Drugs / deutivacaftor
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Alyftrek | — | 2025-06-30 | europa.eu ↗ |
| Approved | US (FDA) | ALYFTREK | — | 2024-12-20 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06299709 | Mar → May 2024 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT06154447 | Dec 2023 → Jul 2026 overdue | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02680249 | Feb → Apr 2016 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02599792 | Nov 2015 → Apr 2016 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03227471 | Jan 2017 → Mar 2018 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03912233 | Apr → Dec 2019 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT03911713 | Apr 2019 → Aug 2020 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT03224351 | Aug 2017 → Feb 2018 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT02971839 | Dec 2016 → Aug 2017 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05444257 | Nov 2022 → Oct 2026 expected | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05422222 | Jun 2022 → Jun 2030 expected | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05033080 | Sep 2021 → May 2023 | cystic fibrosis | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-14 | Vertex Pharmaceuticals Incorporated | Vertex Announces Broad Reimbursement Agreement With NHS England for ALYFTREK® (Deutivacaftor/Tezacaftor/Vanzacaftor) an Innovative Once-Daily CFTR Modulator for the Treatment of Cystic Fibrosis vrtx.com ↗ |
| 2025-03-07 | Vertex Pharmaceuticals Incorporated | Vertex Announces UK MHRA Approval of ALYFTREK® (Deutivacaftor/Tezacaftor/Vanzacaftor), a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis vrtx.com ↗ |
| 2024-07-02 | Vertex Pharmaceuticals Incorporated | Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis vrtx.com ↗ |
| 2024-02-05 | Vertex Pharmaceuticals Incorporated | Vertex Announces Positive Results From Pivotal Trials of Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis vrtx.com ↗ |
| 2017-07-25 | Vertex Pharmaceuticals Incorporated | Vertex and Concert Pharmaceuticals Complete Asset Purchase Agreement for CTP-656 vrtx.com ↗ |
| 2017-03-06 | Vertex Pharmaceuticals Incorporated | Vertex to Acquire CTP-656 from Concert Pharmaceuticals for the Treatment of Cystic Fibrosis vrtx.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | deutivacaftor | “BACKGROUND: In phase 2 trials in people with cystic fibrosis aged 18 years and older, vanzacaftor-tezacaftor-deutivacaftor has been shown to be a safe and effective, once-daily...” PMID 39756425 ↗ Jan 20254“The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.” NCT05444257 ↗ “vanzacaftor (20 mg once daily), tezacaftor (100 mg once daily), and deutivacaftor (250 mg once daily) as two fixed-dose combination tablets in the morning” PMID 39756424 ↗ Jan 2025 “Vanzacaftor/tezacaftor/deutivacaftor” NCT06299709 ↗ |
| Known as | CTP-656 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02680249 ↗ |
| Known as | VX-561 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02971839 ↗ |
| Route | Oral | “CTP-656 solid oral doses” NCT02599792 ↗ |