Drug profile · INN
ivacaftor
KALYDECO
ivacaftor (KALYDECO) is a cystic fibrosis transmembrane conductance regulator positive modulator. Associated with Vertex Pharmaceuticals (Australia) Pty.. Route of administration: oral. Current US regulatory status: approved.
Drug details — ivacaftor
- US status
- approved
- Class
- Respiratory system (R07)
- Route
- ORAL
- Patents
- 20
- Programs
- 18
- Data quality
- 0.89
Quick answer
ivacaftor (KALYDECO) is a cystic fibrosis transmembrane conductance regulator positive modulator. Associated with Vertex Pharmaceuticals (Australia) Pty.. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
Cystic fibrosis transmembrane conductance regulator positive modulator
Primary target: Cystic fibrosis transmembrane conductance regulator
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
Recent coverage
Pipeline programs
Related & competitor drugs
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Frequently asked questions
What is ivacaftor?
ivacaftor (KALYDECO) is a cystic fibrosis transmembrane conductance regulator positive modulator. Associated with Vertex Pharmaceuticals (Australia) Pty.. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for ivacaftor?
KALYDECO is a marketed brand name for ivacaftor. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of ivacaftor?
ivacaftor has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.