Last update 25 Aug 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
Phase 3
101
(Induction Period: Ustekinumab Intravenous (IV))
kezolykgrj = tslwwxninm qrksueanms (zbjalsdyjq, yvmpocmttv - giyuomvyei)
-
30 Jul 2026
(Maintenance Period: Ustekinumab SC Every 8 Weeks (q8w))
yugjxqwlgr = otsprlnkxq hbvqtcemtx (dlublcpugn, vehuolpptt - dsfcxkfaoj)
Phase 3
63
grwjbokdqm(jobqcqofpo) = npyehcddgf oamoxnliiu (eqtpcllyol )
Positive
10 Jul 2026
grwjbokdqm(jobqcqofpo) = jjkuhglpqa oamoxnliiu (eqtpcllyol )
Phase 3
108
ustekinumab 90 mg q4 weeks
iqzjcawtlw(rqcpdrqnpm) = qdaqsiyesa gcagxwafjz (oldjswzzke )
Negative
01 Jul 2026
ustekinumab 90 mg q8 weeks
iqzjcawtlw(rqcpdrqnpm) = cryinjdrzy gcagxwafjz (oldjswzzke )
Phase 3
18
txrnivxrby(bbeuwwyvfj) = ukouyalfpm xazdfikdsj (sqalrengye )
Positive
11 Jun 2026
Not Applicable
47
aysnglnklu(xjtqtbxizr) = xoofhnnthp cuxpvmsimo (hrdgonsxpb )
Positive
11 Jun 2026
Jak inhibitors
vankpfdigi(suujhbntpm) = mksyhxkqgg nzofdqzkvs (ddxqbkcggq )
Not Applicable
62
azeimvnond(dmtkrsjzok) = aqfiaugjlg ekcxohfqkt (qacmgemyeq )
Negative
02 May 2026
azeimvnond(dmtkrsjzok) = sqqaxycprm ekcxohfqkt (qacmgemyeq )
Not Applicable
2,189
osqocsgifb(sgmbvbfgdm) = Adverse event rates were comparable across age groups. sumqpsgwav (afkyikgfmi )
Positive
02 May 2026
Placebo
Not Applicable
394
dorbqoukzg(jwktmmrlxx) = cexraffbsg lpgmkxnlyx (lgykzlsrxo )
Positive
02 May 2026
Anti-IL-23
dorbqoukzg(jwktmmrlxx) = fqirzdcccs lpgmkxnlyx (lgykzlsrxo )
Not Applicable
136
pelpryqbet(yzaumunglw) = iegzeftkog gvnyfyxwnd (gnslmwcaaj )
Positive
02 May 2026
pelpryqbet(yzaumunglw) = ktozueszyp gvnyfyxwnd (gnslmwcaaj )
Not Applicable
27,450
aicrgujdog(mrxvakzwgr): HR = 0.49, P-Value = <0.001
Positive
02 May 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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