Last reviewed · How we verify
VX-121/TEZ/D-IVA
VX-121/TEZ/D-IVA is a triple combination of a cystic fibrosis transmembrane conductance regulator (CFTR) corrector (VX-121), a CFTR potentiator (tezacaftor), and a CFTR amplifier (ivacaftor).
VX-121/TEZ/D-IVA is a triple combination of a cystic fibrosis transmembrane conductance regulator (CFTR) corrector (VX-121), a CFTR potentiator (tezacaftor), and a CFTR amplifier (ivacaftor). Used for Cystic fibrosis in patients with one or two Phe508del alleles, Cystic fibrosis in patients with one F508del allele and one minimal function mutation.
At a glance
| Generic name | VX-121/TEZ/D-IVA |
|---|---|
| Also known as | VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, VX-121/tezacaftor/deutivacaftor |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Drug class | CFTR modulator |
| Target | CFTR |
| Modality | Small molecule |
| Therapeutic area | Pulmonology |
| Phase | Phase 3 |
Mechanism of action
This triple combination aims to improve CFTR function by correcting misfolded CFTR proteins, potentiating the activity of residual CFTR proteins, and amplifying the activity of CFTR proteins. This approach has the potential to improve lung function and reduce pulmonary exacerbations in patients with cystic fibrosis.
Approved indications
- Cystic fibrosis in patients with one or two Phe508del alleles
- Cystic fibrosis in patients with one F508del allele and one minimal function mutation
Common side effects
- Upper respiratory tract infection
- Nausea
- Diarrhea
Key clinical trials
- Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants (PHASE1)
- Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older (PHASE3)
- Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age (PHASE3)
- A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA) (PHASE1)
- A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy (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)
- 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)
- A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists (PHASE1)
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 |