> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/vedolizumab-4085e162-ab16-49f7-aa46-d779d6e24562 > Record changed: 2026-10-13 # Vedolizumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) First approval year 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) ## Development status **First approval year** 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) **Drug name** Vedolizumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) ### Brand names (2) - entyvio - Entyvio ### Other names (45) - adalimumab infliximab ustekinumab golimumab and vedolizumab - Entyvio (Vedolizumab) - immunoglobulin g1 anti human integrin lpam 1 lymphocyte peyer s patch adhesion molecule 1 human mus musculus heavy chain disulfide with human mus musculus kappa chain dimer - IMMUNOGLOBULIN G1, ANTI-(HUMAN INTEGRIN LPAM-1 (LYMPHOCYTE PEYER'S PATCH ADHESION MOLECULE 1)) (HUMAN-MUS MUSCULUS HEAVY CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS .KAPPA.-CHAIN, DIMER - ldp 02 - LDP-02 - ldp02 - LDP02 - mln 0002 - mln 02 - MLN-0002 - MLN-02 - mln0002 - MLN0002 - mln02 - MLN02 - Subcutaneous vedolizumab - vedolizumab - Vedolizumab - VEDOLIZUMAB - Vedolizumab (brand name Entyvio) - Vedolizumab (VDZ) - vedolizumab \[INN\] - VEDOLIZUMAB \[JAN\] - VEDOLIZUMAB \[MART.\] And 20 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L04AG05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) **CAS registry numbers** - 943609-66-3 **ChEMBL ID** CHEMBL1743087 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1743087) **RxNorm IDs (RxCUI)** - 1538097 **FDA ingredient codes (UNII)** - 9RV78Q2002 ## Regulatory information ### United States **Applicant** TAKEDA PHARMS USA **Approval date** 20 May 2014 **Application number** BLA125476 ### European Union **Status** Authorised **Status date** 22 May 2014 **Authorisation date** 22 May 2014 **Approved indications** Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy. **Product number** EMEA/H/C/002782 **Authorisation holder** Takeda Pharma A/S **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Colitis, Ulcerative - Crohn Disease European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio) ### Other regulatory facts **Patents** 0 **Designations** 4 **First in class** Yes **Fast track** Yes **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** vedolizumab **Type** Antibody **Drug name stem** \-mab; -mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (4) - **Action** Antagonist **Action type** Antagonist **Target** integrin α4β7 **Gene symbol** ITGA4 **Protein identifier** P13612 **Median affinity** 8.27 **Affinity units** pIC50 **Primary target** Yes - **Action** Antagonist **Action type** Antagonist **Target** integrin α4β7 **Gene symbol** ITGB7 **Protein identifier** P26010 **Median affinity** 8.27 **Affinity units** pIC50 **Primary target** Yes - **Mechanism** Integrin alpha-4/beta-7 inhibitor **Action type** Inhibitor **Target** Integrin alpha-4/beta-7 **Protein identifier** P13612 - **Mechanism** Integrin alpha-4/beta-7 inhibitor **Action type** Inhibitor **Target** Integrin alpha-4/beta-7 **Protein identifier** P26010 ### Open Targets mechanisms - **Mechanism** Integrin alpha-4/beta-7 inhibitor **Action type** Inhibitor **Target** Integrin alpha-4/beta-7 ### Investigated indications (13) - **Condition** HIV Infections **Highest recorded phase** 2 **Condition identifier** EFO:0000180 **Subject identifier** D015658 - **Condition** Crohn Disease **Highest recorded phase** 4 **Condition identifier** EFO:0000384 **Subject identifier** D003424 - **Condition** Infections **Highest recorded phase** 2 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Colitis, Ulcerative **Highest recorded phase** 4 **Condition identifier** EFO:0000729 **Subject identifier** D003093 - **Condition** Melanoma **Highest recorded phase** 1 **Condition identifier** EFO:0000756 **Subject identifier** D008545 - **Condition** HIV Infections **Highest recorded phase** 2 **Condition identifier** EFO:0000764 **Subject identifier** D015658 - **Condition** Celiac Disease **Highest recorded phase** 2 **Condition identifier** EFO:0001060 **Subject identifier** D002446 - **Condition** Inflammatory Bowel Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003767 **Subject identifier** D015212 - **Condition** Colitis **Highest recorded phase** 2 **Condition identifier** EFO:0003872 **Subject identifier** D003092 - **Condition** Pouchitis **Highest recorded phase** 3 **Condition identifier** EFO:0003921 **Subject identifier** D019449 - **Condition** Salivary Gland Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0000521 **Subject identifier** D012468 - **Condition** Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0004992 **Subject identifier** D009369 - **Condition** Diabetes Mellitus, Type 1 **Highest recorded phase** 0.5 **Condition identifier** MONDO:0005147 **Subject identifier** D003922 ### Open Targets indications (21) - **Condition identifier** EFO\_0000180 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000384 - **Condition identifier** EFO\_0000544 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000729 - **Condition identifier** EFO\_0000756 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000764 - **Condition identifier** EFO\_0001060 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003767 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003921 **Highest recorded phase** 3 - **Condition identifier** HP\_0002014 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004992 - **Condition identifier** MONDO\_0005011 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005101 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005105 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005265 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005292 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005312 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0013730 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018646 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0020546 **Highest recorded phase** 2 ### Reported adverse events (20) - **Event** abdominal pain **Reports** 671 **Reporting signal score** 378.576 - **Event** anal abscess **Reports** 150 **Reporting signal score** 360.694 - **Event** anal fistula **Reports** 95 **Reporting signal score** 209.247 - **Event** clostridium difficile infection **Reports** 234 **Reporting signal score** 409.98 - **Event** colectomy **Reports** 145 **Reporting signal score** 406.462 - **Event** colitis **Reports** 189 **Reporting signal score** 179.158 - **Event** colitis ulcerative **Reports** 1,666 **Reporting signal score** 5,674.09 - **Event** crohn's disease **Reports** 1,409 **Reporting signal score** 3,605.65 - **Event** defaecation urgency **Reports** 86 **Reporting signal score** 219.496 - **Event** diarrhoea haemorrhagic **Reports** 118 **Reporting signal score** 206.205 - **Event** faecal calprotectin increased **Reports** 189 **Reporting signal score** 653.446 - **Event** frequent bowel movements **Reports** 351 **Reporting signal score** 840.274 - **Event** haematochezia **Reports** 401 **Reporting signal score** 600.734 - **Event** intestinal obstruction **Reports** 201 **Reporting signal score** 248.256 - **Event** loss of therapeutic response **Reports** 83 **Reporting signal score** 305.214 - **Event** mucous stools **Reports** 105 **Reporting signal score** 291.297 - **Event** poor venous access **Reports** 157 **Reporting signal score** 370.899 - **Event** pregnancy **Reports** 432 **Reporting signal score** 818.76 - **Event** rectal haemorrhage **Reports** 205 **Reporting signal score** 201.353 - **Event** therapeutic reaction time decreased **Reports** 284 **Reporting signal score** 1,401.57 ### Trial references (68) - NCT00619489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00619489) - NCT00655135 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00655135) - NCT00783692 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00783692) - NCT00790933 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00790933) - NCT01224171 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01224171) - NCT02038920 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02038920) - NCT02324699 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02324699) - NCT02425111 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02425111) - NCT02559713 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02559713) - NCT02611817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02611817) - NCT02620046 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02620046) - NCT02630966 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02630966) - NCT02646683 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02646683) - NCT02743806 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02743806) - NCT02760615 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02760615) - NCT02764762 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02764762) - NCT02768532 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02768532) - NCT02820493 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02820493) - NCT02834754 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02834754) - NCT02913508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02913508) - NCT02953275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02953275) - NCT03138655 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03138655) - NCT03142321 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03142321) - NCT03196427 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03196427) - NCT03219359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03219359) And 43 more, listed on the interactive page. ## Dosing **Dose** 300 mg **Route** Intravenous **How often** Every 8 weeks after initial doses ### Conditions of use (2) - Administer by a healthcare provider - Infuse over approximately 30 minutes ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Heavy chain **Type** Protein **Sequence** QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNYNQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELAGAPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK - **Component** Light chain **Type** Protein **Sequence** DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRFSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC ## National Drug Codes - 64764-107 - 64764-108 - 64764-300 ## Related records ### Trials (132) - 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) - A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02) - A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) - A Multicentered Prospective Cohort Study of Chinese IBD Patients - 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 Autoinjector (PFS+AI) in Healthy Participants - 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 - A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease - A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease - A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis - A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease - A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting - A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) - A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease - A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) - A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease - A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease - A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease - A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) - A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab ### Approved for (2) - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) - [Ulcerative colitis](https://trialight.com/data/condition/ulcerative-colitis-afbc4579-f001-5a8a-b904-28f09f344ab5.md) ### In development for (9) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2 - [Celiac disease](https://trialight.com/data/condition/celiac-disease-4cbc090d-ae58-587f-a833-9f3b17bc0ea0.md) Phase 2 - Colitis Phase 2 - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 2 - [Inflammatory bowel disease](https://trialight.com/data/condition/inflammatory-bowel-disease-619080ac-2d43-5ad3-b078-9699e1241655.md) Phase 1 - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 1 - Pouchitis Phase 3 - Salivary gland carcinoma Phase 2 - Type 1 diabetes mellitus Early phase 1 ### Targets (2) - [ITGA4](https://trialight.com/data/target/itga4-bb7d0d23-7ab8-5354-b421-1d71630aa5ed.md) Integrin alpha-4/beta-7 inhibitor - [ITGB7](https://trialight.com/data/target/itgb7-bf8fa252-11e0-5372-8590-934645d9a1fc.md) Integrin alpha-4/beta-7 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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