Drugs / TEZ/IVA
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03227471 | Jan 2017 → Mar 2018 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Real-world evidence and clinical studies of TRIKAFTA® continue to show sustained long-term benefits including improvement in pancreatic function in young patients |
| 2019-05-30 | Vertex Pharmaceuticals Incorporated | Results Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis vrtx.com ↗
Vertex previously announced that both of these Phase 3 studies met their primary endpoints, and the company today announced the final results of these studies, including results for key secondary endpoints and safety data. |
| 2019-02-14 | Vertex Pharmaceuticals Incorporated | Results Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission vrtx.com ↗
The study met its primary endpoint of absolute change in lung clearance index (LCI2.5) through 8 weeks of treatment, demonstrating a statistically significant improvement in LCI2.5 among patients treated with tezacaftor/ivacaftor. |
| 2018-10-18 | Vertex Pharmaceuticals Incorporated | Results Vertex Data Presented at North American Cystic Fibrosis Conference (NACFC) Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating the Underlying Cause of Cystic Fibrosis vrtx.com ↗
Patient-reported outcomes data from Phase 3 EVOLVE and EXPAND studies continue to support the clinical benefit of SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-09-26 | Vertex Pharmaceuticals Incorporated | 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 ↗ |
| 2019-05-30 | Vertex Pharmaceuticals Incorporated | Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis vrtx.com ↗ |
| 2019-02-14 | Vertex Pharmaceuticals Incorporated | Positive Phase 3 Study for Tezacaftor/Ivacaftor Combination in Children Aged 6-11 Years with Cystic Fibrosis Supports European Medicines Agency Submission vrtx.com ↗ |
| 2018-10-18 | Vertex Pharmaceuticals Incorporated | Vertex Data Presented at North American Cystic Fibrosis Conference (NACFC) Demonstrate Rapid Progress Toward Expanding and Enhancing Options for Treating the Underlying Cause of Cystic Fibrosis vrtx.com ↗ |
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 | TEZ/IVA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03227471 ↗ |
| Route | Oral | “TEZ/IVA fixed-dose combination for oral administration.” NCT03227471 ↗ |