Last reviewed 2026-05-31 · How we verify

Cefroxadin (CEFROXADINE)

Phase 2 active Small molecule ✓ Verified May 2026

Cefroxadin (generic name: CEFROXADINE) is a cefroxadine drug. It is currently in Phase 2 development.

Cefroxadine works by inhibiting the bacterial enzyme responsible for cell wall synthesis.

Cefroxadin is a small molecule antibiotic. It has been studied in clinical trials for the treatment of cystitis.

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	CEFROXADINE
Drug class	cefroxadine
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall as a brick wall. Cefroxadine blocks the enzyme that helps 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.

Key clinical trials

Efficacy of Oxybutynin in Paediatric Cystitis (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

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

Frequently asked questions about Cefroxadin

What is Cefroxadin?

Cefroxadin (CEFROXADINE) is a cefroxadine drug.

How does Cefroxadin work?

Cefroxadine works by inhibiting the bacterial enzyme responsible for cell wall synthesis.

What is the generic name of Cefroxadin?

CEFROXADINE is the generic (nonproprietary) name of Cefroxadin.

What drug class is Cefroxadin in?

Cefroxadin belongs to the cefroxadine class. See all cefroxadine drugs at /class/cefroxadine.

What development phase is Cefroxadin in?

Cefroxadin is in Phase 2.

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

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