AZACTAM

LOE Approaching

aztreonam

NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

CLINICAL PHARMACOLOGY Single 30-minute intravenous infusions of 500 mg, 1 g, and 2 g doses of AZACTAM in healthy subjects produced aztreonam peak serum levels of 54 mcg/mL, 90 mcg/mL, and 204 mcg/mL, respectively, immediately after administration; at 8 hours, serum levels were 1 mcg/mL, 3 mcg/mL,…

Pharmacologic Class:

Monobactam Antibacterial

Clinical Trials (5)

NCT06462235Phase 2Recruiting

A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

Started Sep 2024
48 enrolled
Gram-negative Bacterial Infection
NCT05639647Phase 2Recruiting

Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections

Started Apr 2023
48 enrolled
Gram-negative Bacterial Infections
NCT04973826Phase 1Completed

Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.

Started Aug 2021
12 enrolled
Healthy
NCT04486625Phase 1Completed

Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment

Started Aug 2020
11 enrolled
Renal Insufficiency
NCT03696290Phase 4Terminated

Value of Inhaled Treatment With Aztreonam Lysine in Bronchiectasis

Started Oct 2019
34 enrolled
Bronchiectasis Adult