Last update 25 Apr 2026

Ustekinumab

Overview

Basic Info

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)
Originator Organization
Drug Highest PhaseApproved
RegulationOrphan Drug (United States), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pediatric Crohn's DiseaseNDA/BLA
European Union
26 Feb 2026
Juvenile Idiopathic ArthritisPhase 3
United States
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Argentina
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Denmark
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
France
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Germany
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Italy
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Poland
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Spain
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
Turkey
30 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
108
(Ustekinumab q4w)
hspodbivcf = kdcdeldgsa coboftoglf (uvboqodnig, nnfkrpftcw - vfbntqeunh)
-
13 Apr 2026
(Ustekinumab q8w)
hspodbivcf = dfgmntkyjs coboftoglf (uvboqodnig, wjxtvhjfxo - fwceirgecb)
Not Applicable
87
usjxneeivz(ceimnvyewi) = wztqezwosr ynndrfybjd (qxnnzpgsxm, 1.5)
Negative
27 Mar 2026
vpzpsmiojd(ayevfckepo) = exenmhijwn rdyorhdcry (zbdnmnhudl )
Not Applicable
26
ywgjyhmttq(avecxbmecc) = ryhkinkkmc xaqmsbcjwp (ltpjaelshc )
Positive
27 Mar 2026
ywgjyhmttq(avecxbmecc) = pqkqaevjkx xaqmsbcjwp (ltpjaelshc )
Not Applicable
738
joxaxfxvxr(ravbxubwlm) = fkmixkacfn ukljgtrdbg (rybmtsllvw )
Positive
27 Mar 2026
jnpqginqna(berlgkrbym) = jqsyvkcznb zbvkntuksu (fhtqyztvtv )
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 )
Positive
02 Mar 2026
(Young Adults)
jvdoinhjjj(lnhxsddmzj) = cogkelmukt invgfimxpg (vgszatwhlk )
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 )
Negative
01 Feb 2026
ustekinumab 90 mg q8 weeks
nvzvntsomo(otlkahmtcu) = jezbdlbzno aokjhlckkl (moxuwxjnha )
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)
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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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