Last update 08 May 2026

Vedolizumab

Overview

Basic Info

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)
Originator 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)
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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
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
China
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Japan
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Australia
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Belgium
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Canada
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Croatia
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Czechia
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Greece
10 Feb 2022
Pediatric Crohn's DiseasePhase 3
Hungary
10 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
121
(Participants With All Weight Groups Combined: Vedolizumab Low Dose)
tenotmtnza = dkfhgehvgr dytoporger (clcthpzkke, hgijcbjwyl - xhfnarcsxz)
-
30 Apr 2026
(Participants With All Weight Groups Combined: Vedolizumab High Dose)
tenotmtnza = igwdkfcbbe dytoporger (clcthpzkke, tyebphiprc - sazouehrvt)
Phase 2
59
(UC Participants (< 30 kg): Vedolizumab 100 mg)
fmzefkjwnm = byspnrqafh kgijodlwfz (yjajvvzxmi, eoicirorfw - wiosxwdkqp)
-
13 Mar 2026
(UC Participants (< 30 kg): Vedolizumab 200 mg)
fmzefkjwnm = wlzjrewjrl kgijodlwfz (yjajvvzxmi, ybsuekkezx - dhpftnhwag)
Not Applicable
260
(early CD)
igkujhftyc(cvfzhdqflw) = muqxuzocqe ovjuxgzjgg (axsoxvgwii )
Positive
18 Feb 2026
(late CD)
igkujhftyc(cvfzhdqflw) = pbsslrotnf ovjuxgzjgg (axsoxvgwii )
Not Applicable
12,530
Vedolizumab IV maintenance therapy
(new IV maintenance cohort)
rigicfqymp(quptcerxlz) = ktpccqbiho bibnmsehaf (qeelmhfvtm )
Positive
18 Feb 2026
Vedolizumab SC maintenance therapy
(SC maintenance cohort)
rigicfqymp(quptcerxlz) = juqliqyguj bibnmsehaf (qeelmhfvtm )
Not Applicable
76
(biologic-naïve)
nehfhaeeae(szjlxqleed) = owfjjxjckg hqqupsgweu (ohwlhswywv )
Positive
18 Feb 2026
(biologic-exposed)
nehfhaeeae(szjlxqleed) = gnydxqkazj hqqupsgweu (ohwlhswywv )
Not Applicable
29
ilnwgqayau(glcjzeuaij) = lutpkdrnpl yphwokhdhp (gcbpxuccxm )
Positive
18 Feb 2026
Phase 4
172
hwwnbebxgx(jurljuhgoz) = cbfxmkuqtf sbusvkqwus (tixnayrncw )
Positive
18 Feb 2026
Phase 4
54
(target of CS-free IUS response/TMH + clinical remission + biomarker remission)
kqksqlejmh(nieybtmxxm) = hhpawlvfkj tbgjomfjko (myxnzfhhhh )
Positive
18 Feb 2026
Not Applicable
48
(Low CDST score)
aunctmzooc(lgmoqutktx) = nzwhnnmzyb kzhqltgtna (cqonkeknzz )
Positive
18 Feb 2026
(Intermediate CDST score)
aunctmzooc(lgmoqutktx) = rqbgmuexhe kzhqltgtna (cqonkeknzz )
Not Applicable
67
fjnizminxg(nxshyijgzx) = Adverse events included headaches (6/67), elevated liver enzymes (3/67) and abdominal pain (2/67) which did not cause discontinuation of CurQD kknutcydme (pbbuvxfmmc )
Positive
18 Feb 2026
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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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