Lumacaftor
- Generic Name
- Lumacaftor
- Brand Names
- Orkambi
- Drug Type
- Small Molecule
- Chemical Formula
- C24H18F2N2O5
- CAS Number
- 936727-05-8
- Unique Ingredient Identifier
- EGP8L81APK
- Background
Lumacaftor is a drug used in combination with Ivacaftor as the fixed dose combination product Orkambi for the management of Cystic Fibrosis (CF) in patients aged 6 years and older. Cystic Fibrosis is an autosomal recessive disorder caused by one of several different mutations in the gene for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) prot...
- Indication
When used in combination with the drug lumacaftor as the product Orkambi, ivacaftor is indicated for the management of CF in patients aged one year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both ...
- Associated Conditions
- Cystic Fibrosis (CF)
- Associated Therapies
- -
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
- 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
Phase 1, QT/QTC Interval Study in Healthy Subjects
- Conditions
- Interventions
- 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
- 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
- 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 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
- Conditions
- Interventions
- First Posted Date
- 2013-01-15
- Last Posted Date
- 2013-11-15
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Target Recruit Count
- 80
- Registration Number
- NCT01768663
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
Drug Development Updates
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