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VX-445/TEZ/IVA
VX-445/TEZ/IVA is a combination of three cystic fibrosis transmembrane conductance regulator (CFTR) modulators.
VX-445/TEZ/IVA is a combination of three cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Used for Cystic fibrosis.
At a glance
| Generic name | VX-445/TEZ/IVA |
|---|---|
| Also known as | VX-445/VX-661/VX-770, VX-445/tezacaftor/ivacaftor |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Drug class | CFTR modulator |
| Target | CFTR |
| Modality | Small molecule |
| Therapeutic area | Pulmonology |
| Phase | Phase 3 |
Mechanism of action
VX-445 is a corrector that stabilizes the CFTR protein, while TEZ and IVA are potentiators that increase the activity of the CFTR protein. This combination aims to improve CFTR function in patients with cystic fibrosis.
Approved indications
- Cystic fibrosis
Common side effects
- Upper respiratory tract infection
- Nausea
- Headache
Key clinical trials
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older (PHASE3)
- Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del (PHASE3)
- Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age (PHASE3)
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older (PHASE3)
- A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF) (PHASE3)
- A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy (PHASE3)
- Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older (PHASE3)
- 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)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |