MDL | - |
---|---|
Molecular Weight | 146814.90 |
Molecular Formula | - |
SMILES | [Vedolizumab] |
Integrin [1]
Vedolizumab does not bind to the majority of memory CD4+ T lymphocytes (60%), neutrophils, and most monocytes. The highest level of vedolizumab binding is to a subset (25%) of human peripheral blood memory CD4+ T lymphocytes that include gut-homing interleukin 17 T-helper lymphocytes. Vedolizumab also binds to eosinophils at high levels, and to naive T-helper lymphocytes, naive and memory cytotoxic T lymphocytes, B lymphocytes, natural killer cells, and basophils at lower levels; vedolizumab binds to memory CD4+ T and B lymphocytes with subnanomolar potency (EC 50 =0.3-0.4 nM). Vedolizumab selectively inhibits adhesion of α4β7-expressing cells to mucosal addressin cell adhesion molecule 1 (IC 50 =0.02-0.06 μg/mL) and fibronectin (IC 50 =0.02 μg/mL), but not vascular cell adhesion molecule 1 [1] .
MCE has not independently confirmed the accuracy of these methods. They are for reference only.
Blockade of α4β7 receptors on T-lymphocytes has been shown to occur for several weeks after a single dose of vedolizumab. The drug concentration following the infusion has been shown to be dose related with a mean maximum concentration of 12.5 μg/mL in those receiving 0.5 mg/kg of vedolizumab and 52.0 μg/mL in those receiving 2 mg/kg. The serum half-life of these two doses is 9-12 days respectively and saturation of α4β7 receptors on T-lymphocytes is >90% at both 4-6 weeks following infusion. In a dose ranging study, the serum drug concentrations increase with increasing dose and when regular induction infusions are used (on day 1, 15, 29 and 85), the serum half-life is between 15 and 22 days across all groups [1] .
MCE has not independently confirmed the accuracy of these methods. They are for reference only.
NCT Number | Sponsor | Condition | Start Date | Phase |
---|---|---|---|---|
NCT02674308 | Takeda |
Ulcerative Colitis and Crohn´s Disease
|
March 24, 2015 | |
NCT00783718 | Millennium Pharmaceuticals, Inc. |
Ulcerative Colitis
|
January 2009 | Phase 3 |
NCT03961308 | Takeda |
Healthy Volunteers
|
March 12, 2018 | Phase 1 |
NCT04779307 | Takeda |
Colitis, Ulcerative
|
October 19, 2021 | Phase 3 |
NCT05442567 | Takeda |
Ulcerative Colitis|Crohn´s Disease
|
February 28, 2023 | Phase 3 |
NCT03029143 | Takeda |
Colitis, Ulcerative
|
March 29, 2017 | Phase 4 |
NCT02723006 | Millennium Pharmaceuticals, Inc.|Takeda |
Melanoma
|
June 22, 2016 | Phase 1 |
NCT04919252 | Yonsei University |
Crohn´s Disease and Ulcerative Colitis
|
June 1, 2021 | Phase 3 |
NCT04362735 | Pontifícia Universidade Católica do Paraná|Takeda |
Crohn Disease
|
August 1, 2020 | |
NCT02497469 | Takeda |
Colitis, Ulcerative
|
June 29, 2015 | Phase 3 |
NCT03329209 | Takeda |
Colitis, Ulcerative|Crohn Disease
|
March 5, 2018 | Phase 1 |
NCT03802214 | Stanford University|Takeda|University of Western Ontario, Canada|University of California, San Diego |
Ulcerative Colitis
|
October 29, 2020 | |
NCT03375424 | Ced Service GmbH |
Inflammatory Bowel Diseases|Treatment
|
October 2, 2017 | |
NCT04006080 | Guy´s and St Thomas´ NHS Foundation Trust|Takeda |
Ulcerative Colitis
|
July 1, 2019 | Phase 4 |
NCT03196427 | Takeda|Takeda Development Center Americas, Inc. |
Ulcerative Colitis|Crohn´s Disease
|
July 30, 2018 | Phase 2 |
NCT03558152 | Genentech, Inc. |
Ulcerative Colitis
|
October 26, 2018 | Phase 2 |
NCT03949621 | Takeda |
Healthy Volunteers
|
February 6, 2018 | Phase 1 |
NCT01981616 | Millennium Pharmaceuticals, Inc. |
Inflammatory Bowel Disease
|
September 2011 | Phase 1 |
NCT01177228 | Millennium Pharmaceuticals, Inc. |
Ulcerative Colitis
|
May 2007 | Phase 2 |
NCT03657160 | Millennium Pharmaceuticals, Inc.|Takeda |
Hematopoietic Stem Cells
|
February 6, 2019 | Phase 3 |
NCT05386290 | Peking Union Medical College Hospital |
Ulcerative Colitis|Crohn Disease
|
July 9, 2020 | |
NCT01224171 | Millennium Pharmaceuticals, Inc. |
Crohn´s Disease
|
November 2010 | Phase 3 |
NCT02993783 | Millennium Pharmaceuticals, Inc.|Takeda |
Allogeneic Hematopoietic Stem Cell Transplantation
|
April 28, 2017 | Phase 2 |
NCT05481619 | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Ulcerative Colitis
|
January 1, 2021 | Phase 4 |
NCT05158517 | Groupe d´Etude Therapeutique des Affections Inflammatoires Digestives|Takeda |
Inflammatory Bowel Diseases
|
March 20, 2022 | |
NCT02760615 | Takeda |
Colitis, Ulcerative|Crohn Disease
|
November 1, 2016 | Phase 4 |
NCT02630966 | Takeda |
Crohn´s Disease
|
August 10, 2016 | Phase 4 |
NCT02712866 | Parc de Salut Mar |
Inflammatory Bowel Disease
|
January 2017 | |
NCT03035058 | Takeda |
Primary Sclerosing Cholangitis|Inflammatory Bowel Disease
|
February 2017 | Phase 3 |
NCT02611830 | Takeda |
Colitis, Ulcerative
|
December 18, 2015 | Phase 3 |
NCT03885713 | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
Inflammatory Bowel Diseases|Crohn Disease|Ulcerative Colitis
|
September 10, 2019 | Phase 4 |
NCT03824561 | Takeda |
Ulcerative Colitis
|
February 1, 2019 | |
NCT02039505 | Takeda |
Ulcerative Colitis
|
February 4, 2014 | Phase 3 |
NCT02820493 | Universita degli Studi di Genova |
Crohn Disease
|
September 2016 | Phase 4 |
NCT02611817 | Takeda |
Crohn´s Disease
|
January 4, 2016 | Phase 3 |
NCT02646683 | Geert D´Haens|Takeda|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Crohn Disease
|
July 2015 | Phase 4 |
NCT02790138 | Takeda |
Pouchitis
|
October 12, 2016 | Phase 4 |
NCT02878083 | Nantes University Hospital|Takeda|Mauna Kea Technologies|Institut National de la Santé Et de la Recherche Médicale, France |
ULCERATIVE COLITIS
|
January 11, 2017 | Not Applicable |
NCT03221036 | Takeda |
Moderately to Severely Active Ulcerative Colitis
|
August 3, 2017 | Phase 3 |
NCT02620046 | Takeda |
Colitis, Ulcerative|Crohn´s Disease
|
April 15, 2016 | Phase 3 |
NCT02972450 | ANRS, Emerging Infectious Diseases|European Commission|Swiss Government|Medical Research Council|FIT Biotech Ltd.|Fred Hutchinson Cancer Center|University College, London|Centre Hospitalier Universitaire Vaudois|Imperial College London|Istituto Nazionale Malattie Infettive Lazaro Spallanzani|Universitätsklinikum Hamburg-Eppendorf|Institut d´Investigacions Biomèdiques August Pi i Sunyer|Henri Mondor University Hospital|European Georges Pompidou Hospital|Saint-Louis Hospital, Paris, France |
HIV-1-infection
|
February 20, 2019 | Phase 1|Phase 2 |
NCT02834754 | Marc Schwartz|Takeda|University of Pittsburgh |
Crohn´s Disease
|
December 1, 2018 | Phase 2 |
NCT02163421 | Takeda |
Healthy
|
June 2014 | Phase 1 |
NCT03819296 | M.D. Anderson Cancer Center|National Cancer Institute (NCI) |
Clinical Stage 0 Cutaneous Melanoma AJCC v8|Clinical Stage I Cutaneous Melanoma AJCC v8|Clinical Stage IA Cutaneous Melanoma AJCC v8|Clinical Stage IB Cutaneous Melanoma AJCC v8|Clinical Stage II Cutaneous Melanoma AJCC v8|Clinical Stage IIA Cutaneous Melanoma AJCC v8|Clinical Stage IIB Cutaneous Melanoma AJCC v8|Clinical Stage IIC Cutaneous Melanoma AJCC v8|Clinical Stage III Cutaneous Melanoma AJCC v8|Clinical Stage IV Cutaneous Melanoma AJCC v8|Colitis|Lung Non-Small Cell Carcinoma|Malignant Genitourinary System Neoplasm|Malignant Solid Neoplasm|Pathologic Stage 0 Cutaneous Melanoma AJCC v8|Pathologic Stage I Cutaneous Melanoma AJCC v8|Pathologic Stage IA Cutaneous Melanoma AJCC v8|Pathologic Stage IB Cutaneous Melanoma AJCC v8|Pathologic Stage II Cutaneous Melanoma AJCC v8|Pathologic Stage IIA Cutaneous Melanoma AJCC v8|Pathologic Stage IIB Cutaneous Melanoma AJCC v8|Pathologic Stage IIC Cutaneous Melanoma AJCC v8|Pathologic Stage III Cutaneous Melanoma AJCC v8|Pathologic Stage IIIA Cutaneous Melanoma AJCC v8|Pathologic Stage IIIB Cutaneous Melanoma AJCC v8|Pathologic Stage IIIC Cutaneous Melanoma AJCC v8|Pathologic Stage IIID Cutaneous Melanoma AJCC v8|Pathologic Stage IV Cutaneous Melanoma AJCC v8|Stage 0 Lung Cancer AJCC v8|Stage I Lung Cancer AJCC v8|Stage IA1 Lung Cancer AJCC v8|Stage IA2 Lung Cancer AJCC v8|Stage IA3 Lung Cancer AJCC v8|Stage IB Lung Cancer AJCC v8|Stage II Lung Cancer AJCC v8|Stage IIA Lung Cancer AJCC v8|Stage IIB Lung Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8
|
February 21, 2021 | Phase 1|Phase 2 |
NCT02862132 | Shaare Zedek Medical Center |
Crohn´s Disease|Ulcerative Colitis|Inflammatory Bowel Disease
|
January 2017 | Not Applicable |
NCT03629379 | Universitaire Ziekenhuizen KU Leuven |
Inflammatory Bowel Diseases|Psoriasis
|
September 1, 2018 | Phase 4 |
NCT04797325 | University of Copenhagen |
Immune-Mediated Colitis
|
August 30, 2021 | Phase 2 |
NCT03219359 | Aaron Etra|Icahn School of Medicine at Mount Sinai |
Crohn Disease
|
July 12, 2017 | Phase 2 |
NCT02788175 | National Institute of Allergy and Infectious Diseases (NIAID)|National Institutes of Health Clinical Center (CC) |
HIV
|
May 28, 2016 | Phase 1 |
NCT03309865 | Mayo Clinic |
Ulcerative Colitis|Dietary Modification
|
December 25, 2017 | Early Phase 1 |
NCT02953275 | University of Miami|Takeda |
Crohn Disease
|
April 13, 2017 | Early Phase 1 |
NCT03948581 | Takeda |
Healthy Volunteers
|
February 21, 2018 | Phase 1 |
NCT02929316 | AGA Clinical Research Associates, LLC|Takeda |
Celiac Disease
|
June 25, 2018 | Phase 2 |
NCT02694588 | University Hospital Schleswig-Holstein |
IBD
|
June 2014 | Not Applicable |
NCT02324699 | Icahn School of Medicine at Mount Sinai|Takeda |
Crohn´s Disease
|
April 2016 | Phase 4 |
NCT03138655 | Takeda|Takeda Development Center Americas, Inc. |
Ulcerative Colitis|Crohn´s Disease
|
November 8, 2017 | Phase 2 |
NCT02743806 | Takeda |
Colitis, Ulcerative|Crohn Disease
|
August 1, 2016 | Phase 4 |
NCT02646657 | Geert D´Haens|Takeda|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Colitis, Ulcerative
|
July 2015 | Phase 4 |
NCT04738942 | Takeda |
Ulcerative Colitis|Crohn´s Disease
|
June 4, 2021 | Phase 3 |
NCT02768532 | Centre Hospitalier Universitaire de Saint Etienne|Theradiag|Takeda |
Crohn Disease
|
July 1, 2016 | Phase 4 |
NCT03234907 | Takeda |
Crohn´s Disease
|
August 3, 2017 | Phase 3 |
NCT04002180 | Takeda |
Crohn´s Disease
|
July 1, 2019 | |
NCT03237260 | University of Pennsylvania|Takeda|Corporal Michael J. Crescenz VA Medical Center |
Ulcerative Colitis
|
July 1, 2017 | Phase 4 |
NCT02038920 | Takeda |
Crohn´s Disease
|
January 28, 2014 | Phase 3 |
NCT00790933 | Takeda |
Ulcerative Colitis|Crohn´s Disease
|
May 22, 2009 | Phase 3 |
NCT04120415 | ANRS, Emerging Infectious Diseases|EuroVacc Foundation|European AIDS Treatment Group (EATG)|Medical Research Council|University College London Hospitals|University of Liverpool|Erasmus Medical Center|Henri Mondor University Hospital|European Georges Pompidou Hospital|Saint-Louis Hospital, Paris, France|Centre Hospitalier Universitaire Vaudois|Chelsea and Westminster Hospital, UK|Universitätsklinikum Hamburg-Eppendorf|Hospital Clinic of Barcelona|Istituto Nazionale Malattie Infettive Lazaro Spallanzani|Imperial College London|Institut d´Investigacions Biomèdiques August Pi i Sunyer|European Commission|Swiss Government |
HIV-1-infection
|
June 21, 2022 | Phase 2 |
NCT02913508 | Takeda |
Ulcerative Colitis|Crohn´s Disease
|
April 2014 | Phase 2 |
NCT02954159 | Medical College of Wisconsin|Takeda |
Ulcerative Colitis
|
May 18, 2017 | Phase 3 |
NCT03961295 | Takeda |
Healthy Volunteers
|
February 22, 2018 | Phase 1 |
NCT04804540 | Takeda |
Ulcerative Colitis|Crohn Disease
|
December 29, 2021 | Phase 4 |
NCT03147859 | Ottawa Hospital Research Institute|CHEO Research Institute|Nebraska Centre for Substance Abuse Research |
HIV-infection+AIDS
|
November 1, 2017 | Phase 2 |
NCT02559713 | Takeda |
Colitis, Ulcerative|Crohn´s Disease
|
November 29, 2017 | Phase 4 |
NCT00783692 | Millennium Pharmaceuticals, Inc. |
Crohn´s Disease
|
December 2008 | Phase 3 |
NCT04407247 | M.D. Anderson Cancer Center|National Cancer Institute (NCI) |
Colitis|Lung Non-Small Cell Carcinoma|Malignant Genitourinary System Neoplasm|Malignant Solid Neoplasm|Melanoma
|
July 9, 2020 | Phase 1|Phase 2 |
NCT03142321 | Washington University School of Medicine |
Crohn Disease of Small Intestine
|
June 8, 2018 | Phase 4 |
NCT02678052 | Takeda|The Organization of Teratology Information Specialists |
Colitis, Ulcerative|Crohn´s Disease
|
December 1, 2015 | |
NCT03679546 | Rennes University Hospital |
Ulcerative Colitis
|
January 4, 2019 | Phase 4 |
NCT03043677 | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
Inflammatory Bowel Disease
|
April 1, 2016 | |
NCT00619489 | Millennium Pharmaceuticals, Inc. |
Ulcerative Colitis|Crohn´s Disease
|
December 2007 | Phase 2 |
NCT04779320 | Takeda |
Crohn´s Disease (CD)
|
April 30, 2022 | Phase 3 |
NCT02764762 | Takeda |
Crohn Disease
|
June 12, 2017 | Phase 4 |
NCT03577782 | Hospitales Universitarios Virgen del Rocío|Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
HIV Infections
|
September 2018 | Phase 1|Phase 2 |
NCT05281614 | Benaroya Research Institute|University of California, San Diego |
Type 1 Diabetes
|
August 1, 2022 | Early Phase 1 |
NCT02425111 | Takeda |
Crohn´s Disease
|
March 30, 2015 | Phase 3 |
NCT02728895 | Takeda |
Allogeneic Hematopoietic Stem Cell Transplantation
|
June 15, 2016 | Phase 1 |
NCT05205603 | Sixth Affiliated Hospital, Sun Yat-sen University |
Ulcerative Colitis|Efficacy, Self|Biologics|Mesalazine
|
January 15, 2022 | Phase 4 |
NCT04469062 | Eli Lilly and Company |
Ulcerative Colitis
|
April 20, 2021 | Phase 3 |
Liquid
Shipping with dry ice.
Please store the product under the recommended conditions in the Certificate of Analysis.