Last reviewed 2026-06-02 · How we verify

BUTIBUFEN

Phase 2 active Small molecule ✓ Verified Jun 2026

BUTIBUFEN is a butibufen drug. It is currently in Phase 2 development.

Butibufen works by blocking enzymes that transmit pain signals to the brain.

Butibufen is a small molecule with the chemical name 2-(P-ISOBUTYLPHENYL)BUTYRIC ACID. It is also known by the synonyms butibufen and butibuferene.

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	BUTIBUFEN
Drug class	butibufen
Modality	Small molecule
Therapeutic area	Pain
Phase	Phase 2

Mechanism of action

Think of it like a phone line - butibufen is like a switch that disconnects the line, preventing pain signals from reaching the brain. This can help reduce pain and discomfort. By blocking these enzymes, butibufen can help alleviate pain without affecting other bodily functions.

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:

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

Frequently asked questions about BUTIBUFEN

What is BUTIBUFEN?

BUTIBUFEN is a butibufen drug.

How does BUTIBUFEN work?

Butibufen works by blocking enzymes that transmit pain signals to the brain.

What drug class is BUTIBUFEN in?

BUTIBUFEN belongs to the butibufen class. See all butibufen drugs at /class/butibufen.

What development phase is BUTIBUFEN in?

BUTIBUFEN is in Phase 2.

Drug class: All butibufen drugs
Therapeutic area: All drugs in Pain

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