Drug Type Monoclonal antibody |
Synonyms Anti-interleukin-12 p40 monoclonal antibody, Stellara, Sterrara + [13] |
Target |
Action inhibitors |
Mechanism IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (15 Jan 2009), |
RegulationOrphan Drug (United States), Overseas New Drugs Urgently Needed in Clinical Settings (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09214 | Ustekinumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Colitis, Ulcerative | Australia | 28 Jul 2009 | |
Crohn Disease | Australia | 28 Jul 2009 | |
Arthritis, Psoriatic | European Union | 15 Jan 2009 | |
Arthritis, Psoriatic | Iceland | 15 Jan 2009 | |
Arthritis, Psoriatic | Liechtenstein | 15 Jan 2009 | |
Arthritis, Psoriatic | Norway | 15 Jan 2009 | |
Crohn's disease, active moderate | European Union | 15 Jan 2009 | |
Crohn's disease, active moderate | Iceland | 15 Jan 2009 | |
Crohn's disease, active moderate | Liechtenstein | 15 Jan 2009 | |
Crohn's disease, active moderate | Norway | 15 Jan 2009 | |
Crohn's disease, active severe | European Union | 15 Jan 2009 | |
Crohn's disease, active severe | Iceland | 15 Jan 2009 | |
Crohn's disease, active severe | Liechtenstein | 15 Jan 2009 | |
Crohn's disease, active severe | Norway | 15 Jan 2009 | |
Plaque psoriasis | European Union | 15 Jan 2009 | |
Plaque psoriasis | Iceland | 15 Jan 2009 | |
Plaque psoriasis | Liechtenstein | 15 Jan 2009 | |
Plaque psoriasis | Norway | 15 Jan 2009 | |
Ulcerative colitis, active moderate | European Union | 15 Jan 2009 | |
Ulcerative colitis, active moderate | Iceland | 15 Jan 2009 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Juvenile Idiopathic Arthritis | Phase 3 | United States | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Argentina | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Denmark | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | France | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Germany | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Italy | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Poland | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Spain | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | Turkey | 30 Aug 2022 | |
Juvenile Idiopathic Arthritis | Phase 3 | United Kingdom | 30 Aug 2022 |
Phase 3 | 14 | yeuyfixmep(xceqgxcbci) = ypwvblircz mfgycqspru (xqqollxwdg, 4.14 - NE) | Negative | 14 Mar 2025 | |||
Placebo | yeuyfixmep(xceqgxcbci) = fhhkvvidkf mfgycqspru (xqqollxwdg, 12.14 - NE) | ||||||
Early Phase 1 | 13 | thccezmxmz(nsoziazsrg) = gvexxochru jkbyhmhsfr (nmzcqccrts, 29.9) View more | - | 12 Feb 2025 | |||
Phase 3 | 14 | placebo+ustekinumab (Double-blind: Placebo) | yqfvpuavhv(lizuhtbuak) = myhjfzfsgr lalkqllkyx (grroxgcptu, bphmlqjswe - vwxhriowqw) View more | - | 02 Dec 2024 | ||
(Double-blind: Ustekinumab) | yqfvpuavhv(lizuhtbuak) = nlrqoxyspo lalkqllkyx (grroxgcptu, cadjezqypi - argxsmwnkt) View more | ||||||
Phase 4 | 12 | (IV Weight-Based Induction Dose) | sfpylwfsbm(gklcjwwbmk) = bgirbmufmj yvdqhqxbdq (wkdediekmp, 64.82) View more | - | 05 Nov 2024 | ||
(Standard Subcutaenous Dose) | sfpylwfsbm(gklcjwwbmk) = flzmngoxlr yvdqhqxbdq (wkdediekmp, 47.14) View more | ||||||
Not Applicable | - | - | Cohort 1 | qvkaufwrom(peesetrplo) = kewpgisalj cjhoyjzzqg (sylwqxvhux ) View more | - | 13 Oct 2024 | |
Cohort 2 | qvkaufwrom(peesetrplo) = yvrnehmeph cjhoyjzzqg (sylwqxvhux ) | ||||||
Not Applicable | - | nzuxrgzbnr(koqexrkopy) = 2 patients (both with CD) experienced recurrent respiratory infections as an adverse effect, without the need to discontinue UST xjtvcjvlet (qrjtrrllru ) | - | 13 Oct 2024 | |||
Not Applicable | - | dolxlvlnvf(tjesnxvwzw) = A total of 176 patients (28%) had at least one adverse event, with infections being the most frequent (11%). No negative impact on extraintestinal manifestations and/or immunomediated diseases was seen. yusxkmbnzt (cuoqxzbkbe ) | - | 13 Oct 2024 | |||
Not Applicable | - | lmzxjgsiof(bqeinzrpyn) = 62 adverse drug reactions were recorded in 36 patients tcikipgtpb (kflqzdvkip ) View more | - | 13 Oct 2024 | |||
Not Applicable | - | 17 | niljrxpqud(kjmgupwdwa) = knhwamsndv fstoqzturw (uvqthjccqg ) | Positive | 13 Oct 2024 | ||
Not Applicable | - | dbvdombpjg(kczxollbxv) = Adverse events were reported in 14.1% (18/198), with colectomies exclusively observed in bio-exposed individuals (8.6%; 17/198) hxvsgbjotf (trnrlqilve ) | - | 13 Oct 2024 | |||
(Bio-naive patients) |