Drugs / Ceftolozane
Ceftolozane
also known as
CXA-101 · CEFTOLOZANE SULFATE · Ceftolozane sulfate component of zerbaxa · Ceftolozano · CXA-101 (FOR SULFATE) · CXA-101 FREE BASE · FR-264205
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pneumonia caused by pseudomonas aeruginosa infection 1 milestone | |||||
| Filed | US (FDA) | ZERBAXA | pneumonia caused by pseudomonas aeruginosa infection | 2019-02-05 | “FDA acceptance for priority review of a supplemental New Drug Application for ZERBAXA (ceftolozane and tazobactam) for the treatment of adult patients with nosocomial pneumonia” merck.com ↗ “a sNDA accepted for Priority Review for ZERBAXA ® (ceftolozane and tazobactam) to treat adult patients with nosocomial pneumonia” merck.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Zerbaxa | — | 2015-09-18 | europa.eu ↗ |
| Approved | US (FDA) | ZERBAXA | — | 2014-12-19 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04223752 | Apr 2020 → Sep 2024 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02387372 | Feb 2015 → Jun 2017 | pneumonia | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02266706 | Sep 2014 → Jun 2017 | gram-negative bacterial infections | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02508753 | Jun → Jul 2010 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03485950 | May 2018 → May 2021 | infectious disease | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03230838 | Apr 2018 → Dec 2020 | pyelonephritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03217136 | Apr 2018 → Mar 2020 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00921024 | Jun 2009 → Feb 2010 | urinary tract infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04238390 | Jan 2022 → Jun 2024 | gram-negative bacterial infections | The University of Queensland | Withdrawn | No outcome recorded |
| Phase 3 | NCT02728089 | Apr 2016 → Sep 2017 | pyelonephritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02739997 | Apr 2016 → Jul 2017 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01853982 | Jun → Nov 2013 | — | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT04673175 | Jan 2023 → Mar 2025 | Pseudomonas aeruginosa infectious disease, disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm, pneumonia | Weill Medical College of Cornell University | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT03002506 | Aug 2017 → Jun 2020 | — | Texas Tech University Health Sciences Center | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-02-05 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam, and Supplemental NDA (sNDA) for ZERBAXA® (Ceftolozane and Tazobactam) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review regulatory filings for two antibacterial agents. |
| 2018-10-25 | Merck Sharp & Dohme LLC | Results Merck Announces Third-Quarter 2018 Financial Results merck.com ↗
met the pre-specified primary endpoints, demonstrating non-inferiority to meropenem, the active comparator, in day 28 all-cause mortality and in clinical cure rate at the test-of-cure visit. |
| 2018-09-11 | Merck Sharp & Dohme LLC | Results Merck’s ZERBAXA® (ceftolozane and tazobactam) Met Primary Endpoints of Non-Inferiority Compared to Meropenem in Pivotal Phase 3 Study of Adult Patients with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia merck.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ceftolozane | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02728089 ↗ |
| Known as | CEFTOLOZANE SULFATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103872 ↗ |
| Known as | Ceftolozane sulfate component of zerbaxa | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103872 ↗ |
| Known as | Ceftolozano | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103872 ↗ |
| Known as | CXA-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00921024 ↗ |
| Known as | CXA-101 (FOR SULFATE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103872 ↗ |
| Known as | CXA-101 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103872 ↗ |
| Known as | FR-264205 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103872 ↗ |
| Modality | Small molecule | “Ceftolozane/tazobactam, a cephalosporin-β-lactamase inhibitor combination” PMID 37000942 ↗ Mar 2023 |
| Route | Intravenous | “single intravenous dose of ceftolozane/tazobactam” NCT02266706 ↗ |