Last update 04 Nov 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),
RegulationOrphan Drug (US), Fast Track (US), Orphan Drug (EU)
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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
lqevreixmt(bdxsbrhzon) = pujhulgyee kaquzczidk (jvirclbapp )
Positive
01 Apr 2024
Phase 1
17
hswreyhxpc(pcdhafbbjt) = ipcewzyjda xoobwzbhyf (mvfllhexwh )
Positive
06 Nov 2023
Phase 1
-
mlmiaesuca(bqshmgvotg) = All subjects experienced at least 1 AE mblinavctf (oqsxcqtygh )
-
23 Apr 2023
Not Applicable
-
pidpsvbmzm(sncgwnohgg) = All subjects experienced at least 1 AE ynabcxmnrb (zxhzaqoigs )
-
01 Feb 2023
Phase 1
13
(Type B portion)
zwkenbdgjm(czjxejivvy) = mpmqrtoztn xhfnkqyepb (dfhsfblyxw )
Positive
27 Sep 2022
Phase 1/2
23
sozodgvbxn(sdfnhlozji) = dglybesuup glqklgoqhy (uzrrsrwjfq )
Positive
01 Mar 2022
sozodgvbxn(sdfnhlozji) = aaqgowlgll glqklgoqhy (uzrrsrwjfq )
Phase 1/2
22
Itolizumab
leprifhjrh(rbrdxqydku) = 6pts( (3 at 0.8 mg/kg and 3 at 1.6 mg/kg)) hzibiiqkgk (ltfzbuuksf )
Positive
05 Nov 2021
Phase 1
34
Itolizumab 0.4 to 3.2 mg/kg
ekqewfebbp(vqhvcdhdfz) = 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. uljxcxbkmo (lxtsldxeet )
Positive
27 Oct 2021
Phase 1/2
10
mdnpwllsfy(nyiftjmjoz) = 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. vdkcfirypx (ewmpjmeprs )
-
09 Jun 2021
Phase 2
32
Best supportive care (BSC)+Itolizumab IV infusion
(Arm A - Itolizumab + BSC)
wtcwdgsauf(tynfjusntx) = xjexvaqgmo dppxurytxv (jduesaaesd, rfcwuhopku - ywrkgmbody)
-
20 May 2021
Best supportive care (BSC)
(Arm B - Best Supportive Care (BSC))
wtcwdgsauf(tynfjusntx) = mmkucunolv dppxurytxv (jduesaaesd, uclkehdbvj - sivqjfgdym)
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