Last reviewed 2026-04-20 · How we verify

Bufemid (FENBUFEN)

Phase 2 active Small molecule

Bufemid (generic name: FENBUFEN) is a fenbufen drug. It is currently in Phase 2 development.

Bufemid works by inhibiting the enzyme Prostaglandin G/H synthase 1, which is responsible for producing prostaglandins that cause inflammation.

Bufemid (FENBUFEN) is a small molecule drug that targets Prostaglandin G/H synthase 1, a key enzyme involved in inflammation. It belongs to the fenbufen class and is used to treat various inflammatory conditions. However, its commercial status and approved indications are unknown. Bufemid's safety profile and pharmacokinetic properties, such as half-life and bioavailability, are also not well-documented. Further research is needed to fully understand its clinical utility and potential risks.

Likelihood of approval

16.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	FENBUFEN
Drug class	fenbufen
Target	Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2, Prostaglandin G/H synthase 1
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 2

Mechanism of action

Think of prostaglandins like messengers that tell your body to get inflamed. Bufemid blocks these messengers from being made, which helps to reduce inflammation and relieve pain. This can be especially helpful for people with conditions like arthritis or other inflammatory diseases.

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:

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

Frequently asked questions about Bufemid

What is Bufemid?

Bufemid (FENBUFEN) is a fenbufen drug.

How does Bufemid work?

Bufemid works by inhibiting the enzyme Prostaglandin G/H synthase 1, which is responsible for producing prostaglandins that cause inflammation.

What is the generic name of Bufemid?

FENBUFEN is the generic (nonproprietary) name of Bufemid.

What drug class is Bufemid in?

Bufemid belongs to the fenbufen class. See all fenbufen drugs at /class/fenbufen.

What development phase is Bufemid in?

Bufemid is in Phase 2.

What does Bufemid target?

Bufemid targets Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2, Prostaglandin G/H synthase 1 and is a fenbufen.

Drug class: All fenbufen drugs
Target: All drugs targeting Prostaglandin G/H synthase 1, Prostaglandin G/H synthase 2, Prostaglandin G/H synthase 1
Therapeutic area: All drugs in Immunology

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