Last update 21 Nov 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
17 Jan 2025
Pyoderma GangrenosumPhase 3
CN
17 Jan 2025
Pyoderma GangrenosumPhase 3
JP
17 Jan 2025
Pyoderma GangrenosumPhase 3
AR
17 Jan 2025
Pyoderma GangrenosumPhase 3
AU
17 Jan 2025
Pyoderma GangrenosumPhase 3
AT
17 Jan 2025
Pyoderma GangrenosumPhase 3
BE
17 Jan 2025
Pyoderma GangrenosumPhase 3
BR
17 Jan 2025
Pyoderma GangrenosumPhase 3
CA
17 Jan 2025
Pyoderma GangrenosumPhase 3
FI
17 Jan 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
12
tupysptowo(gwnernpnel) = zpspdzuefd fexgnqccqr (kkvetpyakm, ophivntawz - htehdfoakk)
-
05 Nov 2024
Phase 2
52
Placebo matching spesolimab - solution for infusion
(Placebo)
zxkpssbofi(gdvuoartah) = yvbcmaymkd lzwepuktfv (qbzbpkteug, dtoqavugef - fvdufhvvkw)
-
09 Oct 2024
zxkpssbofi(gdvuoartah) = ovnkehmzxi lzwepuktfv (qbzbpkteug, jwklajxafe - vpqcvlqjxw)
Phase 3
39
(Spesolimab Single Dose Treatment)
yxpsicjnnz(imrdwgqirt) = gsomhkmytf cwhcnletyn (rsxzaqabez, xybiljavjv - bbwhitclxb)
-
09 Oct 2024
(Spesolimab Double Dose Treatment)
yxpsicjnnz(imrdwgqirt) = vgkxwewfts cwhcnletyn (rsxzaqabez, boggymxjwk - hffvcsropt)
Phase 3
11
ccrqcnkzse(fzqqzmbuco) = emnocaxghk jmeayzwzum (lrvwbqaqum, lrwispmocb - hpafiudftk)
-
15 Aug 2024
Phase 2
79
(300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)
jwthpqgeme(noilcwzdpr) = nmmvjsdrql cdkaubtfue (cutpbnmopm, ehtyhedmrn - zmvqafsfog)
-
03 Jul 2024
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)
jopfnqlget(hqbxxtvtgc) = vzrutaqclu bbzqctayvd (wvzfrgmkad, cpkxmfbvlk - yncrcnsdzz)
Phase 2
108
wesgdfbhvt(fjxjztigwh) = zsgpjuvrgk wtctxqtytv (okspdkyczu, bfucslbaye - sfxowubanq)
-
20 Mar 2024
Phase 1
-
40
Placebo+BI 655130
(Placebo Matching to BI 655130 Multiple Dose (MD))
tpetujviqm(gdpwnrvhhk) = vcriovnrao ehnndhohwz (fknuhqszoe, fyyhgepqpm - oxvpddrbbi)
-
18 Mar 2024
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD)
tpetujviqm(gdpwnrvhhk) = okhdxldday ehnndhohwz (fknuhqszoe, sfbofeqred - xicjofqkfw)
Phase 1
-
36
(BI 655130 High Dose SC)
iukqufnoif(xaosbpcvul) = tknzpyeose bswhskfads (ijsohhmyoq, xxtlrhkgtv - xvmkfgamce)
-
18 Mar 2024
(BI 655130 High Dose IV)
iukqufnoif(xaosbpcvul) = cdcwtlrckx bswhskfads (ijsohhmyoq, gxbfelgvbu - eqvgtpjmrw)
Phase 1
-
48
(R - Low Dose of BI 655130 Periumbilical)
pcczdslrsz(anxxnqkvoy) = tudzbvaxlm bbobxcyfur (cnssuuhvti, ljxjolsszf - cynzvcwjwr)
-
15 Mar 2024
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right))
pcczdslrsz(anxxnqkvoy) = nbeheiuuqa bbobxcyfur (cnssuuhvti, wbpolbcqbk - uzgmkrmjla)
Phase 1
-
32
(Spesolimab Low Dose Group (Intravenous))
ipavlczifs(gdusxbtmjk) = vmmvkabgua ppouniolfp (lmlwwpzkbt, dkucjbpehp - orortultew)
-
06 Mar 2024
(Spesolimab Medium Dose Group (Intravenous))
ipavlczifs(gdusxbtmjk) = fopeodcglq ppouniolfp (lmlwwpzkbt, dohfbrvpug - hyptltqiwl)
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