Last reviewed 2026-04-20 · How we verify

Bufeniod (BUFENIODE)

Phase 2 active Small molecule

Bufeniod (generic name: BUFENIODE) is a bufeniode drug. It is currently in Phase 2 development.

Bufeniode is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

Bufeniode is a small molecule drug in the bufeniode class, but specific details about its development, approval status, and indications are not available. As a result, there is limited information on its commercial status, safety considerations, and pharmacokinetic properties. Further research is needed to understand the target, mechanism of action, and clinical applications of bufeniode. The lack of information on its half-life, bioavailability, and generic manufacturers suggests that it may be a relatively new or experimental compound. Overall, more data is required to fully assess the potential of bufeniode 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 name	BUFENIODE
Drug class	bufeniode
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine bufeniode as a key that fits into a lock on a cell's surface. When it binds to this lock, it triggers a series of events that ultimately help to treat a particular disease or condition. This process is highly specific, allowing bufeniode to target only certain cells or pathways without affecting others.

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:

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

Frequently asked questions about Bufeniod

What is Bufeniod?

Bufeniod (BUFENIODE) is a bufeniode drug.

How does Bufeniod work?

Bufeniode is thought to work by interacting with a specific molecular target to produce a therapeutic effect.

What is the generic name of Bufeniod?

BUFENIODE is the generic (nonproprietary) name of Bufeniod.

What drug class is Bufeniod in?

Bufeniod belongs to the bufeniode class. See all bufeniode drugs at /class/bufeniode.

What development phase is Bufeniod in?

Bufeniod is in Phase 2.

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

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