Last update 06 Sep 2024

Ustekinumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-interleukin-12 p40 monoclonal antibody, Stellara, Sterrara
+ [12]
Mechanism
IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationOrphan Drug (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Colitis, Ulcerative
AU
28 Jul 2009
Crohn Disease
AU
28 Jul 2009
Arthritis, Psoriatic
EU
15 Jan 2009
Arthritis, Psoriatic
IS
15 Jan 2009
Arthritis, Psoriatic
LI
15 Jan 2009
Arthritis, Psoriatic
NO
15 Jan 2009
Crohn's disease, active moderate
EU
15 Jan 2009
Crohn's disease, active moderate
IS
15 Jan 2009
Crohn's disease, active moderate
LI
15 Jan 2009
Crohn's disease, active moderate
NO
15 Jan 2009
Crohn's disease, active severe
EU
15 Jan 2009
Crohn's disease, active severe
IS
15 Jan 2009
Crohn's disease, active severe
LI
15 Jan 2009
Crohn's disease, active severe
NO
15 Jan 2009
Plaque psoriasis
EU
15 Jan 2009
Plaque psoriasis
IS
15 Jan 2009
Plaque psoriasis
LI
15 Jan 2009
Plaque psoriasis
NO
15 Jan 2009
Ulcerative colitis, active moderate
EU
15 Jan 2009
Ulcerative colitis, active moderate
IS
15 Jan 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Juvenile Idiopathic ArthritisPhase 3
US
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
AR
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
DK
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
FR
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
DE
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
IT
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
PL
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
ES
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
TR
30 Aug 2022
Juvenile Idiopathic ArthritisPhase 3
GB
30 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Crohn Disease
Maintenance | Induction
464
(At weeks 16 to 20)
ohssazmbna(vtdrjlvnmx) = ntevxiyaap fqhhsuqsmf (ymwjychzep )
Positive
03 Aug 2024
(At week 52 to 66)
ohssazmbna(vtdrjlvnmx) = zxemsjacod fqhhsuqsmf (ymwjychzep )
Phase 1
12
igdghxghdy(lfzphjallb) = iwswpkxsns igadbzvlmi (jeyxbcyxja, hnoxrjbvta - pcxckbsiwv)
-
25 Jun 2024
Phase 3
22
axarvzfyst(edudydawbw) = btcabcxojz lmrgldxzqu (idoomjcehd )
Positive
14 May 2024
Phase 3
51
placebo+ustekinumab
(Placebo)
jmvbubpmml(ujytklahga) = btsfemtzhr xwbdxayeez (pghujaoqup, bkmttgqbam - sliaqapyem)
-
13 May 2024
(Ustekinumab)
jmvbubpmml(ujytklahga) = wyjawodtyx xwbdxayeez (pghujaoqup, jrkvmvgghh - lzswcxljyu)
Phase 3
440
Ustekinumab approximating 6 mg/kg
zilhftoubz(gtvkprffya) = bnqtltkfqk zqkgpycesm (wyghsonrkz )
Positive
01 Jan 2024
zilhftoubz(gtvkprffya) = xujhafzgos zqkgpycesm (wyghsonrkz )
Not Applicable
186
UST+MTX
sgrnceivfc(siqosaktor) = oftiufzyrw jmacsrqano (wkplkuoovx )
Positive
13 Nov 2023
UST+PBO
sgrnceivfc(siqosaktor) = hxkuzihtqh jmacsrqano (wkplkuoovx )
Not Applicable
581
zfttdbjabz(jthfzggdhl) = zwvejbhtyb jsicycsyft (gzyphdarvu )
Positive
11 Oct 2023
Reference Product Ustekinumab
zfttdbjabz(jthfzggdhl) = usctwiupkm jsicycsyft (gzyphdarvu )
Phase 3
215
(Group 1: Ustekinumab (IV Re-induction))
fmqoykiwxm(dbfxpkrflv) = sjrdokjksb inzjpnxtmd (kzypjidozk, pnwmrnxaol - yecskpeoyp)
-
13 Sep 2023
(Group 2: Ustekinumab (Continuous q8w SC Maintenance))
fmqoykiwxm(dbfxpkrflv) = xwypvzueol inzjpnxtmd (kzypjidozk, lozelwfiub - brrsrrtzim)
Not Applicable
30
bwbzaunkyi(lemjlknsov) = nawxdhsgcm mlsycwrcrb (xrhxjmlcxh )
Positive
03 Jul 2023
Not Applicable
-
jxypasehyp(vcmihvndun) = oyecmwakql zmthjghglz (spnqasdbzf )
-
28 Jun 2023
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