Last reviewed · How we verify
Cefepime-zidebactam (FEP-ZID)
Cefepime-zidebactam is a combination of a fourth-generation cephalosporin (cefepime) and a novel beta-lactamase inhibitor (zidebactam) that together restore cefepime's activity against beta-lactamase-producing gram-negative bacteria.
Cefepime-zidebactam is a combination of a fourth-generation cephalosporin (cefepime) and a novel beta-lactamase inhibitor (zidebactam) that together restore cefepime's activity against beta-lactamase-producing gram-negative bacteria. Used for Complicated urinary tract infections (cUTI) caused by susceptible gram-negative bacteria, Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), Complicated intra-abdominal infections (cIAI).
At a glance
| Generic name | Cefepime-zidebactam (FEP-ZID) |
|---|---|
| Sponsor | Wockhardt |
| Drug class | Beta-lactam/beta-lactamase inhibitor combination |
| Target | Bacterial penicillin-binding proteins (PBPs); serine beta-lactamases |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Cefepime acts as a beta-lactam antibiotic by inhibiting bacterial cell wall synthesis. Zidebactam is a non-beta-lactam beta-lactamase inhibitor that protects cefepime from degradation by serine beta-lactamases, including extended-spectrum beta-lactamases (ESBLs) and AmpC beta-lactamases. This combination extends cefepime's spectrum to cover resistant gram-negative pathogens including Pseudomonas aeruginosa and Enterobacteriaceae with acquired resistance mechanisms.
Approved indications
- Complicated urinary tract infections (cUTI) caused by susceptible gram-negative bacteria
- Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)
- Complicated intra-abdominal infections (cIAI)
Common side effects
- Diarrhea
- Nausea
- Headache
- Phlebitis at infusion site
- Hypersensitivity reactions
Key clinical trials
- Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PHASE3)
- A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination. (PHASE1)
- Plasma and Intrapulmonary Concentrations Study of WCK 5222 (PHASE1)
- To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment (PHASE1)
- Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers (PHASE1)
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:
- Cefepime-zidebactam (FEP-ZID) CI brief — competitive landscape report
- Cefepime-zidebactam (FEP-ZID) updates RSS · CI watch RSS
- Wockhardt portfolio CI