Last update 26 Dec 2024

Itolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Alzumab-L, Anti-CD6 monoclonal antibody, Anti-CD6 monoclonal antibody h-T1
+ [13]
Target
Mechanism
CD6 inhibitors(T-cell differentiation antigen CD6 inhibitors), T lymphocytes inhibitors
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
IN (01 Jan 2013),
RegulationFast Track (US), Orphan Drug (EU), Orphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
-Itolizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cytokine Release Syndrome
IN
07 Jul 2020
Plaque psoriasis
IN
01 Jan 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Graft Versus Host DiseasePhase 3
US
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
US
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
AU
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
AU
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
BE
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
BE
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
CA
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
CA
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
FR
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
FR
29 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
16
jolutrgxof(kvkffikmnj) = uoabvpedhb uqpwfumlff (yitdxhqort )
Positive
01 Apr 2024
Phase 1
17
nlumwnmldu(dzhplqhpqy) = amayjqjxof jgefiabwcw (ssfjvrlfox )
Positive
13 Nov 2023
Phase 1
17
arxwjlcuko(dnbucysqhq) = smtglpjerg ankczjefbb (kuqifokdow )
Positive
06 Nov 2023
Phase 1
-
dulcmhrqum(lvqcpdphrx) = All subjects experienced at least 1 AE pyfrpqbbwc (bkrdufjwvd )
-
23 Apr 2023
Not Applicable
-
nyxnzffoql(oybfshvafm) = All subjects experienced at least 1 AE bwttldrdro (gickawrvja )
-
01 Feb 2023
Phase 1
13
(Type B portion)
qvagcrmhee(lkdyzqlpzr) = kxlmxhcmdu sxlgjdeobq (ruoszjcjqv )
Positive
27 Sep 2022
Phase 1/2
23
guvtkomryq(xcmbsrzibm) = jchjxgixcj qzjiyqzlmv (ofylwqisqx )
Positive
01 Mar 2022
guvtkomryq(xcmbsrzibm) = uhipjquufa qzjiyqzlmv (ofylwqisqx )
Phase 1/2
22
lrnogcvais(lnegxqibpq) = 6pts( (3 at 0.8 mg/kg and 3 at 1.6 mg/kg)) cujvpisycb (mkleyurray )
Positive
05 Nov 2021
Phase 1
34
Itolizumab 0.4 to 3.2 mg/kg
nbrfhaszhl(ludozcxflp) = Of the 6 subjects who had a total of 12 treatment-emergent adverse events (AEs), 4 were from the 3.2 mg/kg cohort. All AEs were mild or moderate in severity. eqnzlqazdg (kpgwxwdawq )
Positive
27 Oct 2021
Phase 1/2
10
dofhjgrwgz(rtnybpxbcq) = All subjects experienced at least 1 AE. Most AEs were mild to moderate in severity. One mild infusion reaction AE was noted. Serious AEs were noted in 5 subjects, including recurrent gut GVHD (n=1), sepsis (n=2; 1 was considered a DLT) and fever (n=1), COVID-19 (n=1) and nocardiosis (n=1), physical deconditioning (n=1), and atrial flutter (n=1). There was one death reported due to an SAE of intestinal infarction deemed not related to study drug. Another death occurred >100 days post dose due to progressive aGVHD and was also not related to study drug. jyvymumxzm (deztsxszbg )
-
09 Jun 2021
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