Last reviewed 2026-05-31 · How we verify

CEFBUPERAZONE

Phase 2 active Small molecule ✓ Verified May 2026 Quality 32/100

CEFBUPERAZONE is a cefbuperazone drug. It is currently in Phase 2 development.

Cefbuperazone works by binding to penicillin-binding proteins in bacterial cell walls, preventing them from forming a strong bond and ultimately leading to cell lysis.

CEFBUPERAZONE is a small molecule with multiple synonyms, including BMY-25182 and CEFBUPERAZONE SODIUM.

Likelihood of approval

17.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	CEFBUPERAZONE
Drug class	cefbuperazone
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall as a brick wall. Cefbuperazone blocks the enzymes that help hold the bricks together, causing the wall to weaken and eventually collapse. This ultimately leads to the death of the bacterial cell.

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:

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

Frequently asked questions about CEFBUPERAZONE

What is CEFBUPERAZONE?

CEFBUPERAZONE is a cefbuperazone drug.

How does CEFBUPERAZONE work?

Cefbuperazone works by binding to penicillin-binding proteins in bacterial cell walls, preventing them from forming a strong bond and ultimately leading to cell lysis.

What drug class is CEFBUPERAZONE in?

CEFBUPERAZONE belongs to the cefbuperazone class. See all cefbuperazone drugs at /class/cefbuperazone.

What development phase is CEFBUPERAZONE in?

CEFBUPERAZONE is in Phase 2.

Drug class: All cefbuperazone drugs
Therapeutic area: All drugs in Infectious Disease

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