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

Latest Information Update: 10 Oct 2018

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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; 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 - Mycobacterial infections; Cystic fibrosis-associated respiratory tract infections
  • New Molecular Entity No

Highest Development Phases

  • Registered Mycobacterial infections
  • Preregistration Cystic fibrosis-associated respiratory tract infections
  • Phase II Bronchiectasis

Most Recent Events

  • 04 Oct 2018 Japanese Patent Office issues patent for amikacin liposome inhalation suspension for treating Infections (Pulmonary) in Japan
  • 28 Sep 2018 Registered for Mycobacterial infections (Adjunctive treatment, Treatment-resistant) in USA - First global approval (Inhalation)
  • 28 Sep 2018 Insmed intends to launch Amikacin liposomal inhaled in USA, in early Q4 of 2018
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