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) | lprplymhjy = lqweuujsyo csmtlukzrf (lcfesnfbqf, edbajsypos - vepbnumozx) View more | - | 17 Jun 2026 | ||
(Spesolimab High Dose) | lprplymhjy = eevvykwabe csmtlukzrf (lcfesnfbqf, hvvrgtyudc - jhqhdfujtz) View more | ||||||
Phase 2 | 5 | zvuhljermf(agwbmszpro) = xwoswogaqf bvnschiuyo (edmkfoqvym, 2) View more | - | 31 Mar 2026 | |||
Not Applicable | Generalized Pustular Psoriasis IL36RN mutations | 233 | Imsidolimab | aprtslelfv(olwqedcdvd) = ptvzxeyfhs ajksamoefr (kbvqskfhws ) View more | Positive | 27 Mar 2026 | |
Recibokibart | goypnginie(njpoxkbxvq) = fspppvlnmk bimgpdmffu (oxnitfgizn ) View more | ||||||
Phase 2 | 131 | Intravenous spesolimab | okhqamukdo(wtqhdemjgw) = gyoloslvlr gemhbfkifh (clxyufpdzl ) View more | Positive | 27 Mar 2026 | ||
Phase 2/3 | 43 | Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Placebo) | wqfgcwdqnn = qyspumbkyz ergofykcwk (owlduacfzt, kntgtvaglf - mfzaxkbnld) View more | - | 12 Mar 2026 | ||
Placebo matching to spesolimab - solution for infusion+Spesolimab - solution for injection (Spesolimab) | wqfgcwdqnn = kacaivjisg ergofykcwk (owlduacfzt, wgbexzjlpx - kleqagwjut) View more | ||||||
Phase 2/3 | 209 | Placebo matching Spesolimab i.v.+Spesolimab s.c. (Placebo) | urrvsozjwl(qiaiqobyyh) = rforsxddue sxadbhlajh (jxldurujgx, 7.7) View more | - | 05 Nov 2025 | ||
(Spesolimab low dose group) | urrvsozjwl(qiaiqobyyh) = jlrnvdedli sxadbhlajh (jxldurujgx, 7.8) View more | ||||||
Phase 2 | 45 | Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP)) | qyfkhpnhdk = nsyqsfneid nqkorcctce (pthdscfcdl, taklxdwopv - pwtigminjk) View more | - | 08 Jun 2025 | ||
Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS)) | qyfkhpnhdk = hiporxgkul nqkorcctce (pthdscfcdl, ygnmcisxqv - jhpxdaakir) View more | ||||||
Phase 2 | 150 | Spesolimab 600 mg SC LD followed by 300 mg SC q4w | pmlsmwfvke(tjkdqwqyaw) = xawoxmijab zimrwbjtni (esplbegsqh ) View more | Positive | 01 Jun 2025 | ||
Placebo | pmlsmwfvke(tjkdqwqyaw) = htqwpqwgfq zimrwbjtni (esplbegsqh ) View more | ||||||
Phase 3 | 94 | Spesolimab 300 mg every 4 weeks | gonipydhjf(tpdpjdphjz) = bbnnxtwale ojlaaszedt (bqqmrhxucw ) View more | Positive | 07 Mar 2025 | ||
Phase 3 | 90 | spesolimab + low-dose oral corticosteroid (ulcerative pyoderma gangrenosum) | llyzelwywz(ngirjjmpnz) = zyzihqfloz xcachkvgrb (uowadvyhla ) View more | Positive | 07 Mar 2025 | ||
placebo + low-dose oral corticosteroid (ulcerative pyoderma gangrenosum) | qcwidpxnze(ksaakpgwoo) = bezugugyfv xayuhhgirg (kgogbrazhx ) View more |






