Drugs / Ceftazidime-avibactam
Ceftazidime-avibactam
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed urinary tract infection 1 milestone | |||||
| Filed | US (FDA) | AVYCAZ | urinary tract infection | 2018-11-20 | “FDA has accepted for review the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam)” abbvie.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | EU (EMA) | — | — | — | “the regulatory submission seeking approval for a broad range of indications, was accepted and validated by the European Medicines Agency (EMA) in May 2015.” astrazeneca.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04040621 | Jun 2020 → Apr 2021 | — | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03978091 | Jul 2019 → Nov 2020 | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02732327 | May → Jun 2016 | neoplasm, neutropenia | Forest Laboratories | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02475733 | Aug 2015 → Jun 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07089186 | Apr 2025 → Dec 2026 expected | bacterial pneumonia, urinary tract infection | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05258851 | Jun 2022 → Apr 2023 | — | King Faisal Specialist Hospital & Research Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 43 trials | ||||||
| Phase 4 | NCT07478484 | Mar 2026 → Dec 2027 expected | gram-negative bacterial infections | Jing Zhou | Recruiting | No outcome recorded |
| Phase 4 | NCT06939829 | May 2025 → Dec 2027 expected | — | Southeast University, China | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05862402 | May 2023 → May 2024 | Klebsiella pneumonia | Phramongkutklao College of Medicine and Hospital | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06818565 | Feb 2025 → Dec 2026 expected | liver disorder | Institute of Liver and Biliary Sciences, India | Not yet recruiting | No outcome recorded |
| — | NCT05850871 | Jan 2023 → Jan 2025 | — | Qianfoshan Hospital | Unknown | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 3 | NCT07634198 Comparator | Jun 2026 → Apr 2028 expected | bacterial pneumonia | Nanjing Yoko Biomedical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06633718 Comparator | Oct 2024 → May 2027 expected | infectious peritonitis | Qilu Pharmaceutical Co., Ltd. | Not yet 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 |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| — | NCT06051513 Background | Nov 2023 → Dec 2025 overdue | — | Southeast University, China | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2019-03-18 | AbbVie | Regulatory Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients abbvie.com ↗
This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade. |
| 2018-11-20 | AbbVie | Regulatory Allergan Announces FDA Acceptance of Supplemental New Drug Application for AVYCAZ® (ceftazidime and avibactam) abbvie.com ↗ |
| 2018-02-01 | AbbVie | Regulatory FDA Approves AVYCAZ® (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia abbvie.com ↗ |
| 2017-04-24 | Pfizer | Results Pivotal Phase III Study Underscores Efficacy Of Zavicefta™ (ceftazidime-avibactam) For Treatment Of Hospital-Acquired Pneumonia, A Leading Cause Of Mortality In Hospitals pfizer.com ↗
In addition, patients treated with Zavicefta and Meropenem experienced comparable rates of tolerability consistent with the known profile of ceftazidime alone. |
| 2015-09-02 | AstraZeneca | Results Positive Phase III results demonstrate efficacy of antibiotic medicine CAZ-AVI in complicated Urinary Tract Infections astrazeneca.com ↗
AstraZeneca today announced positive topline results from RECAPTURE 1 and RECAPTURE 2, the pivotal Phase III studies evaluating the antibiotic, CAZ-AVI (ceftazidime-avibactam), as a treatment for adult hospitalised patients with complicated Urinary Tract Infections (cUTI), including pyelonephritis. |
| 2014-08-19 | AstraZeneca | Results AstraZeneca announces positive top-line results from the Phase III programme of CAZ-AVI in patients with complicated intra-abdominal infections (cIAI) astrazeneca.com ↗
AstraZeneca today announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal Phase III studies investigating the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalised adult patients with complicated intra-abdominal infections. |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ceftazidime-avibactam | “Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or...” NCT05862402 ↗16“The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.” NCT07089186 ↗ “Ceftazidime-avibactam is a novel β-lactam β-lactamase inhibitor combination approved for adults and children 3 months and older with complicated intra-abdominal infection” PMID 34687548 ↗ Nov 2021 “This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone.” NCT03978091 ↗ “Ceftazidime-avibactam will be administered as 2.5 g q8h by intermittent infusion for 2 h” NCT06939829 ↗ “Ceftazidime-avibactam, tigecycline combined with metroperan or imipenem（MIC≤8mg/L）” NCT06051513 ↗ “Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)” NCT02732327 ↗ “ceftazidime-avibactam (CAZ-AVI)” NCT05850871 ↗ |
| Known as | AVYCAZ | “This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone.” NCT03978091 ↗ |
| Known as | CAZ-AVI | “continuous infusion of ceftazidime-avibactam (CAZ-AVI)” NCT06939829 ↗ |
| Action | Inhibit | “avibactam (AVI) inhibits co-produced serine β-lactamases” NCT07478484 ↗ |
| Modality | Other / unclassified | “novel β-lactam β-lactamase inhibitor combination” PMID 34687548 ↗ Nov 2021 |
| Route | Intravenous | “Patients will receive intravenous (IV) treatment for a minimum of 72 hours” NCT02475733 ↗ |