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Zerbaxa (CEFTOLOZANE)
Zerbaxa works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.
Zerbaxa (ceftolozane) is a cephalosporin antibacterial drug developed by Cubist Pharmaceuticals. It is a small molecule that targets a range of bacterial infections, including urinary tract infections, pneumonia, and intra-abdominal infections. Zerbaxa was approved by the FDA in 2014 and is used to treat various bacterial infections. The commercial status of Zerbaxa is patented, and it is not yet available as a generic. Key safety considerations include its potential to cause diarrhea, nausea, and headache.
At a glance
| Generic name | CEFTOLOZANE |
|---|---|
| Sponsor | Cubist Pharms |
| Drug class | Cephalosporin Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2014 |
Mechanism of action
ZERBAXA is an antibacterial drug [see Clinical Pharmacology (12.4)].
Approved indications
- Abdominal abscess
- Abscess of liver
- Acute pyelonephritis
- Bacterial cystitis
- Bacterial peritonitis
- Bacterial pyelonephritis
- Cholecystitis
- Haemophilus influenzae pneumonia
- Infectious disease of abdomen
- Nosocomial pneumonia
- Sepsis caused by Haemophilus influenzae
- Sepsis caused by Serratia
- Urinary tract infectious disease
- Ventilator-acquired pneumonia
Common side effects
- Nausea
- Diarrhea
- Headache
- Pyrexia
- Constipation
- Insomnia
- Vomiting
- Hypokalemia
- ALT increased
- AST increased
- Anemia
- Thrombocytosis
Key clinical trials
- Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation (PHASE4)
- Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036) (PHASE1)
- Optimising TREATment for Severe Gram-Negative Bacterial Infections (PHASE4)
- Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens (PHASE4)
- Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia (PHASE3)
- Nosocomial Infections in ECMO Patients
- Use of New Antibiotics in Sweden
- Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zerbaxa CI brief — competitive landscape report
- Zerbaxa updates RSS · CI watch RSS
- Cubist Pharms portfolio CI