Obinutuzumab
As of the edition of 20 October 2026, Obinutuzumab is an antibody: marketed, first approved in 2013 (US); acts on MS4A1; US protection ended in 2025.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Antibody
- Brand name
- Gazyva
- First approved
- 1 November 2013 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Roche; 5 holders in all
- Registered trials
- 313, 40 stopped early
- Disease areas
- Immune system; Cancer; Blood and lymph; Pregnancy and women's health; Urinary and reproductive; Skin and connective tissue
US protection
US protection ended in 2025.
US protection ended in 2025, 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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Target
| Gene | Protein | UniProt |
|---|---|---|
| MS4A1 | B-lymphocyte antigen CD20 | P11836 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 4 | 5 | 0 |
| Phase 1 | 64 | 28 | 20 | 15 |
| Phase 2 | 193 | 50 | 112 | 20 |
| Phase 3 | 42 | 11 | 26 | 5 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 313 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2007 to now |