Tocilizumab
As of the edition of 20 October 2026, Tocilizumab is an antibody: marketed, first approved in 2008 (JP); acts on IL6R; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Antibody
- Brand name
- Actemra
- First approved
- 6 March 2008 (JP)
- Approvals on record
- 24 in 5 regions
- Holder of the most recent approval
- Celltrion HealthCare; 6 holders in all
- Registered trials
- 449, 54 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Bones, joints and muscles; Cancer; Blood and lymph; Lungs and airways
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Roche.
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 product4 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| IL6R | Interleukin-6 receptor subunit alpha | P08887 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 68 | 48 | 7 | 1 |
| Phase 1 | 68 | 31 | 23 | 11 |
| Phase 2 | 132 | 39 | 50 | 29 |
| Phase 3 | 133 | 101 | 16 | 7 |
| Phase 4 | 48 | 27 | 4 | 6 |
| All trials | 449 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Originator, Applicant and Lead sponsor of trials | 2001 to now |
| Celltrion HealthCare | Later holder | 2025 to now |