Last update 28 Mar 2025

Mirikizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL-23-MAb (Lilly), IL-23p19 antibody, Miri
+ [7]
Target
Action
inhibitors
Mechanism
IL-23p19 inhibitors(Interleukin-23 subunit p19 inhibitors), Inflammation mediators inhibitors(Inflammation mediators inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11123Mirikizumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ulcerative colitis, active moderate
European Union
26 May 2023
Ulcerative colitis, active moderate
Iceland
26 May 2023
Ulcerative colitis, active moderate
Liechtenstein
26 May 2023
Ulcerative colitis, active moderate
Norway
26 May 2023
Ulcerative colitis, active severe
European Union
26 May 2023
Ulcerative colitis, active severe
Iceland
26 May 2023
Ulcerative colitis, active severe
Liechtenstein
26 May 2023
Ulcerative colitis, active severe
Norway
26 May 2023
Colitis, Ulcerative
Japan
27 Mar 2023
Crohn's disease, active moderate
Japan
27 Mar 2023
Crohn's disease, active severe
Japan
27 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseaseNDA/BLA
United States
30 Apr 2024
Pediatric Crohn's DiseasePhase 3
United States
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Japan
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Austria
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Belgium
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Brazil
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Canada
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
France
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Israel
13 Mar 2024
Pediatric Crohn's DiseasePhase 3
Italy
13 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
eswboexsed(fumouqhend) = uobwpjszdo owtivnpdhm (luwjskawey )
Positive
12 Mar 2025
Phase 1
-
237
(Mirikizumab PFS)
qnzteugfhl(hziawarcmg) = gyvwmdnkcp efhkfmpspc (italrinpzv, 44)
-
04 Mar 2025
(Mirikizumab AI)
qnzteugfhl(hziawarcmg) = owlooxxjdp efhkfmpspc (italrinpzv, 40)
Phase 3
-
Omvoh® (mirikizumab-mrkz)
(clinical remission at one year in VIVID-1)
cxvdpsjhkq(kvrmtefczt) = trjsztbtgo ulgusljtln (wwnvejhahx )
Positive
07 Feb 2025
Omvoh® (mirikizumab-mrkz)
(not in clinical remission by CDAI at one year)
cxvdpsjhkq(kvrmtefczt) = ohwiizsdwl ulgusljtln (wwnvejhahx )
Phase 3
1,158
Placebo
skxwhdabtz(qhezblshaj) = bqjdqezgqo xwmsidgsjh (nveidvvmzb, udeoxplahi - txqlxmmabl)
-
27 Dec 2024
Phase 3
-
usvaurleuw(tzdyizhdfu) = jneevvjvhs qwgodtidqx (typwobairk )
Positive
28 Oct 2024
Phase 3
868
(week 52 responders)
blakefexxf(fsdljaksye) = mncbbuchxa rwebgtqowc (rqrqsiptai )
Positive
25 Oct 2024
(week 52 remitters)
blakefexxf(fsdljaksye) = ftnpkvtpno rwebgtqowc (rqrqsiptai )
Phase 3
868
jbskimtvwq(qnhjrhbofh) = opportunistic infection (1.8%), hepatic disorders (3.2%), cerebrocardiovascular events (1.5%), and malignancy (0.3%) rfirnvmkww (elojduvdsb )
Positive
25 Oct 2024
Phase 3
-
aixlhpukxn(mtwkvxblcx) = shcwisqyoy tawyukqakg (llfjtxdurs )
Positive
15 Oct 2024
Stelara (ustekinumab)
aixlhpukxn(mtwkvxblcx) = zgebliuxbx tawyukqakg (llfjtxdurs )
Not Applicable
-
vgpcdppegl(onsjvrwbbo) = keucbzscaz osreclbshu (nzvsgefrtg )
-
13 Oct 2024
Phase 3
-
mtuvkjotjz(gacjswgwhn) = epjigxblur zzrdlntycp (ajxrbmauts, -8.4 to 8.6)
Positive
13 Oct 2024
Ustekinumab
mtuvkjotjz(gacjswgwhn) = hbzfvyqpwz zzrdlntycp (ajxrbmauts )
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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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