satralizumab
Trade name: Enspryng
mAbapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Aug 14, 2020
Clinical trial activity
15 trials · 11 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
12
Phase 3
9
Phase 4
2
Earliest trial started Feb 1, 2014 (NCT02028884)
Timeline
2010s
- Jan 1, 2014
Earliest Phase 3 Sponsor(trial)
- Jun 30, 2014
Orphan Drug Designation
Indications
Approved for
Studied for
- Autoimmune Diseases of the Nervous System · Phase 3
- Brain Ischemia · Early Phase 1
- Graves Ophthalmopathy · Phase 3
- Muscular Dystrophies · Phase 2
- Muscular Dystrophy, Duchenne · Phase 2
- Myasthenia Gravis · Phase 3
- Myelin-Oligodendrocyte Glycoprotein · Phase 3
- Neuromyelitis Optica · Phase 4
- Pulmonary Arterial Hypertension · Phase 2
- Subarachnoid Hemorrhage · Early Phase 1
Mechanism of action
- IL6Ralpha/GP130ANTAGONIST
IL6Ralpha/GP130 antagonist
It blocks IL-6-mediated signal transduction by inhibiting IL-6 binding to transmembrane and soluble IL-6R.
It binds to IL-6 receptor multiple times.
- Interleukin-6 receptor alpha subunitINHIBITOR
IL6R inhibitor
Approval history
- approvedFast trackBreakthroughAug 14, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- ChEMBLCHEMBL3833307 ↗
Also known as
- sa237
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07010302 | Phase 4 | Nov 30, 2025 | Harvard University, Humboldt University, Patient-Centered Outcomes Research Institute |
| NCT06450639 | Phase 2 | Nov 29, 2024 | Roche |
| NCT06222827 | Phase 2 | Jan 24, 2024 | University of Nice Sophia Antipolis |
| NCT05727657 | Early Phase 1 (Phase 1) | Jan 1, 2024 | Genentech, University of Florida |
| NCT06106828 | Phase 3 | Nov 15, 2023 | Roche |
| NCT05987423 | Phase 3 | Oct 26, 2023 | Roche |
| NCT05199688 | Phase 3 | Feb 28, 2023 | Roche |
| NCT05503264 | Phase 3 | Sep 27, 2022 | Chugai, Roche |
| NCT05271409 | Phase 3 | Aug 30, 2022 | Chugai, Roche |
| NCT05269667 | Phase 4 | Aug 2, 2022 | Chugai, Roche |
| NCT05679570 | Phase 2 | Jul 12, 2022 | Chugai, International University of Health and Welfare, Japan Agency for Medical Research and Development, Keio University |
| NCT04963270 | Phase 3 | Sep 30, 2021 | Roche |
| NCT04660539 | Phase 3 | Jan 11, 2021 | Roche |
| NCT02073279 | Phase 3 | Aug 1, 2014 | Chugai |
| NCT02028884 | Phase 3 | Feb 1, 2014 | Chugai |
Showing 15 of 15 trials
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Organizations
Research & Development (11)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 9 | 9 | 3 | 2021 |
| Chugai | For profit | 6 | 2 | 3 | 2014 |
| Genentech | For profit | 1 | 0 | 1 | 2024 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Humboldt University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| International University of Health and Welfare | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Japan Agency for Medical Research and Development | Government | 1 | 0 | 1 | 2022 |
| Keio University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Patient-Centered Outcomes Research Institute | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of Florida | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Nice Sophia Antipolis | Academic/Hospital | 1 | 1 | 1 | 2024 |
11 organizations
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