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Full Name:Vertex Pharmaceuticals Incorporated Industry:pharmaceuticals CIK:875320 Fiscal Year End:12-31 State/Country:MASSACHUSETTS

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US clinical trial status

Size of symbol reflects the phase of clinical trial. E.g. Phase 3 trial has the largest size.
Shape definition
Up-triangle: study first submitted.
Square: study completion(actual/anticipated).
Circle: result first posted.
Color definition
Green: study is ongoing.
Blue: recruitment completed.
Red: study aborted/terminated/withdrawn.
Pink: study in abnormal state.

US FDA submission

Size of symbol reflects the type of submission. E.g. Type 1 drug has the largest size.
: Approved.
: Tentative Approval.

Drug marketing & current status

Circle bubble denotes new drug marketing. Size is determined by drug type and market(i.e. population) size. E.g. Type 1 drug marketed in US has the largest size. Drug marketed in CA has the smallest size due to small population size.
Color definition
Blue circle: drug marketed (EU,CA), FDA submission approved (US).
Cyan circle: drug approved (CA), tentative approval (US), received positive opinion (EU)
Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.

Drug marketing status change

Square bubble denotes marketing status change. Size is determined by drug type and market(i.e. population) size.
Color definition
Blue square: change from other status to marketed.
Cyan square: change from other status to tentative status.
Red square: change from other status to abnormal or withdrawn status.

US Clinical Trials

Clinical Trials Summary Statistics

Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 7 1 2 41
2024 4 1
2023 3 2 5
2022 12
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 4 5 1
2024
2023 2
2022 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 1 45 8
2024
2023 1
2022 1 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 2 1 1
2024
2023
2022 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 4 2 4 1 57 5
2024
2023 1 1 1
2022 3 3 4
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 2
2024
2023
2022
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1
2024
2023
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 7 4 1 1 4
2024 4
2023 3 2 1 1
2022 1 1 3
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1 2
2024 1
2023 1
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 2 1 2 4
2024
2023 2
2022 1 3
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1
2024
2023 1
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 41 5 45 1 57 1
2024
2023 5
2022 12 1 4
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1 8 1 5 2
2024
2023
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 1
2024
2023
2022
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 7 1 2 41
Phase 1|Phase 2 4 5 1
Phase 2 1 1 45 8
Phase 2|Phase 3 1 2 1 1
Phase 3 4 2 4 1 57 5
Phase 4 1 2
Others 1
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 4 1
Phase 1|Phase 2
Phase 2
Phase 2|Phase 3
Phase 3
Phase 4
Others
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 3 2 5
Phase 1|Phase 2 2
Phase 2 1
Phase 2|Phase 3
Phase 3 1 1 1
Phase 4
Others
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 12
Phase 1|Phase 2 1
Phase 2 1 1
Phase 2|Phase 3 1
Phase 3 3 3 4
Phase 4
Others

Note: "Year" represents clinical trail start year determined by study first submit date.
Three grouping strategies present the same statistical data from different angles, choose any one you are comfortable with.
at least one study with latest update posted within 7 days.  at least one study with latest update posted within 30 days.  at least one study with latest update posted within 90 days. 

Clinical Trials Records

Sponsor Overall Status Phase Brief Title Disease Condition Intervention Name Study First Submit Date Last Update Post Date Results First Post Date Completion Date Completion Date Type Enrollment Count
Vertex Pharmaceuticals Incorporated Not yet recruiting Phase 3 Evaluation of Efficacy and Safety of a Single Dose of Exa-cel in Participants With Severe Sickle Cell Disease, βS/βC Genotype Sickle Cell Disease Exa-cel 2023-06-23 2024-02-29 2029-12-01 Anticipated 12
Vertex Pharmaceuticals Incorporated Recruiting Phase 3 Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age Cystic Fibrosis ELX/TEZ/IVA|IVA 2023-05-19 2023-10-27 2025-10-01 Anticipated 64
Vertex Pharmaceuticals Incorporated Enrolling by invitation Phase 3 Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Cystic Fibrosis VNZ/TEZ/D-IVA 2023-04-24 2024-04-11 2030-10-01 Anticipated 180
Vertex Pharmaceuticals Incorporated Completed Phase 3 A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain Pain VX-548 2022-12-14 2024-03-20 2023-12-12 Actual 258
Vertex Pharmaceuticals Incorporated Completed Phase 3 Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty Acute Pain VX-548|HB/APAP|Placebo (matched to VX-548)|Placebo (matched to HB/APAP) 2022-09-23 2024-03-20 2023-09-11 Actual 1118
Vertex Pharmaceuticals Incorporated Completed Phase 3 Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy Acute Pain VX-548|HB/APAP|Placebo (matched to VX-548)|Placebo (matched to HB/APAP) 2022-09-20 2024-03-20 2023-12-15 Actual 1075
Vertex Pharmaceuticals Incorporated Recruiting Phase 3 Evaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease Beta-Thalassemia|Thalassemia|Hematologic Diseases|Genetic Diseases, Inborn|Hemoglobinopathies|Sickle Cell Anemia CTX001 2022-07-26 2024-03-15 2025-02-01 Anticipated 26
Vertex Pharmaceuticals Incorporated Active, not recruiting Phase 3 A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Cystic Fibrosis VX-121/TEZ/D-IVA 2022-06-29 2023-12-22 2025-10-01 Anticipated 822
Vertex Pharmaceuticals Incorporated Active, not recruiting Phase 3 Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Cystic Fibrosis VX-121/TEZ/D-IVA 2022-06-13 2024-01-25 2030-06-01 Anticipated 210
Vertex Pharmaceuticals Incorporated Active, not recruiting Phase 3 Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del Cystic Fibrosis ELX/TEZ/IVA|IVA 2022-04-08 2023-08-04 2025-04-01 Anticipated 297
Vertex Pharmaceuticals Incorporated Recruiting Phase 3 Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD) Sickle Cell Disease|Hydroxyurea Failure|Hydroxyurea Intolerance|Hemoglobinopathies|Hematological Diseases CTX001 2022-04-07 2024-02-21 2026-05-01 Anticipated 15
Vertex Pharmaceuticals Incorporated Recruiting Phase 3 Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Transfusion-Dependent β-Thalassemia (TDT) Beta-Thalassemia|Thalassemia|Genetic Diseases, Inborn|Hematologic Diseases|Hemoglobinopathies CTX001 2022-04-07 2024-04-10 2026-05-01 Anticipated 15
Vertex Pharmaceuticals Incorporated Recruiting Phase 2|Phase 3 Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease Mediated Proteinuric Kidney Disease Proteinuric Kidney Disease VX-147|Placebo 2022-03-28 2024-04-23 2026-06-01 Anticipated 466
Vertex Pharmaceuticals Incorporated Completed Phase 3 Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation Cystic Fibrosis ELX/TEZ/IVA|IVA|Placebo (matched to ELX/TEZ/IVA)|Placebo (matched to IVA) 2022-03-01 2023-08-01 2023-07-05 Actual 307

Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "phase 3" (case insensitive, with double quote) to show Phase 3 trials.
latest update posted within 7 days.  latest update posted within 30 days.  latest update posted within 90 days. 

US FDA Submissions

US FDA Submission Summary Statistics*

Year TYPE 1 TYPE 1/4 TYPE 3
ALL 2 3 3
2024
2023 1
2022

Note: "Year" determined by submission status date.
* Original submissions only. Supplementary records not counted.
at least one submission within 7 days.  at least one submission within 30 days.  at least one submission within 90 days. 

US FDA Submission Records

Sponsor Application Type Drug Name Active Ingredient Submission Code Submission Type Submission Status Status Date Application Number
Vertex Pharms Inc NDA Trikafta (Copackaged) Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor Type 3 Orig Approval 2023-04-26 217660

Note: Use 'Search' box on top right cornor to narrow down search results. E.g. type in "NDA" (case insensitive) to show records with "NDA" (New Drug Applications) tag.
submission status date within 7 days.  submission status date within 30 days.  submission status date within 90 days. 

US Drug Marketing Status
Category Sponsor Marketing Date Current Marketing Status Drug Name Active Ingredient Submission Status Date Submission Code Submission Status Marketing Status Change Date
Human Non-Bioproduct Vertex Pharms Inc 2023-04-26 Prescription Trikafta (Copackaged) Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor 2023-04-26 Type 3 Approval 2023-11-30
Human Non-Bioproduct Vertex Pharms Inc 2023-04-26 Prescription Trikafta (Copackaged) Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor 2023-04-26 Type 3 Approval 2023-11-30
Human Non-Bioproduct Vertex Pharms Inc 2018-08-07 Prescription Orkambi Ivacaftor; Lumacaftor 2018-08-07 Type 3 Approval 2023-11-30
Human Non-Bioproduct Vertex Pharms Inc 2015-03-17 Prescription Kalydeco Ivacaftor 2015-03-17 Type 3 Approval 2023-11-30
Human Non-Bioproduct Vertex Pharms Inc 2015-03-17 Prescription Kalydeco Ivacaftor 2015-03-17 Type 3 Approval 2023-11-30
Human Bioproduct Vertex Pharmaceuticals Incorporated 2023-12-09 Marketed Casgevy Exagamglogene Autotemcel (Exa Cel)

Note: This table contains human and animal drugs regulated by US FDA, and biological products regulated by CBER (Center for Biologics Evaluation and Research).
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "discontinued" (case insensitive) to show discontinued drug products.
For human non-bioproduct, marketing date was set to submission approval date.
Possible marketing statuses: Marketed, Prescription, Over-the-counter, Discontinued, None (Tentative Approval).
any of (marketing/submission/status change) within 7 days.  any of (marketing/submission/status change) within 30 days.  any of (marketing/submission/status change) within 90 days. 

EU Drug Marketing Status
Category Sponsor Authorization Date Current Marketing Status Latest Status Update Drug Name Active Ingredient Withdraw Date Opinion Date Summary of Opinion
Human Vertex Pharmaceuticals (Ireland) Limited Summary of Opinion Kaftrio, Ivacaftor, Tezacaftor, Elexacaftor 2023-09-14 Positive

Note: This table contains human and animal drugs regulated by EMA (European Medicines Agency), and summary of opinion published by EMA based on the CHMP's or CVMP's positive or negative recommendation.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "withdrawn" (case insensitive) to show drugs withdrawn.
Possible marketing statuses: Authorised, Refused, Withdrawn, Summary of Opinion.
Summary of Opinion: published by European Medicines Agency (EMA) based on the CHMP's or CVMP's positive or negative recommendation. Further marketing authorization is partially based on this opinion.
any of (authorization/withdrawn/opinion/status change) date within 7 days.  any of (authorization/withdrawn/opinion/status change) date within 30 days.  any of (authorization/withdrawn/opinion/status change) date within 90 days. 

CA Drug Marketing Status
Category Sponsor Authorization Date Current Marketing Status Status Date Drug Name Active Ingredient
Human Vertex Pharmaceuticals (Canada) Incorporated 2023-11-28 Approved 2023-11-28 Kalydeco Ivacaftor (13.4 Mg)
Human Vertex Pharmaceuticals (Canada) Incorporated 2023-10-16 Marketed 2023-10-27 Trikafta Ivacaftor (75 Mg)|Elexacaftor (100 Mg)|Tezacaftor (50 Mg)
Human Vertex Pharmaceuticals (Canada) Incorporated 2023-10-16 Marketed 2023-10-27 Trikafta Ivacaftor (60 Mg)|Ivacaftor (59.5 Mg)|Elexacaftor (80 Mg)|Tezacaftor (40 Mg)
Human Vertex Pharmaceuticals (Canada) Incorporated 2023-04-06 Marketed 2023-04-14 Orkambi Lumacaftor (75 Mg)|Ivacaftor (94 Mg)
Human Vertex Pharmaceuticals (Canada) Incorporated 2022-04-20 Marketed 2022-04-22 Trikafta Tezacaftor (25 Mg)|Ivacaftor (37.5 Mg)|Ivacaftor (75 Mg)|Elexacaftor (50 Mg)

Note: This table contains human, animal drugs, radiopharmaceutical and disinfectant regulated by CFIA(Canadian Food Inspection Agency) and Health Canada.
Use 'Search' box on top right cornor to narrow down search results. E.g. type in "marketed" (case insensitive) to show drugs marketed.
Possible marketing statuses: Marketed, Approved, Dormant, Cancelled Pre Market, Cancelled Post Market, Cancelled (Safety Issue), Cancelled (Unreturned Annual).
any of (authorization/status change) date within 7 days.  any of (authorization/status change) date within 30 days.  any of (authorization/status change) date within 90 days.