Drugs / Vedolizumab
Vedolizumab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ENTYVIO | — | 2023-01-25 | fda.gov ↗ |
| Approved | EU (EMA) | Entyvio | — | 2014-05-22 | europa.eu ↗ |
| Approved | US (FDA) | ENTYVIO | — | 2014-05-20 | fda.gov ↗ |
Trials 93 · started per year
today
US approved 2014
EU approved 2014
1
2
1
2
1
1
4
5
11
13
11
4
3
5
6
6
8
8
1
20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05281614 | Sep 2022 → Jan 2024 | type 1 diabetes mellitus | Benaroya Research Institute | Completed | No outcome recorded |
| Phase 0 | NCT03309865 | Dec 2017 → Aug 2018 | ulcerative colitis | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT04112212 | Nov 2020 → Oct 2022 | Crohn disease, ulcerative colitis | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 1 | NCT03961308 | Mar → Oct 2018 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03329209 | Mar → Jul 2018 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03961295 | Feb → Jul 2018 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03948581 | Feb → Aug 2018 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03949621 | Feb → Jul 2018 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02723006 | Jun 2016 → May 2018 | melanoma | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT02728895 | Jun 2016 → Jul 2018 | disease related to hematopoietic stem cell transplant | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02788175 | May 2016 → Mar 2019 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02163421 | Jun → Dec 2014 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01981616 | Sep 2011 → May 2012 | inflammatory bowel disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04407247 | Jul 2020 → Dec 2027 expected | colitis, malignant urinary system neoplasm, melanoma, non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02972450 | Feb → Jul 2019 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Terminated | No outcome recorded |
| Phase 1/2 | NCT03577782 | Sep 2018 → May 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Unknown | No outcome recorded |
| Phase 217 trials | ||||||
| Phase 2 | NCT06841705 | Jul 2025 → Jul 2026 overdue | — | Shilpa Grover, MD, MPH | Recruiting | No outcome recorded |
| Phase 2 | NCT06850727 | Jun 2025 → Apr 2026 overdue | ulcerative colitis | Odyssey Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT06815003 | Apr 2025 → Oct 2028 expected | acute lymphoblastic leukemia, acute myeloid leukemia, chronic myelomonocytic leukemia, graft versus host disease +1 | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06317220 | Dec 2024 → Feb 2026 overdue | collagenous gastritis | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04120415 | Jun 2022 → Jul 2023 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 2 | NCT05132166 | Dec 2021 → Apr 2026 overdue | graft versus host disease | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02834754 | Dec 2018 → May 2019 | Crohn disease | Marc Schwartz | Withdrawn | No outcome recorded |
| Phase 2 | NCT03196427 | Jul 2018 → Apr 2025 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT02929316 | Jun → Oct 2018 | celiac disease | AGA Clinical Research Associates, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT03219359 | Feb 2018 → Oct 2028 expected | Crohn disease | Aaron Etra | Recruiting | No outcome recorded |
| Phase 2 | NCT03138655 | Nov 2017 → Mar 2020 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT03147859 | Nov 2017 → Dec 2023 | HIV infectious disease | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02993783 | Apr 2017 → May 2018 | disease related to hematopoietic stem cell transplant | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02913508 | Apr 2014 → Dec 2015 | Crohn disease, ulcerative colitis | Takeda | Withdrawn | No outcome recorded |
| Phase 2 | NCT00619489 | Dec 2007 → Mar 2010 | Crohn disease, ulcerative colitis | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01177228 | May 2007 → Jun 2008 | ulcerative colitis | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00655135 | Feb 2000 → Jun 2002 | Crohn disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06337695 | Jul 2024 → Nov 2026 expected | metastatic malignant neoplasm | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06475820 | Dec 2023 → Jul 2024 overdue | acute biphenotypic leukemia, myelodysplastic syndrome | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Active not recruiting | No outcome recorded |
| Phase 328 trials | ||||||
| Phase 3 | NCT06405087 | Oct 2025 → Aug 2030 expected | Crohn disease, ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06100289 | Jan 2025 → Nov 2027 expected | Crohn disease, ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06227910 | Jan 2025 → Jun 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06443502 | Nov 2024 → Dec 2029 expected | pouchitis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT06614387 | Oct 2024 → Apr 2028 expected | ulcerative colitis | JAROSLAW KIERKUS | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05771155 | Jul 2023 → Sep 2025 overdue | ulcerative colitis | Polpharma Biologics S.A. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05837897 | Jun 2023 → Mar 2030 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT05442567 | May 2023 → Feb 2033 expected | Crohn disease, ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT05515029 | Aug 2022 → Aug 2024 overdue | acute biphenotypic leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04779320 | Feb 2022 → Sep 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT04779307 | Oct 2021 → Jul 2025 | ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT04738942 | Jun 2021 → May 2025 overdue | Crohn disease, ulcerative colitis | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04919252 | Jun 2021 → Dec 2022 | inflammatory bowel disease | Yonsei University | Unknown | No outcome recorded |
| Phase 3 | NCT03657160 | Feb 2019 → Feb 2022 | disease related to hematopoietic stem cell transplant | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03221036 | Aug 2017 → Sep 2027 expected | ulcerative colitis | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03234907 | Aug 2017 → Aug 2020 | Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03035058 | Feb 2017 → Sep 2020 | inflammatory bowel disease, primary sclerosing cholangitis | Takeda | Withdrawn | No outcome recorded |
| Phase 3 | NCT02620046 | Apr 2016 → Jun 2024 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02611817 | Jan 2016 → May 2019 | Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02611830 | Dec 2015 → May 2018 | ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02497469 | Jun 2015 → Sep 2018 | ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02425111 | Mar 2015 → Jun 2017 | Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02039505 | Feb 2014 → Feb 2018 | ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02038920 | Jan 2014 → Jan 2019 | Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01224171 | Nov 2010 → Feb 2012 | Crohn disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00790933 | May 2009 → Oct 2017 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00783718 | Jan 2009 → Dec 2011 | ulcerative colitis | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00783692 | Dec 2008 → Mar 2012 | Crohn disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 427 trials | ||||||
| Phase 4 | NCT07576452 | Jun 2026 → Jun 2030 expected | ulcerative colitis | University Hospital, Clermont-Ferrand | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06788340 | Sep 2025 → Aug 2027 expected | Crohn disease, ulcerative colitis | Odense University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06581328 | Mar 2025 → Oct 2027 expected | Crohn disease, ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT06180382 | Oct 2024 → Oct 2027 expected | Crohn disease | University Hospital of Saint-Etienne | Recruiting | No outcome recorded |
| Phase 4 | NCT06257706 | Aug 2024 → Jan 2029 expected | Crohn disease | Alimentiv Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT06095128 | Jun 2024 → Jul 2027 expected | ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT06045754 | Apr 2024 → Jun 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT06584162 | Feb 2023 → Jan 2025 overdue | inflammatory bowel disease | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 4 | NCT05169593 | Sep 2022 → Oct 2027 expected | Crohn disease | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT06066840 | Aug 2022 → Jul 2025 | — | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 4 | NCT04804540 | Dec 2021 → Feb 2024 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT07398586 | Jan 2020 → Dec 2024 | ulcerative colitis | Second Affiliated Hospital of Wenzhou Medical University | Completed | No outcome recorded |
| Phase 4 | NCT04006080 | Jul 2019 → Mar 2020 | ulcerative colitis | Guy's and St Thomas' NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 4 | NCT03679546 | Jan 2019 → Dec 2024 | ulcerative colitis | Rennes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03142321 | Jun 2018 → May 2024 | small bowel Crohn disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT02559713 | Nov 2017 → Feb 2019 | Crohn disease, ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03237260 | Jul 2017 → Feb 2019 | ulcerative colitis | University of Pennsylvania | Withdrawn | No outcome recorded |
| Phase 4 | NCT02764762 | Apr 2017 → Sep 2020 | Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03029143 | Mar 2017 → Oct 2020 | ulcerative colitis | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02760615 | Nov 2016 → Aug 2020 | Crohn disease, ulcerative colitis | Takeda | Withdrawn | No outcome recorded |
| Phase 4 | NCT02790138 | Oct 2016 → Jun 2020 | pouchitis | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02820493 | Sep 2016 → Mar 2019 | Crohn disease | University of Genoa | Withdrawn | No outcome recorded |
| Phase 4 | NCT02630966 | Aug 2016 → Sep 2018 | Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02743806 | Aug 2016 → Jan 2023 | Crohn disease, ulcerative colitis | Takeda | Terminated | No outcome recorded |
| Phase 4 | NCT02768532 | Jul 2016 → Jan 2022 | Crohn disease | University Hospital of Saint-Etienne | Terminated | No outcome recorded |
| Phase 4 | NCT02646657 | Jul 2015 → Aug 2020 | ulcerative colitis | Geert D'Haens | Completed | No outcome recorded |
| Phase 4 | NCT02646683 | Jul 2015 → May 2023 | Crohn disease | Geert D'Haens | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06095596 | Nov 2023 → Oct 2025 overdue | ulcerative colitis | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| — | NCT02878083 | Jan 2017 → Jan 2020 | ulcerative colitis | Nantes University Hospital | Terminated | No outcome recorded |
| — | NCT02862132 | Jan 2017 → Jan 2022 | Crohn disease, ulcerative colitis | Shaare Zedek Medical Center | Completed | No outcome recorded |
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02953275 Background | Apr 2017 → Mar 2019 | Crohn disease | University of Miami | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06732804 Comparator | Feb 2025 → Jan 2026 | — | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 1 | NCT03819296 Background | Feb 2021 → Oct 2026 expected | colitis, cutaneous melanoma, lung carcinoma in situ, malignant urinary system neoplasm +1 | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07619898 Comparator | Jul 2026 → Dec 2028 expected | colitis, hepatitis, melanoma | Therakos | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06646016 Comparator | Dec 2025 → Feb 2026 | colitis | Therakos | Withdrawn | No outcome recorded |
| Phase 2 | NCT04118556 Comparator | Dec 2021 → Apr 2026 | acute graft versus host disease | Mats Remberger | Terminated | No outcome recorded |
| Phase 2 | NCT04797325 Comparator | Aug 2021 → Apr 2025 | — | University of Copenhagen | Unknown | No outcome recorded |
| Phase 2 | NCT03558152 Comparator | Oct 2018 → Dec 2021 | ulcerative colitis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06880744 Comparator | Jun 2025 → Aug 2027 expected | ulcerative colitis | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06570772 Comparator | Sep 2024 → Nov 2025 | ulcerative colitis | Alvotech Swiss AG | Terminated | No outcome recorded |
| Phase 3 | NCT04469062 Comparator | Apr 2021 → Mar 2024 | ulcerative colitis | Eli Lilly and Company | Withdrawn | No outcome recorded |
| Phase 3 | NCT02954159 Comparator | May 2017 → Jan 2019 | ulcerative colitis | Medical College of Wisconsin | Terminated | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07665294 Background | Jun 2026 → Jun 2027 expected | ulcerative colitis | Ryan C Ungaro | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06609447 Background | Sep 2024 → Dec 2027 expected | ulcerative colitis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 4 | NCT06626165 Comparator | Jul 2024 → Sep 2025 | ulcerative colitis | Showa Inan General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05928039 Comparator | Oct 2023 → Jul 2027 expected | Crohn disease | University of Calgary | Recruiting | No outcome recorded |
| Phase 4 | NCT05205603 Background | Jan 2022 → Jan 2024 | ulcerative colitis | Sixth Affiliated Hospital, Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT05481619 Comparator | Jan 2021 → Jan 2026 overdue | ulcerative colitis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 4 | NCT04259138 Background | Feb 2020 → Mar 2026 overdue | ulcerative colitis | Alimentiv Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03629379 Comparator | Jan 2019 → Jan 2021 | inflammatory bowel disease, psoriasis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT02324699 Background | Apr 2016 → Feb 2018 | Crohn disease | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02694588 Comparator | Jun 2014 → Oct 2018 | inflammatory bowel disease | University Hospital Schleswig-Holstein | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06856135 Background | — | Crohn disease, ulcerative colitis | Takeda | Available | No outcome recorded |
Press releases naming this drug 49 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-09 | Takeda | U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
| 2024-04-18 | Takeda | U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease takeda.com ↗ |
| 2023-09-27 | Takeda | U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis takeda.com ↗ |
| 2023-09-13 | Takeda | Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease takeda.com ↗ |
| 2023-04-27 | Takeda | Takeda Announces FDA Acceptance of BLA Resubmission for Investigational Subcutaneous Administration of Entyvio® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis takeda.com ↗ |
| 2023-03-30 | Takeda | Takeda Announces Results from Phase 4 Vedolizumab Study in Patients with Chronic Pouchitis Published in New England Journal of Medicine takeda.com ↗ |
| 2023-03-27 | Takeda | Takeda Receives Approval to Manufacture and Market Entyvio ® Subcutaneous Injection in Japan for the Maintenance Treatment of Moderate to Severe Ulcerative Colitis takeda.com ↗ |
| 2023-02-18 | Takeda | Takeda Presents Positive Results from Phase 3 Study of Vedolizumab for Prevention of Intestinal Acute Graft-Versus-Host Disease (aGvHD) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) takeda.com ↗ |
| 2021-12-17 | Takeda | Takeda Receives Positive CHMP Opinion for Vedolizumab IV for the Treatment of Active Chronic Pouchitis takeda.com ↗ |
| 2020-10-12 | Takeda | Safety and Efficacy of Subcutaneous Entyvio ® (Vedolizumab) Sustained During Long-term Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis takeda.com ↗ |
| 2020-06-23 | Takeda | Takeda Receives U.S. FDA Approval to Manufacture ENTYVIO ® (vedolizumab) Drug Substance at Manufacturing Facility in Brooklyn Park, Minnesota takeda.com ↗ |
| 2020-05-08 | Takeda | European Commission Approves Subcutaneous Formulation of Entyvio ® (Vedolizumab) for use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease takeda.com ↗ |
| 2020-03-23 | Takeda | Takeda Receives Approval of Entyvio ® (Vedolizumab) in China for the Treatment of Patients with Moderate to Severe Active Ulcerative Colitis (UC) and Crohn's Disease (CD) takeda.com ↗ |
| 2020-02-28 | Takeda | Takeda Receives Positive CHMP Opinion for Subcutaneous Formulation of Vedolizumab for use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease takeda.com ↗ |
| 2020-02-14 | Takeda | Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn’s Disease takeda.com ↗ |
| 2019-12-20 | Takeda | Takeda Receives Complete Response Letter from U.S. FDA for the Investigational Subcutaneous Formulation of ENTYVIO ® (vedolizumab) as a Maintenance Therapy in Adults with Moderate to Severe Ulcerative Colitis takeda.com ↗ |
| 2019-10-21 | Takeda | Retrospective Real-World Comparative Analysis Highlights Safety of Vedolizumab and Anti-TNFα Therapies in Biologic-Naïve Patients with Ulcerative Colitis or Crohn’s Disease takeda.com ↗ |
| 2019-09-25 | Takeda | First Head-to-Head Biologic Study in Ulcerative Colitis Published in The New England Journal of Medicine Highlights Benefit of Vedolizumab vs. Adalimumab takeda.com ↗ |
| 2019-08-08 | Takeda | Takeda Submits New Drug Application for a Subcutaneous Formulation of Vedolizumab for Patients with Moderately to Severely Active Ulcerative Colitis in Japan takeda.com ↗ |
| 2019-07-22 | Takeda | Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease takeda.com ↗ |
| 2019-05-22 | Takeda | Entyvio ® (vedolizumab) Approved in Japan for the Treatment of Patients with Moderately to Severely Active Crohn's Disease takeda.com ↗ |
| 2019-05-19 | Takeda | New Exploratory Data from VARSITY, the First Head-to-Head Ulcerative Colitis Biologic Study Which Demonstrated Superiority of Vedolizumab to Adalimumab in Clinical Remission at Week 52, Presented at 2019 Digestive Disease Week ® takeda.com ↗ |
| 2019-05-09 | Takeda | U.S. Food & Drug Administration Accepts Takeda’s Biologics License Application for a Subcutaneous Formulation of Vedolizumab (Entyvio ® ) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis takeda.com ↗ |
| 2019-04-01 | Takeda | European Medicines Agency Accepts Takeda’s Marketing Authorization Application for a Subcutaneous Formulation of Vedolizumab for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis and Crohn’s Disease takeda.com ↗ |
| 2019-03-09 | Takeda | Vedolizumab (Entyvio ® ) Achieves Superior Rates of Clinical Remission vs. Adalimumab (Humira ® ) in First Ever Head-to-Head Biologic Clinical Study in Ulcerative Colitis takeda.com ↗ |
| 2018-11-07 | Takeda | Takeda Announces Launch of Entyvio ® (vedolizumab) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis in Japan takeda.com ↗ |
| 2018-10-22 | Takeda | Investigational Subcutaneous Formulation of Vedolizumab Achieves and Maintains Clinical Remission and Mucosal Healing at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis takeda.com ↗ |
| 2018-07-19 | Takeda | New Phase 3 Data Show Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis takeda.com ↗ |
| 2018-07-18 | Takeda | Takeda Submits an Application for a New Indication of Entyvio ® (vedolizumab) for the Treatment of Adult Patients with Moderately to Severely Active Crohn’s Disease in Japan takeda.com ↗ |
| 2018-07-02 | Takeda | Takeda Obtains New Drug Application Approval for Entyvio ® (vedolizumab) for the Treatment of Ulcerative Colitis in Japan takeda.com ↗ |
| 2018-06-03 | Takeda | Takeda Highlights Favorable Safety Profile of Entyvio ® (vedolizumab) Through Comparative Real-World Data Versus TNFα-Antagonist Therapy in Ulcerative Colitis and Crohn’s Disease takeda.com ↗ |
| 2018-02-16 | Takeda | Entyvio ® (vedolizumab) Shows Higher Rates of Mucosal Healing Versus TNFα-Antagonist Therapy in Ulcerative Colitis and Crohn’s Disease Patients in Comparative Effectiveness Real-World Data Analysis takeda.com ↗ |
| 2017-11-01 | Takeda | Meta-Analysis Using Real-World Data Evaluates Safety Profile of Entyvio ® (vedolizumab) in Patients with Moderate to Severe Ulcerative Colitis or Crohn’s Disease takeda.com ↗ |
| 2017-10-16 | Takeda | New Post-Hoc Analyses Report Early Symptomatic Improvement in Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Patients Taking Entyvio ® (vedolizumab), Particularly in Biologic-Naïve Patients takeda.com ↗ |
| 2017-08-22 | Takeda | Takeda Submits a New Drug Application for Vedolizumab for the Treatment of Moderately to Severely Ulcerative Colitis in Japan takeda.com ↗ |
| 2017-05-08 | Takeda | New Real-World Analyses Support Effectiveness and Safety of Entyvio ® (vedolizumab) for Ulcerative Colitis and Crohn’s Disease takeda.com ↗ |
| 2017-02-17 | Takeda | Five-Year Open-Label Prospective Study Data Presented at the 12 th Congress of European Crohn's and Colitis Organisation (ECCO) Provides Information on the Long-Term Use of Vedolizumab in Adult Patients with Moderate to Severely Active Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
| 2016-12-12 | Takeda | GEMINI II & III Post-hoc Analysis Reports Clinical Benefits of Vedolizumab as Induction and Maintenance Therapy in Tumor Necrosis Factor-Naive Patients with Moderately to Severely Active Crohn's Disease takeda.com ↗ |
| 2016-10-17 | Takeda | Takeda's Vedolizumab Demonstrated Robust Clinical Effectiveness and Safety in Inflammatory Bowel Disease in More Than 50 Real-World Studies takeda.com ↗ |
| 2016-09-29 | Takeda | Additional Interim Data Supporting Long-Term Use of Vedolizumab in Patients with Ulcerative Colitis and Crohn's Disease Published in Journal of Crohn's and Colitis takeda.com ↗ |
| 2016-09-16 | Takeda | Favorable Benefit: Risk Profile for Vedolizumab as Induction and Maintenance Therapy in TNF-Naïve or TNF-Failure Patients with Moderately to Severely Active Ulcerative Colitis Published in Clinical Gastroenterology and Hepatology takeda.com ↗ |
| 2016-05-24 | Takeda | Takeda Presents Analyses From Vedolizumab Data in Ulcerative Colitis at 2016 Digestive Disease Week (DDW) Annual Meeting takeda.com ↗ |
| 2016-03-19 | Takeda | New Data Presented at European Crohn's and Colitis Organisation (ECCO) Scientific Meeting on Efficacy of Long-Term Vedolizumab Treatment takeda.com ↗ |
| 2015-10-20 | Takeda | Takeda Presents Vedolizumab Data at the 2015 American College of Gastroenterology (ACG) Annual Meeting and United European Gastroenterology Week (UEGW) takeda.com ↗ |
| 2014-06-17 | Takeda | ENTYVIO TM (vedolizumab) Now Available in the United States for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
| 2014-05-28 | Takeda | Takeda Receives European Commission Marketing Authorisation for Entyvio ® (vedolizumab) for the Treatment of Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
| 2014-05-21 | Takeda | FDA Approves Takeda's Entyvio™ (vedolizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease takeda.com ↗ |
| 2014-03-24 | Takeda | Takeda Receives Positive CHMP Opinion for Entyvio ® (vedolizumab) in Europe for the Treatment of Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
| 2014-01-08 | Takeda | Takeda's New Investigational Drug Vedolizumab Entered Phase 3 Clinical Trials in Japan for the Treatment of Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 121 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vedolizumab | “The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗113“Vedolizumab: Induction with 300 mg IV at day 0, and 300 mg IV at week 2; maintenance with 300 mg IV at week 6 and every eight weeks thereafter or with 108 mg SC at week 6, week...” NCT05169593 ↗ “Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®” NCT05771155 ↗ “Infliximab will be administered at a dose 5mg/kg body weight, and vedolizumab at a dose of 300 mg” NCT06614387 ↗ “mTOR inhibitors (everolimus or sirolimus), vedolizumab, ruxolitinib.” NCT05132166 ↗ “Vedolizumab 10 mg/kg/day, max. 300 mg on the days 0, +14, +28, +60” NCT06475820 ↗ “Participants will change to intravenous vedolizumab therapy.” NCT04259138 ↗ |
| Known as | Entyvio | “Participants will continue to receive vedolizumab IV at the same dose administered at the end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks.
• Other...” NCT06856135 ↗6“Vedolizumab infusion (Entyvio): Vedolizumab (300mg) is administered as an intravenous infusion (255 ml).” NCT04120415 ↗ “Vedolizumab (brand name Entyvio)” NCT03147859 ↗ “Vedolizumab 300 MG [Entyvio]” NCT02972450 ↗ “Entyvio (Vedolizumab)” NCT03577782 ↗ “Entyvio (Vedolizumab)” NCT02788175 ↗ |
| Known as | KYNTELES | “Participants will continue to receive vedolizumab IV at the same dose administered at the end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks. • Other...” NCT06856135 ↗ |
| Known as | LDP-02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00655135 ↗ |
| Known as | MLN-02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743087 ↗ |
| Known as | MLN0002 | “Vedolizumab (also called MLN0002) is approved for the treatment of adult participants with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) who...” NCT02728895 ↗1“Participants will continue to receive vedolizumab IV at the same dose administered at the end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks. • Other...” NCT06856135 ↗ |
| Known as | VDZ | “Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut.” NCT02862132 ↗2“Biologic therapies, such as vedolizumab (VDZ) and ustekinumab (UST), offer effective treatment options for inflammatory bowel disease.” PMID 41453773 ↗ Dec 2025 “Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut lymphocyte trafficking.” NCT02820493 ↗ |
| Known as | Vedolizumab SC | “Vedolizumab Subcutaneous (also known as Vedolizumab SC)” NCT02620046 ↗ |
| Action | Inhibit | “vedolizumab, a gut-selective α4β7 integrin antagonist approved for treating moderately to severely active CD” PMID 29471381 ↗ Apr 2018 |
| Modality | Monoclonal antibody | “humanized monoclonal antibody” PMID 29857145 ↗ May 2018 |
| Route | Intravenous | “vedolizumab administered intravenously (IV) every 8 weeks” NCT00619489 ↗ |