Last reviewed 2026-05-27 · How we verify

Usual Cefepime Infusion

Hospital de Clinicas de Porto Alegre · Phase 3 active Small molecule ✓ Verified May 2026

Usual Cefepime Infusion is a Cephalosporin antibiotic Small molecule drug developed by Hospital de Clinicas de Porto Alegre. It is currently in Phase 3 development for Nosocomial pneumonia, Complicated urinary tract infections, Complicated skin and skin structure infections. Also known as: Regular Cefepime Infusion.

Cefepime is a fourth-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis.

Cefepime is a small molecule antibiotic used to treat urinary tract infections and respiratory tract infections. It is administered through infusion, with both prolonged and usual infusion methods being studied in clinical trials.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Usual Cefepime Infusion
Also known as	Regular Cefepime Infusion
Sponsor	Hospital de Clinicas de Porto Alegre
Drug class	Cephalosporin antibiotic
Target	Penicillin-binding proteins (PBPs)
Modality	Small molecule
Therapeutic area	Infectious diseases
Phase	Phase 3

Mechanism of action

Cefepime works by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, resulting in the disruption of the bacterial cell wall synthesis and ultimately leading to bacterial cell death. This mechanism of action is specific to Gram-positive and Gram-negative bacteria.

Approved indications

Nosocomial pneumonia
Complicated urinary tract infections
Complicated skin and skin structure infections

Common side effects

Nausea
Vomiting
Diarrhea
Headache
Infusion site reaction

Key clinical trials

Prolonged Infusion Cefepime and Nosocomial Infections (PHASE3)

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:

Usual Cefepime Infusion CI brief — competitive landscape report
Usual Cefepime Infusion updates RSS · CI watch RSS
Hospital de Clinicas de Porto Alegre portfolio CI

Frequently asked questions about Usual Cefepime Infusion

What is Usual Cefepime Infusion?

Usual Cefepime Infusion is a Cephalosporin antibiotic drug developed by Hospital de Clinicas de Porto Alegre, indicated for Nosocomial pneumonia, Complicated urinary tract infections, Complicated skin and skin structure infections.

How does Usual Cefepime Infusion work?

Cefepime is a fourth-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis.

What is Usual Cefepime Infusion used for?

Usual Cefepime Infusion is indicated for Nosocomial pneumonia, Complicated urinary tract infections, Complicated skin and skin structure infections.

Who makes Usual Cefepime Infusion?

Usual Cefepime Infusion is developed by Hospital de Clinicas de Porto Alegre (see full Hospital de Clinicas de Porto Alegre pipeline at /company/hospital-de-clinicas-de-porto-alegre).

Is Usual Cefepime Infusion also known as anything else?

Usual Cefepime Infusion is also known as Regular Cefepime Infusion.

What drug class is Usual Cefepime Infusion in?

Usual Cefepime Infusion belongs to the Cephalosporin antibiotic class. See all Cephalosporin antibiotic drugs at /class/cephalosporin-antibiotic.

What development phase is Usual Cefepime Infusion in?

Usual Cefepime Infusion is in Phase 3.

What are the side effects of Usual Cefepime Infusion?

Common side effects of Usual Cefepime Infusion include Nausea, Vomiting, Diarrhea, Headache, Infusion site reaction.

What does Usual Cefepime Infusion target?

Usual Cefepime Infusion targets Penicillin-binding proteins (PBPs) and is a Cephalosporin antibiotic.

Drug class: All Cephalosporin antibiotic drugs
Target: All drugs targeting Penicillin-binding proteins (PBPs)
Manufacturer: Hospital de Clinicas de Porto Alegre — full pipeline
Therapeutic area: All drugs in Infectious diseases
Indication: Drugs for Nosocomial pneumonia
Indication: Drugs for Complicated urinary tract infections
Indication: Drugs for Complicated skin and skin structure infections
Also known as: Regular Cefepime Infusion

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