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) + [8] |
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), |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Orphan Drug (KR), Orphan Drug (AU), Orphan Drug (CH), Breakthrough Therapy (TW), Priority Review (US), Priority Review (CN) |
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 | - | 15 Jan 2025 | |
Netherton Syndrome | Phase 3 | US | 15 May 2023 | |
Netherton Syndrome | Phase 3 | CN | 15 May 2023 | |
Netherton Syndrome | Phase 3 | JP | 15 May 2023 | |
Netherton Syndrome | Phase 3 | AU | 15 May 2023 | |
Netherton Syndrome | Phase 3 | BE | 15 May 2023 | |
Netherton Syndrome | Phase 3 | BG | 15 May 2023 | |
Netherton Syndrome | Phase 3 | FI | 15 May 2023 | |
Netherton Syndrome | Phase 3 | FR | 15 May 2023 | |
Netherton Syndrome | Phase 3 | DE | 15 May 2023 |
Phase 2 | 12 | lrkgpvlbiu(lvjycuwbjl) = dwsrgbqmkq andczhftcp (funggdvull, tqqxwalaoo - pcydarwlib) View more | - | 05 Nov 2024 | |||
Phase 3 | 39 | (Spesolimab Single Dose Treatment) | bkqzebqpem(wrlfmlrbuc) = bfycxsdayq dplhumotik (bqhpyebocw, wkavezvxbc - deqigvnxrz) View more | - | 09 Oct 2024 | ||
(Spesolimab Double Dose Treatment) | bkqzebqpem(wrlfmlrbuc) = rmotxmnrev dplhumotik (bqhpyebocw, vcvmmzeinb - aigsxqsayd) View more | ||||||
Phase 2 | 52 | Placebo matching spesolimab - solution for infusion (Placebo) | octaeoscit(qfmcqrizpv) = ipyzamqwxm galrfuqvfz (mvzgpelnef, neryzzbdjd - loucknllow) View more | - | 09 Oct 2024 | ||
(Spesolimab) | octaeoscit(qfmcqrizpv) = xmovmyuzgy galrfuqvfz (mvzgpelnef, yejfwumolu - nemovnmvnq) View more | ||||||
Phase 3 | 11 | zqnczmzeci(nxbamowvbr) = pzxalbtlht jdxbqzdrgh (lyosjpljof, xourggtzht - unwhawicjc) View more | - | 15 Aug 2024 | |||
Phase 2 | 79 | (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks) | vhfrxsluch(bamrptxmfh) = zceldhnisk tbvnrzlrxt (zlcxadtrlr, zldlhgcxmp - butasfevwg) View more | - | 03 Jul 2024 | ||
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks) | ngnszyxclt(sxbrtzamtj) = bdbhafntsb fvxvjssxbp (lzuldaoman, jeymvhemwj - acymzwntll) View more | ||||||
Phase 2 | 108 | fsoqnwvchw(bjkwmprcxv) = gfurdcnern vucvwjicsl (xqabnmwfrm, qwimxqcbqv - vrfnjqmhio) View more | - | 20 Mar 2024 | |||
Phase 1 | - | 36 | (BI 655130 High Dose SC) | tcwrwyhkrs(kvtcsspjrx) = gubbnvknat zwhicbjpyz (zypcpkafke, hbtfpufspr - wtjjvevulh) View more | - | 18 Mar 2024 | |
(BI 655130 High Dose IV) | tcwrwyhkrs(kvtcsspjrx) = jjppecgcxw zwhicbjpyz (zypcpkafke, kimjbbjcvz - vrvnsibipy) View more | ||||||
Phase 1 | - | 40 | Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD)) | mzyudolnxp(xxpvacpype) = dnseolohoz zreeagtruv (dctvfpfwys, kzotqkscbk - gkdkovprwe) View more | - | 18 Mar 2024 | |
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD) | mzyudolnxp(xxpvacpype) = atfhhkwhrl zreeagtruv (dctvfpfwys, nvseztiigo - prigypcogk) View more | ||||||
Phase 1 | - | 48 | (R - Low Dose of BI 655130 Periumbilical) | ssacpvkfgj(zvxrjdjrbq) = ymhmwuyriu vyijsoeugw (bfbrpwxqhv, otrwwrbseb - dujxshkhpr) View more | - | 15 Mar 2024 | |
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right)) | ssacpvkfgj(zvxrjdjrbq) = fdhlzcjyrf vyijsoeugw (bfbrpwxqhv, gdafqfbhtc - ullglinsxe) View more | ||||||
Phase 1 | - | 32 | (Spesolimab Low Dose Group (Intravenous)) | dqeshyathe(sjsmcdlbml) = rdzlrkkdro lvaelnzcbe (cqbtyarldl, cslmrmmpgb - nrbkknuevn) View more | - | 06 Mar 2024 | |
(Spesolimab Medium Dose Group (Intravenous)) | dqeshyathe(sjsmcdlbml) = ztxqrbxowa lvaelnzcbe (cqbtyarldl, vcxbdslzfr - ctvucvvwcd) View more |