drugset
Drugs / ARIKACE™
last change Feb 2014 re-read 3 minutes ago

ARIKACE™

also known as ALIS · Amikacin Liposome Inhalation Suspension
Developed for
cystic fibrosis
Investigated by
Insmed Incorporated

Trials 1

today NCT00777296 · Ph 1/2
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT00777296 Feb 2007 → Feb 2008 cystic fibrosis Insmed Incorporated Completed No outcome recorded

Press releases naming this drug 18 releases

DateIssuerRelease
2014-02-19 Insmed Incorporated Insmed Provides Interim Update from Two-Year, Open-Label Extension Study of ARIKACE to Treat Pseudomonas aeruginosa in Cystic Fibrosis Patients insmed.com ↗
2014-02-10 Insmed Incorporated ARIKACE to Receive Orphan Medicinal Product Designation in the European Union to Treat Lung Infections Caused by Nontuberculous Mycobacteria insmed.com ↗
2013-10-15 Insmed Incorporated Insmed Completes Enrollment of Phase 2 Clinical Trial of ARIKACE to Treat Nontuberculous Mycobacteria Lung Disease in U.S. and Canada insmed.com ↗
2013-07-01 Insmed Incorporated ARIKACE Meets Primary Endpoint of Non-Inferiority to TOBI in Phase 3 Clinical Trial in Europe and Canada to Treat Pseudomonas aeruginosa in Cystic Fibrosis Patients insmed.com ↗
2013-06-28 Insmed Incorporated Insmed to Report Top-Line Results From Phase 3 Clinical Trial of ARIKACE to Treat Pseudomonas Aeruginosa in Cystic Fibrosis insmed.com ↗
2013-03-28 Insmed Incorporated ARIKACE Receives Orphan Drug Designation for Treating Infections Caused by Non-Tuberculous Mycobacteria insmed.com ↗
2012-11-13 Insmed Incorporated Insmed Announces CLEAR-108 Phase 3 Clinical Study of ARIKACE® in Cystic Fibrosis Patients with Pseudomonas Lung Infections Has Completed Target Enrollment insmed.com ↗
2012-08-02 Insmed Incorporated Insmed Receives Second Composition Of Matter Patent For ARIKACE® insmed.com ↗
2012-06-27 Insmed Incorporated Insmed Announces First Patient Dosed in TARGET-NTM Phase 2 Clinical Trial of ARIKACE® in Patients with Non-Tuberculous Mycobacteria (NTM) Lung Disease insmed.com ↗
2012-05-23 Insmed Incorporated Insmed Incorporated Begins Screening Patients For TARGET-NTM U.S. Clinical Trial Of ARIKACE® In Patients With Non-tuberculous Mycobacterial Lung Disease insmed.com ↗
2012-05-07 Insmed Incorporated Insmed Incorporated Announces Lifting of Clinical Hold by U.S. Food and Drug Administration on ARIKACE® in Cystic Fibrosis Patients With Pseudomonas Lung Infections insmed.com ↗
2012-04-16 Insmed Incorporated Insmed Announces First Patient Dosed in Pivotal European Phase 3 Clinical Study of ARIKACE® in Cystic Fibrosis Patients with Pseudomonas Lung Infections insmed.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as ARIKACE ClinicalTrials.gov intervention name — accepted as the source's own label NCT00777296 ↗
Known as ALIS “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI) and Amikacin Liposome Inhalation Suspension (ALIS) are all the same may be used interchangeably throughout the...” NCT00777296 ↗
Known as Amikacin Liposome Inhalation Suspension “Arikace™, Arikayce™, Liposomal Amikacin for Inhalation (LAI) and Amikacin Liposome Inhalation Suspension (ALIS) are all the same may be used interchangeably throughout the...” NCT00777296 ↗
Route Inhaled “by inhalation via a PARI eFlow® nebulizer” NCT00777296 ↗