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.
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- Associated Conditions
- Cystic Fibrosis (CF)
- Associated Therapies
- -
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
- First Posted Date
- 2016-04-19
- Last Posted Date
- 2018-11-19
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 14
- Registration Number
- NCT02742519
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Phase 2
Completed
- Conditions
- Interventions
- First Posted Date
- 2016-04-06
- Last Posted Date
- 2019-10-23
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 41
- Registration Number
- NCT02730208
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
- First Posted Date
- 2015-08-05
- Last Posted Date
- 2018-06-12
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 168
- Registration Number
- NCT02516410
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Phase 2
Completed
- Conditions
- Interventions
- First Posted Date
- 2015-07-24
- Last Posted Date
- 2021-07-19
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 34
- Registration Number
- NCT02508207
Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)
Completed
- Conditions
- First Posted Date
- 2015-05-15
- Last Posted Date
- 2020-11-13
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 75
- Registration Number
- NCT02445053
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
- First Posted Date
- 2015-04-08
- Last Posted Date
- 2019-01-08
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 156
- Registration Number
- NCT02412111
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
Phase 3
Completed
- Conditions
- Interventions
- First Posted Date
- 2015-03-18
- Last Posted Date
- 2018-06-12
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 248
- Registration Number
- NCT02392234
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
Phase 3
Completed
- Conditions
- Interventions
- First Posted Date
- 2015-03-17
- Last Posted Date
- 2017-12-06
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 46
- Registration Number
- NCT02390219
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
Phase 3
Completed
- Conditions
- Interventions
- First Posted Date
- 2015-01-27
- Last Posted Date
- 2018-06-12
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 510
- Registration Number
- NCT02347657
(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
Not Applicable
Completed
- Conditions
- Interventions
- First Posted Date
- 2014-12-08
- Last Posted Date
- 2019-01-09
- Lead Sponsor
- Richard Barry Moss
- Target Recruit Count
- 8
- Registration Number
- NCT02310789
- Locations
- 🇺🇸
Stanford Hospital and Clinics, Stanford, California, United States
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