avibactam
Trade name: Avycaz
Approved
Feb 25, 2015
Avibactam (formerly NXL104, AVE1330A) is a synthetic non-β-lactam, covalent, slowly reversible β-lactamase inhibitor that inhibits the activities of Ambler class A and C β-lactamases and some Ambler class D enzymes. The combination of ceftazidime with avibactam exhibited broad-spectrum activity against Ambler class A- and class C-producing Enterobacteriaceae. AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam indicated for the treatment of patients with the following infections caused by designated susceptible microorganisms: Complicated Intra-abdominal Infections, used in combination with metronidazole and Complicated Urinary Tract Infections, including Pyelonephritis. — NCATS
Clinical trial activity
49 trials · 35 clinical orgs · 4 marketing orgs
Earliest trial started Nov 1, 2008 (NCT00690378)
Timeline
Indications
Studied for
- Abdominal Injuries · Phase 3
- Anti-Infective Agents · Phase 4
- Bacteremia · Phase 4
- Bacterial Infections · Phase 3
- Corneal Diseases · Phase 3
- Cystic Fibrosis · Phase 4
- Drugs, Investigational · Phase 1
- Febrile Neutropenia · Phase 2
- Gram-Negative Bacterial Infections · Phase 2
- Healthcare-Associated Pneumonia · Phase 4
- Healthy Volunteers · Phase 1
- Infections · Phase 2
- Inflammation · Phase 1
- Intestinal Neoplasms · Phase 1
- Intraabdominal Infections · Phase 4
- Kidney Diseases · Phase 1
- Neoplasms · Phase 2
- Pharmacokinetics · Phase 1
- Pneumonia, Ventilator-Associated · Phase 4
- Pyelonephritis · Phase 4
- Renal Insufficiency · Phase 1
- Safety · Phase 1
- Urinary Tract Infections · Phase 4
Mechanism of action
- Bacterial beta-lactamase TEMINHIBITOR
Bacterial beta-lactamase TEM inhibitor
Combination products
avycaz
with ceftazidime
Also known as avibactam and ceftazidime, zavicefta, ceftazidime-avibactam
emblaveo
with aztreonam
Approval history
- approvedPriority reviewFast trackFeb 25, 2015
Chemistry & pharmacology
SMILES
NC(=O)[C@@H]1CC[C@@H]2CN1C(=O)N2OS(=O)(=O)O- Mol. weight
- 265.25 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL1689063 ↗
- WikipediaAvibactam ↗
- NCATS7352665165 ↗
- ChEMBLCHEMBL2107817 ↗
Also known as
- ave1330a
- avibactam
- avibactam
- avibactam
- avibactam
- avibactam
- avibactam
- avibactam
- avibactam
- avibactam
- avibactam - ceftazidime
- avibactam, ceftazidime drug combination
- avibactam sodium
- avibactam sodium
- avibactam sodium
- avycaz
- avycaz
- avycaz
- ceftazidime / avibactam
- ceftazidime-avibactam
- nxl104
- nxl104
- nxl104
- nxl104
- nxl104
- nxl 104
- nxl-104
- nxl-104
- nxl-104
- nxl-104
- nxl-104
- nxl-104
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06939829 | Phase 4 | May 1, 2025 | Southeast University |
| NCT07089186 | Phase 3 | Apr 12, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06818565 | N/A | Feb 10, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06633718 | Phase 3 | Oct 31, 2024 | Qilu Pharmaceutical Co., Ltd. |
| NCT06462235 | Phase 2 | Sep 25, 2024 | AbbVie, Pfizer |
| NCT06593054 | Phase 1 | Jul 29, 2024 | Pfizer |
| NCT06528028 | Phase 4 | Jul 1, 2024 | Nanjing University |
| NCT05639647 | Phase 2 | Jan 23, 2023 | Pfizer |
| NCT05850871 | N/A | Jan 6, 2023 | Shandong first medical University, Shandong Province Qianfoshan Hospital |
| NCT05258851 | Phase 3 | Jun 1, 2022 | King Faisal University |
| NCT05340530 | Phase 1 | Apr 30, 2022 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT05588531 | Phase 1 | Dec 20, 2021 | Nanjing Yoko Biomedical Co., Ltd. |
| NCT04927312 | Phase 3 | Oct 1, 2021 | Pfizer |
| NCT04882085 | Phase 4 | Aug 26, 2021 | Pfizer |
| NCT04973826 | Phase 1 | Aug 20, 2021 | Pfizer |
| NCT04774094 | Phase 4 | May 21, 2021 | Pfizer |
| NCT04486625 | Phase 1 | Aug 10, 2020 | Pfizer |
| NCT04126031 | Phase 2 | Mar 10, 2020 | Allergan, Pfizer |
| NCT04040621 | Phase 1 | Nov 27, 2019 | Allergan, Pfizer |
| NCT03931876 | Phase 1 | Jun 24, 2019 | Arixa Pharmaceuticals, Nucleus Network Ltd |
Organizations
Research & Development (35)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 19 | 19 | 3 | 2008 |
| Pfizer | For profit | 12 | 12 | 4 | 2018 |
| Forest Laboratories | For profit | 9 | 3 | 3 | 2010 |
| Allergan | For profit | 4 | 0 | 3 | 2016 |
| IQVIA | For profit | 4 | 0 | 1 | 2011 |
| Novexel Inc | For profit | 2 | 1 | 1 | 2008 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 2 | 0 | 1 | 2015 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 2 | 2 | 1 | 2024 |
| AbbVie | For profit | 1 | 0 | 1 | 2024 |
| Arixa Pharmaceuticals | For profit | 1 | 1 | 1 | 2019 |
| Department of Health and Human Services | Government | 1 | 0 | 1 | 2018 |
| European Commission | Government | 1 | 0 | 1 | 2018 |
| Hammersmith Medicines Research | For profit | 1 | 0 | 1 | 2012 |
| Institute of Liver and Biliary Sciences, India | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd | For profit | 1 | 1 | 1 | 2022 |
| Karolinska Institute | Academic/Hospital | 1 | 0 | 1 | 2013 |
| King Faisal University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Michigan State University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Nanjing University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Nanjing Yoko Biomedical Co., Ltd. | For profit | 1 | 1 | 1 | 2021 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | NDA2 | Feb 25, 2015 |
| Allergan | For profit | NDA2 | Feb 25, 2015 |
| Forest Laboratories | For profit | NDA | — |
| GlaxoSmithKline | For profit | NDA2 | Feb 25, 2015 |