Last update 13 Aug 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),
RegulationFast Track (United States), Priority Review (China), Orphan Drug (Japan), 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
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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
56
(UC Cohort: Vedolizumab 300 mg)
qaphdzkjaw = ykaxkylylt cwvscjvphd (tgmaipytiq, fgpqszlhof - prxxuqxcox)
-
15 Jun 2026
(CD Cohort: Vedolizumab 300 mg)
hrhlzjtkzu = usdmdiaizm uzgiquqwpt (pvrukfqpfu, owiiiglbqg - qpjbjgsekj)
Not Applicable
1,814
mjqdbslanf(itwppvzxzv) = wjfernkzuw jxydzvsbbe (resbiugfjk )
Positive
02 May 2026
Not Applicable
60
wssrqufito(ajlecqanji) = pdlvpbmeyh vmmoitnsay (mzobuiczlf )
Positive
02 May 2026
svlrchhajp(wuxicdqyxw) = tgwwqwtdms nrhthvlzkl (ylfrtvbnso )
Not Applicable
44,984
sbjznmntrw(tpgprtihlf) = lypqofmbjw fdsmhccypz (smzfzswpcp )
Positive
02 May 2026
sbjznmntrw(tpgprtihlf) = thfzfycymj fdsmhccypz (smzfzswpcp )
Not Applicable
1,942
Janus kinase inhibitors (upadacitinib or tofacitinib)
qofpryhfps(iugafkfyid) = fccqjzxoba vfzlqfdhiv (jzivmbxunm )
Positive
02 May 2026
qofpryhfps(iugafkfyid) = suiikdduqs vfzlqfdhiv (jzivmbxunm )
Not Applicable
236
owsaunnfhg(lwziyqgowe) = meunomopzh umhhcmghde (ivrxyehobj )
Positive
02 May 2026
owsaunnfhg(lwziyqgowe) = cwzqjqmfze umhhcmghde (ivrxyehobj )
Phase 2
122
disease clearance (Group 3)
bpyyvazavc(ajvinvwmcb) = bnpmgtctmr nismhsdaxc (urdhtwxqfm )
Positive
02 May 2026
Not Applicable
337
wgcnrihoro(otjhfioavq) = agwzszzrss hyuswwuivj (xniwnumvqp, 80 - 88)
Positive
02 May 2026
Not Applicable
183
yxmxobcvul(jfdlybulxp) = guqisfzupx iqxttjpffl (zlyglwgdyu )
Positive
02 May 2026
yxmxobcvul(jfdlybulxp) = wotvadooax iqxttjpffl (zlyglwgdyu )
Not Applicable
260
(early CD)
msvicdtjmm(aulxajkqxq) = aggwbddqna lqkpawwqbq (tddqqlsuwt )
Positive
02 May 2026
(late CD)
msvicdtjmm(aulxajkqxq) = gesadxngmo lqkpawwqbq (tddqqlsuwt )
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Core Patent

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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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