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4-(O-Benzylphenoxy)-N-Methylbutylamine (BIFEMELANE)

Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 36/100

4-(O-Benzylphenoxy)-N-Methylbutylamine (generic name: BIFEMELANE) is a bifemelane drug. It is currently in Phase 2 development for Cerebrovascular disease.

BIFEMELANE works by inhibiting the enzyme Amine oxidase [flavin-containing] A, which plays a role in the breakdown of certain neurotransmitters.

4-(O-Benzylphenoxy)-N-Methylbutylamine is a small molecule. It is also known by the synonyms BIFEMELANE, BIFEMELANE, and BIFEMELANO.

Likelihood of approval
12.3% 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).
  • CNS / neurology attrition -3.0pp
    CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
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 nameBIFEMELANE
Drug classbifemelane
TargetAmine oxidase [flavin-containing] A
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of it like a traffic jam in your brain. When this enzyme breaks down neurotransmitters, it's like cars getting stuck in traffic. BIFEMELANE helps to clear the traffic by blocking this enzyme, allowing neurotransmitters to flow more freely.

Approved indications

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 4-(O-Benzylphenoxy)-N-Methylbutylamine

What is 4-(O-Benzylphenoxy)-N-Methylbutylamine?

4-(O-Benzylphenoxy)-N-Methylbutylamine (BIFEMELANE) is a bifemelane drug, indicated for Cerebrovascular disease.

How does 4-(O-Benzylphenoxy)-N-Methylbutylamine work?

BIFEMELANE works by inhibiting the enzyme Amine oxidase [flavin-containing] A, which plays a role in the breakdown of certain neurotransmitters.

What is 4-(O-Benzylphenoxy)-N-Methylbutylamine used for?

4-(O-Benzylphenoxy)-N-Methylbutylamine is indicated for Cerebrovascular disease.

What is the generic name of 4-(O-Benzylphenoxy)-N-Methylbutylamine?

BIFEMELANE is the generic (nonproprietary) name of 4-(O-Benzylphenoxy)-N-Methylbutylamine.

What drug class is 4-(O-Benzylphenoxy)-N-Methylbutylamine in?

4-(O-Benzylphenoxy)-N-Methylbutylamine belongs to the bifemelane class. See all bifemelane drugs at /class/bifemelane.

What development phase is 4-(O-Benzylphenoxy)-N-Methylbutylamine in?

4-(O-Benzylphenoxy)-N-Methylbutylamine is in Phase 2.

What does 4-(O-Benzylphenoxy)-N-Methylbutylamine target?

4-(O-Benzylphenoxy)-N-Methylbutylamine targets Amine oxidase [flavin-containing] A and is a bifemelane.

Related

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