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Amikacin liposomal inhaled - Insmed

Drug Profile

Amikacin liposomal inhaled - Insmed

Alternative Names: ALIS; Amikacin Liposome Inhalation Suspension; Arikace; ARIKAYCE; Liposomal amikacin for inhalation; SLIT™ Amikacin; TR-02

Latest Information Update: 29 Feb 2024

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At a glance

  • Originator Transave
  • Developer Insmed; National Institute of Allergy and Infectious Diseases; Oregon Health & Science University; University of Texas Health Science Center at Tyler
  • Class Aminoglycosides; Anti-infectives; Antibacterials; Small molecules
  • Mechanism of Action Protein 30S ribosomal subunit inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Nontuberculous mycobacterium infections; Cystic fibrosis-associated respiratory tract infections
  • New Molecular Entity No

Highest Development Phases

  • Marketed Nontuberculous mycobacterium infections
  • Preregistration Cystic fibrosis-associated respiratory tract infections
  • Phase II Bronchiectasis

Most Recent Events

  • 31 Dec 2023 Insmed has patent protection for amikacin liposomal inhaled in Europe, Japan, China, Korea, Australia, and India
  • 31 Dec 2023 Insmed has patents pending that relate to the ARIKAYCE composition and/or its use in treating various pulmonary disorders, including NTM lung disease in multiple countries
  • 05 Sep 2023 Efficacy and adverse events data from the phase III ARISE trial in Nontuberculous mycobacterium infections released by Insmed
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