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Placebo matched to VX-661/ ivacaftor
Placebo matched to VX-661/ ivacaftor is a CFTR modulator combination (corrector + potentiator) Small molecule drug developed by Vertex Pharmaceuticals Incorporated. It is currently in Phase 3 development for Cystic fibrosis in patients with specific CFTR mutations responsive to CFTR modulators.
This is a placebo control arm in a clinical trial comparing VX-661 (a CFTR corrector) combined with ivacaftor (a CFTR potentiator) against placebo in cystic fibrosis patients.
This is a placebo control arm in a clinical trial comparing VX-661 (a CFTR corrector) combined with ivacaftor (a CFTR potentiator) against placebo in cystic fibrosis patients. Used for Cystic fibrosis in patients with specific CFTR mutations responsive to CFTR modulators.
At a glance
| Generic name | Placebo matched to VX-661/ ivacaftor |
|---|---|
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Drug class | CFTR modulator combination (corrector + potentiator) |
| Target | CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) |
| Modality | Small molecule |
| Therapeutic area | Pulmonary / Genetic Disorders |
| Phase | Phase 3 |
Mechanism of action
VX-661 is a cystic fibrosis transmembrane conductance regulator (CFTR) corrector that helps misfolded CFTR protein fold correctly and traffic to the cell surface. Ivacaftor is a CFTR potentiator that increases the open probability of the CFTR channel, allowing chloride ions to flow through. Together, they work synergistically to restore CFTR function in patients with specific CFTR mutations.
Approved indications
- Cystic fibrosis in patients with specific CFTR mutations responsive to CFTR modulators
Common side effects
- Headache
- Nausea
- Diarrhea
- Abdominal pain
- Rash
Key clinical trials
- 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 (PHASE2)
- A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF) (PHASE3)
- Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation (PHASE3)
- A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation (PHASE3)
- Gut Imaging for Function & Transit in Cystic Fibrosis Study 2 (PHASE2)
- A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (PHASE2)
- A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes (PHASE3)
- Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis (PHASE1, PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo matched to VX-661/ ivacaftor CI brief — competitive landscape report
- Placebo matched to VX-661/ ivacaftor updates RSS · CI watch RSS
- Vertex Pharmaceuticals Incorporated portfolio CI
Frequently asked questions about Placebo matched to VX-661/ ivacaftor
What is Placebo matched to VX-661/ ivacaftor?
How does Placebo matched to VX-661/ ivacaftor work?
What is Placebo matched to VX-661/ ivacaftor used for?
Who makes Placebo matched to VX-661/ ivacaftor?
What drug class is Placebo matched to VX-661/ ivacaftor in?
What development phase is Placebo matched to VX-661/ ivacaftor in?
What are the side effects of Placebo matched to VX-661/ ivacaftor?
What does Placebo matched to VX-661/ ivacaftor target?
Related
- Drug class: All CFTR modulator combination (corrector + potentiator) drugs
- Target: All drugs targeting CFTR (Cystic Fibrosis Transmembrane Conductance Regulator)
- Manufacturer: Vertex Pharmaceuticals Incorporated — full pipeline
- Therapeutic area: All drugs in Pulmonary / Genetic Disorders
- Indication: Drugs for Cystic fibrosis in patients with specific CFTR mutations responsive to CFTR modulators
- Compare: Placebo matched to VX-661/ ivacaftor vs similar drugs
- Pricing: Placebo matched to VX-661/ ivacaftor cost, discount & access