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VNZ/TEZ/D-IVA · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| VNZ/TEZ/D-IVA | EXPERIMENTAL | Part A: Participants (Cohort 1: 6 through 11 years of age (inclusive); Cohort 2: 2 through 5 years of age (inclusive) and Cohort 3: 1 to less than (\<) 2 years of age) will receive VNZ/TEZ/D-IVA once daily at doses determined based on their age and weight. The age range is based on date of informed consent in parent study. Part B: Participants in Cohort 1 who meet the eligibility criteria will receive VNZ/TEZ/D-IVA for an additional 96 weeks. |
| VNZ/TEZ/D-IVA and Rosuvastatin | EXPERIMENTAL | Rosuvastatin will be administered to participants as a single oral dose on Day 1 and then co-administered with VNZ/TEZ/D-IVA on Day 18.VNZ/TEZ/D-IVA dose will be administered once daily (qd) from Day 5 to Day 22. |
| Part A: Sequence 1 | EXPERIMENTAL | Participants will receive VNZ/TEZ/D-IVA reference fixed dose combination (FDC) tablet in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods. |
| Part A: Sequence 2 | EXPERIMENTAL | Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 2, and finally VNZ/TEZ/D-IVA reference FDC tablet in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods. |
| Part A: Sequence 3 | EXPERIMENTAL | Participants will receive VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 1, then VNZ/TEZ/D-IVA reference FDC tablet in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods. |
| Part B: Sequence 1 | EXPERIMENTAL | Participants will receive VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods. |
| Part B: Sequence 2 | EXPERIMENTAL | Participants will receive VNZ/TEZ/D-IVA test FDC granules under fed state in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules under fasted condition in dosing period 2. A washout period of 18 days will be maintained between 2 dosing periods. |
| Name | Type | Description |
|---|---|---|
| VNZ/TEZ/D-IVA | DRUG | Fixed-dose combination tablets or granules for oral administration. |
| Rosuvastatin | DRUG | Tablet for oral administration. |
Key Inclusion Criteria: Parts A and B: • Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222) Part B: -Meets at least 1 of the following criteria: * Completed study drug treatment in Part A * Had study drug interruption(s) in Part A, b...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
VNZ/TEZ/D-IVA, also known as vanzacaftor/tezacaftor/deutivacaftor, is an investigational small molecule being developed for the treatment of cystic fibrosis. It is currently in Phase 3 clinical development and is being studied in patients as young as 1 year of age.
VNZ/TEZ/D-IVA is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting clinical trials of this triple combination therapy for cystic fibrosis.
VNZ/TEZ/D-IVA is currently in Phase 3 clinical development for cystic fibrosis. The most advanced trial is a Phase 3 study evaluating long-term safety and efficacy in participants 1 year of age and older, which is currently enrolling by invitation.
VNZ/TEZ/D-IVA has been studied in four clinical trials. The active Phase 3 trial is NCT05844449, evaluating long-term safety and efficacy in cystic fibrosis patients aged 1 year and older. Three Phase 1 trials (NCT06299696, NCT06299709, NCT07349394) have been completed, studying the drug in healthy participants.
Yes, VNZ/TEZ/D-IVA is the abbreviation for vanzacaftor/tezacaftor/deutivacaftor, a triple combination therapy. This naming convention is used in clinical trial documentation to refer to the fixed-dose combination of these three active pharmaceutical ingredients.