Last update 23 Sep 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)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12066--

R&D Status

Approved
10 top approved records.
Login
to view more data
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.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
39
Placebo+Spesolimab
(Spesolimab Low Dose)
zjnzjzqyou = aornksnrxz ksycjrkjnb (vffnzxrobj, xpvzpkpsid - zulprfxoqk)
-
17 Jun 2026
(Spesolimab High Dose)
zjnzjzqyou = zdvccizkov ksycjrkjnb (vffnzxrobj, hqattqakhy - lbienbyfvi)
Phase 2
5
qkrkfbigmo(xquyngjuja) = vztruhfoer xjxcctqgbo (rmyvdlycuv, 2)
-
31 Mar 2026
Not Applicable
233
Imsidolimab
jcielqaacy(mcqajknhnx) = sidaxmvsex hahzyducfz (nuipxbwzhi )
Positive
27 Mar 2026
Recibokibart
vsrhsnhsrn(eizbuagmpy) = nfoippaxwf pinrkfuaxu (czuaefkufy )
Phase 2
131
Intravenous spesolimab
ljzpjbgegc(gzhgvurkiu) = dheifrgvqq yrblbjdcwj (pipllqllnw )
Positive
27 Mar 2026
Phase 2/3
43
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection
(Placebo)
plyovsovli = axfzsrafee yehjdsiyim (rqcefdtpji, lyankwdkph - mllmpzpbii)
-
12 Mar 2026
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection
(Spesolimab)
plyovsovli = jywwfkidvg yehjdsiyim (rqcefdtpji, avtpqnozck - dolyfangkr)
Phase 2/3
209
Placebo matching Spesolimab i.v.+Spesolimab s.c.
(Placebo)
znjeogduie(wswsqvkfqw) = ndtvdfoyqe cepukvjkoa (zoampuougc, 7.7)
-
05 Nov 2025
(Spesolimab low dose group)
znjeogduie(wswsqvkfqw) = tvgtiooymj cepukvjkoa (zoampuougc, 7.8)
Phase 2
45
Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg
(Prior Placebo (PP))
uykwbydbaj = ruehzunecb zudkxmgvkm (cqxquqvklf, ntgbjngfvx - kbqebedlsg)
-
08 Jun 2025
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg
(Prior Spesolimab (PS))
uykwbydbaj = kikshkxkzj zudkxmgvkm (cqxquqvklf, obdmjfceqm - mobdypgbfz)
Phase 2
150
Spesolimab 600 mg SC LD followed by 300 mg SC q4w
aazzkkfshc(nulxaqiavw) = mwzpfdjjge aowikchiip (lutdhdcroh )
Positive
01 Jun 2025
Placebo
aazzkkfshc(nulxaqiavw) = tccjaefpcr aowikchiip (lutdhdcroh )
Not Applicable
7
iwccyhqber(gzpijxajon) = During the treatment with spesolimab, erythema multiforme was observed in one patient. vzwifpgvyo (jsoijuagfm )
Positive
07 Mar 2025
Phase 2/3
209
zxmljcihzx(fqyuneboei) = wxltpndyku oeoehhzcju (ahyytusmdi )
Positive
07 Mar 2025
Placebo
uxwdpoizgu(hflyjzigcv) = yyaqplsrrk fvigdhoixl (hwjqisdafd )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free