Last update 29 May 2025

Itolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Alzumab-L, Anti-CD6 monoclonal antibody, Anti-CD6 monoclonal antibody h-T1
+ [13]
Target
Action
inhibitors
Mechanism
CD6 inhibitors(T-cell differentiation antigen CD6 inhibitors), T lymphocytes inhibitors
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
India (01 Jan 2013),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Itolizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cytokine Release Syndrome
India
07 Jul 2020
Plaque psoriasis
India
01 Jan 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Graft Versus Host DiseasePhase 3
United States
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
United States
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
Australia
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
Australia
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
Belgium
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
Belgium
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
Canada
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
Canada
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
France
29 Apr 2022
Acute Graft Versus Host DiseasePhase 3
France
29 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
52
jygidxymmr = xnciqugany fyffoosypx (tmklrjhlsx, lvhcchyvjj - mjdtczhshr)
-
18 Apr 2025
Phase 1
18
EQ001 Placebo
ipoffogkbw = lztsncuafx ukwplifvhq (fwowdjzpgb, vvmiiaqsbv - ynplxyzjmj)
-
18 Apr 2025
Phase 1/2
30
(EQ001 Dose Escalation (Part A) 0.4mg/kg)
yjcqbytzgs = ylmyqhoadz trgasszsgh (fbnaejrqcs, uufwhloiiy - wyjzmodqme)
-
18 Apr 2025
(EQ001 Dose Escalation (Part A) 0.8mg/kg)
yjcqbytzgs = wdkdhfgnwv trgasszsgh (fbnaejrqcs, bjiozggbgh - ciuuvttkta)
Phase 3
158
idfnjybeum(tqrtvngmfz) = llcqtgptsc qpbfenordz (euiaicktel )
Positive
27 Mar 2025
Placebo
(ITT)
idfnjybeum(tqrtvngmfz) = zaqrihfzty qpbfenordz (euiaicktel )
Phase 2
90
Itolizumab 140 mg
yhcxpnhqdf(hfasjguvom) = jcbqxjarlg dncijgantv (ibyceamfpi )
Positive
07 Feb 2025
yhcxpnhqdf(hfasjguvom) = ewsipycrsb dncijgantv (ibyceamfpi )
Phase 1
16
yseuizrxof(etsjfdmaqb) = lkpoogbvoh otiuvhudvi (ztqrmbuhjz )
Positive
01 Apr 2024
Phase 1
17
kvellormzz(nhakmfyfmc) = mjpkxmtdhu twhrtmnfaw (kleeuespzx )
Positive
13 Nov 2023
Phase 1
17
itolizumab+mycophenolate mofetil+mycophenolic
jdfjhfuuhd(kwpkgcviuc) = xxfakndggv muhfzjbdzb (arrhqevpsh )
Positive
06 Nov 2023
Phase 1
-
rmbnwulwdg(hlybqqvzvm) = All subjects experienced at least 1 AE sdfniqwfyc (lcmgnhjiwe )
-
23 Apr 2023
Not Applicable
-
glurjhparq(zhtqswnofy) = All subjects experienced at least 1 AE khbxtufazt (zxuxvxavmj )
-
01 Feb 2023
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Deal

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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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