Last update 19 Jul 2025

Vedolizumab

Overview

Basic Info

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)
Originator 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)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pediatric Crohn's DiseasePhase 3
United States
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
China
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Japan
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Australia
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Belgium
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Canada
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Croatia
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Czechia
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Greece
30 Apr 2022
Pediatric Crohn's DiseasePhase 3
Hungary
30 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
746
(Ulcerative Colitis: Vedolizumab 108 mg)
nfkbkdoect = ftsybwtrlv yjqzyzxpzq (zuqmvzrahd, tpzcsykixl - fjhmbhital)
-
03 Apr 2025
(Crohn's Disease: Vedolizumab 108 mg)
nfkbkdoect = bhsospatpd yjqzyzxpzq (zuqmvzrahd, dzwlmqrctl - yvuvuztfqi)
Not Applicable
137
yuerlrbqdq(sjbqvmmjfq) = vanyjskflb vnxcrwabbt (undscigxvy )
Positive
01 Mar 2025
Phase 4
172
zwyixxyfly(mqutigeukv) = onsslqsfvy kcyosqdbbw (mztfmdrlaz )
Positive
21 Feb 2025
Phase 4
150
(UC Participants: Vedolizumab 300 mg)
urtouirdkk = yppojiligi yzqvadfdzg (stgvmjlrxk, rwqxxkisez - tairnshsjl)
-
12 Feb 2025
(CD Participants: Vedolizumab 300 mg)
urtouirdkk = ttwfwnguvc yzqvadfdzg (stgvmjlrxk, lddfskfexc - tasqohnpof)
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)
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 )
-
13 Oct 2024
Not Applicable
-
Vedolizumab IV infusion every 8 weeks (Q8W)
ufhmzeuoyg(bwankoucbd) = pgiwlzicmp ypjnxllzfd (gadylqztok )
-
13 Oct 2024
Vedolizumab IV infusion every 4 weeks (Q4W)
ufhmzeuoyg(bwankoucbd) = jedmtounnl ypjnxllzfd (gadylqztok )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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