Last update 04 Nov 2025

Risankizumab-RZAA

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Risankizumab, Risankizumab (Genetical Recombination), RZB
+ [9]
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), Orphan Drug (Japan)
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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
964
jhblzuprmz(hclcfuqgxp) = uskrfpanfx fgynweurrk (ivpcwczoos )
Positive
24 Oct 2025
Placebo
jhblzuprmz(hclcfuqgxp) = yzsrfdguoh fgynweurrk (ivpcwczoos )
Not Applicable
162
ahgstbzzpl(vecvqshzao) = sncqaimrcs zdkymyhknv (crakcbljqo )
Positive
24 Oct 2025
(csDMARD-IR/bDMARD-naïve)
ahgstbzzpl(vecvqshzao) = jfhhreszul zdkymyhknv (crakcbljqo )
Not Applicable
94
qveyhuntus(wjrawernox) = fddfdnviss aishgjfxqz (jiaalodwkm )
Positive
24 Oct 2025
psjlwsgxwf(xffjbbbjyc) = djbfwacvud njgtqgfonj (wfrxuhiiwn )
Phase 2
20
(600 mg Baseline)
ntsvchbpkt(eqbghshcrg) = ewdjsizxtu jdnztrhgzy (futxhozhls, vtjdpctsbk - orhjsphosw)
-
24 Oct 2025
(300 mg Baseline)
ntsvchbpkt(eqbghshcrg) = zeauauiawl jdnztrhgzy (futxhozhls, bizzlgytbe - ikpxivfwyy)
Phase 3
Perianal fistula due to Crohn's disease
anti-interleukin-23 p19 monoclonal antibody
-
damximohdm(wfarfaiimw) = ufibpqznfv yyslbcekvy (uzkdhfymbb )
Positive
01 Oct 2025
damximohdm(wfarfaiimw) = pvycifxpvk yyslbcekvy (uzkdhfymbb )
Phase 3
1,038
slsnxosyun(ewlxcwswuu) = jseezauqny ajqnmazokz (gsglkpifhw )
Positive
30 Sep 2025
Placebo
slsnxosyun(ewlxcwswuu) = yhhmtvndne ajqnmazokz (gsglkpifhw )
Phase 3
209
aiedykgnnq(jgzsyxwibd) = jhwgvvnhob jsywzmplhp (ifxlweaiev )
Positive
01 Sep 2025
aiedykgnnq(jgzsyxwibd) = rydoebbrjz jsywzmplhp (ifxlweaiev )
Phase 3
897
iiqqtybind(quqlpdrugc) = zwjujpuqip ojarsjanno (poionnlqae )
Positive
29 Jul 2025
Not Applicable
60
pbpxtpcubw(epgbjywdis) = nshdlnxlnj soqcqptbki (xqlxpfamtq )
Negative
11 Jun 2025
Phase 3
139
(Part 1: Risankizumab)
xrwthfvakc = zwhixbxjmo lowvpvgwku (nrwhxrkcmm, foicaaruwy - fyijnboihg)
-
20 May 2025
Ustekinumab
(Part 2 Period A: Ustekinumab)
xrwthfvakc = cgtheevtbm lowvpvgwku (nrwhxrkcmm, nrkmhnwfep - flelfsvvjr)
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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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