Satralizumab
As of the edition of 20 October 2026, Satralizumab is an antibody: marketed, first approved in 2020 (CA); acts on IL6R and IL6ST; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Antibody
- Brand name
- Enspryng
- First approved
- 1 June 2020 (CA)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Roche; 5 holders in all
- Registered trials
- 17, 3 stopped early
- Disease areas
- Immune system; Nervous system; Eye; Inherited and neonatal; Hormones; Bones, joints and muscles
US protection
US protection ends in 2032.
US protection ends in 2032, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Roche. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 2 | 0 |
| Phase 1 | 1 | 0 | 0 | 1 |
| Phase 2 | 3 | 1 | 2 | 0 |
| Phase 3 | 9 | 5 | 3 | 1 |
| Phase 4 | 2 | 0 | 1 | 1 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2014 to now |