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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/08 | N/A | Completed | Second Affiliated Hospital of Wenzhou Medical University | ||
2025/03/18 | Phase 3 | Recruiting | |||
2025/03/13 | N/A | Completed | Second Affiliated Hospital of Wenzhou Medical University | ||
2025/03/04 | N/A | AVAILABLE | |||
2025/02/27 | Phase 2 | Recruiting | Odyssey Therapeutics | ||
2025/02/24 | Phase 2 | Not yet recruiting | Shilpa Grover, MD, MPH | ||
2025/02/07 | Phase 2 | Recruiting | City of Hope Medical Center | ||
2024/11/15 | N/A | Recruiting | Humanitas Clinical and Research Center | ||
2024/10/17 | Phase 2 | Suspended | Therakos LLC | ||
2024/10/03 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Takeda Pharmaceuticals America, Inc. | 64764-107 | SUBCUTANEOUS | 108 mg in 0.68 mL | 3/28/2024 | |
Takeda Pharmaceuticals America, Inc. | 64764-300 | INTRAVENOUS | 300 mg in 5 mL | 3/28/2024 | |
Takeda Pharmaceuticals America, Inc. | 64764-108 | SUBCUTANEOUS | 108 mg in 0.68 mL | 3/28/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/22/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ENTYVIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 108MG/0.68ML | SIN16673P | INJECTION, SOLUTION | 108mg/0.68mL | 1/11/2023 | |
ENTYVIO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL | SIN14950P | INJECTION, POWDER, FOR SOLUTION | 300 mg/vial | 2/12/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Vedolizumab for injection | S20200006 | 生物制品 | 注射剂 | 3/11/2020 | |
Vedolizumab for injection | 国药准字SJ20200006 | 生物制品 | 注射剂 | 11/11/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
KYNTELES vedolizumab (rch) 300 mg powder for injection vial | 210042 | Medicine | A | 6/27/2014 | |
ENTYVIO vedolizumab 108 mg/0.68 mL solution for injection pre-filled pen | 317262 | Medicine | A | 5/12/2020 | |
ENTYVIO vedolizumab 108 mg/0.68 mL solution for injection pre-filled syringe | 317261 | Medicine | A | 5/12/2020 | |
ENTYVIO vedolizumab 300 mg powder for injection vial | 210048 | Medicine | A | 6/27/2014 |
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