Last reviewed 2026-04-20 · How we verify

Cepticol (CEFATRIZINE)

Phase 2 active Small molecule Quality 32/100

Cepticol (generic name: CEFATRIZINE) is a cefatrizine drug. It is currently in Phase 2 development.

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

Cefatrizine, also known as Cepticol, is a small molecule antibiotic in the cefatrizine class. Its mechanism of action involves inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death. However, due to the lack of available information, its target and approved indications are unknown. The commercial status of cefatrizine is also unclear, with no information available on its patent status or generic manufacturers. Further research is needed to determine its safety profile and potential side effects.

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	CEFATRIZINE
Drug class	cefatrizine
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like houses, and the bacterial cell wall is like the walls of those houses. Cefatrizine blocks the construction of these walls, making it difficult for bacteria to grow and multiply. This ultimately leads to the death of the bacterial cells.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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:

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

Frequently asked questions about Cepticol

What is Cepticol?

Cepticol (CEFATRIZINE) is a cefatrizine drug.

How does Cepticol work?

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

What is the generic name of Cepticol?

CEFATRIZINE is the generic (nonproprietary) name of Cepticol.

What drug class is Cepticol in?

Cepticol belongs to the cefatrizine class. See all cefatrizine drugs at /class/cefatrizine.

What development phase is Cepticol in?

Cepticol is in Phase 2.

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

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