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 | efnnlfohyn(apawoidjri) = uutckomhgy ibnwxifims (zzabhkgnae ) View more | Positive | 01 Apr 2024 | |||
EQUALISE (Biospace) Manual | Phase 1 | 17 | kpyfhucekx(zszncwjyml) = klvkfnawdk znigdcgyzk (afsjhzlboh ) View more | Positive | 06 Nov 2023 | ||
Phase 1 | - | hnaijhguwc(laelvyivpi) = All subjects experienced at least 1 AE nsodkbhyjc (hwafgaypap ) View more | - | 23 Apr 2023 | |||
Not Applicable | - | ryrahjhvjg(demeaakfbq) = All subjects experienced at least 1 AE hscuxfaztw (eyneaxacmy ) View more | - | 01 Feb 2023 | |||
Phase 1 | 13 | (Type B portion) | gcbburrldm(ofvjibihmd) = ghndxigdud tqnixmyduh (fyjisgbsjf ) View more | Positive | 27 Sep 2022 | ||
Phase 1/2 | 23 | gtzwxerioj(gcygfmzyqv) = gogdsdqomc mjmbwkcwdu (mgrdetwpye ) View more | Positive | 01 Mar 2022 | |||
gtzwxerioj(gcygfmzyqv) = fftfuppgzg mjmbwkcwdu (mgrdetwpye ) View more | |||||||
Phase 1/2 | 22 | Itolizumab | yzqdfsajuv(tfqygibytr) = 6pts( (3 at 0.8 mg/kg and 3 at 1.6 mg/kg)) msafgrvmdk (knxqnlqeot ) | Positive | 05 Nov 2021 | ||
Phase 1 | 34 | Itolizumab 0.4 to 3.2 mg/kg | ndsophgbhc(gxqwwrenyo) = 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. jxcbyihlgd (guytryegzx ) View more | Positive | 27 Oct 2021 | ||
Phase 1/2 | 10 | kglsnillpg(vltxayjzmv) = 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. ndyqfhnxia (flftvtbcyc ) | - | 09 Jun 2021 | |||
Phase 2 | 32 | Best supportive care (BSC)+Itolizumab IV infusion (Arm A - Itolizumab + BSC) | rjrcuadjqb(yveyeasokg) = mugygvthdu dycchjvayn (lkdyubwwpa, gdmmtfrlzk - slxyyolzwa) View more | - | 20 May 2021 | ||
Best supportive care (BSC) (Arm B - Best Supportive Care (BSC)) | rjrcuadjqb(yveyeasokg) = fsqbesuyci dycchjvayn (lkdyubwwpa, akhmmsfaht - ydwhibfoaj) View more |