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Frenolone (METOFENAZATE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Frenolone (generic name: METOFENAZATE) is a drug. It is currently in Phase 2 development.

Frenolone works by binding to specific proteins or receptors in the body to produce a therapeutic effect.

Frenolone, also known as Metofenazate, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it is not FDA approved for any indications. As a small molecule, it is likely to work by interacting with specific biological molecules to produce a therapeutic effect. However, without more information, it is difficult to provide a comprehensive summary of its use and safety considerations. Further research is needed to determine its potential as a therapeutic agent.

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 nameMETOFENAZATE
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells are like locks, and Frenolone is a key that fits into those locks. When it binds to the right lock, it can turn on or off certain cellular processes to help treat a disease or condition. This is a simplified way of understanding how small molecule drugs like Frenolone work at a molecular level.

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 Frenolone

What is Frenolone?

Frenolone (METOFENAZATE) is a Small molecule drug.

How does Frenolone work?

Frenolone works by binding to specific proteins or receptors in the body to produce a therapeutic effect.

What is the generic name of Frenolone?

METOFENAZATE is the generic (nonproprietary) name of Frenolone.

What development phase is Frenolone in?

Frenolone is in Phase 2.

Related

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