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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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Instructions
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▶ Red: study aborted/terminated/withdrawn.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⬤ Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.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◼ Red square: change from other status to abnormal or withdrawn status.
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Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Not Yet Recruiting | Completed | Terminated | Withdrawn |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Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Not Yet Recruiting | Completed | Terminated | Withdrawn |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Year | Recruiting | Enrolling By Invitation | Active, Not Recruiting | Not Yet Recruiting | Completed | Terminated | Withdrawn |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 |
- Recruiting
- Enrolling By Invitation
- Active, Not Recruiting
- Not Yet Recruiting
- Completed
- Terminated
- Withdrawn
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 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.
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.
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.
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.