Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 141 |
| INN | Satralizumab |
| Status | Approved |
| Drug code(s) | SA237, RG6168 |
| Brand name | Enspryng |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-6R |
| Indications of clinical studies | Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD), Rheumatoid arthritis |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | March 15, 2012 |
| Start of Phase 2 | |
| Start of Phase 3 | February 15, 2014 |
| Date BLA/NDA submitted to FDA | August 15, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | August 13, 2020 |
| INN, US product name | Satralizumab, satralizumab-mwge |
| US or EU approved indications | Treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. |
| Company | Chugai Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in the EU on June 24, 2021. Approved in Canada and Japan in or about June 2020. Oct 30, 2019 EMA and FDA accept marketing applications. Marketing application submitted to EMA and validated as of October 3, 2019; application is being reviewed under EMA’s accelerated assessment program. Sep 13, 2019: Orphan drug designation in Japan announced by Chugai. April 2019: Results published - Efficacy of satralizumab (SA237) in subgroups of patients in SAkuraSky: a Phase III double-blind, placebo-controlled, add-on study in patients with neuromyelitis optica spectrum disorder (NMOSD) (S43.008) (https://n.neurology.org/content/92/15_Supplement/S43.008). Dec 2018: FDA has granted Breakthrough Therapy Designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD). October 15, 2018 – Chugai Pharmaceutical Co., Ltd. announced that positive results from the phase III study of satralizumab (development code: SA237), SAkuraSky Study (NCT02028884), were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018 held in Berlin, Germany from October 10 to 12 Phase 1 listed on clinicaltrials.jp as JapicCTI-121786; Two Phase 3 studies of SA237 for neuromyelitis optica and NMO Spectrum Disorder started in Feb 2014. No info on any Phase 2 study. orphan designation (EU/3/16/1680) from the European Commission for SA-237 for the treatment of neuromyelitis optica spectrum disorders. In June 2014, Chugai Pharmaceutical Co., Ltd. received orphan drug designation in US for neuromyelitis optica. |
| Full address of company | 1-1 Nihonbashi-Muromachi 2-Chome Chuo-ku, Tokyo 103-8324 JAPAN Asia Japan https://www.chugai-pharm.co.jp/english/rule/contact/index.html |
Recycling antibody: Designed to have pH-dependent binding to soluble IL-6R. mAb will release bound IL-6R in lysosome, then mAb will recycle via FcRn-mediated pathway. INN was formerly Sapelizumab
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |