include potential side effects and interactions with other medications. Further research is needed to fully understand its pharmacokinetics and safety profile.

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	NIFURTOINOL
Drug class	nifurtoinol
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a city, and bacteria are like unwanted visitors. Urfadine helps to stop the bacteria from multiplying and taking over the city by interfering with their ability to make copies of themselves.

Approved indications

Urinary tract infectious disease

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:

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

Frequently asked questions about Urfadine

What is Urfadine?

Urfadine (NIFURTOINOL) is a nifurtoinol drug, indicated for Urinary tract infectious disease.

How does Urfadine work?

Urfadine works by inhibiting the growth and replication of bacteria in the urinary tract.

What is Urfadine used for?

Urfadine is indicated for Urinary tract infectious disease.

What is the generic name of Urfadine?

NIFURTOINOL is the generic (nonproprietary) name of Urfadine.

What drug class is Urfadine in?

Urfadine belongs to the nifurtoinol class. See all nifurtoinol drugs at /class/nifurtoinol.

What development phase is Urfadine in?

Urfadine is in Phase 2.

Drug class: All nifurtoinol drugs
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Urinary tract infectious disease

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