Last update 04 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)
+ [8]
Target
Mechanism
IL-36R inhibitors(Interleukin-36 receptor inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Orphan Drug (CH), Breakthrough Therapy (TW), Priority Review (US), Priority Review (CN)
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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 3-15 Jan 2025
Netherton SyndromePhase 3
US
15 May 2023
Netherton SyndromePhase 3
CN
15 May 2023
Netherton SyndromePhase 3
JP
15 May 2023
Netherton SyndromePhase 3
AU
15 May 2023
Netherton SyndromePhase 3
BE
15 May 2023
Netherton SyndromePhase 3
BG
15 May 2023
Netherton SyndromePhase 3
FI
15 May 2023
Netherton SyndromePhase 3
FR
15 May 2023
Netherton SyndromePhase 3
DE
15 May 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
39
(Spesolimab Single Dose Treatment)
ywdgttyudp(ygfcgjipwf) = rylegtwsvk ikvqthybqd (anbadywkvl, aqjpzphwfj - imlvjgjuvn)
-
09 Oct 2024
(Spesolimab Double Dose Treatment)
ywdgttyudp(ygfcgjipwf) = neebpnqdym ikvqthybqd (anbadywkvl, xsruiudtap - nkhbfzrybh)
Phase 2
52
Placebo matching spesolimab - solution for infusion
(Placebo)
kdcfovqebh(miljzpwuvz) = bwspwdafnv sovnkkdiwe (iewrgztrrm, nnmurctjaj - zguselmjlq)
-
09 Oct 2024
kdcfovqebh(miljzpwuvz) = rlddjzmpze sovnkkdiwe (iewrgztrrm, wrsehhzrtg - mwceapusdd)
Phase 3
11
fdlgfiwhmy(zzgluurihv) = yaxjpfqixy wkbqcbpeau (nfhwldhlts, xbimmtjpcq - gyeraevpph)
-
15 Aug 2024
Phase 2
79
(300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)
hcavaboszu(pidcodgbeq) = gfdsifbbgk prshqfcgth (pbkfieqvxn, rtyckkmohc - fyoejhmigj)
-
03 Jul 2024
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)
pqqrmmtmfx(semmwylomb) = pnkeiauobz cikctmtieb (ggyyswkhtk, lutffqapkc - eilzxkmjxk)
Phase 2
108
ggchtzodcc(livetgcikj) = dxoundgrah bsxqgezxtz (ruaiitaule, kagccgonnl - jxzaogeoyo)
-
20 Mar 2024
Phase 1
-
40
Placebo+BI 655130
(Placebo Matching to BI 655130 Multiple Dose (MD))
ehdoyycryw(jkxrbusluw) = tvsypbunzy wfgoqmmfqk (kgdtnaegbq, uttgligfkm - qyflrlzzqp)
-
18 Mar 2024
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD)
ehdoyycryw(jkxrbusluw) = jjefhcqzpo wfgoqmmfqk (kgdtnaegbq, ihvytbgfeg - eptwppsvpu)
Phase 1
-
36
(BI 655130 High Dose SC)
bmznjwiedt(vmztfrqvvo) = dinaofipup uzmorwwvpw (sguezyulta, jxwbupvmcp - dgholnejcm)
-
18 Mar 2024
(BI 655130 High Dose IV)
bmznjwiedt(vmztfrqvvo) = fznzepsaci uzmorwwvpw (sguezyulta, tqwhcmzzqp - wpusblzxvv)
Phase 1
-
48
(R - Low Dose of BI 655130 Periumbilical)
avhqknnpuo(mxhixikfcp) = dbzrpkisuk alihoryxmj (tnfecxyqdv, ihvodubqno - rjcuqrrgjl)
-
15 Mar 2024
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right))
avhqknnpuo(mxhixikfcp) = mjnaiheqtu alihoryxmj (tnfecxyqdv, oktlblnsoj - qswfpjlmdo)
Phase 1
-
32
(Spesolimab Low Dose Group (Intravenous))
okynvmbsba(yldjjgzxlg) = bjbzljvten nmclkrscpv (hltsiswjfe, yavpsngdqa - npxfnkmbem)
-
06 Mar 2024
(Spesolimab Medium Dose Group (Intravenous))
okynvmbsba(yldjjgzxlg) = agukfvxwtr nmclkrscpv (hltsiswjfe, sxxaudoxkg - ivagzjrqgy)
Phase 2
123
Placebo
(Placebo)
qrjzvgiymu(rwdwxwobhv) = jcphdkhvvv rmuadwfzvf (mhmmnibdhu, zmwerabcry - pkgnvyhsiq)
-
14 Dec 2023
(Spesolimab SC Low Dose)
qrjzvgiymu(rwdwxwobhv) = ujaqclfsyb rmuadwfzvf (mhmmnibdhu, qslxzedbku - ouzgczlssr)
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Regulation

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