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ELX/TEZ/IVA
ELX/TEZ/IVA is a CFTR modulator combination Small molecule drug developed by Vertex Pharmaceuticals Incorporated. It is currently in Phase 3 development for Cystic fibrosis in patients aged 6 years and older with at least one F508del-CFTR mutation, Cystic fibrosis in patients with other CFTR mutations responsive to CFTR modulation. Also known as: VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor.
ELX/TEZ/IVA is a triple combination of CFTR modulators that work together to restore function of the cystic fibrosis transmembrane conductance regulator protein.
ELX/TEZ/IVA is a medication being studied for the treatment of Cystic Fibrosis, as part of a Phase 3 clinical trial. It is classified as a 80S Ribosome modulator, a type of MODULATOR drug.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Rare-disease pathway favourability
+5.0pp
Rare-disease drugs benefit from FDA Orphan Drug Act, smaller pivotal trials, and more flexible endpoints. Approval rates run ~5pp above baseline. -
Big-pharma sponsor
+3.0pp
Vertex Pharmaceuticals Incorporated is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ELX/TEZ/IVA |
|---|---|
| Also known as | VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Drug class | CFTR modulator combination |
| Target | CFTR (cystic fibrosis transmembrane conductance regulator) |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Genetic Disease |
| Phase | Phase 3 |
Mechanism of action
Elexacaftor (ELX) is a CFTR corrector that helps the protein fold properly and traffic to the cell surface. Tezacaftor (TEZ) is another corrector that enhances this effect. Ivacaftor (IVA) is a potentiator that increases the open probability of the CFTR channel once it reaches the cell membrane. Together, these three agents address multiple defects in CFTR function caused by F508del and other mutations.
Approved indications
- Cystic fibrosis in patients aged 6 years and older with at least one F508del-CFTR mutation
- Cystic fibrosis in patients with other CFTR mutations responsive to CFTR modulation
Common side effects
- Headache
- Nausea
- Diarrhea
- Rash
- Elevated transaminases
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
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:
- ELX/TEZ/IVA CI brief — competitive landscape report
- ELX/TEZ/IVA updates RSS · CI watch RSS
- Vertex Pharmaceuticals Incorporated portfolio CI
Frequently asked questions about ELX/TEZ/IVA
What is ELX/TEZ/IVA?
How does ELX/TEZ/IVA work?
What is ELX/TEZ/IVA used for?
Who makes ELX/TEZ/IVA?
Is ELX/TEZ/IVA also known as anything else?
What drug class is ELX/TEZ/IVA in?
What development phase is ELX/TEZ/IVA in?
What are the side effects of ELX/TEZ/IVA?
What does ELX/TEZ/IVA target?
Related
- Drug class: All CFTR modulator combination drugs
- Target: All drugs targeting CFTR (cystic fibrosis transmembrane conductance regulator)
- Manufacturer: Vertex Pharmaceuticals Incorporated — full pipeline
- Therapeutic area: All drugs in Respiratory / Genetic Disease
- Indication: Drugs for Cystic fibrosis in patients aged 6 years and older with at least one F508del-CFTR mutation
- Indication: Drugs for Cystic fibrosis in patients with other CFTR mutations responsive to CFTR modulation
- Also known as: VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing