Product Description
Ivacaftor is used to treat certain types of cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction) in adults and children 4 months of age and older. Ivacaftor should be used only in people with a certain genetic make-up. Your doctor may order a blood test to help decide if this medication is right for you. Ivacaftor is in a class of medications called cystic fibrosis transmembrane conductance regulator (CFTR) potentiators. It works by improving the function of a protein in the body to decrease the build-up of thick mucus in the lungs and improving other symptoms of cystic fibrosis. (Sourced from: https://medlineplus.gov/druginfo/meds/a612012.html)
Mechanisms of Action: CFTR Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Croatia | Czech | Denmark | Dominican Republic | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Abdominal Pain | Dizziness | Pain Unspecified | Nasopharyngitis | Pharyngitis | Cystic Fibrosis | Diarrhea | Cystic Fibrosis | Cystic Fibrosis
Known Adverse Events: Abdominal Pain | Dizziness | Headache | Pain Unspecified | Nasopharyngitis | Pharyngitis | Respiratory Tract Infections | Diarrhea | Rhinitis | Sinusitis | Influenza, Human
Company: Vertex
Company Location: BOSTON MA 02210
Company CEO: Reshma Kewalramani
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 33
Highest Development Phases
Phase 3: Cystic Fibrosis
Phase 2: Acne Vulgaris|Bronchitis, Chronic|Chronic Obstructive Pulmonary Disease
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| VX22-445-123 | P3 |
Enrolling by invitation |
Cystic Fibrosis |
2027-09-01 |
|
| VX22-445-123 | P3 |
Unknown Status |
Cystic Fibrosis |
2027-08-19 |
|
| VX21-445-125 | P3 |
Unknown Status |
Cystic Fibrosis |
2027-04-06 |
|
| VX21-445-125 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2027-04-01 |
41% |
| VX21-445-125 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2027-04-01 |
41% |