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 |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date IN (01 Jan 2013), |
RegulationOrphan Drug (US), Fast Track (US), Orphan Drug (EU) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Itolizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Cytokine Release Syndrome | IN | 07 Jul 2020 | |
Plaque psoriasis | IN | 01 Jan 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Acute Graft Versus Host Disease | Phase 3 | US | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | US | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | AU | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | AU | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | BE | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | BE | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | CA | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | CA | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | FR | 29 Apr 2022 | |
Acute Graft Versus Host Disease | Phase 3 | FR | 29 Apr 2022 |
Phase 1 | 16 | lqevreixmt(bdxsbrhzon) = pujhulgyee kaquzczidk (jvirclbapp ) View more | Positive | 01 Apr 2024 | |||
EQUALISE (Biospace) Manual | Phase 1 | 17 | hswreyhxpc(pcdhafbbjt) = ipcewzyjda xoobwzbhyf (mvfllhexwh ) View more | Positive | 06 Nov 2023 | ||
Phase 1 | - | mlmiaesuca(bqshmgvotg) = All subjects experienced at least 1 AE mblinavctf (oqsxcqtygh ) View more | - | 23 Apr 2023 | |||
Not Applicable | - | pidpsvbmzm(sncgwnohgg) = All subjects experienced at least 1 AE ynabcxmnrb (zxhzaqoigs ) View more | - | 01 Feb 2023 | |||
Phase 1 | 13 | (Type B portion) | zwkenbdgjm(czjxejivvy) = mpmqrtoztn xhfnkqyepb (dfhsfblyxw ) View more | Positive | 27 Sep 2022 | ||
Phase 1/2 | 23 | sozodgvbxn(sdfnhlozji) = dglybesuup glqklgoqhy (uzrrsrwjfq ) View more | Positive | 01 Mar 2022 | |||
sozodgvbxn(sdfnhlozji) = aaqgowlgll glqklgoqhy (uzrrsrwjfq ) View more | |||||||
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 ) View more | 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) View more | - | 20 May 2021 | ||
Best supportive care (BSC) (Arm B - Best Supportive Care (BSC)) | wtcwdgsauf(tynfjusntx) = mmkucunolv dppxurytxv (jduesaaesd, uclkehdbvj - sivqjfgdym) View more |