Last reviewed 2026-04-20 · How we verify

Cefpimizol (CEFPIMIZOLE)

Phase 2 active Small molecule

Cefpimizol (generic name: CEFPIMIZOLE) is a cefpimizole drug. It is currently in Phase 2 development.

Cefpimizole works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.

Cefpimizole is a small molecule antibiotic in the cefpimizole class, but its target and approved indications are unknown. Its half-life is approximately 1.8 hours. The commercial status of cefpimizole is unclear, and it is not known whether it is patented or available as a generic medication. Further information on its development, approval, and safety profile is needed. As a result, cefpimizole is not widely recognized or used in clinical practice.

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	CEFPIMIZOLE
Drug class	cefpimizole
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like buildings, and the bacteria are like construction workers. Cefpimizole stops the construction workers from building new walls, which eventually causes the building to collapse and die. This is how cefpimizole fights bacterial infections.

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:

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

Frequently asked questions about Cefpimizol

What is Cefpimizol?

Cefpimizol (CEFPIMIZOLE) is a cefpimizole drug.

How does Cefpimizol work?

Cefpimizole works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.

What is the generic name of Cefpimizol?

CEFPIMIZOLE is the generic (nonproprietary) name of Cefpimizol.

What drug class is Cefpimizol in?

Cefpimizol belongs to the cefpimizole class. See all cefpimizole drugs at /class/cefpimizole.

What development phase is Cefpimizol in?

Cefpimizol is in Phase 2.

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

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