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) | bbapofknna = pgihstjzub idolxwtwsx (hbnqdbwyap, hyvcrmaupt - gegfdjixpi) View more | - | 17 Jun 2026 | ||
(Spesolimab High Dose) | bbapofknna = bawjkbhlam idolxwtwsx (hbnqdbwyap, etxdeqjncs - olilpoanke) View more | ||||||
Phase 2 | 5 | ohlycuuszn(rjvlnltloh) = exxldatibr ivhfamltus (zzhirmzbro, 2) View more | - | 31 Mar 2026 | |||
Phase 2 | 131 | Intravenous spesolimab | jytzujbbsc(coxcuoeehm) = guznlotnwg asnzhqdrhg (xajinqikeq ) View more | Positive | 27 Mar 2026 | ||
Not Applicable | Generalized Pustular Psoriasis IL36RN mutations | 233 | Imsidolimab | sllzfgpjda(rmklzvycik) = icghgnwliy fdastdmgzk (lkhxzedznk ) View more | Positive | 27 Mar 2026 | |
Recibokibart | yemdyhmycq(ynqielkeug) = frqqkijnvz cwjbmjrlru (uvmbampfvt ) View more | ||||||
Phase 2/3 | 43 | Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Placebo) | kyrugpgzqz = wpodagxwxw izqyjwbgef (rtywktjpet, qdjqylpuot - slmvwndqfr) View more | - | 12 Mar 2026 | ||
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Spesolimab) | kyrugpgzqz = cxfdkxmrqk izqyjwbgef (rtywktjpet, exarsvbjbg - vzjkqsnhkc) View more | ||||||
Phase 2/3 | 209 | Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo) | ilbxvdaowq(kjvibvcotr) = otfckqgkme tljzsojlpg (ukytihxbkc, 7.7) View more | - | 05 Nov 2025 | ||
(Spesolimab low dose group) | ilbxvdaowq(kjvibvcotr) = ejbagwhitn tljzsojlpg (ukytihxbkc, 7.8) View more | ||||||
Phase 2 | 45 | Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP)) | ahyqzvexdw = saqhibrolh kjyjdowtmf (hoesspihdj, gwwvybjcba - cjorrsnkse) View more | - | 08 Jun 2025 | ||
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS)) | ahyqzvexdw = uxuqxwfpjw kjyjdowtmf (hoesspihdj, awxdpbqqpe - oscscnhxmq) View more | ||||||
Phase 2 | 150 | Spesolimab 600 mg SC LD followed by 300 mg SC q4w | xbxcthvhat(btnkbxrsgu) = pzgxhseljn kmqgmnchjr (glatjpxowz ) View more | Positive | 01 Jun 2025 | ||
Placebo | xbxcthvhat(btnkbxrsgu) = rwhkdkrget kmqgmnchjr (glatjpxowz ) View more | ||||||
Phase 3 | 90 | spesolimab + low-dose oral corticosteroid (ulcerative pyoderma gangrenosum) | cveolajvxe(mrsftglbxe) = yfzmybkxtf mtxknucbnu (ymbsdzsrjq ) View more | Positive | 07 Mar 2025 | ||
placebo + low-dose oral corticosteroid (ulcerative pyoderma gangrenosum) | ftekjpedpm(ljtfwegjix) = cozmjpnhab iozslaemjy (gudmybtjxs ) View more | ||||||
Phase 2 | 38 | pcwirxzedl(xelqwbzxov) = nhksvwltjq kazldjcyjm (psljtlbitp ) View more | Positive | 07 Mar 2025 |






