Last reviewed 2026-05-30 · How we verify

CEFOZOPRAN

Phase 2 active Small molecule ✓ Verified May 2026 Quality 27/100

CEFOZOPRAN is a cefozopran drug. It is currently in Phase 2 development.

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

Cefozopran is a third-generation cephalosporin antibiotic, classified as a small molecule drug. It is a synthetic derivative of cephalosporin, but its original developer and current owner are unknown. Cefozopran is not FDA-approved, and its approved indications are also unknown. It has a half-life of approximately 1.7 hours, but its bioavailability and commercial status are not well-documented. As a result, its availability and safety profile are uncertain.

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	CEFOZOPRAN
Drug class	cefozopran
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall as a brick wall. Cefozopran blocks the enzymes that help build the wall, causing the wall to weaken and eventually collapse. This makes it difficult for the bacteria to survive and multiply.

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:

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

Frequently asked questions about CEFOZOPRAN

What is CEFOZOPRAN?

CEFOZOPRAN is a cefozopran drug.

How does CEFOZOPRAN work?

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

What drug class is CEFOZOPRAN in?

CEFOZOPRAN belongs to the cefozopran class. See all cefozopran drugs at /class/cefozopran.

What development phase is CEFOZOPRAN in?

CEFOZOPRAN is in Phase 2.

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

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