Last reviewed 2026-04-20 · How we verify

ALIS

At a glance

Approved indications

• Hypertensive disorder

Common side effects

• Diarrhea
• Rash
• Cough
• Edema (face, hands, or whole body)
• Elevated uric acid
• Gout
• Renal stones
• Abdominal pain
• Dyspepsia
• Gastroesophageal reflux

Serious adverse events

• Angioedema with respiratory symptoms
• Periorbital edema
• Seizures (tonic-clonic)

Key clinical trials

• Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
• Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
• A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants (PHASE1)
• Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection (PHASE3)
• Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections (PHASE3)
• Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone (PHASE3)
• Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212 (PHASE3)
• Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria (PHASE2)

Patents

Primary sources

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