Inotuzumab ozogamicin
As of the edition of 20 October 2026, Inotuzumab ozogamicin is an antibody drug conjugate: marketed, first approved in 2017 (EU); acts on CD22; 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 drug conjugate
- Brand name
- Besponsa
- First approved
- 28 June 2017 (EU)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Registered trials
- 61, 7 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Infections
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 Pfizer.
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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Target
| Gene | Protein | UniProt |
|---|---|---|
| CD22 | B-cell receptor CD22 | P20273 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 2 | 0 |
| Phase 1 | 10 | 7 | 2 | 0 |
| Phase 2 | 37 | 10 | 19 | 5 |
| Phase 3 | 6 | 1 | 3 | 2 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 61 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2007 to now |