Avibactam - PharmaKB

Avycaz, Zavicefta(avibactam)

Avycaz, Emblaveo, 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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Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
respiratory tract diseases	D012140
urogenital diseases	D000091642

Trade Name

FDA

EMA

Combinations

Avycaz, Emblaveo

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Avibactam sodium

Ceftazidime

Tradename	Company	Number	Date	Products
AVYCAZ	AbbVie	N-206494 RX	2015-02-25	1 products, RLD, RS

Avibactam sodium

Aztreonam

Tradename	Company	Number	Date	Products
EMBLAVEO	AbbVie	N-217906 RX	2025-02-07	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
avycaz	New Drug Application	2025-04-25
emblaveo	New Drug Application	2025-02-07

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
sepsis	EFO_0001420	D018805	A41.9
neutropenia	—	D009503	D70
fever	—	D005334	R50.9
urinary tract infections	EFO_0003103	D014552	N39.0
bacterial infections	—	D001424	A49
intraabdominal infections	—	D059413	—
pseudomonas infections	EFO_0001076	D011552	A41.52
bacterial skin diseases	—	D017192	—
escherichia coli infections	EFO_1001318	D004927	B96.20
soft tissue infections	—	D018461	—

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Agency Specific

FDA

EMA

Expiration	Code
AVIBACTAM SODIUM / CEFTAZIDIME, AVYCAZ, ALLERGAN
2025-12-20	NPP
2025-02-25	GAIN
2020-02-25	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Avibactam Sodium / Ceftazidime, Avycaz, Allergan
8969566	2032-06-15	DP
9284314	2032-06-15	DP
9695122	2032-06-15	DP
8471025	2031-08-12	DP
8835455	2030-10-08	DP
7612087	2026-11-12	DP
7112592	2026-01-07	DS, DP	U-282, U-2244, U-2508, U-3818

ATC Codes

No data

HCPCS

Code	Description
J0714	Injection, ceftazidime and avibactam, 0.5 g/0.125 g

Clinical

Clinical Trials

81 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544	—	3	4	7	6	11	31
Communicable diseases	D003141	—	—	1	2	6	5	8	22
Intraabdominal infections	D059413	—	—	1	3	7	1	3	15
Healthcare-associated pneumonia	D000077299	—	—	1	—	2	3	4	10
Urinary tract infections	D014552	EFO_0003103	N39.0	1	3	4	1	1	10
Bacterial infections	D001424	—	A49	2	2	1	2	3	9
Sepsis	D018805	EFO_0001420	A41.9	1	—	2	3	3	9
Pneumonia	D011014	EFO_0003106	J18	2	—	2	3	1	8
Gram-negative bacterial infections	D016905	—	—	—	3	1	1	3	8
Ventilator-associated pneumonia	D053717	EFO_1001865	J95.851	—	—	2	2	3	7

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Septic shock	D012772	—	A48.3	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neutropenia	D009503	—	D70	—	1	—	—	—	1
Neoplasms	D009369	—	C80	—	1	—	—	—	1
Fever	D005334	—	R50.9	—	1	—	—	—	1
Febrile neutropenia	D064147	—	—	—	1	—	—	—	1
Hyperthermia	D000084462	—	—	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	8	—	—	—	—	8
Renal insufficiency	D051437	—	N19	1	—	—	—	2	3
Pharmacokinetics	D010599	—	—	2	—	—	—	—	2
Systemic inflammatory response syndrome	D018746	EFO_1001478	R65.10	1	—	—	—	—	1
Aids-related complex	D000386	EFO_0007137	B20	1	—	—	—	—	1
Peritonitis	D010538	EFO_0008588	K65	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Mycoses	D009181	—	B35-B49	—	—	—	—	1	1
Respiratory distress syndrome	D012128	EFO_1000637	J80	—	—	—	—	1	1
Acute lung injury	D055371	EFO_0004610	—	—	—	—	—	1	1
Newborn respiratory distress syndrome	D012127	—	P22	—	—	—	—	1	1
End stage liver disease	D058625	EFO_1001311	K72.1	—	—	—	—	1	1
Liver failure	D017093	—	K72.9	—	—	—	—	1	1
Acute-on-chronic liver failure	D065290	—	—	—	—	—	—	1	1
Critical care	D003422	—	—	—	—	—	—	1	1
Microbial drug resistance	D004352	—	—	—	—	—	—	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