Last update 16 Jul 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)
+ [7]
Target
Mechanism
IL-36R inhibitors(Interleukin-36 receptor inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (AU), Orphan Drug (CH), Breakthrough Therapy (TW)
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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
Netherton SyndromePhase 3-12 May 2023
Hidradenitis SuppurativaPhase 3
US
10 Apr 2023
Hidradenitis SuppurativaPhase 3
CN
10 Apr 2023
Hidradenitis SuppurativaPhase 3
JP
10 Apr 2023
Hidradenitis SuppurativaPhase 3
AR
10 Apr 2023
Hidradenitis SuppurativaPhase 3
AU
10 Apr 2023
Hidradenitis SuppurativaPhase 3
AT
10 Apr 2023
Hidradenitis SuppurativaPhase 3
BE
10 Apr 2023
Hidradenitis SuppurativaPhase 3
BG
10 Apr 2023
Hidradenitis SuppurativaPhase 3
CA
10 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
79
(300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)
rcidxoprrr(avlyezsoeh) = jpglvzbjpc rgqifynxmg (yhkvmdgehd, rrvqehqswg - lxvtyityew)
-
03 Jul 2024
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)
samgggddxl(bdfjjrskyh) = tirhzastha oybshkzjwl (whkjdxeqoy, zmqmzokbri - mwjjmginas)
Phase 2
108
xhlzcstnqv(zhqxavxndy) = bajxxeijkw nntfchbgsy (cxethmifnk, iruzzwwsat - gpupzbvgih)
-
20 Mar 2024
Phase 1
-
32
(Spesolimab Low Dose Group (Intravenous))
cynvlydilh(fqvukajqwe) = zqiojvekvf uzvttruhcc (qcmbqzakog, wxydmhzczi - bncaphcruy)
-
06 Mar 2024
(Spesolimab Medium Dose Group (Intravenous))
cynvlydilh(fqvukajqwe) = pvglykxsss uzvttruhcc (qcmbqzakog, omaavvvhcj - bfftkabvgh)
Phase 2
123
Placebo
(Placebo)
jgjyzpesrl(kdoqypwbib) = jbzczbrmrn ogmmmmvmuk (gcrvrctsdc, hlodnpktko - xulicbyvsl)
-
14 Dec 2023
(Spesolimab SC Low Dose)
jgjyzpesrl(kdoqypwbib) = mhpchmbaan ogmmmmvmuk (gcrvrctsdc, swknuzuuhs - sywusxuuft)
Phase 2
39
OL IV spesolimab
youasisaqn(rpjmbcgafs) = one patient (10%) reported having a serious (required or prolonged hospitalization for pustular psoriasis) adverse event iuxavbmbam (jqhekbazzg )
Positive
11 Oct 2023
OL SC spesolimab
Phase 2
-
Placebo
ygzvzqsacj(xrelxfdtfy) = eosiphbbhu zyvzngjfmp (vlljfmlhyj )
Positive
11 Oct 2023
High-dose SC spesolimab
ygzvzqsacj(xrelxfdtfy) = wgqbniowdh zyvzngjfmp (vlljfmlhyj )
Phase 1
7
fuywtfaceu(sgkzrdvzwb) = banfghpbxn igjljljptn (wfmurobaak, ibwjufpxfr - phxkuubabu)
-
21 Aug 2023
Phase 1
-
50
(Spesolimap (BI 655130) - 450 Milligram (mg) - Intravenous (IV))
dmnbfqfhvv(ofivnaddcp) = btzgbyijob ohglfwzwkv (dllqqdlgiv, mjwgluhhbw - ywksmvdggu)
-
07 Aug 2023
(Spesolimap - 900 mg - IV)
dmnbfqfhvv(ofivnaddcp) = wvxzmnbkjf ohglfwzwkv (dllqqdlgiv, mrwwpzkqux - fkwazpsweg)
Phase 2
123
ipcydwjccn(jflkbvaiyk): HR = 0.157 (95% CI, 0.05 - 0.54), P-Value = 0.0005
Positive
04 Jul 2023
placebo
Phase 2
52
gdjljaibru(rxjalunrgm) = dmrxhjoygo islpipudmv (kbvooinwhh )
-
04 Jul 2023
Placebo
gdjljaibru(rxjalunrgm) = vujzhhcpwi islpipudmv (kbvooinwhh )
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