Vedolizumab
- Generic Name
- Vedolizumab
- Brand Names
- Entyvio
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 943609-66-3
- Unique Ingredient Identifier
- 9RV78Q2002
- Background
Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation implicated in diseases like ulcerative colitis or Crohn's disease. α4β7 integrin facilitates the interaction between lymphocytes and gut endothelial cells through the α4β7 integrin-MAdCAM1 interaction, leading to the mobilization of lymphocytes and thus contributing to gastrointestinal inflammation. Integrins implicated in cell migration into the intestinal tract included α2β2, α4β1, and α4β7; however, the selective activity of vedolizumab against α4β7 integrin has been thought to contribute to its more favorable safety profile compared to its predecessor natalizumab, the first integrin receptor antagonist approved by the FDA. Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter.
Vedolizumab was developed by Takeda and approved by the FDA under the brand name ENTYVIO for the maintenance therapy of moderately to severely active Ulcerative Colitis and Crohn’s Disease in April and September 2023, respectively.
- Indication
Vedolizumab is indicated for adult patients with moderately to severely active Ulcerative Colitis or Crohn’s disease.
- Associated Conditions
- Moderately to Severely Active Crohn's Disease, Moderately to Severely Active Ulcerative Colitis
- Associated Therapies
- -
Vedolizumab Induction May Prevent Celiac Enteritis
- First Posted Date
- 2016-10-11
- Last Posted Date
- 2018-10-10
- Lead Sponsor
- AGA Clinical Research Associates, LLC
- Target Recruit Count
- 1
- Registration Number
- NCT02929316
- Locations
- 🇺🇸
AGA Clinical Research Associates, LLC, Egg Harbor Township, New Jersey, United States
🇺🇸Theresa Stevens, Egg Harbor Township, New Jersey, United States
Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)
- First Posted Date
- 2016-08-25
- Last Posted Date
- 2023-02-17
- Lead Sponsor
- Nantes University Hospital
- Target Recruit Count
- 19
- Registration Number
- NCT02878083
- Locations
- 🇫🇷
Chu Angers, Angers, France
🇫🇷Chd Vendee, La Roche Sur Yon, France
🇫🇷Chu Nantes, Nantes, France
Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
- Conditions
- Crohn's DiseaseUlcerative ColitisInflammatory Bowel Disease
- Interventions
- First Posted Date
- 2016-08-10
- Last Posted Date
- 2022-10-25
- Lead Sponsor
- Shaare Zedek Medical Center
- Target Recruit Count
- 142
- Registration Number
- NCT02862132
- Locations
- 🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇸🇮University Children's Hospital Ljubljana, Ljubljana, Slovenia
🇮🇱Assaf Harofeh, Tzrifin, Israel
Vedolizumab Post Op Study
- First Posted Date
- 2016-07-15
- Last Posted Date
- 2020-05-14
- Lead Sponsor
- Marc Schwartz
- Registration Number
- NCT02834754
- Locations
- 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
- First Posted Date
- 2016-07-01
- Last Posted Date
- 2018-05-14
- Lead Sponsor
- Universita degli Studi di Genova
- Registration Number
- NCT02820493
A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
- Conditions
- Pouchitis
- Interventions
- First Posted Date
- 2016-06-03
- Last Posted Date
- 2022-02-24
- Lead Sponsor
- Takeda
- Target Recruit Count
- 102
- Registration Number
- NCT02790138
- Locations
- 🇧🇪
UZ Leuven - University Hospital Gasthuisberg, Leuven, Belgium
🇳🇱Academic Medical Center, Amsterdam, Netherlands
🇮🇹Azienda Ospedaliera S. Orsola-Malpighi, Bologna, Italy
Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease
- First Posted Date
- 2016-05-11
- Last Posted Date
- 2023-06-15
- Lead Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Target Recruit Count
- 47
- Registration Number
- NCT02768532
- Locations
- 🇫🇷
Chu Saint Etienne, Saint Etienne, France
🇫🇷CHU Kremlin Bicetre, Paris, Le Kremlin-Bicêtre, France
🇫🇷CHU Lyon-Sud, Hospices Civils de Lyon, PIERRE-BENITE, Pierre Bénite, France
Triple Combination Therapy in High Risk Crohn's Disease (CD)
- Conditions
- Crohn Disease
- Interventions
- First Posted Date
- 2016-05-06
- Last Posted Date
- 2023-07-14
- Lead Sponsor
- Takeda
- Target Recruit Count
- 55
- Registration Number
- NCT02764762
- Locations
- 🇺🇸
Cotton O'Neil Clinical Research, Topeka, Kansas, United States
🇺🇸University of Mississippi Medical Center, Jackson, Mississippi, United States
🇨🇦PerCuro Clinical Research Ltd, Victoria, British Columbia, Canada
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study
- Conditions
- Colitis, UlcerativeCrohn Disease
- Interventions
- First Posted Date
- 2016-05-03
- Last Posted Date
- 2020-10-27
- Lead Sponsor
- Takeda
- Registration Number
- NCT02760615
- Locations
- 🇺🇸
WCCT, Cypress, California, United States
🇺🇸QPS MRA, Miami, Florida, United States
Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
- First Posted Date
- 2016-04-19
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- Takeda
- Target Recruit Count
- 331
- Registration Number
- NCT02743806
- Locations
- 🇦🇺
The Canberra Hospital, Garran, Australian Capital Territory, Australia
🇦🇺Western Hospital, Footscray, Victoria, Australia
🇦🇺Box Hill Hospital, Box Hill, Australia
Drug Development Updates
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