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Full Name:Takeda Pharmaceutical Company Limited Industry:pharmaceuticals CIK:1395064 Fiscal Year End: State/Country:JAPAN

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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Red: study aborted/terminated/withdrawn.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Red circle: drug marketed/approved on the corresponding day but was later withdrawn, discontinued, cancelled, or received negative opinion.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Red square: change from other status to abnormal or withdrawn status.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Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn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 5 7 4 133 13 8
2024 1 3 1
2023 4 1 4
2022 1 4 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 5 7 11 4 1
2024
2023 1
2022 1 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 9 9 95 16 9
2024 2
2023 3 1 1
2022 1 1 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 3 13
2024
2023 3
2022
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 17 1 18 4 207 33 5
2024 1 1
2023 5 1 1 2
2022 3 4 1 2
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 4 6 2 51 2 6
2024 1
2023 1 1
2022 2 1 1
Year Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
ALL 1 1
2024
2023
2022 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 5 5 9 3 17 4 1
2024 1 2 1
2023 4 1 3 3 5 1
2022 1 1 3 2 1
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 7 7 9 18 6
2024
2023 1 1
2022 1 1 1 4 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 4 4 2
2024 3 1 1
2023 1 2 1
2022 1
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 133 11 95 13 207 51 1
2024 1
2023 4 1
2022 4 2
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 13 4 16 33 2
2024
2023
2022
Year Phase 1 Phase 1|Phase 2 Phase 2 Phase 2|Phase 3 Phase 3 Phase 4 Others
ALL 8 1 9 5 6
2024
2023
2022 1 1 1
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 5 7 4 133 13 8
Phase 1|Phase 2 5 7 11 4 1
Phase 2 9 9 95 16 9
Phase 2|Phase 3 3 13
Phase 3 17 1 18 4 207 33 5
Phase 4 4 6 2 51 2 6
Others 1 1
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 1 3 1
Phase 1|Phase 2
Phase 2 2
Phase 2|Phase 3
Phase 3 1 1
Phase 4 1
Others
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 4 1 4
Phase 1|Phase 2 1
Phase 2 3 1 1
Phase 2|Phase 3 3
Phase 3 5 1 1 2
Phase 4 1 1
Others
Phase Recruiting Enrolling By Invitation Active, Not Recruiting Not Yet Recruiting Completed Terminated Withdrawn
Phase 1 1 4 1
Phase 1|Phase 2 1 1
Phase 2 1 1 1
Phase 2|Phase 3
Phase 3 3 4 1 2
Phase 4 2 1 1
Others 1

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
Takeda Recruiting Phase 3 A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Generalized Pustular Psoriasis|Erythrodermic Psoriasis TAK-279 2024-03-15 2024-04-10 2026-03-27 Anticipated 20
Takeda Not yet recruiting Phase 3 A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease Crohn's Disease Vedolizumab|Upadacitinib|Placebo 2024-01-19 2024-02-08 2028-08-01 Anticipated 396
Takeda Recruiting Phase 3 Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) Alpha1-Antitrypsin Deficiency Fazirsiran Injection|Placebo 2023-12-01 2024-04-25 2028-08-26 Anticipated 50
Takeda Recruiting Phase 3 A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period Plaque Psoriasis TAK-279|Placebo|Apremilast 2023-10-25 2024-04-09 2026-06-10 Anticipated 1000
Takeda Not yet recruiting Phase 3 A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Ulcerative Colitis|Crohn's Disease Vedolizumab IV|Vedolizumab SC 2023-10-17 2024-04-12 2027-06-30 Anticipated 70
Takeda Recruiting Phase 3 A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment Plaque Psoriasis TAK-279|Placebo|Apremilast 2023-10-12 2024-04-09 2026-04-15 Anticipated 600
Takeda Not yet recruiting Phase 3 A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases Primary Immunodeficiency Diseases (PID) TAK-881 2023-10-04 2023-10-11 2027-05-07 Anticipated 39
Takeda Recruiting Phase 3 A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India Healthy Volunteers TDV|Placebo 2023-09-22 2024-04-26 2025-04-01 Anticipated 480
Takeda Recruiting Phase 2|Phase 3 Extension Study of Idursulfase-IT Along With Elaprase in Children and Adults With Hunter Syndrome and Cognitive Impairment Hunter Syndrome Idursulfase-IT|Elaprase 2023-09-04 2024-04-04 2034-06-01 Anticipated 8
Takeda Enrolling by invitation Phase 3 An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease Alpha1-Antitrypsin Deficiency Fazirsiran Injection 2023-06-02 2024-03-15 2026-05-29 Anticipated 37
Takeda Recruiting Phase 3 A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease Crohn's Disease Vedolizumab IV|Placebo 2023-04-20 2023-09-29 2031-05-30 Anticipated 408
Takeda Recruiting Phase 2|Phase 3 A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions Narcolepsy Type 1|Narcolepsy Type 2 TAK-861 2023-03-31 2024-02-16 2026-12-31 Anticipated 160
Takeda Recruiting Phase 2|Phase 3 A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases Primary Immunodeficiency Diseases (PID) TAK-881|HYQVIA 2023-01-26 2024-04-18 2026-09-30 Anticipated 75
Takeda Active, not recruiting Phase 3 A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A Hemophilia A Adynovate 2023-01-23 2024-04-05 2024-10-08 Anticipated 37
Takeda Recruiting Phase 3 Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein Alpha1-Antitrypsin Deficiency Fazirsiran Injection|Placebo 2022-12-28 2024-03-29 2029-03-31 Anticipated 160
Takeda Not yet recruiting Phase 3 A Study of Recombinant Von Willebrand Factor (rVWF) (TAK-577) in Children With Severe Von Willebrand Disease (vWD) Von Willebrand Disease (VWD) Recombinant von Willebrand Factor (rVWF)|ADVATE 2022-10-14 2023-06-02 2027-02-20 Anticipated 24
Takeda Active, not recruiting Phase 3 A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS) Alagille Syndrome (ALGS) TAK-625 2022-09-14 2023-11-07 2025-07-24 Anticipated 7
Takeda Active, not recruiting Phase 3 A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) Progressive Familial Intrahepatic Cholestasis (PFIC) TAK-625 2022-09-14 2023-11-07 2025-05-09 Anticipated 5
Takeda Active, not recruiting Phase 3 A Study of Velaglucerase Alfa (VPRIV) in Chinese Children, Teenagers, and Adults With Type 1 Gaucher Disease Gaucher Disease Velaglucerase Alfa 2022-09-02 2024-02-22 2024-08-25 Anticipated 20
Takeda Active, not recruiting Phase 3 A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants Primary Immunodeficiency Diseases (PID) TAK-771 2022-08-22 2024-02-20 2025-04-30 Anticipated 15
Takeda Completed Phase 3 A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE) Hereditary Angioedema (HAE) Lanadelumab 2022-07-13 2024-01-22 2023-11-28 Actual 20
Takeda Recruiting Phase 3 A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) Ulcerative Colitis|Crohn's Disease Vedolizumab IV|No Intervention 2022-06-30 2024-03-06 2031-08-15 Anticipated 240
Takeda Recruiting Phase 3 A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection Cytomegalovirus (CMV) Maribavir 2022-04-01 2024-04-08 2026-11-22 Anticipated 80
Takeda Completed Phase 3 A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19) Coronavirus Disease (COVID-19) TAK-019 2022-03-27 2023-11-28 2023-07-28 2023-10-18 Actual 150

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 2 TYPE 3 TYPE 4 TYPE 5 TYPE 7
ALL 23 1 13 6 1 1
2024
2023 1 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
Takeda Pharms Usa BLA Entyvio Vedolizumab Orig 1 Approval 2024-04-18 761359
Takeda Pharms Usa NDA Eohilia Budesonide Orig 1 Approval 2024-02-09 213976
Takeda Pharms Usa NDA Fruzaqla Fruquintinib Type 1 Orig Approval 2023-11-08 217564
Takeda Pharms Usa BLA Entyvio Vedolizumab Type 5 Orig Approval 2023-09-27 761133

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 Takeda Pharms Usa 2023-11-08 Prescription Fruzaqla Fruquintinib 2023-11-08 Type 1 Approval 2023-11-30
Human Non-Bioproduct Takeda Pharms Usa 2023-11-08 Prescription Fruzaqla Fruquintinib 2023-11-08 Type 1 Approval 2023-11-30
Human Non-Bioproduct Takeda Pharms Usa 2023-09-27 Prescription Entyvio Vedolizumab 2023-09-27 Type 5 Approval 2023-11-30
Human Non-Bioproduct Takeda Pharms Usa 2023-09-27 Prescription Entyvio Vedolizumab 2023-09-27 Type 5 Approval 2023-11-30
Human Non-Bioproduct Takeda Pharms Usa 2013-01-25 Discontinued Oseni Alogliptin Benzoate; Pioglitazone Hydrochloride 2013-01-25 Type 4 Approval 2022-03-29
Human Non-Bioproduct Takeda Pharms Usa 2013-01-25 Discontinued Oseni Alogliptin Benzoate; Pioglitazone Hydrochloride 2013-01-25 Type 4 Approval 2022-03-29
Human Non-Bioproduct Takeda Pharms Usa 2005-08-29 Discontinued Actoplus Met Metformin Hydrochloride; Pioglitazone Hydrochloride 2005-08-29 Type 4 Approval 2023-11-30
Human Bioproduct Takeda Pharmaceuticals U.S.A., Inc. 2023-11-26 Marketed Adzynma Adamts13, Recombinant Krhn
Human Bioproduct Takeda Pharmaceuticals U.S.A., Inc. 2023-11-26 Marketed Adynovate Antihemophilic Factor (Recombinant), Pe Gylated

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 Takeda Gmb H 2022-12-05 Authorised 2022-12-16 Qdenga Dengue Virus, Serotype 2, Expressing Dengue Virus, Serotype 1, Surface Proteins, Live, Attenuated, D
Human Takeda Pharmaceuticals International Ag Ireland Branch 2022-11-09 Authorised 2022-11-24 Livtencity Maribavir
Human Takeda Gmb H 2009-06-11 Withdrawn 2022-01-19 Pantoloc Control Pantoprazole
Human Takeda Pharma A/S 2007-12-11 Withdrawn 2022-10-18 Glubrava Metformin Hydrochloride, Pioglitazone Hydrochloride
Human Takeda Pharma A/S 2000-10-11 Withdrawn 2022-10-17 Glustin Pioglitazone Hydrochloride
Human Takeda Pharma A/S Withdrawn Exkivity, Mobocertinib 2022-07-20
Human Takeda Pharmaceuticals International Ag Ireland Branch Summary of Opinion Takhzyro, Lanadelumab 2023-09-14 Positive
Human Takeda Pharmaceuticals International Ag Ireland Branch Summary of Opinion Revestive, Teduglutide 2023-04-26 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 Takeda Canada Inc 1997-11-19 Cancelled Post Market 2024-02-19 Agrylin Anagrelide (Anagrelide Hydrochloride) (0.5 Mg)
Human Takeda Canada Inc 2021-11-12 Marketed 2024-01-02 Glassia Alpha1 Proteinase Inhibitor (Human) (1000 Mg)
Human Takeda Canada Inc 2022-01-14 Marketed 2023-11-07 Hyqvia Immunoglobulin (Human) (2.5 G)|Hyaluronidase (Human Recombinant) (200 Unit)
Human Takeda Canada Inc 2022-01-14 Marketed 2023-11-07 Hyqvia Immunoglobulin (Human) (5 G)|Hyaluronidase (Human Recombinant) (400 Unit)
Human Takeda Canada Inc 2022-01-14 Marketed 2023-11-07 Hyqvia Immunoglobulin (Human) (10 G)|Hyaluronidase (Human Recombinant) (800 Unit)
Human Takeda Canada Inc 2022-01-14 Marketed 2023-11-07 Hyqvia Immunoglobulin (Human) (20 G)|Hyaluronidase (Human Recombinant) (1600 Unit)
Human Takeda Canada Inc 2022-01-14 Marketed 2023-11-07 Hyqvia Immunoglobulin (Human) (30 G)|Hyaluronidase (Human Recombinant) (2400 Unit)
Human Takeda Canada Inc 2018-09-04 Cancelled Pre Market 2023-08-09 Feiba Nf Anti Inhibitor Coagulant Complex (650 Unit)
Human Takeda Pharmaceuticals U.S.A., Inc. 2015-02-11 Marketed 2023-06-29 Iclusig Ponatinib (Ponatinib Hydrochloride) (15 Mg)
Human Takeda Canada Inc 2006-10-17 Cancelled Post Market 2023-04-25 Fosrenol Lanthanum (Lanthanum Carbonate Hydrate) (250 Mg)
Human Takeda Canada Inc 2022-09-15 Marketed 2022-10-25 Livtencity Maribavir (200 Mg)
Human Takeda Pharmaceuticals U.S.A., Inc. 2015-02-11 Dormant 2022-08-08 Iclusig Ponatinib (Ponatinib Hydrochloride) (45 Mg)
Human Takeda Canada Inc 2020-09-25 Marketed 2022-02-28 Takhzyro Lanadelumab (300 Mg)
Human Takeda Canada Inc 1997-06-11 Marketed 2022-02-09 Gammagard S/D Immunoglobulin (Human) (5 G)
Human Takeda Canada Inc 1998-04-15 Marketed 2022-01-28 Antithrombin Iii Nf Antithrombin Iii (Human) (1100 Unit)
Human Takeda Canada Inc 2018-09-19 Marketed 2022-01-12 Takhzyro Lanadelumab (300 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.