NDAINHALATIONSUSPENSION, LIPOSOMALPriority Review
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
6/8 — Strong
Priority Review
ARIKAYCE KIT (amikacin) by Insmed. Approved for aminoglycoside antibacterial [epc]. First approved in 2018.
Drug data last refreshed 25m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARIKAYCE KIT is a liposomal inhalation suspension of amikacin, an aminoglycoside antibiotic approved in 2018 for treatment of nontuberculous mycobacterial (NTM) lung infections. It delivers the drug directly to the lungs via inhalation to treat chronic airway infections caused by Mycobacterium avium complex (MAC) and other resistant organisms.
Peak8.9 years to LOE
Product is at peak commercial stage with stable market presence; team is likely at full capacity with focus on maintaining market share and optimizing market penetration in NTM specialist segments.
Mechanism of Action
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin
Started Jun 2025
105 enrolled
Ototoxicity, Drug-Induced
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Started Apr 2021
425 enrolled
Mycobacterium Infections, Nontuberculous
Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease
Started Oct 2016
30 enrolled
Mycobacterium Infections, NontuberculousMycobacteria, Atypical
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Started Apr 2013
725 enrolled
Pneumonia, Bacterial
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
Started Oct 2012
206 enrolled
Cystic Fibrosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.