Drugs / Satralizumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Enspryng | — | 2021-06-24 | europa.eu ↗ |
| Approved | US (FDA) | ENSPRYNG | — | 2020-08-14 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05727657 | Jun 2024 | acquired aneurysmal subarachnoid hemorrhage, brain ischemia | University of Florida | Withdrawn | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06450639 | Apr 2025 → Aug 2026 overdue | Duchenne muscular dystrophy | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06222827 | Jan 2024 → Mar 2027 expected | facioscapulohumeral muscular dystrophy 1 | Centre Hospitalier Universitaire de Nice | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05679570 | Jul 2022 → Apr 2026 | pulmonary arterial hypertension | International University of Health and Welfare | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05199688 | May 2026 → Mar 2027 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT06106828 | Nov 2023 → Jul 2025 overdue | endocrine exophthalmos | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05987423 | Oct 2023 → Jul 2025 overdue | endocrine exophthalmos | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05503264 | Sep 2022 → Dec 2026 expected | anti-NMDA receptor encephalitis, limbic encephalitis with LGI1 antibodies | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05271409 | Aug 2022 → Nov 2025 overdue | myelin oligodendrocyte glycoprotein antibody-associated disease | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04963270 | Oct 2021 → Jan 2024 | generalized myasthenia gravis | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT04660539 | Mar 2021 → May 2024 | neuromyelitis optica | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02073279 | Aug 2014 → Oct 2018 | neuromyelitis optica | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02028884 | Feb 2014 → Jun 2018 | neuromyelitis optica | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07010302 | Aug 2026 → Jan 2030 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05269667 | Aug 2022 → Oct 2023 | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Hoffmann-La Roche | Terminated | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | Roche Global Development | FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) roche.com ↗ |
| 2026-04-21 | Roche Global Development | Roche’s ENSPRYNG (satralizumab) reduces risk of relapses by 68% demonstrating potential to become first treatment for MOGAD roche.com ↗ |
| 2021-10-14 | Roche Global Development | New four-year data show Roche's ENSPRYNG significantly reduces debilitating relapses in people with neuromyelitis optica spectrum disorder roche.com ↗ |
| 2021-10-05 | Roche Global Development | Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021 roche.com ↗ |
| 2021-06-28 | Roche Global Development | Roche’s ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD) roche.com ↗ |
| 2021-04-23 | Roche Global Development | CHMP recommends EU approval of Roche’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD) roche.com ↗ |
| 2020-09-10 | Roche Global Development | New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD) roche.com ↗ |
| 2020-08-17 | Roche Global Development | FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD) roche.com ↗ |
| 2020-06-29 | Roche Global Development | Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder roche.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Satralizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06450639 ↗ |
| Known as | Enspryng | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | RG6168 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | SA-237 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | Sapelizumab | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | Satralizumab mwge | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Action | Inhibit | “Satralizumab, an interleukin 6 receptor inhibitor” PMID 36724181 ↗ Dec 2022 |
| Modality | Monoclonal antibody | “Satralizumab is a humanized monoclonal antibody targeting the interleukin-6 receptor.” PMID 31774956 ↗ Nov 2019 |
| Route | Subcutaneous | “Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).” NCT02028884 ↗ |
| Target | IL6R | “Anti-IL-6 Receptor Antibody” NCT05679570 ↗ |