Last reviewed 2026-04-22 · How we verify

Amikacin (Inhalation)

Amikacin (Inhalation) is a Aminoglycoside antibiotic Small molecule drug developed by The University of Queensland. It is currently FDA-approved for Cystic fibrosis with chronic Pseudomonas aeruginosa lung infection, Chronic respiratory tract infections caused by susceptible gram-negative bacteria.

Amikacin is an aminoglycoside antibiotic that binds to bacterial ribosomes and inhibits protein synthesis, leading to bacterial cell death.

Amikacin is an aminoglycoside antibiotic that binds to bacterial ribosomes and inhibits protein synthesis, leading to bacterial cell death. Used for Cystic fibrosis with chronic Pseudomonas aeruginosa lung infection, Chronic respiratory tract infections caused by susceptible gram-negative bacteria.

At a glance

Mechanism of action

Amikacin irreversibly binds to the 30S ribosomal subunit of susceptible bacteria, disrupting protein synthesis and causing bactericidal activity. The inhalation formulation delivers the drug directly to the lungs, achieving high local concentrations to treat respiratory tract infections, particularly in cystic fibrosis and chronic Pseudomonas aeruginosa infections.

Approved indications

• Cystic fibrosis with chronic Pseudomonas aeruginosa lung infection
• Chronic respiratory tract infections caused by susceptible gram-negative bacteria

Common side effects

• Cough
• Bronchospasm
• Wheezing
• Dyspnea
• Ototoxicity (with systemic absorption)
• Nephrotoxicity (with systemic absorption)

Key clinical trials

• Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
• Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
• Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia (PHASE4)
• Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia (PHASE3)
• Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection (PHASE2)
• ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension (PHASE3)
• Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (PHASE2, PHASE3)
• A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Amikacin (Inhalation) CI brief — competitive landscape report
• Amikacin (Inhalation) updates RSS · CI watch RSS
• The University of Queensland portfolio CI

Frequently asked questions about Amikacin (Inhalation)

Related

• Drug class: All Aminoglycoside antibiotic drugs
• Target: All drugs targeting Bacterial 30S ribosomal subunit
• Manufacturer: The University of Queensland — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for Cystic fibrosis with chronic Pseudomonas aeruginosa lung infection
• Indication: Drugs for Chronic respiratory tract infections caused by susceptible gram-negative bacteria

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing