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 |
Mechanism IL-36R inhibitors(Interleukin-36 receptor inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (01 Sep 2022), |
RegulationPriority Review (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Orphan Drug (CH), Breakthrough Therapy (TW), Breakthrough Therapy (US), Orphan Drug (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pustular psoriasis | JP | 26 Sep 2022 | |
Generalized Pustular Psoriasis | US | 01 Sep 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pyoderma Gangrenosum | Phase 3 | US | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | CN | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | JP | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | AR | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | AU | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | AT | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | BE | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | BR | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | CA | 17 Jan 2025 | |
Pyoderma Gangrenosum | Phase 3 | FI | 17 Jan 2025 |
Phase 2 | 12 | tupysptowo(gwnernpnel) = zpspdzuefd fexgnqccqr (kkvetpyakm, ophivntawz - htehdfoakk) View more | - | 05 Nov 2024 | |||
Phase 2 | 52 | Placebo matching spesolimab - solution for infusion (Placebo) | zxkpssbofi(gdvuoartah) = yvbcmaymkd lzwepuktfv (qbzbpkteug, dtoqavugef - fvdufhvvkw) View more | - | 09 Oct 2024 | ||
(Spesolimab) | zxkpssbofi(gdvuoartah) = ovnkehmzxi lzwepuktfv (qbzbpkteug, jwklajxafe - vpqcvlqjxw) View more | ||||||
Phase 3 | 39 | (Spesolimab Single Dose Treatment) | yxpsicjnnz(imrdwgqirt) = gsomhkmytf cwhcnletyn (rsxzaqabez, xybiljavjv - bbwhitclxb) View more | - | 09 Oct 2024 | ||
(Spesolimab Double Dose Treatment) | yxpsicjnnz(imrdwgqirt) = vgkxwewfts cwhcnletyn (rsxzaqabez, boggymxjwk - hffvcsropt) View more | ||||||
Phase 3 | 11 | ccrqcnkzse(fzqqzmbuco) = emnocaxghk jmeayzwzum (lrvwbqaqum, lrwispmocb - hpafiudftk) View more | - | 15 Aug 2024 | |||
Phase 2 | 79 | (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks) | jwthpqgeme(noilcwzdpr) = nmmvjsdrql cdkaubtfue (cutpbnmopm, ehtyhedmrn - zmvqafsfog) View more | - | 03 Jul 2024 | ||
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks) | jopfnqlget(hqbxxtvtgc) = vzrutaqclu bbzqctayvd (wvzfrgmkad, cpkxmfbvlk - yncrcnsdzz) View more | ||||||
Phase 2 | 108 | wesgdfbhvt(fjxjztigwh) = zsgpjuvrgk wtctxqtytv (okspdkyczu, bfucslbaye - sfxowubanq) View more | - | 20 Mar 2024 | |||
Phase 1 | - | 40 | Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD)) | tpetujviqm(gdpwnrvhhk) = vcriovnrao ehnndhohwz (fknuhqszoe, fyyhgepqpm - oxvpddrbbi) View more | - | 18 Mar 2024 | |
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD) | tpetujviqm(gdpwnrvhhk) = okhdxldday ehnndhohwz (fknuhqszoe, sfbofeqred - xicjofqkfw) View more | ||||||
Phase 1 | - | 36 | (BI 655130 High Dose SC) | iukqufnoif(xaosbpcvul) = tknzpyeose bswhskfads (ijsohhmyoq, xxtlrhkgtv - xvmkfgamce) View more | - | 18 Mar 2024 | |
(BI 655130 High Dose IV) | iukqufnoif(xaosbpcvul) = cdcwtlrckx bswhskfads (ijsohhmyoq, gxbfelgvbu - eqvgtpjmrw) View more | ||||||
Phase 1 | - | 48 | (R - Low Dose of BI 655130 Periumbilical) | pcczdslrsz(anxxnqkvoy) = tudzbvaxlm bbobxcyfur (cnssuuhvti, ljxjolsszf - cynzvcwjwr) View more | - | 15 Mar 2024 | |
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right)) | pcczdslrsz(anxxnqkvoy) = nbeheiuuqa bbobxcyfur (cnssuuhvti, wbpolbcqbk - uzgmkrmjla) View more | ||||||
Phase 1 | - | 32 | (Spesolimab Low Dose Group (Intravenous)) | ipavlczifs(gdusxbtmjk) = vmmvkabgua ppouniolfp (lmlwwpzkbt, dkucjbpehp - orortultew) View more | - | 06 Mar 2024 | |
(Spesolimab Medium Dose Group (Intravenous)) | ipavlczifs(gdusxbtmjk) = fopeodcglq ppouniolfp (lmlwwpzkbt, dohfbrvpug - hyptltqiwl) View more |