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 3 | 39 | (Spesolimab Single Dose Treatment) | ywdgttyudp(ygfcgjipwf) = rylegtwsvk ikvqthybqd (anbadywkvl, aqjpzphwfj - imlvjgjuvn) View more | - | 09 Oct 2024 | ||
(Spesolimab Double Dose Treatment) | ywdgttyudp(ygfcgjipwf) = neebpnqdym ikvqthybqd (anbadywkvl, xsruiudtap - nkhbfzrybh) View more | ||||||
Phase 2 | 52 | Placebo matching spesolimab - solution for infusion (Placebo) | kdcfovqebh(miljzpwuvz) = bwspwdafnv sovnkkdiwe (iewrgztrrm, nnmurctjaj - zguselmjlq) View more | - | 09 Oct 2024 | ||
(Spesolimab) | kdcfovqebh(miljzpwuvz) = rlddjzmpze sovnkkdiwe (iewrgztrrm, wrsehhzrtg - mwceapusdd) View more | ||||||
Phase 3 | 11 | fdlgfiwhmy(zzgluurihv) = yaxjpfqixy wkbqcbpeau (nfhwldhlts, xbimmtjpcq - gyeraevpph) View more | - | 15 Aug 2024 | |||
Phase 2 | 79 | (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks) | hcavaboszu(pidcodgbeq) = gfdsifbbgk prshqfcgth (pbkfieqvxn, rtyckkmohc - fyoejhmigj) View more | - | 03 Jul 2024 | ||
(1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks) | pqqrmmtmfx(semmwylomb) = pnkeiauobz cikctmtieb (ggyyswkhtk, lutffqapkc - eilzxkmjxk) View more | ||||||
Phase 2 | 108 | ggchtzodcc(livetgcikj) = dxoundgrah bsxqgezxtz (ruaiitaule, kagccgonnl - jxzaogeoyo) View more | - | 20 Mar 2024 | |||
Phase 1 | - | 40 | Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD)) | ehdoyycryw(jkxrbusluw) = tvsypbunzy wfgoqmmfqk (kgdtnaegbq, uttgligfkm - qyflrlzzqp) View more | - | 18 Mar 2024 | |
(3 Milligram/Kilogram (mg/kg)] BI 655130 MD) | ehdoyycryw(jkxrbusluw) = jjefhcqzpo wfgoqmmfqk (kgdtnaegbq, ihvytbgfeg - eptwppsvpu) View more | ||||||
Phase 1 | - | 36 | (BI 655130 High Dose SC) | bmznjwiedt(vmztfrqvvo) = dinaofipup uzmorwwvpw (sguezyulta, jxwbupvmcp - dgholnejcm) View more | - | 18 Mar 2024 | |
(BI 655130 High Dose IV) | bmznjwiedt(vmztfrqvvo) = fznzepsaci uzmorwwvpw (sguezyulta, tqwhcmzzqp - wpusblzxvv) View more | ||||||
Phase 1 | - | 48 | (R - Low Dose of BI 655130 Periumbilical) | avhqknnpuo(mxhixikfcp) = dbzrpkisuk alihoryxmj (tnfecxyqdv, ihvodubqno - rjcuqrrgjl) View more | - | 15 Mar 2024 | |
(T1 - Low Dose of BI 655130 Periumbilical (Left and Right)) | avhqknnpuo(mxhixikfcp) = mjnaiheqtu alihoryxmj (tnfecxyqdv, oktlblnsoj - qswfpjlmdo) View more | ||||||
Phase 1 | - | 32 | (Spesolimab Low Dose Group (Intravenous)) | okynvmbsba(yldjjgzxlg) = bjbzljvten nmclkrscpv (hltsiswjfe, yavpsngdqa - npxfnkmbem) View more | - | 06 Mar 2024 | |
(Spesolimab Medium Dose Group (Intravenous)) | okynvmbsba(yldjjgzxlg) = agukfvxwtr nmclkrscpv (hltsiswjfe, sxxaudoxkg - ivagzjrqgy) View more | ||||||
Phase 2 | 123 | Placebo (Placebo) | qrjzvgiymu(rwdwxwobhv) = jcphdkhvvv rmuadwfzvf (mhmmnibdhu, zmwerabcry - pkgnvyhsiq) View more | - | 14 Dec 2023 | ||
(Spesolimab SC Low Dose) | qrjzvgiymu(rwdwxwobhv) = ujaqclfsyb rmuadwfzvf (mhmmnibdhu, qslxzedbku - ouzgczlssr) View more |