Blinatumomab
As of the edition of 20 October 2026, Blinatumomab is an antibody: marketed, first approved in 2014 (US); acts on CD19, CD3D and CD3E and 1 more; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Antibody
- Brand name
- Blincyto
- First approved
- 3 December 2014 (US)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Amgen; 2 holders in all
- Registered trials
- 153, 16 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Infections; Nervous system; Chemically induced
US protection
US protection ends in 2031.
The orphan exclusivity ends in 2031 (it covers one use only). The application that gives this date is held by Amgen.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 0 | 9 | 0 |
| Phase 1 | 25 | 8 | 11 | 4 |
| Phase 2 | 90 | 20 | 55 | 10 |
| Phase 3 | 21 | 3 | 17 | 1 |
| Phase 4 | 3 | 0 | 2 | 1 |
| All trials | 153 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Applicant and Lead sponsor of trials | 2004 to now |