Drugs / Vedolizumab
Vedolizumab
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Crohn jejunoileitis 1 milestone | |||||
| Filed | Japan (PMDA) | Entyvio | Crohn jejunoileitis | 2018-07-18 | “has submitted an Application to the Ministry of Health, Labour and Welfare (MHLW) in Japan” takeda.com ↗ |
| Filed ulcerative colitis 5 milestones | |||||
| Filed | EU (EMA) | ENTYVIO | ulcerative colitis | 2026-05-06 | “Takeda submitted a Marketing Authorisation Application (MAA) to the EMA in March 2013 for vedolizumab for the treatment of adults with moderately to severely active UC or CD.” takeda.com ↗ “Submitted a Marketing Authorization Application to the European Medicines Agency for AVT16 and AVT80, proposed biosimilars to Entyvio® (vedolizumab)” alvotech.com ↗ “Takeda has also submitted a marketing authorization application (MAA) to the European Medicines Agency for ENTYVIO IV” takeda.com ↗ |
| Filed | Japan (PMDA) | ENTYVIO | ulcerative colitis | 2019-10-31 | “Submitted a Marketing Authorization Application (MAA) in Japan for a subcutaneous formulation of ENTYVIO for patients with moderately to severely active ulcerative colitis.” takeda.com ↗ “Takeda submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare (MHLW) in August 2017” takeda.com ↗ |
| Filed | Japan (PMDA) | — | ulcerative colitis | 2019-08-08 | “submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan” takeda.com ↗ |
| Filed | US (FDA) | — | ulcerative colitis | 2019-05-09 | “the U.S. Food & Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab” takeda.com ↗ |
| Filed | Japan (PMDA) | — | ulcerative colitis | 2017-08-22 | “announced today that it has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare in Japan” takeda.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 ↗ |
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| 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 Stop: Enrollment |
| Phase 110 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 | NCT02723006 | Jun 2016 → May 2018 | melanoma | Millennium Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| 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 · 1 missed | ||||||
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| 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 · 5 met primary · 3 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT02611830 | Dec 2015 → May 2018 | ulcerative colitis | Takeda | Completed | Met primary |
| Phase 3 | NCT02497469 | Jun 2015 → Sep 2018 | ulcerative colitis | Takeda | Completed | Met primary |
| 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 | Mixed |
| Phase 3 | NCT02038920 | Jan 2014 → Jan 2019 | Crohn disease | Takeda | Completed | Missed primary |
| Phase 3 | NCT01224171 | Nov 2010 → Feb 2012 | Crohn disease | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT00783692 | Dec 2008 → Mar 2012 | Crohn disease | Millennium Pharmaceuticals, Inc. | Completed | Mixed |
| Phase 427 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07576452 | Dec 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 → May 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 Stop: Enrollment |
| 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 | Missed primary |
| Phase 4 | NCT02760615 | Nov 2016 → Aug 2020 | Crohn disease, ulcerative colitis | Takeda | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02790138 | Oct 2016 → Jun 2020 | pouchitis | Takeda | Completed | Met primary |
| 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 · 1 met primary | ||||||
| — | NCT06095596 | Nov 2023 → Oct 2025 overdue | ulcerative colitis | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Met primary |
| — | 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 |
| Comparator or background therapy24 trials | ||||||
| Phase 0 | NCT02953275 Background | Apr 2017 → Mar 2019 | Crohn disease | University of Miami | Completed | No outcome recorded |
| Phase 1 | NCT06732804 Comparator | Feb 2025 → Jan 2026 | — | Alvotech Swiss AG | Completed | Met primary |
| 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 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 Stop: Enrollment |
| Phase 2 | NCT04118556 Comparator | Dec 2021 → Apr 2026 | acute graft versus host disease | Mats Remberger | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| 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 Stop: Business |
| Phase 3 | NCT04469062 Comparator | Apr 2021 → Mar 2024 | ulcerative colitis | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02954159 Comparator | May 2017 → Jan 2019 | ulcerative colitis | Medical College of Wisconsin | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT07665294 Background | Oct 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 → Apr 2026 | ulcerative colitis | Alimentiv Inc. | Completed | 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 Stop: Enrollment |
| — | NCT02694588 Comparator | Jun 2014 → Oct 2018 | inflammatory bowel disease | University Hospital Schleswig-Holstein | Completed | No outcome recorded |
| — | NCT06856135 Background | — | Crohn disease, ulcerative colitis | Takeda | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 50
| Date | Issuer | Release |
|---|---|---|
| 2026-07-31 | Fresenius Kabi | Regulatory Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate fresenius.com ↗
“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. |
| 2026-07-31 | Fresenius Kabi | Regulatory Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate fresenius.com ↗
the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and the Marketing Authorisation Application (MAA), respectively, for PB016 |
| 2026-07-31 | Fresenius Kabi | Regulatory Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate
Fresenius Kabi announced that the FDA and EMA have accepted for review PB016, a proposed vedolizumab biosimilar candidate for adults with ulcerative colitis and Crohn’s disease. fresenius-kabi.com ↗
U.S. FDA acceptance for review of Biologics License Application (BLA) and European Medicines Agency (EMA) acceptance for review of the Marketing Authorization Application (MAA) of intravenous vedolizumab biosimilar candidate, an integrin receptor antagonist. |
| 2026-07-31 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate polpharmabiologics.com ↗
The BLA and MAA acceptances represent significant milestones in Polpharma Biologics’ development program and underscore the company’s commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. |
| 2026-06-09 | Takeda | Regulatory U.S. FDA Accepts Takeda's Application for Intravenous ENTYVIO® (vedolizumab) in Pediatric Ulcerative Colitis and Crohn's Disease takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for intravenous (IV) ENTYVIO® (vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease in pediatric patients ages 2 years and older. |
| 2024-04-18 | Takeda | Regulatory U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO. |
| 2024-03-18 | Polpharma Biologics S.A. | Results Konstantin Matentzoglu for Puls Biznesu polpharmabiologics.com ↗
We have completed a pharmacokinetics & pharmacodynamics clinical study, which achieved all the pre-defined endpoints. |
| 2023-09-27 | Takeda | Regulatory 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 | Regulatory 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 | Regulatory 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 | Results Takeda Announces Results from Phase 4 Vedolizumab Study in Patients with Chronic Pouchitis Published in New England Journal of Medicine takeda.com ↗
The Phase 4 EARNEST Study Met Its Primary Efficacy Endpoint of Remission of Chronic Or Recurrent Pouchitis at Week 14, with 31% of Participants Receiving Vedolizumab Achieving Remission versus 10% Receiving Placebo. |
| 2023-03-27 | Takeda | Regulatory Takeda Receives Approval to Manufacture and Market Entyvio ® Subcutaneous Injection in Japan for the Maintenance Treatment of Moderate to Severe Ulcerative Colitis takeda.com ↗
the Japanese Ministry of Health, Labour and Welfare has approved the use of Entyvio ® Pens for subcutaneous (SC) injection 108 mg / Syringes for SC injection 108 mg |
| 2023-02-18 | Takeda | Results 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 ↗
The Phase 3 GRAPHITE Study Met Its Primary Efficacy Endpoint of Significant and Clinically Meaningful Intestinal aGvHD-Free Survival as Compared to Placebo by Day 180 after Allo-HSCT (p<0.001) |
| 2021-12-17 | Takeda | Regulatory Takeda Receives Positive CHMP Opinion for Vedolizumab IV for the Treatment of Active Chronic Pouchitis takeda.com ↗ |
| 2020-10-12 | Takeda | Results Safety and Efficacy of Subcutaneous Entyvio ® (Vedolizumab) Sustained During Long-term Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis takeda.com ↗
In evaluating the primary safety endpoint of the trial, interim data of the UC patient population showed that following two years of maintenance therapy with vedolizumab SC, long-term safety findings were consistent with the known safety profile of vedolizumab. |
| 2020-06-23 | Takeda | Regulatory Takeda Receives U.S. FDA Approval to Manufacture ENTYVIO ® (vedolizumab) Drug Substance at Manufacturing Facility in Brooklyn Park, Minnesota takeda.com ↗
The approval for commercial production of Entyvio drug substance from Brooklyn Park will expand Takeda’s capacity to supply patients with this important product. |
| 2020-05-08 | Takeda | Regulatory 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 ↗
This decision by the European Commission means that Entyvio SC is now approved for use in the 27 member states of the European Union, plus the United Kingdom, Norway, Liechtenstein and Iceland. |
| 2020-03-23 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) has announced that the gut-selective biologic Entyvio ® (vedolizumab) was approved by China’s National Medical Products Administration (NMPA). |
| 2020-02-28 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). |
| 2020-02-14 | Takeda | Results Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn’s Disease takeda.com ↗
The results show that at week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission (48.0% [n=132/275] vs. 34.3% [n=46/134] respectively; [p=0.008]),** meeting the study’s primary endpoint. |
| 2019-12-20 | Takeda | Regulatory 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 | Results 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 ↗
The incidence rates for the first occurrence of a serious adverse event (vedolizumab: 4.6 [3.5-6.8]; anti-TNFα: 10.3 [9.5-14.9]) and serious infections (vedolizumab: 1.4 [0.8-2.5]; anti-TNFα: 2.6 [1.7-4.3]) were estimated to be lower with vedolizumab treatment. |
| 2019-09-25 | Takeda | Results 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 ↗
Clinical remission rates at week 52 were superior with vedolizumab at 31.3% (n=120/383) versus 22.5% (n=87/386) with adalimumab (p=0.006). |
| 2019-08-08 | Takeda | Regulatory Takeda Submits New Drug Application for a Subcutaneous Formulation of Vedolizumab for Patients with Moderately to Severely Active Ulcerative Colitis in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) ( TSE: 4502/NYSE: TAK ) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). |
| 2019-07-22 | Takeda | Results 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 ↗
In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission** at week 52 compared to placebo. |
| 2019-05-22 | Takeda | Regulatory Entyvio ® (vedolizumab) Approved in Japan for the Treatment of Patients with Moderately to Severely Active Crohn's Disease takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) ( TSE: 4502/NYSE: TAK ) today announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Entyvio ® (generic name: vedolizumab, development code: MLN0002) for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan. |
| 2019-05-19 | Takeda | Results 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 ↗
New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response** at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. |
| 2019-05-09 | Takeda | Regulatory 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 ↗
Acceptance of this regulatory submission for review brings us one step closer to our goal of better meeting the diverse needs of patients with ulcerative colitis in the U.S. |
| 2019-04-01 | Takeda | Regulatory 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 | Results 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 ↗
Vedolizumab superior to adalimumab in achieving clinical remission and mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis |
| 2018-10-22 | Takeda | Results 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 ↗
At week 52, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission ** compared to patients receiving placebo (46.2% vs. 14.3%; p<0.001). |
| 2018-07-19 | Takeda | Results 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 ↗
In the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC beginning at week 6 and every two weeks following achieved clinical remission** at week 52 compared to placebo. |
| 2018-07-18 | Takeda | Regulatory 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 ↗
Takeda Pharmaceutical Company Limited ( TSE: 4502 ) (“Takeda”) today announced that it has submitted an Application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the investigational humanized monoclonal antibody Entyvio ® (generic name: vedolizumab, development code: MLN0002) for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan. |
| 2018-07-02 | Takeda | Regulatory Takeda Obtains New Drug Application Approval for Entyvio ® (vedolizumab) for the Treatment of Ulcerative Colitis in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE: 4502 ) today announced that it has obtained a New Drug Application Approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Entyvio (generic name: vedolizumab, development code: MLN0002) for the treatment of patients with moderately to severely active ulcerative colitis (UC) in Japan. |
| 2018-06-03 | Takeda | Results 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 ↗
The results showed numerically lower rates of serious infections (SIs) [6.9% vs 10.1%; odds ratio (OR) 0.67, 95% confidence interval (CI) 0.41-1.07] and significantly lower rates of serious adverse events (SAEs) [7.1% vs 13.1%; OR 0.51, 95% CI 0.32-0.81] in patients treated with Entyvio (n=436) compared to TNFα-antagonist therapy (n=436). |
| 2018-02-16 | Takeda | Results 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 | Results 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 ↗
Takeda Pharmaceutical Company Limited [TSE:4502] (“Takeda”) today announced the presentation of real-world evidence from two analyses evaluating the safety profile of Entyvio ® (vedolizumab), during the 25 th United European Gastroenterology (UEG) Week in Barcelona, Spain (28 October - 1 November ). |
| 2017-10-16 | Takeda | Results 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 ↗
In patients who reported improvements, the greatest differences from placebo were observed in biologic-naïve patients versus the overall treatment group, some as early as week 2. |
| 2017-08-22 | Takeda | Regulatory 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 | Results New Real-World Analyses Support Effectiveness and Safety of Entyvio ® (vedolizumab) for Ulcerative Colitis and Crohn’s Disease takeda.com ↗ |
| 2017-02-17 | Takeda | Results 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 ↗
This interim analysis reports clinical effectiveness evaluated at five years. |
| 2016-12-12 | Takeda | Results 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 ↗
The data demonstrated higher rates of response in patients receiving vedolizumab as a first-line biologic after conventional therapy failure versus patients who had previously experienced tumor necrosis factor-alpha （TNF-α） antagonist therapy failure. |
| 2016-10-17 | Takeda | Results Takeda's Vedolizumab Demonstrated Robust Clinical Effectiveness and Safety in Inflammatory Bowel Disease in More Than 50 Real-World Studies takeda.com ↗
Findings indicated notable clinical remission rates, reductions in disease activity scores and improved mucosal healing in more than 5,000 patients with UC and CD receiving treatment with vedolizumab in real-world clinical practice. |
| 2016-09-29 | Takeda | Results 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 ↗
The data showed that patients with moderately to severely active UC experienced clinical and health-related quality of life (HRQL) improvements with continued vedolizumab treatment. |
| 2016-09-16 | Takeda | Results 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 ↗
Overall, the publication reported a statistically significantly greater efficacy with vedolizumab treatment compared to placebo in both sub-groups of patients. |
| 2016-05-24 | Takeda | Results Takeda Presents Analyses From Vedolizumab Data in Ulcerative Colitis at 2016 Digestive Disease Week (DDW) Annual Meeting takeda.com ↗
Takeda Pharmaceutical Company Limited [ TSE: 4502 ] , (“Takeda”) today announced the oral presentations of two data analyses: one evaluating the optimal position of vedolizumab in the ulcerative colitis (UC) treatment paradigm, and a second separate analysis assessing whether early vedolizumab trough levels were associated with subsequent drug efficacy. |
| 2016-03-19 | Takeda | Results New Data Presented at European Crohn's and Colitis Organisation (ECCO) Scientific Meeting on Efficacy of Long-Term Vedolizumab Treatment takeda.com ↗
The presented data showed that patients with moderately to severely active ulcerative colitis (UC) reported clinical improvements with approximately three years of treatment with vedolizumab. |
| 2014-05-28 | Takeda | Regulatory Takeda Receives European Commission Marketing Authorisation for Entyvio ® (vedolizumab) for the Treatment of Ulcerative Colitis and Crohn's Disease takeda.com ↗
Vedolizumab is now approved for marketing in the 28 member states of the European Union as well as Norway, Iceland and Liechtenstein. |
| 2014-05-21 | Takeda | Regulatory 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 | Regulatory Takeda Receives Positive CHMP Opinion for Entyvio ® (vedolizumab) in Europe for the Treatment of Ulcerative Colitis and Crohn's Disease takeda.com ↗ |
All press releases naming this drug 65 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 120 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)” NCT02788175 ↗ “Entyvio (Vedolizumab)” NCT03577782 ↗ |
| 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 ↗ |