Overview
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/22 | Phase 4 | Recruiting | |||
2023/11/24 | Phase 2 | Recruiting | Peking Union Medical College | ||
2023/10/25 | Phase 3 | Recruiting | |||
2023/10/23 | Not Applicable | Recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | ||
2023/10/23 | Phase 4 | Recruiting | |||
2023/10/04 | Phase 4 | Recruiting | The First Affiliated Hospital of Soochow University | ||
2023/09/21 | Phase 4 | Recruiting | |||
2023/05/01 | Phase 3 | Recruiting | |||
2023/01/27 | N/A | Recruiting | |||
2022/08/01 | Phase 4 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University |
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