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Tezacaftor

Alternative Names: tezacaftor, vx-661, symdeko (copackaged), trikafta (copackaged), symdeko, trikafta
Latest Update: 2025-05-08
Latest Update Note: Clinical Trial Update

Product Description

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 | 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: BOSTON MA 02210
Company CEO: Reshma Kewalramani
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Tezacaftor

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: 19

Highest Development Phases

Phase 3: Cystic Fibrosis

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

VX21-121-105

P3

Recruiting

Cystic Fibrosis

2030-06-30

77%

VX22-121-106

P3

Enrolling by invitation

Cystic Fibrosis

2029-07-30

77%

VX22-445-123

P3

Enrolling by invitation

Cystic Fibrosis

2027-09-30

46%

VX22-445-123

P3

Recruiting

Cystic Fibrosis

2027-08-19

46%

VX21-121-105

P3

Not yet recruiting

Cystic Fibrosis

2027-08-02

VX21-445-125

P3

Active, not recruiting

Cystic Fibrosis

2027-04-06

37%

VX21-445-125

P3

Active, not recruiting

Cystic Fibrosis

2027-04-06

37%

VX20-121-104

P3

Active, not recruiting

Cystic Fibrosis

2026-10-01

33%

VX20-445-112

P3

Active, not recruiting

Cystic Fibrosis

2026-04-30

46%

VX22-121-106

P3

Recruiting

Cystic Fibrosis

2025-10-31

77%

VX22-445-122

P3

Active, not recruiting

Cystic Fibrosis

2025-10-06

34%

VX22-445-122

P3

Active, not recruiting

Cystic Fibrosis

2025-10-06

34%

VX20-445-112

P3

Active, not recruiting

Cystic Fibrosis

2025-06-20

VNZ/TEZ/D-IVA

P1

Completed

Cystic Fibrosis

2024-05-23

12%

VX23-121-011

P1

Completed

Cystic Fibrosis

2024-04-16

12%

2020-002239-31

P3

Active, not recruiting

Cystic Fibrosis

2024-02-18

46%

VX21-445-124

P3

Completed

Cystic Fibrosis

2023-07-05

67%

VX20-445-119

P3

Completed

Cystic Fibrosis

2023-03-24

76%

VX21-121-008

P1

Completed

Cystic Fibrosis

2023-03-16

69%

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