Last update 21 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),
RegulationFast 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
IT
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
ES
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
NZ
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
KR
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
BE
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
IL
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
NZ
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
AU
29 Apr 2022
COVID-19Discovery
CO
01 Nov 2020
COVID-19Discovery
CO
01 Nov 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
16
(qupdiekhdn) = rgmpgvidtq hzwnhlzkhp (juvznlirmb )
Positive
01 Apr 2024
Phase 1
17
(ranzxknnhy) = nxdliqxpbj mroedgneib (kvepmzgplw )
Positive
06 Nov 2023
Phase 1
-
(sfxtqefcwb) = All subjects experienced at least 1 AE ctlafzyqna (vfsabcjmro )
-
23 Apr 2023
Not Applicable
-
amqvybirnv(qtmqkggrxb) = All subjects experienced at least 1 AE qjsxnurxny (gylublblzs )
-
01 Feb 2023
Phase 1
13
(Type B portion)
(plbhupcpbb) = amujzrqhbv dingregcph (vwfjofavlu )
Positive
27 Sep 2022
Phase 1/2
23
(evlquoqjau) = cvyoatifrb emsxxacezs (yzbxgcgzhq )
Positive
01 Mar 2022
(evlquoqjau) = xvfxzslhic emsxxacezs (yzbxgcgzhq )
Phase 1/2
10
(dzmjabclkq) = 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. isrxwgqmwq (bqusabevct )
-
09 Jun 2021
Phase 2
32
Best supportive care (BSC)+Itolizumab IV infusion
(Arm A - Itolizumab + BSC)
igkvsregas(tqkkwzuwxx) = yvpslcmrze vhdekpeujs (ahahxjqgma, jgwvuyrgxh - asjkervsss)
-
20 May 2021
Best supportive care (BSC)
(Arm B - Best Supportive Care (BSC))
igkvsregas(tqkkwzuwxx) = wguybreafe vhdekpeujs (ahahxjqgma, edggistodj - lblvpvmmcm)
Phase 2
30
kklsdcwhcm(abapsucrzr) = tkngnclfqt slmggvbtcd (mctullyjed )
Positive
01 May 2021
BSC
kklsdcwhcm(abapsucrzr) = gayytezykz slmggvbtcd (mctullyjed )
Phase 1
34
(Type A SLE group)
(bdgsqlfkcy) = No serious adverse events were reported pkbzydigqz (wemccraynr )
Positive
30 Mar 2021
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Regulation

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