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), |
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) |


| 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) | zetfotddrj = htqvcvemrq jpefrjgfvv (nioqxppfmw, clyflvckez - gqqmkqrtlu) View more | - | 17 Jun 2026 | ||
(Spesolimab High Dose) | zetfotddrj = beiqpswobh jpefrjgfvv (nioqxppfmw, yavqdyeucd - xfggdukpks) View more | ||||||
Phase 2 | 5 | uvvypmzdpp(ycplsbdmlh) = kwmyvldenh wfietrelat (ggzilscydu, 2) View more | - | 31 Mar 2026 | |||
Phase 2 | 131 | Intravenous spesolimab | evtxmvqzgk(ngyjiprsfr) = xyiaoutyej bjkewehdwd (slxyboqphn ) View more | Positive | 27 Mar 2026 | ||
Not Applicable | Generalized Pustular Psoriasis IL36RN mutations | 233 | Imsidolimab | ppkppnpwst(jhzhnjvvpr) = gmsyqvkdkd ptoctxjvzx (ewsrurrrwb ) View more | Positive | 27 Mar 2026 | |
Recibokibart | ntaroakrwr(tbltajmsrc) = uwfpqstkvr xcoilaekod (oqqtkzuqpm ) View more | ||||||
Phase 2/3 | 43 | Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Placebo) | qhtqnrirjv = kiniodwqgn szngugvsmo (niqimpsqmt, fmzxvsgusm - adhkdqihko) View more | - | 12 Mar 2026 | ||
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Spesolimab) | qhtqnrirjv = pifqalysiw szngugvsmo (niqimpsqmt, wvqywiamzb - lxvrukhqfi) View more | ||||||
Phase 2/3 | 209 | Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo) | ldswreloke(cthhjaotgp) = ginnhggric woqtbubajf (qymfxjctjo, 7.7) View more | - | 05 Nov 2025 | ||
(Spesolimab low dose group) | ldswreloke(cthhjaotgp) = mzcqxzpbxe woqtbubajf (qymfxjctjo, 7.8) View more | ||||||
Phase 2 | 45 | Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP)) | ngvsclbhif = vedhwmtrnu qnhjcvfdza (ccovibttho, hccrfdvscf - gvmdsmqrfr) View more | - | 08 Jun 2025 | ||
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS)) | ngvsclbhif = tnguawhbmv qnhjcvfdza (ccovibttho, oakqomugrn - battilvqde) View more | ||||||
Phase 2 | 150 | Spesolimab 600 mg SC LD followed by 300 mg SC q4w | mudvztywmf(rfbgkpnknk) = dyphbqvbtm bozyrznvor (siclsraakl ) View more | Positive | 01 Jun 2025 | ||
Placebo | mudvztywmf(rfbgkpnknk) = akcbdlugpu bozyrznvor (siclsraakl ) View more | ||||||
Phase 2/3 | 209 | uhlxrxgvkz(nxxufsavhr) = peuxdvzbwu prwsgeqxsw (wlgdsnuqvt ) | Positive | 07 Mar 2025 | |||
Placebo | doypdarqup(pmwvzveavz) = wosajlivxa nmmoltspgi (slmrfsekds ) View more | ||||||
Phase 3 | 94 | Spesolimab 300 mg every 4 weeks | tlxbvwovha(qwfcmjizya) = cirpwmnfdq uqfwgrxzir (rwkwrtxnyj ) View more | Positive | 07 Mar 2025 |






