Avycaz, Zavicefta(avibactam)
Avycaz, Zavicefta (avibactam) is a small molecule pharmaceutical. Avibactam was first approved as Avycaz on 2015-02-25. It is used to treat escherichia coli infections, intraabdominal infections, klebsiella infections, proteus infections, and pseudomonas infections in the USA. It has been approved in Europe to treat bacterial pneumonia, gram-negative bacterial infections, pneumonia, soft tissue infections, and urinary tract infections.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Combinations
Avycaz
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Avibactam sodium
+
Ceftazidime
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AVYCAZ | Allergan | N-206494 RX | 2015-02-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| avycaz | New Drug Application | 2020-12-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
| intraabdominal infections | — | D059413 | — |
| klebsiella infections | EFO_1001353 | D007710 | — |
| proteus infections | EFO_1001130 | D011512 | — |
| pseudomonas infections | EFO_0001076 | D011552 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AVIBACTAM SODIUM / CEFTAZIDIME, AVYCAZ, ALLERGAN | |||
| 2025-12-20 | NPP | ||
| 2025-02-25 | GAIN | ||
| 2020-02-25 | NCE | ||
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J0714 | Injection, ceftazidime and avibactam, 0.5 g/0.125 g |
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 3 | 3 | 1 | — | 7 |
| Intraabdominal infections | D059413 | — | 2 | 2 | 1 | 1 | 6 | ||
| Healthcare-associated pneumonia | D000077299 | 1 | — | 1 | 2 | 1 | 5 | ||
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | 1 | 1 | 1 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | — | 1 | — | 1 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | 2 | — | 1 | — | 2 | 5 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | 1 | 2 |
| Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | 1 | — | — | — | — | 1 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 1 | 1 |
| Cross infection | D003428 | — | — | — | — | 1 | 1 | ||
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | A41.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AVIBACTAM |
| INN | avibactam |
| Description | Avibactam is a member of the class of azabicycloalkanes that is (2S,5R)-7-oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide in which the amino hydrogen at position 6 is replaced by a sulfooxy group. Used (in the form of its sodium salt) in combination with ceftazidime pentahydrate for the treatment of complicated urinary tract infections including pyelonephritis. It has a role as an antibacterial drug, an antimicrobial agent and an EC 3.5.2.6 (beta-lactamase) inhibitor. It is a monocarboxylic acid amide, a member of ureas, an azabicycloalkane and a hydroxylamine O-sulfonic acid. It is a conjugate acid of an avibactam(1-). |
| Classification | Small molecule |
| Drug class | beta-lactamase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)[C@@H]1CC[C@@H]2CN1C(=O)N2OS(=O)(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 1192500-31-4 |
| RxCUI | 1603834 |
| ChEMBL ID | CHEMBL1689063 |
| ChEBI ID | 85984 |
| PubChem CID | 9835049 |
| DrugBank | DB09060 |
| UNII ID | 7352665165 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Avycaz - Allergan
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Avycaz - Warner Chilcott
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Zavicefta - Pfizer
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,790 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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521 adverse events reported
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