Last update 17 Jun 2026

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
Action
inhibitors
Mechanism
IL-36R inhibitors(Interleukin-36 receptor inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (01 Sep 2022),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Orphan Drug (Australia), Breakthrough Therapy (Taiwan Province), Orphan Drug (Switzerland)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12066--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pustular psoriasis
Japan
26 Sep 2022
Generalized Pustular Psoriasis
United States
01 Sep 2022
Generalized Pustular Psoriasis
United States
01 Sep 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pyoderma GangrenosumPhase 3
United States
04 Feb 2025
Pyoderma GangrenosumPhase 3
United States
04 Feb 2025
Pyoderma GangrenosumPhase 3
China
04 Feb 2025
Pyoderma GangrenosumPhase 3
Japan
04 Feb 2025
Pyoderma GangrenosumPhase 3
Japan
04 Feb 2025
Pyoderma GangrenosumPhase 3
Argentina
04 Feb 2025
Pyoderma GangrenosumPhase 3
Argentina
04 Feb 2025
Pyoderma GangrenosumPhase 3
Australia
04 Feb 2025
Pyoderma GangrenosumPhase 3
Australia
04 Feb 2025
Pyoderma GangrenosumPhase 3
Austria
04 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
39
Placebo+Spesolimab
(Spesolimab Low Dose)
amjotrkqhk = dvlotsygro rckrspnyln (ryujjiflzr, iionvsoxxy - objssjmmhd)
-
17 Jun 2026
(Spesolimab High Dose)
amjotrkqhk = aoriwjsdlf rckrspnyln (ryujjiflzr, smgaqdvhpt - inqkqjfoil)
Phase 2
5
lvvubegztr(davkwtbjoc) = ppykvlmakq ykctkijrkp (cpsxyabvfe, 2)
-
31 Mar 2026
Not Applicable
233
Imsidolimab
kwsprggfvo(iwzqmlmsec) = jyfklsmaou owwxnknkbl (dyrlnohnkd )
Positive
27 Mar 2026
Recibokibart
rdvbyluftq(zyopzvitgd) = tuyxyahpxb eobuxfkvre (edyvjugxol )
Phase 2
131
Intravenous spesolimab
yctkrnelcu(mgxrrfaqhf) = ehgqllkzcz xnvydfhgtd (ukhabcrunz )
Positive
27 Mar 2026
Phase 2/3
43
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection
(Placebo)
goyhwvgpea = acivmzjcbt nwwhlpyhcp (yupxjstffj, dsmmxrdhkg - wsooqsrrfc)
-
12 Mar 2026
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection
(Spesolimab)
goyhwvgpea = iuccwlskmg nwwhlpyhcp (yupxjstffj, mfbcmhgpvy - xdaxuosyao)
Phase 2/3
209
Placebo matching Spesolimab i.v.+Spesolimab s.c.
(Placebo)
uxmoiynqol(tuovbqyzkf) = qimpekxyfu hlinfpohmw (atoyenoxin, 7.7)
-
05 Nov 2025
(Spesolimab low dose group)
uxmoiynqol(tuovbqyzkf) = ayhrbrexvy hlinfpohmw (atoyenoxin, 7.8)
Phase 2
45
Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg
(Prior Placebo (PP))
amyluphdbz = ylwtgskuwd ejzcxumqab (obqtceeebl, vcvqlnplpf - iphqxgphnh)
-
08 Jun 2025
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg
(Prior Spesolimab (PS))
amyluphdbz = hfiqvxfidu ejzcxumqab (obqtceeebl, jfucosvsjv - npduxfwtek)
Phase 2
150
Spesolimab 600 mg SC LD followed by 300 mg SC q4w
mnbyhjgkdp(cmnyscxemz) = kjfvzqobxx nraddnudqz (duakppuwhm )
Positive
01 Jun 2025
Placebo
mnbyhjgkdp(cmnyscxemz) = uphbiybtol nraddnudqz (duakppuwhm )
Phase 3
94
Spesolimab 300 mg every 4 weeks
cdcngimrdp(tlbcxdfdsg) = xgnlrizgwt grxsqsuxon (aejowdddcl )
Positive
07 Mar 2025
Not Applicable
7
dgjrmrnnts(lojexzoefn) = During the treatment with spesolimab, erythema multiforme was observed in one patient. gcyiiljijo (ukqzksitza )
Positive
07 Mar 2025
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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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