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VX-661 plus ivacaftor combination
VX-661 is a cystic fibrosis transmembrane conductance regulator (CFTR) corrector, and ivacaftor is a CFTR potentiator.
VX-661 is a cystic fibrosis transmembrane conductance regulator (CFTR) corrector, and ivacaftor is a CFTR potentiator. Used for Cystic fibrosis in patients with one or two copies of the F508del mutation.
At a glance
| Generic name | VX-661 plus ivacaftor combination |
|---|---|
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Drug class | CFTR modulator |
| Target | CFTR |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
The combination of VX-661 and ivacaftor works by correcting and potentiating the function of the CFTR protein, which is responsible for transporting chloride ions across cell membranes in the lungs, liver, pancreas, and intestine. This helps to improve the function of these organs and reduce the severity of cystic fibrosis symptoms.
Approved indications
- Cystic fibrosis in patients with one or two copies of the F508del mutation
Common side effects
- Upper respiratory tract infection
- Nausea
- Headache
Key clinical trials
- Modulate-CF: Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators
- Trikafta for Patients With Non-cystic Fibrosis Bronchiectasis (PHASE4)
- Personalized Theratyping Trial (EARLY_PHASE1)
- Impact of Elexacaftor-Tezacaftor-Ivacaftor Treatment on Metabolic, Epigenetic and Fecal Microbiota Profiles in People With Cystic Fibrosis.
- Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del (PHASE3)
- Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial (NA)
- Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age (PHASE3)
- Sinus Disease in Young Children With Cystic Fibrosis
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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