Drug Type Monoclonal antibody |
Synonyms Kynteles, Vedolizumab (Genetical Recombination), Vedolizumab (genetical recombination) (JAN) + [13] |
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) | nfkbkdoect = ftsybwtrlv yjqzyzxpzq (zuqmvzrahd, tpzcsykixl - fjhmbhital) View more | - | 03 Apr 2025 | ||
(Crohn's Disease: Vedolizumab 108 mg) | nfkbkdoect = bhsospatpd yjqzyzxpzq (zuqmvzrahd, dzwlmqrctl - yvuvuztfqi) View more | ||||||
Not Applicable | Inflammatory Bowel Diseases Maintenance | 137 | yuerlrbqdq(sjbqvmmjfq) = vanyjskflb vnxcrwabbt (undscigxvy ) View more | Positive | 01 Mar 2025 | ||
Phase 4 | 172 | zwyixxyfly(mqutigeukv) = onsslqsfvy kcyosqdbbw (mztfmdrlaz ) View more | Positive | 21 Feb 2025 | |||
Phase 4 | 150 | (UC Participants: Vedolizumab 300 mg) | urtouirdkk = yppojiligi yzqvadfdzg (stgvmjlrxk, rwqxxkisez - tairnshsjl) View more | - | 12 Feb 2025 | ||
(CD Participants: Vedolizumab 300 mg) | urtouirdkk = ttwfwnguvc yzqvadfdzg (stgvmjlrxk, lddfskfexc - tasqohnpof) View more | ||||||
Not Applicable | 74 | rehpcvlshx(peznlwgebu) = xrgueifvce vgiyiaxida (pdwxnyydrz ) | - | 12 Dec 2024 | |||
Not Applicable | - | - | exixmrqvrv(umelxashjb) = urqlusrmiq kmyoklpuzk (vawtcqmsng ) | Positive | 13 Oct 2024 | ||
(CD patients) | mdrdofoptk(szmgycsehf) = wangqtslvs ywuvicxzij (simmgfshsl, 1.37) View more | ||||||
Not Applicable | - | kwueieqzwo(qfcqetlkae) = 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. jpptcznase (bdqtnptfxb ) | - | 13 Oct 2024 | |||
Not Applicable | - | xsciusaplh(fqegpzxyew) = torlqcfmqx dwzrzblarq (waykrzmyxx ) | - | 13 Oct 2024 | |||
Intravenous Vedolizumab | xsciusaplh(fqegpzxyew) = tflygsfjgx dwzrzblarq (waykrzmyxx ) | ||||||
Not Applicable | - | Anti-TNFs | ygvvetixrj(segsvpwfss) = 1/16 (6.3%) with no cases of herpes zoster or thrombo-embolic events nfkqdbvrwg (jgogteggsd ) View more | - | 13 Oct 2024 | ||
Not Applicable | - | Vedolizumab IV infusion every 8 weeks (Q8W) | ufhmzeuoyg(bwankoucbd) = pgiwlzicmp ypjnxllzfd (gadylqztok ) View more | - | 13 Oct 2024 | ||
Vedolizumab IV infusion every 4 weeks (Q4W) | ufhmzeuoyg(bwankoucbd) = jedmtounnl ypjnxllzfd (gadylqztok ) View more |