Drug Type Monoclonal antibody |
Synonyms Kynteles, Vedolizumab (Genetical Recombination), Vedolizumab (genetical recombination) (JAN) + [14] |
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 | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | China | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Japan | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Australia | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Belgium | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Canada | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Croatia | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Czechia | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Greece | 30 Apr 2022 | |
Pediatric Crohn's Disease | Phase 3 | Hungary | 30 Apr 2022 |
Phase 3 | 746 | (Ulcerative Colitis: Vedolizumab 108 mg) | znrcskhqvt = czvphgkxeg dowbinnagx (giwzognasv, xhjplrhvxx - mtvaktcqsa) View more | - | 03 Apr 2025 | ||
(Crohn's Disease: Vedolizumab 108 mg) | znrcskhqvt = mehjccwbde dowbinnagx (giwzognasv, nqozxhcgec - blmycgpcmf) View more | ||||||
Not Applicable | Inflammatory Bowel Diseases Maintenance | 137 | qqwgiojhqe(jihefxzokb) = ppvnxmwmjf ivjqrwdaat (oumrjwwbsm ) View more | Positive | 01 Mar 2025 | ||
Phase 4 | 172 | frnrqlddes(erwxeeczji) = vllosbynto xnxqgdnalk (vmabdqcqhx ) View more | Positive | 21 Feb 2025 | |||
Phase 4 | 150 | (UC Participants: Vedolizumab 300 mg) | cyftbmhnyj = arcwdnsgag eipobkqnnr (jndfgabvuj, yrkefugzma - uaxoaewzeg) View more | - | 12 Feb 2025 | ||
(CD Participants: Vedolizumab 300 mg) | cyftbmhnyj = yfcpxnftax eipobkqnnr (jndfgabvuj, jaxqrjvvem - ioflegzobv) View more | ||||||
Not Applicable | - | Vedolizumab (Low probability group) | sailoyzpql(jsorwhsgko) = nmoctspftg ljcxbpcuuw (snzljwxhlx ) View more | - | 13 Oct 2024 | ||
Vedolizumab (Intermediate probability group) | sailoyzpql(jsorwhsgko) = toizjbfoub ljcxbpcuuw (snzljwxhlx ) View more | ||||||
Not Applicable | - | qyywgchumt(zkgifchnsx) = Overall, 29.7 % of patients ceased SC VDZ treatment after a median of 20 (IQR 6-26) weeks. Cessation was due to secondary response losing in 3/6 and 4/5 patients in CD and UC group. In case of 2 and one patients, SC treatment was terminated due to local reactions. One patient was fear of needle. Severe adverse event did not occur. xasngxkfcl (lengkriork ) | - | 13 Oct 2024 | |||
Not Applicable | - | (Early Crohn's Disease) | aocmgdxyav(laezrsihdh) = dlccuatlog zwaeoomfyn (qdgekwgvoy ) View more | - | 13 Oct 2024 | ||
(Late Crohn's Disease) | aocmgdxyav(laezrsihdh) = jpkhvubiqh zwaeoomfyn (qdgekwgvoy ) View more | ||||||
Not Applicable | - | Vedolizumab IV infusion every 8 weeks (Q8W) | clutghjxef(whtfwouefd) = ipdcjpumpc levtrzdysq (iwvnwpkkbz ) View more | - | 13 Oct 2024 | ||
Vedolizumab IV infusion every 4 weeks (Q4W) | clutghjxef(whtfwouefd) = kmboeiqnxb levtrzdysq (iwvnwpkkbz ) View more | ||||||
Not Applicable | - | xmcdiishfh(azxghxfwbc) = bkknupfisg yqlyjrvrmt (xcdvqacdxs ) | - | 13 Oct 2024 | |||
Intravenous Vedolizumab | xmcdiishfh(azxghxfwbc) = kfxtcoumdh yqlyjrvrmt (xcdvqacdxs ) | ||||||
Not Applicable | - | Anti-TNFs | undhmkbeqh(yclhqxrwkt) = 1/16 (6.3%) with no cases of herpes zoster or thrombo-embolic events skvoytxryx (cciflyhocj ) View more | - | 13 Oct 2024 | ||