Ivacaftor

Generic Name: Ivacaftor

Brand Names: Kalydeco, Orkambi, Symdeko, Trikafta (100 Mg / 50 Mg / 75 Mg; 150 Mg)

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈N_₂O_₃

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

TOPIC Trial for COPD

Early Phase 1

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Placebo
Drug: Ivacaftor

First Posted Date: 2014-05-12

Last Posted Date: 2017-02-24

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 12

Registration Number: NCT02135432

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

Phase 2

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: VX-661
Drug: Placebo matched to VX-661
Drug: Ivacaftor
Drug: Placebo matched to Ivacaftor

First Posted Date: 2014-02-25

Last Posted Date: 2018-04-13

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 40

Registration Number: NCT02070744

An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: ivacaftor
Drug: ciprofloxacin
Drug: VX-661

First Posted Date: 2013-12-19

Last Posted Date: 2014-03-26

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 34

Registration Number: NCT02015507

Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation

Phase 3

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Ivacaftor

First Posted Date: 2013-09-19

Last Posted Date: 2017-02-01

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 33

Registration Number: NCT01946412

CPET in CF Patients With One G551D Mutation Taking VX770

Phase 4

Conditions: Cystic Fibrosis

Interventions: Drug: placebo
Drug: ivacaftor

First Posted Date: 2013-09-09

Last Posted Date: 2016-07-25

Lead Sponsor: The Alfred

Target Recruit Count: 20

Registration Number: NCT01937325

Locations: 🇦🇺
The Alfred, Melbourne, Victoria, Australia

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

Phase 3

Completed

Conditions: Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Interventions: Drug: Lumacaftor Plus Ivacaftor Combination
Drug: Ivacaftor

First Posted Date: 2013-08-29

Last Posted Date: 2017-05-12

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 1164

Registration Number: NCT01931839

Phase 1, QT/QTC Interval Study in Healthy Subjects

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Lumacaftor
Drug: Lumacaftor Placebo
Drug: Ivacaftor
Drug: Ivacaftor Placebo
Drug: moxifloxacin hydrochloride

First Posted Date: 2013-07-29

Last Posted Date: 2014-08-11

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 200

Registration Number: NCT01910415

A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: lumacaftor
Drug: ivacaftor

First Posted Date: 2013-07-15

Last Posted Date: 2014-04-03

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 28

Registration Number: NCT01899105

Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Phase 3

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Lumacaftor
Drug: Ivacaftor

First Posted Date: 2013-07-11

Last Posted Date: 2017-06-20

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 62

Registration Number: NCT01897233

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

Phase 3

Completed

Conditions: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Interventions: Drug: Placebo
Drug: Lumacaftor Plus Ivacaftor Combination
Drug: Ivacaftor

First Posted Date: 2013-03-08

Last Posted Date: 2015-08-31

Lead Sponsor: Vertex Pharmaceuticals Incorporated

Target Recruit Count: 559

Registration Number: NCT01807923

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy