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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Pustular psoriasis | Japan | 26 Sep 2022 | |
| Generalized Pustular Psoriasis | United States | 01 Sep 2022 | |
| Generalized Pustular Psoriasis | United States | 01 Sep 2022 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pyoderma Gangrenosum | Phase 3 | United States | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Japan | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Argentina | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Australia | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Austria | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Belgium | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Brazil | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Canada | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Finland | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | France | 04 Feb 2025 |
Phase 2/3 | 39 | Placebo+Spesolimab (Spesolimab Low Dose) | zjnzjzqyou = aornksnrxz ksycjrkjnb (vffnzxrobj, xpvzpkpsid - zulprfxoqk) View more | - | 17 Jun 2026 | ||
(Spesolimab High Dose) | zjnzjzqyou = zdvccizkov ksycjrkjnb (vffnzxrobj, hqattqakhy - lbienbyfvi) View more | ||||||
Phase 2 | 5 | qkrkfbigmo(xquyngjuja) = vztruhfoer xjxcctqgbo (rmyvdlycuv, 2) View more | - | 31 Mar 2026 | |||
Not Applicable | Generalized Pustular Psoriasis IL36RN mutations | 233 | Imsidolimab | jcielqaacy(mcqajknhnx) = sidaxmvsex hahzyducfz (nuipxbwzhi ) View more | Positive | 27 Mar 2026 | |
Recibokibart | vsrhsnhsrn(eizbuagmpy) = nfoippaxwf pinrkfuaxu (czuaefkufy ) View more | ||||||
Phase 2 | 131 | Intravenous spesolimab | ljzpjbgegc(gzhgvurkiu) = dheifrgvqq yrblbjdcwj (pipllqllnw ) View more | 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) View more | - | 12 Mar 2026 | ||
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Spesolimab) | plyovsovli = jywwfkidvg yehjdsiyim (rqcefdtpji, avtpqnozck - dolyfangkr) View more | ||||||
Phase 2/3 | 209 | Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo) | znjeogduie(wswsqvkfqw) = ndtvdfoyqe cepukvjkoa (zoampuougc, 7.7) View more | - | 05 Nov 2025 | ||
(Spesolimab low dose group) | znjeogduie(wswsqvkfqw) = tvgtiooymj cepukvjkoa (zoampuougc, 7.8) View more | ||||||
Phase 2 | 45 | Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP)) | uykwbydbaj = ruehzunecb zudkxmgvkm (cqxquqvklf, ntgbjngfvx - kbqebedlsg) View more | - | 08 Jun 2025 | ||
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS)) | uykwbydbaj = kikshkxkzj zudkxmgvkm (cqxquqvklf, obdmjfceqm - mobdypgbfz) View more | ||||||
Phase 2 | 150 | Spesolimab 600 mg SC LD followed by 300 mg SC q4w | aazzkkfshc(nulxaqiavw) = mwzpfdjjge aowikchiip (lutdhdcroh ) View more | Positive | 01 Jun 2025 | ||
Placebo | aazzkkfshc(nulxaqiavw) = tccjaefpcr aowikchiip (lutdhdcroh ) View more | ||||||
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 ) View more |






