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Fenazol (UFENAMATE)

Phase 2 active Small molecule ✓ Verified May 2026

Fenazol (generic name: UFENAMATE) is a drug. It is currently in Phase 2 development.

Fenazol works by binding to and modifying the activity of specific proteins or enzymes in the body.

Fenazol is a small molecule with the synonyms including Butyl Flufenamate, Combec, and Flufenamic Acid Butyl Ester.

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 nameUFENAMATE
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells are like a factory with many different machines working together. Fenazol is like a tool that fits into one of these machines, changing how it works to produce a specific effect. This can help to treat certain conditions by altering the way the body's cells function.

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:

Frequently asked questions about Fenazol

What is Fenazol?

Fenazol (UFENAMATE) is a Small molecule drug.

How does Fenazol work?

Fenazol works by binding to and modifying the activity of specific proteins or enzymes in the body.

What is the generic name of Fenazol?

UFENAMATE is the generic (nonproprietary) name of Fenazol.

What development phase is Fenazol in?

Fenazol is in Phase 2.

Related

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