Mosunetuzumab
As of the edition of 20 October 2026, Mosunetuzumab is an antibody: marketed, first approved in 2022 (EU); acts on CD3D, CD3E and CD3G and 1 more; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Antibody
- Brand name
- Lunsumio
- First approved
- 3 June 2022 (EU)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Roche; 4 holders in all
- Registered trials
- 53, 2 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Skin and connective tissue; Heart and blood vessels; Infections
US protection
US protection ends in 2034.
US protection ends in 2034, 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.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 9 | 2 | 6 | 1 |
| Phase 2 | 38 | 4 | 33 | 1 |
| Phase 3 | 5 | 0 | 5 | 0 |
| All trials | 53 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2015 to now |