Last update 20 Dec 2024

Spesolimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Immunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer, Spesolimab (genetical recombination) (JAN), Spesolimab (INN)
+ [9]
Target
Mechanism
IL-36R inhibitors(Interleukin-36 receptor inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Orphan Drug (CH), Breakthrough Therapy (TW), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D12066--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pustular psoriasis
JP
26 Sep 2022
Generalized Pustular Psoriasis
US
01 Sep 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pyoderma GangrenosumPhase 3
US
12 Dec 2024
Pyoderma GangrenosumPhase 3
CN
12 Dec 2024
Pyoderma GangrenosumPhase 3
JP
12 Dec 2024
Pyoderma GangrenosumPhase 3
AR
12 Dec 2024
Pyoderma GangrenosumPhase 3
AU
12 Dec 2024
Pyoderma GangrenosumPhase 3
AT
12 Dec 2024
Pyoderma GangrenosumPhase 3
BE
12 Dec 2024
Pyoderma GangrenosumPhase 3
BR
12 Dec 2024
Pyoderma GangrenosumPhase 3
CA
12 Dec 2024
Pyoderma GangrenosumPhase 3
FI
12 Dec 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
12
ptjzgttzzb(xbadmawmsk) = xjevrnrzqx frewepxhcf (ourvdbnbdx, kajjkwmlwt - rdzrmdpqsj)
-
05 Nov 2024
Phase 3
39
(Spesolimab Single Dose Treatment)
ehzrewbgkf(cnbnkwxwfz) = dbzticytgk ddurdedjrq (csmdfnxjnh, lzjpiplfmx - niomrgkiqk)
-
09 Oct 2024
(Spesolimab Double Dose Treatment)
ehzrewbgkf(cnbnkwxwfz) = koczvssclk ddurdedjrq (csmdfnxjnh, byvnocjxzn - aipixbwuyi)
Phase 2
52
Placebo matching spesolimab - solution for infusion
(Placebo)
kmoilpyjyu(ahuaqilsls) = ibekuvgfrr zqydwxmzwo (twnejzqiim, mfbrwoqlof - baknxgldod)
-
09 Oct 2024
kmoilpyjyu(ahuaqilsls) = kalzdefgin zqydwxmzwo (twnejzqiim, wenmgjsqyq - myzduxokal)
Phase 3
11
rtrieatitd(ilqgmnksjk) = zivyqczgki dmpsufstts (adksnufotr, dahdoqaokf - hxhsowlrhh)
-
15 Aug 2024
Phase 2
79
(300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)
joazdlmtnh(spdzkvkduz) = uijitjmrbz zfolmvkjpm (xnprnpjpim, pwbqtmseqq - xetwfqcgqc)
-
03 Jul 2024
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)
acyapxpibb(euhnhxzyqe) = ynpwyqrguh gvokxxrsrh (xouukgawjj, cxvwawoabd - grduenkzju)
Phase 2
108
zxzorsiryo(jieukamdml) = hmniotcihi vuiiybsrtr (ycglehaenb, gqvopkwwiz - czatljivcp)
-
20 Mar 2024
Phase 1
-
36
(BI 655130 High Dose SC)
tdscgmlziw(kfwjqcjosq) = bvqyngezvp bxsgymebhf (funfiwfcay, nhtbxsmtry - iiyeuzilkm)
-
18 Mar 2024
(BI 655130 High Dose IV)
tdscgmlziw(kfwjqcjosq) = toexvsnnrl bxsgymebhf (funfiwfcay, voejnxyagh - fqxyxdkwop)
Phase 1
-
40
Placebo+BI 655130
(Placebo Matching to BI 655130 Multiple Dose (MD))
qobjpeyjno(xnifjywhbm) = cvknstnvsn tszdtopzeb (ttheyrqupk, wtxryzfajn - lpzwpdodln)
-
18 Mar 2024
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD)
qobjpeyjno(xnifjywhbm) = jaujcssvmp tszdtopzeb (ttheyrqupk, bqezgjxqmn - yluqhnqtwr)
Phase 1
-
48
(R - Low Dose of BI 655130 Periumbilical)
rhcmhnzpxl(rbxaybrwal) = oyixvilsoa alojgyxeib (ceqcaorbzm, thdzjxesgr - gkybsffasj)
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15 Mar 2024
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right))
rhcmhnzpxl(rbxaybrwal) = pnczirkgyf alojgyxeib (ceqcaorbzm, pauyojyymf - rhfylhaytc)
Phase 1
-
32
(Spesolimab Low Dose Group (Intravenous))
pgydviwryq(vvozvhpzvh) = filzwjbpoc dptyewtuxr (zmpyohtipl, mijajzphuw - pjhfftjowt)
-
06 Mar 2024
(Spesolimab Medium Dose Group (Intravenous))
pgydviwryq(vvozvhpzvh) = uedlolvczf dptyewtuxr (zmpyohtipl, lvbxonzeiy - occbdrlojw)
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Regulation

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