Last reviewed 2026-05-27 · How we verify

Refosporen (CEFAZEDONE)

Phase 2 active Small molecule ✓ Verified May 2026

Refosporen (generic name: CEFAZEDONE) is a cefazedone drug. It is currently in Phase 2 development.

Refosporen works by inhibiting the enzymes responsible for building the bacterial cell wall, ultimately leading to bacterial cell death.

Refosporen is a small molecule. It is also known by the synonyms CEFAZEDONA, CEFAZEDONE, and CEFAZEDONE.

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	CEFAZEDONE
Drug class	cefazedone
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall like a brick wall. Refosporen blocks the enzymes that help build the wall, causing the wall to weaken and eventually collapse, leading 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:

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

Frequently asked questions about Refosporen

What is Refosporen?

Refosporen (CEFAZEDONE) is a cefazedone drug.

How does Refosporen work?

Refosporen works by inhibiting the enzymes responsible for building the bacterial cell wall, ultimately leading to bacterial cell death.

What is the generic name of Refosporen?

CEFAZEDONE is the generic (nonproprietary) name of Refosporen.

What drug class is Refosporen in?

Refosporen belongs to the cefazedone class. See all cefazedone drugs at /class/cefazedone.

What development phase is Refosporen in?

Refosporen is in Phase 2.

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

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