Gemtuzumab
Mylotarg (gemtuzumab) is an antibody pharmaceutical. Gemtuzumab was first approved as Mylotarg on 2018-04-19. It has been approved in Europe to treat myeloid leukemia acute. The pharmaceutical is active against myeloid cell surface antigen CD33.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mylotarg | Biologic Licensing Application | 2021-09-03 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9203 | Injection, gemtuzumab ozogamicin, 0.1 mg |
Clinical
Clinical Trials
115 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 26 | 60 | 21 | 2 | 9 | 103 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 27 | 54 | 19 | 2 | 8 | 96 |
| Myeloid leukemia | D007951 | — | C92 | 25 | 53 | 16 | 1 | 7 | 89 |
| Electrocardiography | D004562 | EFO_0004327 | — | — | — | — | 1 | — | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | 1 | — | 1 |
| Intravenous infusions | D007262 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 19 | 5 | — | — | 25 |
| Preleukemia | D011289 | — | — | 5 | 19 | 5 | — | — | 24 |
| Syndrome | D013577 | — | — | 3 | 12 | 2 | — | — | 15 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | 5 | 2 | — | 1 | 8 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | — | 4 | 1 | — | — | 4 |
| Refractory anemia with excess of blasts | D000754 | — | D46.2 | — | 1 | 1 | — | — | 2 |
| Bone marrow transplantation | D016026 | — | — | — | — | 1 | — | — | 1 |
| Acute disease | D000208 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 2 | 3 | — | — | — | 4 |
| Megakaryoblastic leukemia acute | D007947 | — | C94.2 | 1 | 3 | — | — | — | 3 |
| Monocytic leukemia acute | D007948 | — | — | 1 | 3 | — | — | — | 3 |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 1 | 3 | — | — | — | 3 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 2 | 1 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 2 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | 1 | — | — | — | 2 |
| Recurrence | D012008 | — | — | — | 1 | — | — | 1 | 2 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 2 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | — | — | 1 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diphtheria | D004165 | EFO_0005549 | A36 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Gemtuzumab |
| INN | gemtuzumab |
| Description | Gemtuzumab ozogamicin, sold under the brand name Mylotarg, is an antibody-drug conjugate (a drug-linked monoclonal antibody) that is used to treat acute myeloid leukemia.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108342 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00056 |
| UNII ID | 8GZG754X6M (ChemIDplus, GSRS) |
Target
Agency Approved
CD33
CD33
Organism
Homo sapiens
Gene name
CD33
Gene synonyms
SIGLEC3
NCBI Gene ID
Protein name
myeloid cell surface antigen CD33
Protein synonyms
CD33, CD33 antigen (gp67), CD33 molecule transcript, gp67, Sialic acid-binding Ig-like lectin 3, Siglec-3
Uniprot ID
Mouse ortholog
Cd33 (12489)
myeloid cell surface antigen CD33 (Q63997)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 4,300 documents
View more details
Safety
Black-box Warning
Black-box warning for: Mylotarg
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
4,852 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use