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VX-581 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants will be randomized to receive VX-581 suspension in dosing period 1 followed by VX-581 tablet in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods. |
| Sequence 2 | EXPERIMENTAL | Participants will be randomized to receive VX-581 tablet in dosing period 1 followed by VX-581 suspension in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods. |
| Part A: Single Ascending Dose | EXPERIMENTAL | Participants will be randomized to receive a single dose of VX-581. |
| Placebo: Part A | PLACEBO_COMPARATOR | Participants will be randomized to receive a single dose of placebo matched to VX-581. |
| Part B: Multiple Ascending Dose | EXPERIMENTAL | Participants will be randomized to receive multiple doses of VX-581. |
| Placebo: Part B | PLACEBO_COMPARATOR | Participants will be randomized to receive multiple doses of placebo matched to VX-581. |
| Part C: VX-581 with TEZ/D-IVA or D-IVA | EXPERIMENTAL | Participants will be randomized to receive multiple doses VX-581 in combination with TEZ/D-IVA or D-IVA. |
| Placebo: Part C | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-581 in combination with TEZ/D-IVA or D-IVA. |
| Name | Type | Description |
|---|---|---|
| VX-581 | DRUG | Tablet and Suspension for Oral Administration. |
| Placebo | DRUG | Suspension for Oral Administration. |
| D-IVA | DRUG | Tablet for Oral Administration. |
| TEZ | DRUG | Tablet for Oral Administration. |
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive * Total body weight of greater than (\>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screen...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
VX-581 is an investigational small molecule developed by Vertex Pharmaceuticals for cystic fibrosis, a respiratory disease. It is in Phase 1 clinical development and has not been approved. Vertex is evaluating it in early-stage trials, including a relative bioavailability study and a dose escalation study in healthy participants.
VX-581 is being developed as a treatment for cystic fibrosis, a genetic respiratory disease. It is an investigational therapy and has not been approved for any indication. Clinical testing so far has enrolled healthy adult volunteers rather than patients with cystic fibrosis.
VX-581 targets CFTR, the cystic fibrosis transmembrane conductance regulator protein. CFTR is the protein whose dysfunction causes cystic fibrosis. VX-581 is a small molecule designed to act on this target, and Vertex is studying it in Phase 1 trials.
VX-581 is being developed by Vertex Pharmaceuticals Incorporated, which trades on Nasdaq under the ticker VRTX. Vertex is the sponsor of the Phase 1 clinical program evaluating the drug in cystic fibrosis.
VX-581 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Vertex Pharmaceuticals is running early-stage studies focused on safety, tolerability, and pharmacokinetics.
VX-581 is being studied in two Phase 1 trials. NCT07283770 is a recruiting dose escalation study evaluating safety and pharmacokinetics in healthy participants, with 136 planned enrollees. NCT07813039 is a relative bioavailability study of a VX-581 tablet formulation, not yet recruiting, with 16 planned male participants.