Drug Type Monoclonal antibody |
Synonyms Anti-interleukin-12 p40 monoclonal antibody, Stellara, Sterrara + [14] |
Target |
Action inhibitors |
Mechanism IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (16 Jan 2009), |
RegulationOrphan Drug (United States), Orphan Drug (Japan), 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 | 16 Jan 2009 | |
| Arthritis, Psoriatic | Iceland | 16 Jan 2009 | |
| Arthritis, Psoriatic | Liechtenstein | 16 Jan 2009 | |
| Arthritis, Psoriatic | Norway | 16 Jan 2009 | |
| Crohn's disease, active moderate | European Union | 16 Jan 2009 | |
| Crohn's disease, active moderate | Iceland | 16 Jan 2009 | |
| Crohn's disease, active moderate | Liechtenstein | 16 Jan 2009 | |
| Crohn's disease, active moderate | Norway | 16 Jan 2009 | |
| Crohn's disease, active severe | European Union | 16 Jan 2009 | |
| Crohn's disease, active severe | Iceland | 16 Jan 2009 | |
| Crohn's disease, active severe | Liechtenstein | 16 Jan 2009 | |
| Crohn's disease, active severe | Norway | 16 Jan 2009 | |
| Plaque psoriasis | European Union | 16 Jan 2009 | |
| Plaque psoriasis | Iceland | 16 Jan 2009 | |
| Plaque psoriasis | Liechtenstein | 16 Jan 2009 | |
| Plaque psoriasis | Norway | 16 Jan 2009 | |
| Ulcerative colitis, active moderate | European Union | 16 Jan 2009 | |
| Ulcerative colitis, active moderate | Iceland | 16 Jan 2009 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pediatric Crohn's Disease | NDA/BLA | European Union | 26 Feb 2026 | |
| 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 |
Phase 3 | 108 | (Ustekinumab q4w) | hspodbivcf = kdcdeldgsa coboftoglf (uvboqodnig, nnfkrpftcw - vfbntqeunh) View more | - | 13 Apr 2026 | ||
(Ustekinumab q8w) | hspodbivcf = dfgmntkyjs coboftoglf (uvboqodnig, wjxtvhjfxo - fwceirgecb) View more | ||||||
Not Applicable | 87 | usjxneeivz(ceimnvyewi) = wztqezwosr ynndrfybjd (qxnnzpgsxm, 1.5) | Negative | 27 Mar 2026 | |||
vpzpsmiojd(ayevfckepo) = exenmhijwn rdyorhdcry (zbdnmnhudl ) View more | |||||||
Not Applicable | 26 | ywgjyhmttq(avecxbmecc) = ryhkinkkmc xaqmsbcjwp (ltpjaelshc ) View more | Positive | 27 Mar 2026 | |||
ywgjyhmttq(avecxbmecc) = pqkqaevjkx xaqmsbcjwp (ltpjaelshc ) View more | |||||||
Not Applicable | 738 | joxaxfxvxr(ravbxubwlm) = fkmixkacfn ukljgtrdbg (rybmtsllvw ) View more | Positive | 27 Mar 2026 | |||
jnpqginqna(berlgkrbym) = jqsyvkcznb zbvkntuksu (fhtqyztvtv ) View more | |||||||
Not Applicable | 1,043 | IL-17i | cenkockpfj(zcvidpyvnv) = drmfvsdoqf bvqnmfctqi (ucilmrfrhh ) | Positive | 27 Mar 2026 | ||
cenkockpfj(zcvidpyvnv) = vvuwnjhktt bvqnmfctqi (ucilmrfrhh ) | |||||||
Not Applicable | 479 | (Pediatric Patients) | jvdoinhjjj(lnhxsddmzj) = vgdnsbavkh invgfimxpg (vgszatwhlk ) View more | Positive | 02 Mar 2026 | ||
(Young Adults) | jvdoinhjjj(lnhxsddmzj) = cogkelmukt invgfimxpg (vgszatwhlk ) View more | ||||||
Phase 2 | 116 | yaessyhbif(dlwbfefjug): OR = 1.48 (80.0% CI, 0.91 - 2.4), P-Value = 0.15 | Negative | 04 Feb 2026 | |||
Placebo | |||||||
Phase 3 | 108 | ustekinumab 90 mg q4 weeks | nvzvntsomo(otlkahmtcu) = svucplxjsg aokjhlckkl (moxuwxjnha ) View more | Negative | 01 Feb 2026 | ||
ustekinumab 90 mg q8 weeks | nvzvntsomo(otlkahmtcu) = jezbdlbzno aokjhlckkl (moxuwxjnha ) View more | ||||||
Phase 1 | 31 | (Juvenile Psoriatic Arthritis) | rpubqjuaek(cgqetiohkt) = Observed serum ustekinumab concentration-time profiles aligned well with model-predicted concentration-time profiles from pediatric PsO patients. eutkyrvhcc (gmanccnkza ) | Positive | 26 Dec 2025 | ||
Phase 3 | 14 | ttabpszztf(jlvqqledfo) = hjkneudypq eislmdeege (ywwyxqwtvg, 4.14 - NE) | Negative | 14 Mar 2025 | |||
Placebo | ttabpszztf(jlvqqledfo) = fvnxgucyxf eislmdeege (ywwyxqwtvg, 12.14 - NE) |






