| Stem definition | Drug id | CAS RN |
|---|---|---|
| fusion proteins | 5323 | 2055491-00-2 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tagraxofusp-erzs is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that inhibits protein synthesis and causes cell death in CD123-expressing cells.
|
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 7, 2021 | EMA | STEMLINE THERAPEUTICS B.V. | |
| Dec. 21, 2018 | FDA | STEMLINE THERAPEEUTICS INC |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Capillary leak syndrome | 93.22 | 49.58 | 12 | 48 | 2188 | 63486774 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Capillary leak syndrome | 322.60 | 55.26 | 48 | 306 | 2210 | 34954367 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Capillary leak syndrome | 348.44 | 58.30 | 50 | 327 | 3875 | 79740136 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01XX67 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| FDA CS | M0005633 | Cytotoxins |
| FDA EPC | N0000193862 | Cytotoxin |
| FDA EPC | N0000193864 | CD123 Interaction |
| FDA MoA | N0000193865 | CD123 Interactions |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Blastic plasmacytoid dendritic cell neoplasm | indication | 445105005 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Elongation factor 2 | Enzyme | UNKNOWN | |||||||
| Interleukin-3 receptor | Membrane receptor | BINDING AGENT | UNKNOWN | DRUG LABEL |
| ID | Source |
|---|---|
| 8ZHS5657EH | UNII |
| C4746084 | UMLSCUI |
| CHEMBL4297573 | ChEMBL_ID |
| DB14731 | DRUGBANK_ID |
| D11358 | KEGG_DRUG |
| 10770 | INN_ID |
| 017871 | NDDF |
| 783435000 | SNOMEDCT_US |
| 783577002 | SNOMEDCT_US |
| 4038207 | VANDF |
| 4038208 | VANDF |
| 2109054 | RXNORM |
| 303404 | MMSL |
| 35833 | MMSL |
| d09110 | MMSL |
| C000592123 | MESH_SUPPLEMENTAL_RECORD_UI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Elzonris | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72187-0401 | INJECTION, SOLUTION | 1000 ug | INTRAVENOUS | BLA | 27 sections |
| Elzonris | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72187-0401 | INJECTION, SOLUTION | 1000 ug | INTRAVENOUS | BLA | 27 sections |
| Elzonris | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72187-0401 | INJECTION, SOLUTION | 1000 ug | INTRAVENOUS | BLA | 27 sections |