FDA · United States
ivacaftor — FDA regulatory status
ivacaftor (KALYDECO) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- KALYDECO
- Originator
- Vertex Pharmaceuticals (Australia) Pty.
- Mechanism
- Cystic fibrosis transmembrane conductance regulator positive modulator
- Target
- Cystic fibrosis transmembrane conductance regulator
- Structured fields
- 8
Sponsor / originator context: Vertex Pharmaceuticals (Australia) Pty.. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Cystic fibrosis transmembrane conductance regulator positive modulator. Target: Cystic fibrosis transmembrane conductance regulator. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 18 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Ivacaftor | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT00909532, NCT00909727 |
| Lumacaftor Plus Ivacaftor Combination | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT01931839 |
| Lumacaftor Plus Ivacaftor Combination | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT01807923 |
| Tezacaftor/Ivacaftor | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT02508207, NCT02730208 |
| VX-661 Plus Ivacaftor Combination | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT02347657, NCT02516410 |
| VX-661/Ivacaftor | Phase 3 | Vertex Pharmaceuticals (Australia) | NCT02392234 |
| VX20-445-112 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-515606-90-00 |
| VX21-121-105 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-513754-29-00 |
| VX21-445-125 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-515637-14-00 |
| VX22-445-122 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2023-503230-49-00 |
| VX22-445-123 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2023-509563-24-00 |
| Ivacaftor | Phase 2 | Vertex Pharmaceuticals (Australia) | NCT04066751 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12421251 | Cystic fibrosis transmembrane conductance regulator modulating agents | US |
| 12384790 | Pteridinone compounds and uses thereof | US |
| 12377252 | Implantation devices, system, and methods | US |
| 12350262 | Methods of treatment for cystic fibrosis | US |
| 12324802 | Modulators of cystic fibrosis transmembrane conductance regulator | US |
| 12281057 | Carboxamides as modulators of sodium channels | US |
| 12269831 | Modulators of cystic fibrosis transmembrane conductance regulator | US |
| 12258333 | N-(hydroxyalkyl (hetero)aryl) tetrahydrofuran carboxamides as modulators of sodium channels | US |
| 12247021 | Substituted tetrahydrofurans as modulators of sodium channels | US |
| 12214083 | Pharmaceutical composition and administrations thereof | US |
| 12194138 | Devices and methods for delivering therapeutics | US |
| 12168009 | Modulators of cystic fibrosis transmembrane conductance regulator | US |
Related hubs
FAQ
What is the FDA approval status of ivacaftor?
ivacaftor currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get ivacaftor regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to ivacaftor?
This spoke lists 18 published programs associated with ivacaftor in our pipeline index.