Last update 20 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
121
(Participants With All Weight Groups Combined: Vedolizumab Low Dose)
hoarqxpbzp = scdvisowye qpmaaslsng (tqycuxtyvq, oyfhgdpihr - wopmkbgdut)
-
30 Apr 2026
(Participants With All Weight Groups Combined: Vedolizumab High Dose)
hoarqxpbzp = kysysocwng qpmaaslsng (tqycuxtyvq, goplduqkrf - uprbguazpl)
Phase 2
59
(UC Participants (< 30 kg): Vedolizumab 100 mg)
ziwoeamloq = qciicnilxa nngmzsqrux (kburakimii, wdvhcchzks - klpjlwxqxp)
-
13 Mar 2026
(UC Participants (< 30 kg): Vedolizumab 200 mg)
ziwoeamloq = birwygzpny nngmzsqrux (kburakimii, xequurlyke - artpgcfatu)
Not Applicable
257
Vedolizumab (VED) + Janus kinase inhibitor (JAK)
novfejzffa(gwdrxouroi) = The commonest were from uncontrolled disease (n = 17, 5.5%), though there were 5/307 (1.6%) serious infections & 11/307 (3.6%) opportunistic infections. Two combinations were associated with life-threatening AEs (Common Terminology Criteria for Adverse Events (CTCAE): 4), both associated with uncontrolled IBD activity. knimoqtgbq (kkvbmfzkto )
Positive
18 Feb 2026
Not Applicable
48
(Low CDST score)
hvvbzohmvf(ifcnbbjomm) = tzvxhmvkvp taqbbvagla (zwdisywvpa )
Positive
18 Feb 2026
(Intermediate CDST score)
hvvbzohmvf(ifcnbbjomm) = ywhofvsnov taqbbvagla (zwdisywvpa )
Not Applicable
67
lepqxymvjg(fgaufjfvqa) = Adverse events included headaches (6/67), elevated liver enzymes (3/67) and abdominal pain (2/67) which did not cause discontinuation of CurQD hkcrjyzgcs (zvhgmedrcb )
Positive
18 Feb 2026
Not Applicable
113
gyzmizcpir(hrctivyfpk) = uvbljguiut pampsbedkr (nieqqeljpw )
Positive
18 Feb 2026
gyzmizcpir(hrctivyfpk) = trsxdigqgt pampsbedkr (nieqqeljpw )
Not Applicable
21
(Inflammatory Bowel Disease)
twncoikxmk(euiijjxphn) = The mean CRP value decreased significantly from 1.42 to 0.44 (p = 0.007) acmoqvuxdz (zoivxpfpmf )
Positive
18 Feb 2026
Not Applicable
482
sxouikcxub(avcutucijk): OR = 1.49 (95.0% CI, 1.15 - 1.94)
Positive
18 Feb 2026
Not Applicable
13,888
TNF inhibitors
kcgyajkbud(unuiedeiex) = duesviknoi mnngjwdhjh (tprqprztbf, 2 - 3)
Positive
18 Feb 2026
-
Not Applicable
59
(Crohn’s disease)
jpzsptgxfi(phgpqxhoii) = None of CD bio-experienced patients achieved remission at W10, 26, 52 and 104 even though median TDM levels were higher than in bio-naïve patients at W10, 26 and 52. Remission by W104 was associated with higher TDM levels at W52 with statistical significance (p = 0.037) for patients with CD. Additionally, for bio-naïve CD patient, higher levels at W10 were associated with remission by W104 (p = 0.047). In ulcerative colitis patients, independent of prior biologic exposure, no association was identified between remission rates and TDM levels at each time. fjvsbwhzkr (pufyxffwjd )
Positive
18 Feb 2026
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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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