{"id":"vedolizumab","brandName":"Entyvio","genericName":"vedolizumab","companyId":"takeda","companyName":"Takeda","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Entyvio, also known as vedolizumab, is a monoclonal antibody medication that targets the integrin alpha-4/beta-7 to inhibit inflammation in the gut. It is used to treat conditions such as ulcerative colitis and Crohn's disease, which are forms of inflammatory bowel disease.","enrichmentLevel":3,"visitCount":5,"mechanism":{"target":"α4β7 integrin and MAdCAM-1 interaction","modality":"Humanized monoclonal antibody","drugClass":"Integrin antagonist; Monoclonal antibody","explanation":"Vedolizumab selectively targets the α4β7 integrin expressed on memory T-lymphocytes that preferentially home to the gastrointestinal tract. By blocking the interaction between α4β7 integrin and mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells, it prevents the migration of these immune cells across the endothelium into inflamed gastrointestinal parenchymal tissue. This mechanism reduces chronic inflammation characteristic of ulcerative colitis and Crohn's disease. Notably, vedolizumab does not affect α4β1 or αEβ7 integrins, nor does it antagonize α4 integrin interactions with VCAM-1, providing gut-selective immunosuppression.","oneSentence":"Vedolizumab is a humanized monoclonal antibody that binds α4β7 integrin and blocks its interaction with MAdCAM-1, preventing memory T-lymphocyte migration into inflamed gastrointestinal tissue."},"administration":{"route":"Subcutaneous"},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"21828 reports"},{"date":"","signal":"COLITIS ULCERATIVE","source":"FDA FAERS","actionTaken":"14515 reports"},{"date":"","signal":"CROHN^S DISEASE","source":"FDA FAERS","actionTaken":"10631 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"9419 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"8171 reports"},{"date":"","signal":"ABDOMINAL PAIN","source":"FDA FAERS","actionTaken":"6952 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"5981 reports"},{"date":"","signal":"HAEMATOCHEZIA","source":"FDA FAERS","actionTaken":"5657 reports"},{"date":"","signal":"FREQUENT BOWEL MOVEMENTS","source":"FDA FAERS","actionTaken":"4906 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"4447 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Nasopharyngitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Arthralgia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Pyrexia","drugRate":"","severity":"common","organSystem":""},{"effect":"Upper respiratory tract infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Cough","drugRate":"","severity":"common","organSystem":""},{"effect":"Bronchitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Influenza","drugRate":"","severity":"common","organSystem":""},{"effect":"Back pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"","severity":"common","organSystem":""},{"effect":"Sinusitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Oropharyngeal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Pain in extremities","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Urticaria","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Infusion-related reaction","drugRate":"4%","severity":"common","organSystem":""}],"contraindications":["Active tuberculosis","Cytomegalovirus infection","Listeriosis","Progressive multifocal leukoencephalopathy","Sepsis"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Serious adverse reactions (overall)","drugRate":"7%","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"0.07%","severity":"serious"},{"effect":"Serious infusion-related reactions","drugRate":"","severity":"serious"},{"effect":"Hypersensitivity reactions","drugRate":"","severity":"serious"}]},"trials":["NCT06604728","NCT05014555","NCT02377258","NCT02790138","NCT05135221","NCT02929316","NCT02610569","NCT03351647","NCT05542459","NCT06614387","NCT04779307","NCT06227910","NCT06788340","NCT05384080","NCT04959851","NCT03237260","NCT06856135","NCT02820493","NCT04231110","NCT02678052","NCT04779320","NCT03819296","NCT02038920","NCT02620046","NCT06584162","NCT02878083","NCT05205603","NCT06691061","NCT01981616","NCT05696106","NCT07398586","NCT03553472","NCT06841705","NCT05158517","NCT02743806","NCT04120415","NCT06095128","NCT05442567","NCT06317220","NCT03378388","NCT06849739","NCT05132166","NCT06180382","NCT05504915","NCT02862132","NCT03266471","NCT06850727","NCT04118556","NCT07495644","NCT06400719"],"indications":{"approved":[{"name":"Chronic antibioticrefractory ileal pouchitis","diseaseId":"chronic-antibioticrefractory-ileal-pouchitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Crohn's disease","diseaseId":"crohn's-disease","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Ulcerative colitis","diseaseId":"ulcerative-colitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"commercial":{"revenueYear":2024,"annualRevenue":7300,"revenueSource":"Takeda AR 2024","revenueCurrency":"USD","revenueConfidence":"verified"},"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT06604728","phase":"N/A","title":"Evaluation of Effectiveness and Tolerance of Intravenous and Subcutaneous Biological Drugs in Gastrointestinal Diseases (BIOES)","status":"RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","isPivotal":false,"enrollment":400,"indication":"Inflammatory Bowel Diseases","completionDate":"2025-09-01"},{"nctId":"NCT05014555","phase":"N/A","title":"Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease","status":"UNKNOWN","sponsor":"GI Alliance","isPivotal":false,"enrollment":400,"indication":"Inflammatory Bowel Diseases","completionDate":"2024-01"},{"nctId":"NCT02377258","phase":"N/A","title":"IBD Cancer and Serious Infection in Europe","status":"COMPLETED","sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","isPivotal":false,"enrollment":13262,"indication":"IBD","completionDate":"2022-05-16"},{"nctId":"NCT02790138","phase":"Phase 4","title":"A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":102,"indication":"Pouchitis","completionDate":"2021-02-02"},{"nctId":"NCT05135221","phase":"N/A","title":"Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.","status":"COMPLETED","sponsor":"Tampere University Hospital","isPivotal":false,"enrollment":16,"indication":"IBD","completionDate":"2021-10-01"},{"nctId":"NCT02929316","phase":"Phase 2","title":"Vedolizumab Induction May Prevent Celiac Enteritis After Gluten Challenge in Established Celiac Patients in Histological Remission","status":"TERMINATED","sponsor":"AGA Clinical Research Associates, LLC","isPivotal":false,"enrollment":1,"indication":"Celiac Disease","completionDate":"2018-10-05"},{"nctId":"NCT02610569","phase":"NA","title":"Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)","status":"COMPLETED","sponsor":"Dr. Arnaud Bourreille","isPivotal":false,"enrollment":50,"indication":"Ulcerative Colitis","completionDate":"2021-09"},{"nctId":"NCT03351647","phase":"N/A","title":"Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Re","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","isPivotal":false,"enrollment":18,"indication":"Crohn Disease","completionDate":"2019-09-23"},{"nctId":"NCT05542459","phase":"N/A","title":"Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease","status":"UNKNOWN","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","isPivotal":false,"enrollment":1050,"indication":"Crohn Disease, Ulcerative Colitis","completionDate":"2024-11-01"},{"nctId":"NCT06614387","phase":"Phase 3","title":"Assessment of Safety and Efficacy of Vedolizumab in Pediatric Uclerative Colitis in Comparison With Standard Biological Therapy With Infliximab","status":"NOT_YET_RECRUITING","sponsor":"JAROSLAW KIERKUS","isPivotal":true,"enrollment":60,"indication":"Ulcerative Colitis","completionDate":"2028-11-30"},{"nctId":"NCT04779307","phase":"Phase 3","title":"A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Coli","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":121,"indication":"Colitis, Ulcerative","completionDate":"2025-07-01"},{"nctId":"NCT06227910","phase":"Phase 3","title":"A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenou","status":"RECRUITING","sponsor":"Takeda","isPivotal":true,"enrollment":396,"indication":"Crohn's Disease","completionDate":"2028-08-01"},{"nctId":"NCT06788340","phase":"Phase 4","title":"MOdel-Informed Precision Dosing (MIPD) of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease - An Independent Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Odense University Hospital","isPivotal":false,"enrollment":166,"indication":"Inflammatory Bowel Diseases, Crohn Disease","completionDate":"2027-11-01"},{"nctId":"NCT05384080","phase":"N/A","title":"Prospective, Non-interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes (VARIETY-POLAND)","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":165,"indication":"Inflammatory Bowel Disease (IBD), Crohn's Disease","completionDate":"2025-06-13"},{"nctId":"NCT04959851","phase":"N/A","title":"Prospective, Non-Interventional, Observational Study in Patients With IBD Receiving IV or SC Vedolizumab Therapy to Observe Route of Administration Choices and Outcomes","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":185,"indication":"Inflammatory Bowel Diseases, Colitis, Ulcerative","completionDate":"2024-06-18"},{"nctId":"NCT03237260","phase":"Phase 4","title":"An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis","status":"WITHDRAWN","sponsor":"University of Pennsylvania","isPivotal":false,"enrollment":0,"indication":"Ulcerative Colitis","completionDate":"2019-02-01"},{"nctId":"NCT06856135","phase":"N/A","title":"Expanded Access Program for United States of America: Vedolizumab Intravenous for the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease","status":"AVAILABLE","sponsor":"Takeda","isPivotal":false,"enrollment":0,"indication":"Crohn's Disease, Ulcerative Colitis","completionDate":""},{"nctId":"NCT02820493","phase":"Phase 4","title":"Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression","status":"WITHDRAWN","sponsor":"Universita degli Studi di Genova","isPivotal":false,"enrollment":0,"indication":"Crohn Disease","completionDate":"2019-03"},{"nctId":"NCT04231110","phase":"Phase 4","title":"Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis","status":"COMPLETED","sponsor":"McMaster University","isPivotal":false,"enrollment":6,"indication":"Ulcerative Colitis","completionDate":"2024-11-18"},{"nctId":"NCT02678052","phase":"N/A","title":"Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry","status":"COMPLETED","sponsor":"Takeda","isPivotal":false,"enrollment":303,"indication":"Colitis, Ulcerative, Crohn's Disease","completionDate":"2022-07-31"},{"nctId":"NCT04779320","phase":"Phase 3","title":"A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","sponsor":"Takeda","isPivotal":true,"enrollment":120,"indication":"Crohn's Disease (CD)","completionDate":"2026-05-22"},{"nctId":"NCT03819296","phase":"Phase 1","title":"Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":800,"indication":"Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8","completionDate":"2026-10-31"},{"nctId":"NCT02038920","phase":"Phase 3","title":"Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Inductio","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":157,"indication":"Crohn's Disease","completionDate":"2019-05-21"},{"nctId":"NCT02620046","phase":"Phase 3","title":"A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease","status":"COMPLETED","sponsor":"Takeda","isPivotal":true,"enrollment":746,"indication":"Colitis, Ulcerative, Crohn's Disease","completionDate":"2024-06-12"},{"nctId":"NCT06584162","phase":"Phase 4","title":"Subcutaneous Vedolizumab Drug De-escalation Using Therapeutic Drug Monitoring in Inflammatory Bowel Disease: a Randomized Controlled Pilot Study","status":"RECRUITING","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","isPivotal":false,"enrollment":40,"indication":"Inflammatory Bowel Diseases","completionDate":"2026-02-01"},{"nctId":"NCT02878083","phase":"NA","title":"Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)","status":"TERMINATED","sponsor":"Nantes University Hospital","isPivotal":false,"enrollment":19,"indication":"ULCERATIVE COLITIS","completionDate":"2021-01-01"},{"nctId":"NCT05205603","phase":"Phase 4","title":"Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study","status":"UNKNOWN","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","isPivotal":false,"enrollment":438,"indication":"Ulcerative Colitis, Efficacy, Self","completionDate":"2025-01-15"},{"nctId":"NCT06691061","phase":"N/A","title":"Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance","status":"RECRUITING","sponsor":"Humanitas Clinical and Research Center","isPivotal":false,"enrollment":450,"indication":"Ulcerative Colitis (Disorder)","completionDate":"2024-12-31"},{"nctId":"NCT01981616","phase":"Phase 1","title":"A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Study in Healthy Subjects to Determine the Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedoliz","status":"COMPLETED","sponsor":"Millennium Pharmaceuticals, Inc.","isPivotal":false,"enrollment":127,"indication":"Inflammatory Bowel Disease","completionDate":"2012-07"},{"nctId":"NCT05696106","phase":"N/A","title":"Risk of Incident Immune-mediated Inflammatory Diseases (IMID) in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","isPivotal":false,"enrollment":750000,"indication":"Inflammatory Disease","completionDate":"2024-01-15"},{"nctId":"NCT07398586","phase":"Phase 4","title":"The Association Between Interleukin-7 Receptor Gene Polymorphism and the Risk of Ulcerative Colitis as Well as the Response to Vedolizumab","status":"COMPLETED","sponsor":"Second Affiliated Hospital of Wenzhou Medical University","isPivotal":false,"enrollment":898,"indication":"Ulcerative Colitis (UC)","completionDate":"2024-12-31"},{"nctId":"NCT03553472","phase":"N/A","title":"Identify Young Immunosuppressed and Non-immunosuppressed Inflammatory Bowel Disease Patients at Risk for HZ","status":"COMPLETED","sponsor":"University of Wisconsin, Madison","isPivotal":false,"enrollment":97,"indication":"Herpes Zoster, Inflammatory Bowel Diseases","completionDate":"2019-05-31"},{"nctId":"NCT06841705","phase":"Phase 2","title":"Early Concomitant Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial","status":"RECRUITING","sponsor":"Shilpa Grover, MD, MPH","isPivotal":false,"enrollment":80,"indication":"Immune Checkpoint Inhibitor-Related Colitis","completionDate":"2026-12-31"},{"nctId":"NCT05158517","phase":"N/A","title":"VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","isPivotal":false,"enrollment":349,"indication":"Inflammatory Bowel Diseases","completionDate":"2025-03-20"},{"nctId":"NCT02743806","phase":"Phase 4","title":"Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease","status":"TERMINATED","sponsor":"Takeda","isPivotal":false,"enrollment":331,"indication":"Colitis, Ulcerative, Crohn Disease","completionDate":"2023-01-03"},{"nctId":"NCT04120415","phase":"Phase 2","title":"EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: A Phase II Randomised, Placebo-controlled Trial of Vedolizumab With or Without Therapeutic HIV MVA Vaccine in Individuals Who ","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","isPivotal":false,"enrollment":2,"indication":"HIV-1-infection","completionDate":"2023-07-12"},{"nctId":"NCT06095128","phase":"Phase 4","title":"An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Sev","status":"RECRUITING","sponsor":"Takeda","isPivotal":false,"enrollment":65,"indication":"Ulcerative Colitis","completionDate":"2027-07-09"},{"nctId":"NCT05442567","phase":"Phase 3","title":"A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease","status":"RECRUITING","sponsor":"Takeda","isPivotal":true,"enrollment":240,"indication":"Ulcerative Colitis, Crohn's Disease","completionDate":"2031-08-15"},{"nctId":"NCT06317220","phase":"Phase 2","title":"Vedolizumab for the Treatment of Collagenous Gastritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","isPivotal":false,"enrollment":11,"indication":"Collagenous Gastritis","completionDate":"2026-10"},{"nctId":"NCT03378388","phase":"N/A","title":"Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life","status":"TERMINATED","sponsor":"Takeda","isPivotal":false,"enrollment":29,"indication":"Colitis, Ulcerative, Crohn Disease","completionDate":"2019-02-15"},{"nctId":"NCT06849739","phase":"N/A","title":"Study on the Correlation and Consistency of Measuring Biologic Drug Plasma Concentrations Based on Different Detection Methods","status":"NOT_YET_RECRUITING","sponsor":"Nanfang Hospital, Southern Medical University","isPivotal":false,"enrollment":60,"indication":"Inflammatory Bowel Diseases","completionDate":"2025-12-31"},{"nctId":"NCT05132166","phase":"Phase 2","title":"A Randomized, Open-label Phase II Trial Comparing Durable Overall Response Rate at 56 Days in Patients With Steroid-resistant Severe Acute GvHD After Allogeneic HSCT Treated With Decidual Stromal Cell","status":"ACTIVE_NOT_RECRUITING","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":50,"indication":"Graft Vs Host Disease","completionDate":"2026-04-26"},{"nctId":"NCT06180382","phase":"Phase 4","title":"Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concent","status":"RECRUITING","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","isPivotal":false,"enrollment":220,"indication":"Crohn's Disease","completionDate":"2027-01"},{"nctId":"NCT05504915","phase":"N/A","title":"Prospective, Non-interventional, Observational Study in Cohort of Patients With IBD at University Hospital Center Osijek Switching From IV to SC Vedolizumab to Observe Vedolizumab Serum Concentration ","status":"COMPLETED","sponsor":"Osijek University Hospital","isPivotal":false,"enrollment":31,"indication":"Inflammatory Bowel Diseases, Crohn Disease","completionDate":"2023-05-31"},{"nctId":"NCT02862132","phase":"NA","title":"Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society","status":"COMPLETED","sponsor":"Shaare Zedek Medical Center","isPivotal":false,"enrollment":142,"indication":"Crohn's Disease, Ulcerative Colitis","completionDate":"2022-01"},{"nctId":"NCT03266471","phase":"N/A","title":"Cytokines and Genes in Therapeutic Response in Crohn's Disease","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","isPivotal":false,"enrollment":96,"indication":"Inflammatory Bowel Diseases","completionDate":"2022-05-03"},{"nctId":"NCT06850727","phase":"Phase 2","title":"A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Co","status":"RECRUITING","sponsor":"Odyssey Therapeutics","isPivotal":false,"enrollment":57,"indication":"Ulcerative Colitis (UC), UC - Ulcerative Colitis","completionDate":"2026-11"},{"nctId":"NCT04118556","phase":"Phase 2","title":"A Multicenter, Open-label, Randomized, Phase I/II Clinical Trial Comparing Safety and Durable Overall Response Day 56 in Patients With Steroid Resistent Acute GvHD After Allogeneic Hematopoietic Stem ","status":"RECRUITING","sponsor":"Mats Remberger","isPivotal":false,"enrollment":50,"indication":"GVHD, Acute","completionDate":"2031-12-31"},{"nctId":"NCT07495644","phase":"N/A","title":"Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","isPivotal":false,"enrollment":95,"indication":"Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)","completionDate":"2027-06"},{"nctId":"NCT06400719","phase":"Phase 1","title":"An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive","status":"COMPLETED","sponsor":"Alvotech Swiss AG","isPivotal":false,"enrollment":18,"indication":"Healthy","completionDate":"2024-11-06"}],"genericFilers":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-03-31T00:00:00.000Z","mah":"TAKEDA PHARMS USA","brand_name_local":null,"application_number":"BLA125476"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2024-02-23T00:00:00.000Z","mah":"TAKEDA PHARMS USA","brand_name_local":null,"application_number":"BLA761133"},{"country_code":"CH","regulator":"Swissmedic","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"NO","regulator":"NoMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"IS","regulator":"IMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"NZ","regulator":"Medsafe","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"AT","regulator":"AGES","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"BE","regulator":"FAMHP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":"EMEA/H/C/002782"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"BG","regulator":"BDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"HR","regulator":"HALMED","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"CY","regulator":"PHS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"CZ","regulator":"SUKL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"DK","regulator":"DKMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"EE","regulator":"SAM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"FI","regulator":"Fimea","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"FR","regulator":"ANSM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"DE","regulator":"BfArM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"GR","regulator":"EOF","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"HU","regulator":"OGYEI","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"IE","regulator":"HPRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"IT","regulator":"AIFA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"LV","regulator":"ZVA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"LT","regulator":"VVKT","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"LU","regulator":"MS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"MT","regulator":"MMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"NL","regulator":"MEB","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"PL","regulator":"URPL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"PT","regulator":"Infarmed","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"RO","regulator":"ANMDMR","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"SK","regulator":"SIDC","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"SI","regulator":"JAZMP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"ES","regulator":"AEMPS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"SE","regulator":"MPA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Entyvio","application_number":null}],"regulatorySummaries":{"US_FDA_approval_26041":{"country_code":"US","agency":"FDA","entity_type":"approval","entity_id":"26041","summary_short":"Takeda Pharmaceuticals USA received FDA marketing authorization for Entyvio on February 23, 2024, under standard expedited pathway.","summary_long":"Takeda Pharmaceuticals USA received marketing authorization from the FDA for Entyvio on February 23, 2024. The approval was granted under the standard expedited pathway. Entyvio is a medication used for its approved indication, as stated in the labeling.","key_points":["Entyvio received FDA marketing authorization on February 23, 2024.","Takeda Pharmaceuticals USA is the marketing authorization holder.","The approval was granted under the standard expedited pathway."],"citations":[{"source":"https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA761133"}],"generated_at":"2026-05-18T11:02:32.940Z"}},"trialStats":{"total":30,"withResults":4},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=vedolizumab","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:30:42.796915+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:30:47.817244+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:30:41.746177+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=vedolizumab","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:30:48.181300+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:30:39.762740+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:30:39.762769+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:30:39.762774+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:30:49.907280+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Integrin alpha-4/beta-7 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:30:49.233511+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1743087/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:30:48.904099+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA761133, BLA125476","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:30:39.762778+00:00"}},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:30:53.028564+00:00","fieldsConflicting":0,"overallConfidence":0.95},"pharmacokinetics":{"tmax":"7 days","halfLife":"Not specified in text","metabolism":"Not specified in text","elimination":"Not specified in text","bioavailability":"75%"},"crossReferences":{"chemblId":"CHEMBL1743087"},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}