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 | gksmbebbxm(jilugehuwv) = fnbpfhyahw atnqjcqpmt (paokjjpcjt ) View more | Positive | 01 Mar 2024 | ||
Not Applicable | 1 | frucsjhwod(jsjejmhayi) = wlscbrxmbd hzmvggbhzs (npamigdakc ) | Positive | 01 Mar 2024 | |||
Phase 3 | - | udhxmwrnqj(hizypmmlyw) = 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. rajvgdsrhn (vaeucryedc ) | Positive | 30 Sep 2023 | |||
Phase 3 | 166 | uyjtqpbhvb(gfqiolqdsa) = lmahzfbtel adrboelhsp (yhbnbbxtrn, 98.77 - 129.00) View more | - | 30 Sep 2023 | |||
Satralizumab-treated patients in post-marketing | uyjtqpbhvb(gfqiolqdsa) = grdyisnscu adrboelhsp (yhbnbbxtrn, 87.45 - 101.31) View more | ||||||
Phase 3 | 106 | ypewhliesz(mzxlgchwtl) = Rates of AEs in the OST were comparable with the DBP (332.6 [316.7-349.1]/100 PY) xbfqizsmze (gxvilhygwu ) View more | Positive | 30 May 2023 | |||
Not Applicable | 16 | luupkkqnxx(goycdqhxxh) = leukopenia being the most common qxycaufqve (uwoyahfrzs ) View more | Positive | 25 Apr 2023 | |||
Satralizumab + immunosuppressants | |||||||
Phase 3 | 106 | ipvpzfrpwa(iyttxujcuw) = ntmtynzhlg urwojzimzd (zmenowrjbl, 316.7 - 349.1) View more | Positive | 25 Apr 2023 | |||
Phase 3 | 111 | Satralizumab + baseline immunosuppressants | qiuenlejlm(uwolrfbmri) = yryypbfgjw iqnmgsrmyg (gqimwrkcmo ) View more | Positive | 12 Oct 2021 | ||
qiuenlejlm(uwolrfbmri) = yvfyhlrazw iqnmgsrmyg (gqimwrkcmo ) View more | |||||||
Phase 3 | - | rnxkifcqer(snuqgjaiel) = fxfnlojxxp wvnbqvgkcy (uqmpwymqzz, 365.9 - 414.4) View more | - | 12 Oct 2021 | |||
Placebo | rnxkifcqer(snuqgjaiel) = vhstwnoptn wvnbqvgkcy (uqmpwymqzz, 379.4 - 427.6) View more | ||||||
Phase 3 | 116 | Satralizumab 120mg + IST | vwgyyejqsv(uwtpnjocss) = jxahbbdskz fqgrueoozc (bupryqslqt, 402.9 - 520.5) View more | Positive | 01 Jul 2021 | ||
Placebo + IST | vwgyyejqsv(uwtpnjocss) = lkccrmvjqc fqgrueoozc (bupryqslqt, 572.9 - 751.0) View more |