Ceftolozane-tazobactam
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute female pelvic peritonitis 1 milestone | |||||
| Filed | US (FDA) | ZERBAXA | acute female pelvic peritonitis | 2021-10-28 | “Additionally, the FDA has accepted for review two supplemental New Drug Applications for ZERBAXA in pediatric complicated urinary tract infections and complicated...” merck.com ↗ |
| Filed pneumonia caused by pseudomonas aeruginosa infection 1 milestone | |||||
| Filed | US (FDA) | ZERBAXA | pneumonia caused by pseudomonas aeruginosa infection | 2019-02-05 | “a sNDA accepted for Priority Review for ZERBAXA® (ceftolozane and tazobactam) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia” merck.com ↗ |
| Filed pyeloureteritis cystica 1 milestone | |||||
| Filed | US (FDA) | ZERBAXA | pyeloureteritis cystica | 2021-10-28 | “Additionally, the FDA has accepted for review two supplemental New Drug Applications for ZERBAXA in pediatric complicated urinary tract infections and complicated...” merck.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01147640 | Jun 2010 → Feb 2011 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06342115 | Mar 2025 → Aug 2027 expected | neutropenia | Beneficência Portuguesa de São Paulo | Recruiting | No outcome recorded |
| Phase 4 | NCT05061654 | Aug 2022 → Jan 2024 | hematopoietic and lymphoid cell neoplasm, neutropenia | Hamad Medical Corporation | Withdrawn | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT03581370 Comparator | Sep 2018 → Feb 2025 overdue | — | University Hospital, Toulouse | Recruiting | No outcome recorded |
| Phase 4 | NCT07004049 Comparator | Apr 2025 → Dec 2028 expected | bacterial pneumonia, infectious disease with sepsis | National University of Singapore | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
All press releases naming this drug 8 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ceftolozane/tazobactam | “Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of...” NCT06342115 ↗5“Ceftolozane-tazobactam (TOL-TAZ) is a novel antibacterial with activity against Pseudomonas aeruginosa and other common Gram-negative pathogens” PMID 24982069 ↗ Jun 2014 “Intravenous administration of ceftolozane-tazobactam (ZERBAXA®) : 2000 mg by infusion for 60 minutes every 8 hours.” NCT03581370 ↗ |
| Known as | CEF/TAZ | “Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of...” NCT06342115 ↗ |
| Known as | TOL-TAZ | “Ceftolozane-tazobactam (TOL-TAZ) is a novel antibacterial with activity against Pseudomonas aeruginosa and other common Gram-negative pathogens” PMID 24982069 ↗ Jun 2014 |
| Known as | ZERBAXA | “Ceftolozane is a new cephalosporin, marketed, in combination with tazobactam (beta-lactamase inhibitor) under the name ZERBAXA®.” NCT03581370 ↗ |
| Action | Inhibit | “tazobactam (beta-lactamase inhibitor)” NCT03581370 ↗ |
| Modality | Small molecule | “Ceftolozane is a new cephalosporin” NCT03581370 ↗ |
| Route | Intravenous | “administered via IV infusion” NCT01147640 ↗ |