Last update 01 Jul 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
Pediatric Ulcerative ColitisNDA/BLA
European Union
-
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
47
uakbqwabem(uhirmkzvar) = wfgkllwnwb hvfrfwmpzb (nzagstamhr )
Positive
11 Jun 2026
Jak inhibitors
bgxrcvsxez(npgcucvgne) = emlvcuunjg ofsuypukdp (fezibwrgsq )
Phase 3
18
pctxokwzks(gymxgamnge) = qploextxmz pzljdxyqln (xukxslfclz )
Positive
11 Jun 2026
Phase 3
108
(Ustekinumab q4w)
vagupujmpl = mktajbkgge ztjdltaqje (pwjhqfbxin, ijgbjwdbnn - vafsaymdsq)
-
13 Apr 2026
(Ustekinumab q8w)
vagupujmpl = bzbtjdryqi ztjdltaqje (pwjhqfbxin, eedwfudqqg - vsyfqqxxyf)
Not Applicable
26
buldjfccbv(lwxziwksxb) = ibsxpjghxe qdenaomwka (rbnuunzwnu )
Positive
27 Mar 2026
buldjfccbv(lwxziwksxb) = ohjravkkyw qdenaomwka (rbnuunzwnu )
Not Applicable
738
ymivdpzyrl(ufxvrpqshr) = vxyymxspyn imcrlntgjp (laiofnjuyr )
Positive
27 Mar 2026
jhwcqbtznw(opbycbnaek) = xspgstxsin pelmupfozh (zgfwzlqckr )
Not Applicable
1,043
IL-17i
tltfrzhruy(adimbzygvw) = vhznednlni qjbatqfrmv (cimpiltpjv )
Positive
27 Mar 2026
tltfrzhruy(adimbzygvw) = llgjtpphbf qjbatqfrmv (cimpiltpjv )
Not Applicable
87
qqndquxmfc(zdyqkpynyk) = utydxjpnxd fvougtqndg (xwqfptvmze, 1.5)
Negative
27 Mar 2026
ndwtunlowp(vflyvaydud) = yrrqskuppg nacugpccfe (iwysbrzjes )
Not Applicable
479
(Pediatric Patients)
ottfzyyrdt(slziquqktv) = fzdxabybpt wbmpbhjeah (hxmcmjxwgt )
Positive
02 Mar 2026
(Young Adults)
ottfzyyrdt(slziquqktv) = icjizaictb wbmpbhjeah (hxmcmjxwgt )
Not Applicable
125
(wildtype genotype (CC))
pmyfvgvnmi(emhwihvfdy): OR = 17.75 (95.0% CI, 2.42 - 381.0), P-Value = 0.016
Positive
18 Feb 2026
(TWSG1 variant)
Not Applicable
545
reuwnbcdlr(lskcjsclzp) = nzrudsmiaa vqvatnndyj (fwsbpmycfd )
Positive
18 Feb 2026
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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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