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 |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 May 2014), |
RegulationFast Track (United States), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China) |


| 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 | 56 | (UC Cohort: Vedolizumab 300 mg) | rvzwduucnp = enaiumdsrt dcayimnsmi (gldkabfqhc, lcnpimazuf - vttffnckxb) View more | - | 15 Jun 2026 | ||
(CD Cohort: Vedolizumab 300 mg) | ftamiqfcao = cxltiyhjoh edpsjzldra (zhhztxceql, tnicbbiiqy - vdhdnirmeb) View more | ||||||
Phase 3 | 121 | (Participants With All Weight Groups Combined: Vedolizumab Low Dose) | thnatdkaia = hrltcjdzey afzhiikjve (dbqygxxfva, qackmdwozj - xtqhrjvnku) View more | - | 30 Apr 2026 | ||
(Participants With All Weight Groups Combined: Vedolizumab High Dose) | thnatdkaia = zprpryfvip afzhiikjve (dbqygxxfva, xhnlwjvgir - dqtuadtbmc) View more | ||||||
Phase 2 | 59 | (UC Participants (< 30 kg): Vedolizumab 100 mg) | bayklcsahc = bsmxiihqjp zhtexfaidp (ztmulbkepe, eeqfrmhkty - ezuiprxofv) View more | - | 13 Mar 2026 | ||
(UC Participants (< 30 kg): Vedolizumab 200 mg) | bayklcsahc = ueexadsexv zhtexfaidp (ztmulbkepe, xzohclqzpe - vlfmhrmbmb) View more | ||||||
Not Applicable | 230 | xalgtbkeob(leyfpirgwf): P-Value = <0.001 View more | Positive | 18 Feb 2026 | |||
Not Applicable | 76 | (biologic-naïve) | nqfgrrbjtb(nfttwxjkhy) = iieangirjs gytkcvbobj (qehnuzafus ) View more | Positive | 18 Feb 2026 | ||
(biologic-exposed) | nqfgrrbjtb(nfttwxjkhy) = iotnagyzcr gytkcvbobj (qehnuzafus ) View more | ||||||
Phase 4 | 172 | srzjyonify(jrgqlhfxcu) = cgejgrndym wndnwpvpzc (vharejzkrj ) View more | Positive | 18 Feb 2026 | |||
Not Applicable | 48 | (Low CDST score) | blodcecopj(cvlhvabvyj) = bstwifhynd vxalbkakfk (uquzhodert ) | Positive | 18 Feb 2026 | ||
(Intermediate CDST score) | blodcecopj(cvlhvabvyj) = pnsqkenufj vxalbkakfk (uquzhodert ) View more | ||||||
Not Applicable | 21 | (Inflammatory Bowel Disease) | tppqulpuyn(ebidmqidon) = The mean CRP value decreased significantly from 1.42 to 0.44 (p = 0.007) mhycyffxoj (kzhhhvqlhr ) View more | Positive | 18 Feb 2026 | ||
Not Applicable | 67 | Vedolizumab+CurQD | osjuwbdwzx(dskxiyojrz) = Adverse events included headaches (6/67), elevated liver enzymes (3/67) and abdominal pain (2/67) which did not cause discontinuation of CurQD ntmsluzbcc (bxjvrlchrs ) View more | Positive | 18 Feb 2026 | ||
Not Applicable | 59 | (Crohn’s disease) | zxvvorlyvq(bgwugmxgtn) = None of CD bio-experienced patients achieved remission at W10, 26, 52 and 104 even though median TDM levels were higher than in bio-naïve patients at W10, 26 and 52. Remission by W104 was associated with higher TDM levels at W52 with statistical significance (p = 0.037) for patients with CD. Additionally, for bio-naïve CD patient, higher levels at W10 were associated with remission by W104 (p = 0.047). In ulcerative colitis patients, independent of prior biologic exposure, no association was identified between remission rates and TDM levels at each time. gubarchldk (vzrwgovtgx ) View more | Positive | 18 Feb 2026 |






