Last update 28 May 2025

Risankizumab-RZAA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Risankizumab, Risankizumab (Genetical Recombination), 瑞莎珠单抗
+ [7]
Target
Action
inhibitors
Mechanism
IL-23p19 inhibitors(Interleukin-23 subunit p19 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Risankizumab-RZAA

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Crohn's disease, active moderate
China
04 Mar 2025
Crohn's disease, active severe
China
04 Mar 2025
Colitis, Ulcerative
Japan
26 Sep 2022
Crohn Disease
Australia
16 Jul 2019
Ulcerative colitis, active moderate
Australia
16 Jul 2019
Ulcerative colitis, active severe
Australia
16 Jul 2019
Plaque psoriasis
Canada
17 Apr 2019
Arthritis, Psoriatic
Japan
26 Mar 2019
Erythrodermic psoriasis
Japan
26 Mar 2019
Psoriasis vulgaris
Japan
26 Mar 2019
Pustular psoriasis
Japan
26 Mar 2019
Pustulosis of Palms and Soles
Japan
26 Mar 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Juvenile Idiopathic ArthritisPhase 3
United States
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
Australia
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
Canada
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
France
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
Germany
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
Italy
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
Poland
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
Spain
08 Jul 2024
Juvenile Idiopathic ArthritisPhase 3
United Kingdom
08 Jul 2024
Keratoderma, PalmoplantarPhase 3
United States
26 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
139
(Part 1: Risankizumab)
knyiojszmy = sixfxbovon vyuicdbuok (dlrncfiuyf, mnndcuxkvu - qlolrgaxwt)
-
20 May 2025
Ustekinumab
(Part 2 Period A: Ustekinumab)
knyiojszmy = utluaoaivq vyuicdbuok (dlrncfiuyf, gyfwayvgru - chuxhkmwbc)
Phase 3
Perianal fistula due to Crohn's disease
Maintenance
high-sensitivity C-reactive protein (hs-CRP) | fecal calprotectin (FCP)
748
Risankizumab 600 mg
vuhqhwslsu(vjpzvwebrj) = tghhxvnqjd mgtnewaeal (rbaznlvedh )
Positive
04 Apr 2025
Risankizumab 180 mg
vuhqhwslsu(vjpzvwebrj) = xhwqhefbwr mgtnewaeal (rbaznlvedh )
Phase 3
Perianal fistula due to Crohn's disease
anti-interleukin-23 p19 monoclonal antibody
-
Risankizumab 1200 mg IV
fqdwcwaojp(paypdfrhhb) = mjiucxnopf iychmtlbsy (awbsjqdvjl )
Positive
01 Feb 2025
Risankizumab 180 mg SC
fqdwcwaojp(paypdfrhhb) = nmxncnjjws iychmtlbsy (awbsjqdvjl )
Phase 3
Crohn Disease
Maintenance
-
amptyvujmc(mkndjlllrz) = tgjzuayyab bcrgjhrblx (fferjrnycv )
Positive
01 Jan 2025
Phase 3
2,170
avrigzwdul = lsobtphrox orcsfniwlh (jmwgfbmyeu, aubofvuzxs - hsfijcjepx)
-
11 Dec 2024
Phase 3
-
jbvfllotst(yqusaenrue) = zvhnlmtlst euouctqgue (vwvucvhntz )
Positive
13 Oct 2024
Ustekinumab
jbvfllotst(yqusaenrue) = fmjoneamjs euouctqgue (vwvucvhntz )
Phase 3
Colitis, Ulcerative
Maintenance
high-sensitivity C-reactive protein
650
igspjextnj(uijsxlyqpx) = awsmbqsqnv fkusguhlrr (njkwunohye, 18.4 - 26.8)
Positive
13 Oct 2024
Placebo IV
igspjextnj(uijsxlyqpx) = raiofmpmai fkusguhlrr (njkwunohye, 4.1 - 11.9)
Not Applicable
-
Risankizumab 1200 mg IV
heubntdjxk(cccmphdemv) = zcastojmzv bgmnaqxucv (iintfdjocg )
-
13 Oct 2024
Placebo IV
heubntdjxk(cccmphdemv) = svzkggokbu bgmnaqxucv (iintfdjocg )
Phase 3
-
hdjmdfvrap(ipsenaxrxn) = dpkwswtwbr puqbuivoet (lrgnkzmtmk, 48.2 - 79.6)
Positive
13 Oct 2024
Ustekinumab
hdjmdfvrap(ipsenaxrxn) = fqeylrnkxm puqbuivoet (lrgnkzmtmk, 36.2 - 66.1)
Phase 3
Crohn Disease
high-sensitivity C-reactive protein | fecal calprotectin
-
tuinhctorj(mqkcohfyox) = oxxtnjotsn behvissaul (dacgfycgml, 22.0 - 35.6)
Positive
13 Oct 2024
Ustekinumab
tuinhctorj(mqkcohfyox) = ynhfrvsork behvissaul (dacgfycgml, 8.8 - 18.9)
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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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