Drugs / ELX/TEZ/IVA
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04599465 | Jan 2021 → Jul 2022 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents New Data on ALYFTREK® at European Cystic Fibrosis Conference vrtx.com ↗
ALYFTREK Phase 3 data on children with cystic fibrosis ages 2 to 5 with vanzacaftor/tezacaftor/deutivacaftor-responsive genotypes including F/F and F/MF shows 65% reached sweat chloride levels of <30 mmol/L; |
| 2025-10-23 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents New Data Across Portfolio of Cystic Fibrosis Medicines Including ALYFTREK® at the North American Cystic Fibrosis Conference vrtx.com ↗
Data presented on outcomes following treatment with CFTR modulators add to growing body of evidence that reduced level of sweat chloride is associated with improved clinical outcomes, particularly in younger people with cystic fibrosis |
| 2025-06-06 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents New Data on Benefits of ALYFTREK® and Importance of Achieving Lower Sweat Chloride Levels at the European Cystic Fibrosis Conference vrtx.com ↗
For all clinical outcomes in the study, SwCl levels below 60 mmol/L were associated with greater benefit including better and more stable lung function, fewer pulmonary exacerbations, better nutritional status and better quality of life. |
| 2024-12-20 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Announces US FDA Approval of ALYFTREK™, a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis vrtx.com ↗
ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies |
| 2024-09-26 | Vertex Pharmaceuticals Incorporated | Results Vertex Highlights First Oral Presentation of Phase 3 Clinical Data of the Vanza Triple and New Data on Long-Term Impact of TRIKAFTA® at the North American Cystic Fibrosis Conference vrtx.com ↗
Phase 3 data on investigational vanza triple demonstrates non-inferiority to TRIKAFTA® in ppFEV1 and further improvement of CFTR function as measured by sweat chloride |
| 2024-06-07 | Vertex Pharmaceuticals Incorporated | Results Vertex Presents New Data at the European Cystic Fibrosis Conference Demonstrating Significant Benefits of Treatment with TRIKAFTA® vrtx.com ↗
Data from a randomized, double-blind, Phase 3 study (abstract WS06.04) demonstrated that people with CF who have rare, non-F508del mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to TRIKAFTA® in vitro demonstrated clinical benefit from receiving TRIKAFTA®. |
| 2019-10-31 | Vertex Pharmaceuticals Incorporated | Results Phase 3 Results from Two Studies of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Triple Combination Treatment for Cystic Fibrosis Concurrently Published in The New England Journal of Medicine and The Lancet vrtx.com ↗
Both studies met primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in lung function and other measures of disease. |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ELX/TEZ/IVA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04599465 ↗ |
| Route | Oral | “Fixed dose combination (FDC) tablets for oral administration.” NCT04599465 ↗ |