Ivacaftor

Generic Name
Ivacaftor
Brand Names
Kalydeco, Orkambi, Symdeko, Trikafta (100 Mg / 50 Mg / 75 Mg; 150 Mg)
Drug Type
Small Molecule
Chemical Formula
C24H28N2O3
CAS Number
873054-44-5
Unique Ingredient Identifier
1Y740ILL1Z
Background

Ivacaftor (also known as Kalydeco or VX-770) is a drug used for the management of Cystic Fibrosis (CF). It is manufactured and distributed by Vertex Pharmaceuticals. It was approved by the Food and Drug Administration on January 31, 2012, and by Health Canada in late 2012. Ivacaftor is administered as a monotherapy and also administered in combination with o...

Indication

When used as monotherapy as the product Kalydeco, ivacaftor is indicated for the treatment of cystic fibrosis (CF) in patients aged one month and older who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
...

Associated Conditions
Cystic Fibrosis (CF)
Associated Therapies
-
Clinical Trials
Related News

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

First Posted Date
2013-03-08
Last Posted Date
2016-09-27
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
563
Registration Number
NCT01807949

Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients

Not Applicable
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: ivacaftor
Drug: Placebo
First Posted Date
2013-02-05
Last Posted Date
2020-09-29
Lead Sponsor
University of California, San Francisco
Target Recruit Count
10
Registration Number
NCT01784419
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

First Posted Date
2013-01-15
Last Posted Date
2013-11-15
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
80
Registration Number
NCT01768663

Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Ivacaftor
First Posted Date
2012-10-16
Last Posted Date
2017-05-12
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
125
Registration Number
NCT01707290

Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Ivacaftor
First Posted Date
2012-10-12
Last Posted Date
2016-04-05
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
35
Registration Number
NCT01705145

Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function

First Posted Date
2012-09-14
Last Posted Date
2015-05-19
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
24
Registration Number
NCT01685801

Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Placebo
Drug: Ivacaftor
First Posted Date
2012-06-08
Last Posted Date
2015-02-12
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
70
Registration Number
NCT01614457

Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Ivacaftor
Drug: Placebo
First Posted Date
2012-06-08
Last Posted Date
2014-10-29
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
39
Registration Number
NCT01614470

Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

First Posted Date
2012-02-13
Last Posted Date
2018-04-13
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
194
Registration Number
NCT01531673
Locations
🇬🇧

Vertex Investigational Site, Cardiff, Vale Of Glamorgen, United Kingdom

Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation

Phase 2
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Ivacaftor
Drug: Placebo
First Posted Date
2010-12-17
Last Posted Date
2013-02-11
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
21
Registration Number
NCT01262352
© Copyright 2024. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy