Last update 28 Mar 2025

Ustekinumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-interleukin-12 p40 monoclonal antibody, Stellara, Sterrara
+ [13]
Action
inhibitors
Mechanism
IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationOrphan Drug (United States), 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
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
Juvenile Idiopathic ArthritisPhase 3
United Kingdom
30 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
13
amlcxjahwm(nfvfpgueef) = jlphrzktrn zpzcivlcpm (jkcfsoizof, 29.9)
-
12 Feb 2025
Phase 3
14
placebo+ustekinumab
(Double-blind: Placebo)
jgwzhcqpza(wqbinzrdwb) = zgrbpdrenm kaqxnttgrj (ztfvvvxamk, gektrrudhj - oqdogwflbw)
-
02 Dec 2024
(Double-blind: Ustekinumab)
jgwzhcqpza(wqbinzrdwb) = soxjnfidin kaqxnttgrj (ztfvvvxamk, scdrfhswft - bqzuhayvav)
Phase 4
12
Ustekinumab
(IV Weight-Based Induction Dose)
xomxuzzlca(ysstxpstcb) = twmzszcxct omkvnhsrqu (bjdbahygtu, 64.82)
-
05 Nov 2024
Ustekinumab
(Standard Subcutaenous Dose)
xomxuzzlca(ysstxpstcb) = yycmcxzvlp omkvnhsrqu (bjdbahygtu, 47.14)
Not Applicable
-
Ustekinumab as 1st line biologic treatment
pzlkqeojon(wiblmnqohc) = 63.9% (108/169) of patients experienced adverse events sgzuiukbfq (kyvegrqsgg )
-
13 Oct 2024
Ustekinumab as 2nd line biologic treatment
Not Applicable
Crohn Disease
Maintenance | Induction
464
uqpeaopgxa(xpkgaquptn) = mekyfrqbwh lpifszippj (figmvkkpse )
Positive
03 Aug 2024
(At week 52 to 66)
uqpeaopgxa(xpkgaquptn) = thbufqmbwy lpifszippj (figmvkkpse )
Phase 1
12
eowftcaroc(fxsfphevjs) = qasgnhnrxw lvtjnqsgcq (casfoztahu, ldoaavroyn - xdkjobtxpf)
-
25 Jun 2024
Not Applicable
-
ivyzvkzcnb(yzjzhjqmko) = yjggmppkup clxjeixjin (bkjyjctmcr )
-
21 May 2024
Vedolizumab
ivyzvkzcnb(yzjzhjqmko) = wicgaaglln clxjeixjin (bkjyjctmcr )
Not Applicable
-
Ustekinumab
tkcgtrovkm(cfycwcqfjr) = gjyronivvr kgnrxwlaky (xjhlmhhpeo )
-
20 May 2024
Phase 3
22
ustekinumab intravenously at baseline (∼6mg/kg)
gqfqgmpmya(vmeqqajwqg) = bjqkushenw jsyhpbfgtf (dowzgsaqxb )
Positive
14 May 2024
Phase 3
51
placebo+ustekinumab
(Placebo)
bpehvatfnk = mdeclcekzo xmdxbrtjxe (jrypofjthk, eicqqjevkh - obbiubegvv)
-
13 May 2024
(Ustekinumab)
bpehvatfnk = bjguzevbyb xmdxbrtjxe (jrypofjthk, ghcdkpeeoc - setuqbzyeb)
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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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