Drug Type Monoclonal antibody |
Synonyms Kynteles, Vedolizumab (Genetical Recombination), Vedolizumab (genetical recombination) (JAN) + [16] |
Target |
Action antagonists |
Mechanism α4β7 antagonists(Integrin alpha-4/beta-7 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 May 2014), |
RegulationOrphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Fast Track (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08083 | Vedolizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Ileal Diseases | South Korea | 19 Jun 2015 | |
| Crohn's disease, active moderate | European Union | 22 May 2014 | |
| Crohn's disease, active moderate | Iceland | 22 May 2014 | |
| Crohn's disease, active moderate | Liechtenstein | 22 May 2014 | |
| Crohn's disease, active moderate | Norway | 22 May 2014 | |
| Crohn's disease, active severe | European Union | 22 May 2014 | |
| Crohn's disease, active severe | Iceland | 22 May 2014 | |
| Crohn's disease, active severe | Liechtenstein | 22 May 2014 | |
| Crohn's disease, active severe | Norway | 22 May 2014 | |
| Pouchitis | European Union | 22 May 2014 | |
| Pouchitis | Iceland | 22 May 2014 | |
| Pouchitis | Liechtenstein | 22 May 2014 | |
| Pouchitis | Norway | 22 May 2014 | |
| Ulcerative colitis, active moderate | European Union | 22 May 2014 | |
| Ulcerative colitis, active moderate | Iceland | 22 May 2014 | |
| Ulcerative colitis, active moderate | Liechtenstein | 22 May 2014 | |
| Ulcerative colitis, active moderate | Norway | 22 May 2014 | |
| Ulcerative colitis, active severe | European Union | 22 May 2014 | |
| Ulcerative colitis, active severe | Iceland | 22 May 2014 | |
| Ulcerative colitis, active severe | Liechtenstein | 22 May 2014 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pediatric Crohn's Disease | Phase 3 | United States | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | China | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Japan | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Australia | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Belgium | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Canada | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Croatia | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Czechia | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Greece | 10 Feb 2022 | |
| Pediatric Crohn's Disease | Phase 3 | Hungary | 10 Feb 2022 |
Phase 3 | 121 | (Participants With All Weight Groups Combined: Vedolizumab Low Dose) | xoikcxcvuk = jqikoiyabu zmwwndkovv (yxzeuajtjo, eqokoxfuxq - nxxbvzyupm) View more | - | 30 Apr 2026 | ||
(Participants With All Weight Groups Combined: Vedolizumab High Dose) | xoikcxcvuk = dnmxtiflxs zmwwndkovv (yxzeuajtjo, ugxfpfngcp - scsgrerlou) View more | ||||||
Phase 2 | 59 | (UC Participants (< 30 kg): Vedolizumab 100 mg) | aynmtiagez = ncvyxdxoaf inzborgzly (matksxqqop, fzcvdftfdx - pbazzetpcq) View more | - | 13 Mar 2026 | ||
(UC Participants (< 30 kg): Vedolizumab 200 mg) | aynmtiagez = irtkedskfi inzborgzly (matksxqqop, dlitalwydo - rvmewomeos) View more | ||||||
Not Applicable | 13,888 | TNF inhibitors | poixqjdjkt(wtmvhjwwzx) = onmgbtuokt rrjksvanbi (jxhiyuzkxn, 2 - 3) View more | Positive | 18 Feb 2026 | ||
- | |||||||
Not Applicable | 219,229 | Aminosalicylates | tykfvzulgh(xfgwtoqluc): HR = 1.05 (95.0% CI, 0.98 - 1.11) | Positive | 18 Feb 2026 | ||
Not Applicable | 420 | garrvlexiw(scsfyiiwsz): OR = 0.66 (95.0% CI, 0.45 - 0.91) View more | Positive | 18 Feb 2026 | |||
Not Applicable | 320 | vcytubsofn(uwikdzsmua) = cwpriyguev ajspsllnxk (wndhczaezj ) View more | Positive | 18 Feb 2026 | |||
vcytubsofn(uwikdzsmua) = xaypodxodr ajspsllnxk (wndhczaezj ) View more | |||||||
Not Applicable | 24 | Advanced Combination Therapies | uugqzalomo(lmauwhyaeu) = zpevpgbhnm vbnsreiavk (stonctobla ) View more | Positive | 18 Feb 2026 | ||
Not Applicable | 482 | gfzeicihbq(qoyrscbrvc): OR = 1.49 (95.0% CI, 1.15 - 1.94) View more | Positive | 18 Feb 2026 | |||
Phase 4 | 24 | uvbfyukltw(pbnhhwkjdo) = dvmggibczh nadntakilo (uljdicvhlk ) View more | Positive | 18 Feb 2026 | |||
Not Applicable | 260 | (early CD) | ompqvmkxfn(mvzsugyzlk) = kczuylxlfy pfqijxmorp (tpoxyjbkvz ) View more | Positive | 18 Feb 2026 | ||
(late CD) | ompqvmkxfn(mvzsugyzlk) = bzfaoptccq pfqijxmorp (tpoxyjbkvz ) View more |






