Last reviewed 2026-06-02 · How we verify

Ceftetrame (CEFTERAM)

Phase 2 active Small molecule ✓ Verified Jun 2026

Ceftetrame (generic name: CEFTERAM) is a drug. It is currently in Phase 2 development.

Ceftetrame is a small molecule that works by binding to specific biological targets to produce its therapeutic effect.

Ceftetrame is a small molecule antibiotic. It is also known by the synonyms Ceftetrame, Ceftetrame, Ceftetrame pivoxil, and RO 19-5247.

Likelihood of approval

15.3% 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).

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	CEFTERAM
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine Ceftetrame as a key that fits into a lock in the body. When it binds to its target, it helps to turn off or turn on specific cellular processes that are involved in the disease. This can help to restore balance and promote healing.

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:

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

Frequently asked questions about Ceftetrame

What is Ceftetrame?

Ceftetrame (CEFTERAM) is a Small molecule drug.

How does Ceftetrame work?

Ceftetrame is a small molecule that works by binding to specific biological targets to produce its therapeutic effect.

What is the generic name of Ceftetrame?

CEFTERAM is the generic (nonproprietary) name of Ceftetrame.

What development phase is Ceftetrame in?

Ceftetrame is in Phase 2.

Therapeutic area: All drugs in Other

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