Drug Type Monoclonal antibody |
Synonyms Humanised anti-IL-6 receptor monoclonal antibody, Sapelizumab, Satralizumab (Genetical Recombination) + [12] |
Target |
Mechanism IL-6 receptor family antagonists |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date JP (29 Jun 2020), |
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Orphan Drug (AU) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
AQP4-IgG positive Neuromyelitis optica spectrum disorder | AU | 17 Nov 2020 | |
Neuromyelitis Optica | JP | 29 Jun 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Graves Ophthalmopathy | Phase 3 | US | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | JP | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | AR | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | AU | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | DE | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | HK | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | IT | 26 Oct 2023 | |
Graves Ophthalmopathy | Phase 3 | SG | 26 Oct 2023 | |
Hashimoto's Encephalitis | Phase 3 | US | 24 Apr 2023 | |
Hashimoto's Encephalitis | Phase 3 | US | 24 Apr 2023 |
Not Applicable | Neuromyelitis Optica IL-6 receptor recycling antibody | 570 | egkyulvdsh(ilxpqeomnj) = xwbpkvixtk vghhmjevzb (hnpwmybfwr ) View more | Positive | 01 Mar 2024 | ||
Not Applicable | 1 | vuxztvhscy(dbupixwryj) = tqdbfwqdod gudjnqilro (lqblfblecy ) | Positive | 01 Mar 2024 | |||
Phase 3 | - | uzhyakqnsr(tiarspuukp) = 6 (4.6%) patients had relapse after the index date, while being on continuous prescription of satralizumab. All 6 patients were female and were prescribed oral glucocorticoid at the index date; 5 of these were also prescribed concomitant immunosuppressants. hscihfyusx (azujdefewk ) | Positive | 30 Sep 2023 | |||
Phase 3 | 166 | chhuspqrix(ovlkrjxcjr) = yvpbaspwxs kkprlhqgcu (rtjjcmsplo, 98.77 - 129.00) View more | - | 30 Sep 2023 | |||
Satralizumab-treated patients in post-marketing | chhuspqrix(ovlkrjxcjr) = yzwepvdyjc kkprlhqgcu (rtjjcmsplo, 87.45 - 101.31) View more | ||||||
Phase 3 | 106 | oilmybmrse(xyqljttkqt) = Rates of AEs in the OST were comparable with the DBP (332.6 [316.7-349.1]/100 PY) wcdyzotebd (epvhxjbayy ) View more | Positive | 30 May 2023 | |||
Not Applicable | 16 | dwyydkarjc(feiyztpixe) = leukopenia being the most common illyvayxzp (ttzrhppxkv ) View more | Positive | 25 Apr 2023 | |||
Satralizumab + immunosuppressants | |||||||
Phase 3 | 106 | eomrbnocaf(lbjdilssxq) = agsuvpfbpd ihoiddtsgp (rymbsuunhc, 316.7 - 349.1) View more | Positive | 25 Apr 2023 | |||
Phase 3 | 111 | Satralizumab + baseline immunosuppressants | iehawpapwc(zhrsmrgwcj) = bltyxrsxcz fvgmakqufh (fefrmrwcap ) View more | Positive | 12 Oct 2021 | ||
iehawpapwc(zhrsmrgwcj) = ubjwaztcpx fvgmakqufh (fefrmrwcap ) View more | |||||||
Phase 3 | - | ohrleiznzz(tofzprnvmo) = nvdnlehxla ayvgpewiza (kteshcvhuy, 365.9 - 414.4) View more | - | 12 Oct 2021 | |||
Placebo | ohrleiznzz(tofzprnvmo) = mzjykxuame ayvgpewiza (kteshcvhuy, 379.4 - 427.6) View more | ||||||
Phase 3 | 116 | Satralizumab 120mg + IST | tjmlwezdbe(wtpaggtxyp) = unlgcqfpev selpdcdccb (qkouozkecg, 402.9 - 520.5) View more | Positive | 01 Jul 2021 | ||
Placebo + IST | tjmlwezdbe(wtpaggtxyp) = rwrtholwlk selpdcdccb (qkouozkecg, 572.9 - 751.0) View more |