Entyvio

(Vedolizumab)

ApprovedMonoclonal antibody

Vedolizumab is used to treat inflammatory bowel diseases like Crohn's disease and ulcerative colitis by reducing inflammation in the digestive tract. It helps reduce symptoms and allows the intestines to heal.[2] Entyvio is currently approved and in use across 16 indications[4].[1]

Entyvio is one of 368 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

117

Total Trials

Active Trials

367

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

ColitisActive, not recruiting

HIV-1 InfectionActive, not recruiting

Acute Graft Versus Host DiseaseActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

Acute Lymphoblastic LeukemiaRecruiting

MelanomaActive, not recruiting

Crohn's DiseaseRecruiting

Ulcerative ColitisNot yet recruiting

Celiac DiseaseActive, not recruiting

HIV InfectionPhase 1

Active, not recruiting

ColitisPhase 2

Active, not recruiting

HIV-1 InfectionPhase 2

Active, not recruiting

Acute Graft Versus Host DiseasePhase 3

Active, not recruiting

Inflammatory Bowel DiseasePhase 1

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 2

Recruiting

MelanomaPhase 1

Active, not recruiting

Crohn's DiseaseApproved

Recruiting

Ulcerative ColitisApproved

Not yet recruiting

Celiac DiseasePhase 2

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

947 competitors in Melanoma

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

13 2

Entyvio

Takeda

Approved

2 3

Fabhalta

Regeneron

Phase 3

3 4

Spartalizumab

Novartis

Phase 3

2 5

KIMMTRAK

IImmunocore Ltd

Phase 3

2 6

Fotemustine

Roche

Phase 3

2 7

Peg-IFN Alfa-2b

Merck & Co.

Phase 3

1 8

Histamine Dihydrochloride

MMaxim Pharmaceuticals

Phase 3

1 9

Zelboraf

CConrado Roberto Hoffmann Filho

Intron a

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Gastritis

NCT06317220

N/ARecruiting

Ulcerative Colitis

NCT06095596

Phase 1Recruiting

Complication

NCT03819296

Recruiting

Inflamatory Bowel Disease

NCT07694674

Phase 2Recruiting

Ulcerative Colitis

NCT06850727

Recruiting

Observational Study

NCT06249555

Clinical

Trials by Indication[1]

Ulcerative Colitis47 trials

Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05481619·30 enrolled

Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis

Recruiting·OOdyssey Therapeutics·Phase 2·NCT06850727·57 enrolled

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 3·NCT00783718·895 enrolled

Show 44 more trials

Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

Unknown status·IInsel Gruppe AG, University Hospital Bern··NCT05702879·240 enrolled

The Efficacy and Safety of Combining Probiotic VSL#3 With Vedolizumab for the Treatment of Moderate Ulcerative Colitis

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT06609447·100 enrolled

Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF（Tumor Necrosis Factor）Therapy

Terminated·SStanford University··NCT03802214·1 enrolled

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Completed· Takeda logo

Takeda·Phase 3·NCT04779307·121 enrolled

EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

Completed·RRennes University Hospital·Phase 4·NCT03679546·151 enrolled

An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis

Completed·GGeert D'Haens·Phase 4·NCT02646657·120 enrolled

Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.

Withdrawn·MMayo Clinic·Phase 1·NCT03309865

Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease

Withdrawn· Takeda logo

Takeda·Phase 2·NCT02913508

Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

Terminated· Takeda logo

Takeda·Phase 4·NCT02743806·331 enrolled

An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis

Withdrawn·UUniversity of Pennsylvania·Phase 4·NCT03237260

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Completed· Takeda logo

Takeda·Phase 2·NCT03196427·59 enrolled

Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Completed· Takeda logo

Takeda·Phase 2·NCT03138655·89 enrolled

Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

Completed· Takeda logo

Takeda·Phase 2·NCT00619489·72 enrolled

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

Completed· Takeda logo

Takeda·Phase 3·NCT00790933·2,243 enrolled

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 3·NCT02497469·771 enrolled

Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

Terminated·NNantes University Hospital·N/A·NCT02878083·19 enrolled

Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 3·NCT02039505·292 enrolled

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 4·NCT05205603·438 enrolled

A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Active, not recruiting· Takeda logo

Takeda·Phase 3·NCT04738942·57 enrolled

Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University··NCT07442045·150 enrolled

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

Recruiting· Takeda logo

Takeda·Phase 3·NCT05442567·240 enrolled

Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA

Available· Takeda logo

Takeda··NCT06856135

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Recruiting· Takeda logo

Takeda·Phase 3·NCT06100289·70 enrolled

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

Withdrawn· Eli Lilly logo

Eli Lilly·Phase 3·NCT04469062

A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

Completed· Takeda logo

Takeda·Phase 3·NCT02620046·746 enrolled

Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

Recruiting· Takeda logo

Takeda·Phase 3·NCT03221036·402 enrolled

Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 4·NCT03029143·278 enrolled

A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

Completed· Takeda logo

Takeda·Phase 4·NCT04804540·150 enrolled

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 3·NCT02611830·383 enrolled

Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

Completed· Takeda logo

Takeda··NCT03824561·1,110 enrolled

Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

Completed· Takeda logo

Takeda·Phase 4·NCT02559713·11 enrolled

An Analysis of the Relationship Between the Genetic Polymorphisms of Plasminogen Activator Inhibitor-1 and Ulcerative Colitis in Chinese Patients

Completed·SSecond Affiliated Hospital of Wenzhou Medical University··NCT06961435·900 enrolled

Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis

Unknown status·GGuy's and St Thomas' NHS Foundation Trust·Phase 4·NCT04006080·30 enrolled

The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis

Recruiting·HHumanitas Clinical and Research Center··NCT06691061·450 enrolled

A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06880744·530 enrolled

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Completed· Roche logo

Roche·Phase 2·NCT03558152·195 enrolled

The Association Between Interleukin-7 Receptor Gene Polymorphism and the Risk of Ulcerative Colitis

Completed·SSecond Affiliated Hospital of Wenzhou Medical University·Phase 4·NCT07398586·898 enrolled

Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 2·NCT01177228·47 enrolled

The Associations of Microribonucleic Acid Gene Polymorphisms With the Risk of Ulcerative Colitis

Completed·SSecond Affiliated Hospital of Wenzhou Medical University··NCT06873711·926 enrolled

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·N/A·NCT06095596·334 enrolled

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 Severely Active Ulcerative Colitis

Recruiting· Takeda logo

Takeda·Approved·NCT06095128·65 enrolled

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

Recruiting· Takeda logo

Takeda·Approved·NCT06581328·400 enrolled

CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)

Not yet recruiting·RRyan C Ungaro·Approved·NCT07665294·160 enrolled

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

Recruiting· Takeda logo

Takeda·Phase 3·NCT06405087·70 enrolled

Crohn's Disease12 trials

Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease

Terminated·—·Phase 4·NCT02768532·47 enrolled

A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study

Completed·GGeert D'Haens·Phase 4·NCT02646683·260 enrolled

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Recruiting· Takeda logo

Takeda·Phase 3·NCT06227910·396 enrolled

Show 9 more trials

Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Completed· Takeda logo

Takeda·Phase 4·NCT02630966·34 enrolled

Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease

Completed· Takeda logo

Takeda·Phase 3·NCT02038920·157 enrolled

VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

Recruiting·AAlimentiv Inc.·Phase 4·NCT06257706·304 enrolled

Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease

Completed· Takeda logo

Takeda·Phase 3·NCT02425111·101 enrolled

Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.

Completed· Takeda logo

Takeda·Phase 3·NCT03234907·215 enrolled

Corticosteroids With Vedolizumab in Crohn's Disease

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT02324699·1 enrolled

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 Concentration.

Recruiting·—·Phase 4·NCT06180382·220 enrolled

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)

Recruiting· Takeda logo

Takeda·Approved·NCT06045754·100 enrolled

Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]

Completed· Takeda logo

Takeda··NCT04002180·335 enrolled

Moderate to Severe Crohn's Disease4 trials

Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Completed· Takeda logo

Takeda·Phase 3·NCT01224171·416 enrolled

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Completed· Takeda logo

Takeda·Phase 3·NCT00783692·1,116 enrolled

A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease

Recruiting· Takeda logo

Takeda·Phase 3·NCT05837897·408 enrolled

Show 1 more trial

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Recruiting· Takeda logo

Takeda·Phase 3·NCT04779320·120 enrolled

Inflammatory Bowel Disease4 trials

Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease

Withdrawn· Takeda logo

Takeda·Phase 3·NCT03035058

Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany

Unknown status·CCed Service GmbH··NCT03375424·2,500 enrolled

Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

Completed·SShaare Zedek Medical Center·N/A·NCT02862132·142 enrolled

Show 1 more trial

Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease

Unknown status·YYonsei University·Phase 3·NCT04919252·60 enrolled

Colitis3 trials

Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial

Recruiting·SShilpa Grover, MD, MPH·Phase 2·NCT06841705·80 enrolled

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis

Withdrawn·TTherakos LLC·Phase 2·NCT06646016

Vedolizumab for Immune Mediated Colitis

Unknown status·UUniversity of Copenhagen·Phase 2·NCT04797325·82 enrolled

33 more indications

Effectiveness3 trials

Association Between Effectiveness of Mirikizumab and UC Patients With High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa

Completed·SShowa Inan General Hospital·Phase 4·NCT06626165·100 enrolled

VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation

Completed·AAryoGen Pharmed Co.··NCT07273760·150 enrolled

Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

Withdrawn·UUniversita degli Studi di Genova·Phase 4·NCT02820493

Tics3 trials

A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03949621·24 enrolled

A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03961308·204 enrolled

Bioavailability and Pharmacokinetics of Vedolizumab in Healthy Participants Following Single Subcutaneous Administration

Completed· Takeda logo

Takeda·Phase 1·NCT02163421·48 enrolled

Intravenous2 trials

A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03329209·16 enrolled

VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER)

Active, not recruiting·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives··NCT05158517·349 enrolled

Pouchitis2 trials

A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

Completed· Takeda logo

Takeda·Phase 4·NCT02790138·102 enrolled

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Recruiting· Takeda logo

Takeda·Phase 3·NCT06443502·30 enrolled

Inflamatory Bowel Disease2 trials

Early Biomarkers in Circulating α 4β7 + T Cells to Predict Response to Vedolizumab in Inflamatory Bowel Disease Patients.

Completed·PParc de Salut Mar··NCT02712866·24 enrolled

Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease

Recruiting·SShanghai 10th People's Hospital··NCT07694674·198 enrolled

Melanoma2 trials

Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04407247·47 enrolled

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma

Terminated· Takeda logo

Takeda·Phase 1·NCT02723006·22 enrolled

Crohn's Disease (CD)2 trials

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Completed· Takeda logo

Takeda·Phase 3·NCT02611817·644 enrolled

Triple Combination Therapy in High Risk Crohn's Disease (CD)

Completed· Takeda logo

Takeda·Phase 4·NCT02764762·55 enrolled

Pilot Study2 trials

A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03948581·102 enrolled

Completed· Takeda logo

Takeda·Phase 1·NCT03961295·24 enrolled

Gastrointestinal1 trial

Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT06066840·45 enrolled

Enteritis1 trial

Vedolizumab Induction May Prevent Celiac Enteritis

Terminated·AAGA Clinical Research Associates, LLC·Phase 2·NCT02929316·1 enrolled

Pregnancy1 trial

OTIS Vedolizumab Pregnancy Exposure Registry

Completed· Takeda logo

Takeda··NCT02678052·303 enrolled

Interaction1 trial

Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

Withdrawn· Takeda logo

Takeda·Phase 4·NCT02760615

HIV infection1 trial

Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection

Unknown status·OOttawa Hospital Research Institute·Phase 2·NCT03147859·10 enrolled

Treatment1 trial

Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D

Completed·—·Phase 1·NCT05281614·20 enrolled

Infection1 trial

An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection

Terminated·AANRS, Emerging Infectious Diseases·Phase 1/2·NCT02972450·1 enrolled

Observational Study1 trial

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

Recruiting·AAlimentiv Inc.··NCT06249555·300 enrolled

Diarrhea1 trial

VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer

Not yet recruiting·UUniversity of Calgary·Phase 2/3·NCT06337695·298 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Terminated· Takeda logo

Takeda·Phase 2·NCT02993783·17 enrolled

Cohort Study1 trial

A Multicentered Prospective Cohort Study of Chinese IBD Patients

Unknown status·PPeking Union Medical College Hospital··NCT05386290·200 enrolled

Immunogenicity1 trial

Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

Terminated·AAlvotech Swiss AG·Phase 3·NCT06570772·301 enrolled

Immune Response1 trial

Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

Completed· Takeda logo

Takeda·Phase 1·NCT01981616·127 enrolled

Gastritis1 trial

Vedolizumab for the Treatment of Collagenous Gastritis

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT06317220·11 enrolled

GIST1 trial

Synergistic Effect of Vedolizumab and Pentoxifylline

Completed·UUniversity of Miami·Phase 1·NCT02953275·37 enrolled

GvHD1 trial

Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT

Completed· Takeda logo

Takeda·Phase 1·NCT02728895·24 enrolled

Combination Therapy1 trial

Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC

Terminated·MMedical College of Wisconsin·Phase 3·NCT02954159·4 enrolled

Biologics1 trial

Prediction Model for Response to Biologics and Small Molecular Agent for UC

Recruiting·—··NCT05186623·300 enrolled

Skin Lesions1 trial

Response to Ustekinumab for Anti-tnf Induced Psoriasiform Skin Lesions

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT03629379·20 enrolled

Stem Cell Transplant1 trial

Autologous Stem Cell Transplant for Crohn's Disease

Recruiting·AAaron Etra·Phase 2·NCT03219359·50 enrolled

Biological Therapy1 trial

Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy

Unknown status·—··NCT04362735·100 enrolled

Acute Graft Versus Host Disease1 trial

Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

Completed· Takeda logo

Takeda·Phase 3·NCT03657160·343 enrolled

Complication1 trial

Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03819296·800 enrolled

Acute Lymphoblastic Leukemia1 trial

Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation

Recruiting·CCity of Hope Medical Center·Phase 2·NCT06815003·35 enrolled

Unspecified5 trials

Defining Predictors of RT Response to Vedolizumab in IBD

Completed·WWashington University School of Medicine·Phase 4·NCT03142321·48 enrolled

Subcutaneous Interval Lengthening of Vedolizumab for Economic Research

Recruiting·—·Phase 4·NCT06584162·40 enrolled

Clinical and Molecular Phenotyping in IBD

Completed·UUniversity Hospital Schleswig-Holstein·N/A·NCT02694588·90 enrolled

Show 2 more trials

Vedolizumab Post Op Study

Withdrawn·MMarc Schwartz·Phase 2·NCT02834754

Entyvio (Vedolizumab) Long Term Safety Study

Completed· Takeda logo

Takeda··NCT02674308·5,302 enrolled

Regulatory

FDA Approval Timeline[5]

May 20, 2014

ENTYVIO

BLA BLA125476

Sep 27, 2023

ENTYVIO

BLA BLA761133

Sources

References

[1]
ClinicalTrials.gov — 117 trial records for Vedolizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Entyvio drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Vedolizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Vedolizumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA761133). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Integrin Alpha-4/beta-7 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Takeda

Entyvio

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Ulcerative Colitis47 trials

Crohn's Disease12 trials

Moderate to Severe Crohn's Disease4 trials

Inflammatory Bowel Disease4 trials

Colitis3 trials

Effectiveness3 trials

Tics3 trials

Intravenous2 trials

Pouchitis2 trials

Inflamatory Bowel Disease2 trials

Melanoma2 trials

Crohn's Disease (CD)2 trials

Pilot Study2 trials

Gastrointestinal1 trial

Enteritis1 trial

Pregnancy1 trial

Interaction1 trial

HIV infection1 trial

Treatment1 trial

Infection1 trial

Observational Study1 trial

Diarrhea1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Cohort Study1 trial

Immunogenicity1 trial

Immune Response1 trial

Gastritis1 trial

GIST1 trial

GvHD1 trial

Combination Therapy1 trial

Biologics1 trial

Skin Lesions1 trial

Stem Cell Transplant1 trial

Biological Therapy1 trial

Acute Graft Versus Host Disease1 trial

Complication1 trial

Acute Lymphoblastic Leukemia1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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