Avibactam

Overview

Avibactam is a non-β-lactam β-lactamase inhibitor that is available in combination with ceftazidime (Avycaz). This combination was approved by the FDA on February 25, 2015 for the treatment of complicated intra-abdominal infections in combination with metronidazole, and the treatment of complicated urinary tract infections, including pyelonephritis caused by antibiotic resistant-pathogens, including those caused by multi-drug resistant gram-negative bacterial pathogens. As there is limited clinical safety and efficacy data, Avycaz should be reserved for patients over 18 years old who have limited or not alternative treatment options.

Indication

临床用于成人复杂性腹腔内感染；复杂性尿路感染（cUTI），包括肾脏感染（肾盂肾炎）；革兰氏阴性菌感染

Associated Conditions

Bacterial Infections
Complicated Intra-Abdominal Infections (cIAIs)
Complicated Urinary Tract Infection
Nosocomial Pneumonia
Ventilator Associated Bacterial Pneumonia (VABP)
Complicated Pyelonephritis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria	2025/09/16	NCT07176247	N/A	ENROLLING_BY_INVITATION	French Society for Intensive Care
To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults	2024/09/19	NCT06593054	Phase 1	Completed	Pfizer
To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects	2022/04/22	NCT05340530	Phase 1	UNKNOWN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.	2021/07/22	NCT04973826	Phase 1	Completed	Pfizer
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment	2020/07/24	NCT04486625	Phase 1	Completed	Pfizer
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)	2012/09/21	NCT01689207	Phase 1	Completed	Pfizer
A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately	2011/09/09	NCT01430910	Phase 1	Completed	Pfizer
Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma	2011/07/15	NCT01395420	Phase 1	Completed	Pfizer
A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects	2011/02/08	NCT01291602	Phase 1	Completed	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
AVYCAZ	Allergan, Inc.	0456-2700	INTRAVENOUS	0.5 g in 1 1	2/1/2024
EMBLAVEO	AbbVie Inc.	0074-3878	INTRAVENOUS	42.3 mg in 1 mL	2/7/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Emblaveo	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	4/22/2024
Zavicefta	Pfizer Ireland Pharmaceuticals Unlimited Company,Operations Support Group,Ringaskiddy P43 X336,Ireland	Authorised	6/23/2016

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G	ACS Dobfar S.p.A., ACS Dobfar SpA (Sterile ceftazidime carbonate blend) (Drug Product Intermediate)	SIN15870P	INJECTION, POWDER, FOR SOLUTION	500mg	12/12/2019

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Hospira Australia Emblaveo for Injection Aztreonam and Avibactam (1.5g/0.5g) Powder for Solution for Injection Single-Dose Vial	490652	Hospira Australia Pty Ltd	Medicine	A	6/3/2025
Emblaveo powder for concentrate for solution for infusion Aztreonam and Avibactam 1.5 g/0.5 g vial	456351	Hospira Australia Pty Ltd	Medicine	A	7/25/2024
ZAVICEFTA 2000/500 ceftazidime (as pentahydrate) and avibactam (as sodium) powder for injection vial	301205	Pfizer Australia Pty Ltd	Medicine	A	2/22/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Prokaryotics Secures Global Rights to Novel Gram-Negative Antibiotic Potentiator NAB741

4 months ago

Prokaryotics Inc. has entered into a licensing agreement with Northern Antibiotics for worldwide rights to develop NAB741, a non-bioactive polymyxin designed to enhance antibiotic efficacy against Gram-negative bacteria.

Complicated Urinary Tract Infection Pipeline Shows Robust Development with 12+ Companies Advancing Novel Therapies

5 months ago

DelveInsight's 2025 pipeline analysis reveals 12+ pharmaceutical companies actively developing therapies for complicated urinary tract infections, with several candidates in advanced clinical stages.

FDA Approves Novel Antibiotic Combination Emblaveo for Complex Abdominal Infections

8 months ago

AbbVie's Emblaveo, a groundbreaking aztreonam-avibactam combination, receives FDA approval for treating complicated intra-abdominal infections with limited treatment options.

Aztreonam-Avibactam Shows Promise Against Multidrug-Resistant Gram-Negative Infections

a year ago

• A Phase 3 clinical trial indicates that aztreonam-avibactam is a potential treatment for patients with serious gram-negative bacterial infections that are resistant to multiple drugs. • The European Medicines Agency approved aztreonam-avibactam in April based on two Phase 3 trials demonstrating its efficacy against various multidrug-resistant infections. • A study in Massachusetts found that nursing home residents with documented penicillin allergies are less likely to receive beta-lactam antibiotics, potentially increasing broad-spectrum antibiotic use.

DAV132 Adsorbent Does Not Interfere with Plasma Concentrations of Key Antibiotics