Gemtuzumab
As of the edition of 20 October 2026, Gemtuzumab is an antibody: marketed, first approved in 2019 (CH); acts on CD33.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody
- Brand name
- Mylotarg
- First approved
- 5 December 2019 (CH)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Pfizer
- Registered trials
- 3, 0 stopped early
- Disease areas
- Blood and lymph; Cancer
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CD33 | Myeloid cell surface antigen CD33 | P20138 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 0 | 1 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 3 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant | 2019 to now |