Ozmosi | Tezacaftor Drug Profile
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Tezacaftor

Pronounced as: teh-ZAH-kaf-tor

Alternative Names: tezacaftor, vx-661, symdeko (copackaged), trikafta (copackaged), symdeko, trikafta
Clinical Status: Active
Latest Update: 2026-03-10
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: *

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 Founding Year: 1989
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: 22

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

NCT07349394

VX25-121-014

P1

Active, not recruiting

Cystic Fibrosis

2026-04-04

50%

2026-03-11

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

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

29%

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

51%

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

51%

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

NCT05153317

VX20-445-112

P3

Completed

Cystic Fibrosis

2026-01-29

47%

2026-03-04

2022-503081-74-00

VX22-121-106

P3

Recruiting

Cystic Fibrosis

2025-10-31

29%

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

47%

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

NCT04545515

VX20-445-119

P3

Completed

Cystic Fibrosis

2023-03-24

76%

2024-05-09