Last reviewed 2026-05-31 · How we verify

Menbuton (MENBUTONE)

Phase 2 active Small molecule ✓ Verified May 2026

Menbuton (generic name: MENBUTONE) is a menbutone drug. It is currently in Phase 2 development.

Menbutone works by inhibiting an enzyme involved in cellular energy production.

Menbuton is a small molecule. It is also known by the synonyms GENABILIC ACID, GENABILIN, GENABILINE, MENBUTONA, MENBUTONE, and NSC-53969.

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	MENBUTONE
Drug class	menbutone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a car engine: Menbutone blocks a key part of the engine that helps it run, which can slow down or stop the growth of certain cells. This can be helpful in treating diseases where cells are growing too quickly. However, it's essential to be cautious when using Menbutone because it can also affect healthy cells.

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:

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

Frequently asked questions about Menbuton

What is Menbuton?

Menbuton (MENBUTONE) is a menbutone drug.

How does Menbuton work?

Menbutone works by inhibiting an enzyme involved in cellular energy production.

What is the generic name of Menbuton?

MENBUTONE is the generic (nonproprietary) name of Menbuton.

What drug class is Menbuton in?

Menbuton belongs to the menbutone class. See all menbutone drugs at /class/menbutone.

What development phase is Menbuton in?

Menbuton is in Phase 2.

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

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