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 |
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 | United States | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | China | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Japan | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Japan | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Argentina | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Argentina | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Australia | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Australia | 04 Feb 2025 | |
| Pyoderma Gangrenosum | Phase 3 | Austria | 04 Feb 2025 |
Phase 2/3 | 39 | Placebo+Spesolimab (Spesolimab Low Dose) | amjotrkqhk = dvlotsygro rckrspnyln (ryujjiflzr, iionvsoxxy - objssjmmhd) View more | - | 17 Jun 2026 | ||
(Spesolimab High Dose) | amjotrkqhk = aoriwjsdlf rckrspnyln (ryujjiflzr, smgaqdvhpt - inqkqjfoil) View more | ||||||
Phase 2 | 5 | lvvubegztr(davkwtbjoc) = ppykvlmakq ykctkijrkp (cpsxyabvfe, 2) View more | - | 31 Mar 2026 | |||
Not Applicable | Generalized Pustular Psoriasis IL36RN mutations | 233 | Imsidolimab | kwsprggfvo(iwzqmlmsec) = jyfklsmaou owwxnknkbl (dyrlnohnkd ) View more | Positive | 27 Mar 2026 | |
Recibokibart | rdvbyluftq(zyopzvitgd) = tuyxyahpxb eobuxfkvre (edyvjugxol ) View more | ||||||
Phase 2 | 131 | Intravenous spesolimab | yctkrnelcu(mgxrrfaqhf) = ehgqllkzcz xnvydfhgtd (ukhabcrunz ) View more | 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) View more | - | 12 Mar 2026 | ||
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Spesolimab) | goyhwvgpea = iuccwlskmg nwwhlpyhcp (yupxjstffj, mfbcmhgpvy - xdaxuosyao) View more | ||||||
Phase 2/3 | 209 | Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo) | uxmoiynqol(tuovbqyzkf) = qimpekxyfu hlinfpohmw (atoyenoxin, 7.7) View more | - | 05 Nov 2025 | ||
(Spesolimab low dose group) | uxmoiynqol(tuovbqyzkf) = ayhrbrexvy hlinfpohmw (atoyenoxin, 7.8) View more | ||||||
Phase 2 | 45 | Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP)) | amyluphdbz = ylwtgskuwd ejzcxumqab (obqtceeebl, vcvqlnplpf - iphqxgphnh) View more | - | 08 Jun 2025 | ||
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS)) | amyluphdbz = hfiqvxfidu ejzcxumqab (obqtceeebl, jfucosvsjv - npduxfwtek) View more | ||||||
Phase 2 | 150 | Spesolimab 600 mg SC LD followed by 300 mg SC q4w | mnbyhjgkdp(cmnyscxemz) = kjfvzqobxx nraddnudqz (duakppuwhm ) View more | Positive | 01 Jun 2025 | ||
Placebo | mnbyhjgkdp(cmnyscxemz) = uphbiybtol nraddnudqz (duakppuwhm ) View more | ||||||
Phase 3 | 94 | Spesolimab 300 mg every 4 weeks | cdcngimrdp(tlbcxdfdsg) = xgnlrizgwt grxsqsuxon (aejowdddcl ) View more | 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 |






