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
- -
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
- Conditions
- Interventions
- First Posted Date
- 2010-10-20
- Last Posted Date
- 2015-10-05
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 312
- Registration Number
- NCT01225211
Rollover Study of VX-770 in Cystic Fibrosis Subjects
- First Posted Date
- 2010-05-05
- Last Posted Date
- 2015-07-07
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 192
- Registration Number
- NCT01117012
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation
- First Posted Date
- 2009-08-06
- Last Posted Date
- 2015-09-11
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 140
- Registration Number
- NCT00953706
- Locations
- 🇺🇸
Maine Medical Center, Portland, Maine, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸University of Miami Miller School of Medicine, Miami, Florida, United States
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation
- First Posted Date
- 2009-05-28
- Last Posted Date
- 2012-08-21
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 52
- Registration Number
- NCT00909727
- Locations
- 🇺🇸
The Children's Mercy Hospital, Kansas City, Missouri, United States
🇺🇸Children's Memorial Hospital, Chicago, Illinois, United States
🇺🇸Riley Hospital for Children, Indianapolis, Indiana, United States
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
- First Posted Date
- 2009-05-28
- Last Posted Date
- 2013-01-18
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 167
- Registration Number
- NCT00909532
- Locations
- 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇦🇺Royal Children's Hospital Brisbane, Herston, Queensland, Australia
Drug Development Updates
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