Product Description
Lumacaftor is a drug used in combination with [DB08820] as the fixed dose combination product Orkambi for the management of Cystic Fibrosis (CF) in patients aged 6 years and older. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Lumacaftor)
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 Kingdom | United States | Uruguay
Approved Indications: Cystic Fibrosis
Known Adverse Events: Nasopharyngitis | Pharyngitis | Respiratory Tract Infections | Dyspnea | Diarrhea | Flatulence | Influenza, Human
Company: Vertex
Company Location: BOSTON MA 02210
Company CEO: Reshma Kewalramani
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 9
Highest Development Phases
Phase 3: Cystic Fibrosis
Phase 1: Healthy Volunteers|Tobacco Use Disorder
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| QP586-01 | P1 |
Completed |
Tobacco Use Disorder|Cystic Fibrosis |
2023-12-18 |
|
| VX19-809-124 | P3 |
Completed |
Cystic Fibrosis |
2023-08-22 |
50% |
| 2017-001078-41 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2022-03-05 |
|
| VX16-809-122 | P3 |
Completed |
Cystic Fibrosis |
2021-10-29 |