Product Description
Mechanisms of Action: CFTR Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Netherlands | New Zealand | Norway | Poland | Portugal | Romania | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Vertex
Company Location: Eastern America
Company CEO: Reshma Kewalramani
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 21
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Vertex presented P3 Cystic Fibrosis results on 2025-06-04 for Tezacaftor
- Clinical Outcomes Reported - Vertex presented P3 Cystic Fibrosis results on 2024-09-27 for Tezacaftor
- Clinical Outcomes Reported - Vertex presented P3 Cystic Fibrosis results on 2024-06-07 for Tezacaftor
Highest Development Phases
Phase 3: Cystic Fibrosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05153317 |
VX20-445-112 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2026-04-30 |
48% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06299696 |
VX23-121-011 | P1 |
Completed |
Cystic Fibrosis |
2024-04-16 |
12% |
2024-05-17 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05437120 |
VX21-121-008 | P1 |
Completed |
Cystic Fibrosis |
2023-03-16 |
69% |
2023-03-31 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-002189-11 |
2019-002189-11 | P2 |
Active, not recruiting |
Cystic Fibrosis |
2017-05-07 |
2025-07-02 |
||
NCT05422222 |
VX21-121-105 | P3 |
Recruiting |
Cystic Fibrosis |
2030-06-30 |
46% |
2025-02-05 |
|
NCT05844449 |
VX22-121-106 | P3 |
Enrolling by invitation |
Cystic Fibrosis |
2029-07-30 |
28% |
2025-05-08 |
|
NCT06460506 |
VX22-445-123 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2027-09-30 |
34% |
2025-10-07 |
Primary Endpoints|Treatments|Trial Status |
2023-509563-24-00 |
VX22-445-123 | P3 |
Recruiting |
Cystic Fibrosis |
2027-08-19 |
34% |
2025-05-02 |
|
2024-513754-29-00 |
VX21-121-105 | P3 |
Not yet recruiting |
Cystic Fibrosis |
2027-08-02 |
2025-05-02 |
Treatments |
|
NCT05331183 |
VX21-445-125 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2027-04-06 |
49% |
2025-04-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2024-515637-14-00 |
VX21-445-125 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2027-04-06 |
49% |
2025-05-02 |
Treatments |
NCT05444257 |
VX20-121-104 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2026-10-30 |
64% |
2025-09-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2022-503081-74-00 |
VX22-121-106 | P3 |
Recruiting |
Cystic Fibrosis |
2025-10-31 |
28% |
2025-05-02 |
Treatments |
2023-503230-49-00 |
VX22-445-122 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2025-10-06 |
35% |
2025-05-02 |
Treatments |
NCT05882357 |
VX22-445-122 | P3 |
Completed |
Cystic Fibrosis |
2025-09-04 |
35% |
2025-10-07 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-515606-90-00 |
VX20-445-112 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2025-06-20 |
2025-05-02 |
Treatments |
|
NCT04183790 |
VX19-445-107 | P3 |
Completed |
Cystic Fibrosis |
2024-02-24 |
49% |
2025-05-20 |
|
2020-002239-31 |
2020-002239-31 | P3 |
Active, not recruiting |
Cystic Fibrosis |
2024-02-18 |
48% |
||
NCT05274269 |
VX21-445-124 | P3 |
Completed |
Cystic Fibrosis |
2023-07-05 |
41% |
2023-08-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06299709 |
VNZ/TEZ/D-IVA | P1 |
Completed |
Cystic Fibrosis |
2024-05-23 |
12% |
2024-07-23 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04545515 |
VX20-445-119 | P3 |
Completed |
Cystic Fibrosis |
2023-03-24 |
76% |
2024-05-09 |