Last reviewed 2026-04-20 · How we verify

Budifin (BUTINOLINE)

Phase 2 active Small molecule

Budifin (generic name: BUTINOLINE) is a butinoline drug. It is currently in Phase 2 development.

Budifin is believed to work by interacting with a specific molecular target to produce a therapeutic effect.

Budifin (Butinoline) is a small molecule drug in the butinoline class, but specific details about its development, approval status, and commercial availability are not provided. As a pharma professional, it is essential to note that the target, indications, pharmacokinetics, and safety profile of Budifin are unknown. Further research is necessary to understand its mechanism of action, efficacy, and potential side effects. The commercial status of Budifin, including patent status and generic availability, is also unclear. A comprehensive review of the available literature is required to determine the current status of this compound.

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	BUTINOLINE
Drug class	butinoline
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Budifin is a key that fits into those locks. When it binds to the lock, it triggers a series of events that help to treat a particular condition. This process is called a molecular interaction, and it's a fundamental way that many medications work.

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:

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

Frequently asked questions about Budifin

What is Budifin?

Budifin (BUTINOLINE) is a butinoline drug.

How does Budifin work?

Budifin is believed to work by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Budifin?

BUTINOLINE is the generic (nonproprietary) name of Budifin.

What drug class is Budifin in?

Budifin belongs to the butinoline class. See all butinoline drugs at /class/butinoline.

What development phase is Budifin in?

Budifin is in Phase 2.

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

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