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VX-121/TEZ/D-IVA · 8 trials · 1 indication
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
| Arm | Type | Description |
|---|---|---|
| VX-121/TEZ/D-IVA | EXPERIMENTAL | Part A: Participants will receive VX-121/TEZ/D-IVA once daily for 96 weeks. Part B: Participants will receive VX-121/TEZ/D-IVA once daily for an additional 48 weeks. |
| Part A: VX-121/TEZ/D-IVA | EXPERIMENTAL | Participants will receive VX-121/TEZ/D-IVA in the morning. |
| Part B: VX-121/TEZ/D-IVA | EXPERIMENTAL | Participants will receive VX-121/TEZ/D-IVA in the morning with the dose(s) to be based on the outcome of Part A. |
| ELX/TEZ/IVA | ACTIVE_COMPARATOR | Following elexacftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) run-in period of 4 weeks, participants received ELX 200 milligram (mg) once daily (qd) /TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for 52 weeks. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to VX-121/TEZ/VX-561 triple combination (TC) for 4 weeks in the treatment period and placebo matched to TEZ/VX-561 for 18 days in the washout period. |
| Part 1: VX-121/TEZ/VX-561 TC - Low Dose | EXPERIMENTAL | Participants received VX-121 5 milligram (mg) once daily (qd)/TEZ 100 mg qd/VX-561 150 mg qd TC for 4 weeks in the treatment period and TEZ 100 mg qd/VX-561 150 mg qd for 18 days in the washout period |
| Part 1: VX-121/TEZ/VX-561 TC - Medium Dose | EXPERIMENTAL | Participants received VX-121 10 mg qd/TEZ 100 mg qd/VX-561 150 mg qd TC for 4 weeks in the treatment period and TEZ 100 mg qd/VX-561 150 mg qd for 18 days in the washout period. |
| Part 1: VX-121/TEZ/VX-561 TC - High Dose | EXPERIMENTAL | Participants received VX-121 20 mg qd/TEZ 100 mg qd/VX-561 150 mg qd TC for 4 weeks in the treatment period and TEZ 100 mg qd/VX-561 150 mg qd for 18 days in the washout period. |
| Part 2: TEZ/IVA | ACTIVE_COMPARATOR | Following run-in period with TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) for 4 weeks, participants received TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the treatment period and TEZ 100 mg/IVA 150 mg q12h for 4 weeks in the washout period. |
| Part 2: VX-121/TEZ/VX-561 TC - High Dose | EXPERIMENTAL | Following run-in period with TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks, participants received VX-121 20 mg qd/TEZ 100 mg qd/VX-561 150 mg qd TC for 4 weeks in the treatment period and TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks in the washout period. |
| Sequence 1 | EXPERIMENTAL | Participants will receive a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods. |
| Sequence 2 | EXPERIMENTAL | Participants will receive a single dose of test FDC tablet of VX-121/TEZ/D-IVA in dosing period 1, followed by a single dose of reference FDC tablet of VX-121/TEZ/D-IVA in dosing period 2. A washout period of 14 days will be maintained between the 2 dosing periods. |
| Cohort 1: Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment will receive single dose of VX-121/TEZ/D-IVA . |
| Cohort 2: Matched Healthy Participants | EXPERIMENTAL | Healthy participants will receive single dose of VX-121/TEZ/D-IVA. |
| Part A: Pooled Placebo (Cohorts A1-5; Except A3) | PLACEBO_COMPARATOR | Participants received single dose of placebo matched to VX-121. |
| Part A: VX-121 (Cohort A1) | EXPERIMENTAL | Participants received single dose of VX-121 10 milligrams (mg). |
| Part A: VX-121 (Cohort A2) | EXPERIMENTAL | Participants received single dose of VX-121 20 mg. |
| Part A: VX-121 (Cohort A3) | EXPERIMENTAL | Participants received single dose of VX-121 5 mg or matched placebo without milk, followed by open label VX-121 5 mg with milk. |
| Part A: VX-121 (Cohort A4) | EXPERIMENTAL | Participants received single dose of VX-121 40 mg. |
| Part A: VX-121 (Cohort A5) | EXPERIMENTAL | Participants received single dose of VX-121 60 mg. |
| Part A: VX-121 (Cohort A9) | EXPERIMENTAL | Participants received single dose of VX-121 10 mg suspension on Day 1, VX-121 10 mg tablet on Day 9, followed by VX-121 10 mg tablet with milk on Day 17. |
| Part B: Pooled Placebo (Cohorts B1-4) | PLACEBO_COMPARATOR | Participants received placebo matched to VX-121 for 10 days. |
| Part B: VX-121 (Cohort B1) | EXPERIMENTAL | Participants received VX-121 10 mg once daily (qd) for 10 days. |
| Part B: VX-121 (Cohort B2) | EXPERIMENTAL | Participants received VX-121 20 mg qd for 10 days. |
| Part B: VX-121 (Cohort B3) | EXPERIMENTAL | Participants received VX-121 40 mg qd for 10 days. |
| Part B: VX-121 (Cohort B4) | EXPERIMENTAL | Participants received VX-121 60 mg qd for 10 days. |
| Part C: Pooled Placebo (Cohorts C1-3) | PLACEBO_COMPARATOR | Participants received placebo matched to VX-121/TEZ/IVA for 14 days. |
| Part C: VX-121 (Cohort C1) | EXPERIMENTAL | Participants received VX-121 10 mg qd/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) for 14 days. |
| Part C: VX-121 (Cohort C2) | EXPERIMENTAL | Participants received VX-121 20 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days. |
| Part C: VX-121 (Cohort C3) | EXPERIMENTAL | Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 14 days. |
| Part D: Placebo | PLACEBO_COMPARATOR | Participants received placebo matched to VX-121/TEZ/IVA for 4 weeks. |
| Part D: VX-121/TEZ/IVA | EXPERIMENTAL | Participants received VX-121 5 mg qd/TEZ 100 mg qd/IVA 150 mg q12h for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| VX-121/TEZ/D-IVA | DRUG | Fixed-dose combination tablets for oral administration. |
| ELX/TEZ/IVA | DRUG | Fixed-dose combination tablets for oral administration. |
| IVA | DRUG | Tablet for oral administration. |
| Placebo (matched to VX-121/TEZ/D-IVA) | DRUG | Placebo matched to VX-121/TEZ/D-IVA for oral administration. |
| Placebo (matched to ELX/TEZ/IVA) | DRUG | Placebo matched to ELX/TEZ/IVA for oral administration. |
| Placebo (matched to IVA) | DRUG | Placebo matched to IVA for oral administration. |
| VX-121 | DRUG | Tablets for oral administration. |
| TEZ | DRUG | TEZ tablet for oral administration. |
| VX-561 | DRUG | Tablets for oral administration. |
| TEZ/IVA | DRUG | Fixed-dose combination tablets for oral administration. |
| Placebo | DRUG | Placebos matched to VX-121, TEZ, and VX-561 for oral administration. |
| Placebo (matched to VX-121 suspension) | DRUG | Placebo matched to VX-121 suspension for oral administration. |
| VX-121 (Suspension) | DRUG | Suspension for oral administration. |
| Placebo (matched to TEZ/IVA) | DRUG | Placebo matched to TEZ/IVA for oral administration. |
| VX-121 (Tablet) | DRUG | Tablet for oral administration. |
| Placebo (matched to VX-121 tablet) | DRUG | Placebo matched to VX-121 tablet for oral administration. |
Key Inclusion Criteria: * Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit...
| 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 |
VX-121/TEZ/D-IVA is an investigational small molecule combination therapy being developed for the treatment of cystic fibrosis. It is currently in Phase 3 clinical development and is being studied in patients with cystic fibrosis, including pediatric patients as young as 1 year old.
VX-121/TEZ/D-IVA is being developed by Vertex Pharmaceuticals Incorporated, which trades on the NASDAQ under the ticker symbol VRTX. The company is conducting multiple clinical trials to evaluate the safety and efficacy of this combination therapy for cystic fibrosis.
VX-121/TEZ/D-IVA is in Phase 3 clinical development for cystic fibrosis. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trials are evaluating its long-term safety and efficacy in patients with cystic fibrosis.
VX-121/TEZ/D-IVA is being studied in several clinical trials, including NCT05422222, a Phase 3 trial in cystic fibrosis patients aged 1 to 11 years, and NCT05444257, a Phase 3 long-term safety and efficacy study in patients aged 12 years and older. Both trials are active but not recruiting.
Yes, VX-121/TEZ/D-IVA is the same as VX-121/tezacaftor/deutivacaftor. The abbreviation TEZ refers to tezacaftor and D-IVA refers to deutivacaftor. This combination therapy is being evaluated in clinical trials for the treatment of cystic fibrosis.