Last update 09 Jul 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),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Orphan Drug (Switzerland), Breakthrough Therapy (Taiwan Province), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China)
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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
Japan
04 Feb 2025
Pyoderma GangrenosumPhase 3
Argentina
04 Feb 2025
Pyoderma GangrenosumPhase 3
Australia
04 Feb 2025
Pyoderma GangrenosumPhase 3
Austria
04 Feb 2025
Pyoderma GangrenosumPhase 3
Belgium
04 Feb 2025
Pyoderma GangrenosumPhase 3
Brazil
04 Feb 2025
Pyoderma GangrenosumPhase 3
Canada
04 Feb 2025
Pyoderma GangrenosumPhase 3
Finland
04 Feb 2025
Pyoderma GangrenosumPhase 3
France
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)
zetfotddrj = htqvcvemrq jpefrjgfvv (nioqxppfmw, clyflvckez - gqqmkqrtlu)
-
17 Jun 2026
(Spesolimab High Dose)
zetfotddrj = beiqpswobh jpefrjgfvv (nioqxppfmw, yavqdyeucd - xfggdukpks)
Phase 2
5
uvvypmzdpp(ycplsbdmlh) = kwmyvldenh wfietrelat (ggzilscydu, 2)
-
31 Mar 2026
Phase 2
131
Intravenous spesolimab
evtxmvqzgk(ngyjiprsfr) = xyiaoutyej bjkewehdwd (slxyboqphn )
Positive
27 Mar 2026
Not Applicable
233
Imsidolimab
ppkppnpwst(jhzhnjvvpr) = gmsyqvkdkd ptoctxjvzx (ewsrurrrwb )
Positive
27 Mar 2026
Recibokibart
ntaroakrwr(tbltajmsrc) = uwfpqstkvr xcoilaekod (oqqtkzuqpm )
Phase 2/3
43
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection
(Placebo)
qhtqnrirjv = kiniodwqgn szngugvsmo (niqimpsqmt, fmzxvsgusm - adhkdqihko)
-
12 Mar 2026
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection
(Spesolimab)
qhtqnrirjv = pifqalysiw szngugvsmo (niqimpsqmt, wvqywiamzb - lxvrukhqfi)
Phase 2/3
209
Placebo matching Spesolimab i.v.+Spesolimab s.c.
(Placebo)
ldswreloke(cthhjaotgp) = ginnhggric woqtbubajf (qymfxjctjo, 7.7)
-
05 Nov 2025
(Spesolimab low dose group)
ldswreloke(cthhjaotgp) = mzcqxzpbxe woqtbubajf (qymfxjctjo, 7.8)
Phase 2
45
Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg
(Prior Placebo (PP))
ngvsclbhif = vedhwmtrnu qnhjcvfdza (ccovibttho, hccrfdvscf - gvmdsmqrfr)
-
08 Jun 2025
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg
(Prior Spesolimab (PS))
ngvsclbhif = tnguawhbmv qnhjcvfdza (ccovibttho, oakqomugrn - battilvqde)
Phase 2
150
Spesolimab 600 mg SC LD followed by 300 mg SC q4w
mudvztywmf(rfbgkpnknk) = dyphbqvbtm bozyrznvor (siclsraakl )
Positive
01 Jun 2025
Placebo
mudvztywmf(rfbgkpnknk) = akcbdlugpu bozyrznvor (siclsraakl )
Phase 2/3
209
uhlxrxgvkz(nxxufsavhr) = peuxdvzbwu prwsgeqxsw (wlgdsnuqvt )
Positive
07 Mar 2025
Placebo
doypdarqup(pmwvzveavz) = wosajlivxa nmmoltspgi (slmrfsekds )
Phase 3
94
Spesolimab 300 mg every 4 weeks
tlxbvwovha(qwfcmjizya) = cirpwmnfdq uqfwgrxzir (rwkwrtxnyj )
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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