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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (humanized origin); lymphocyte | 5692 | 876387-05-2 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes) and delays the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 17, 2022 | FDA | PROVENTION BIO 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 |
|---|---|---|---|---|---|---|
| Lymphocyte count decreased | 68.45 | 54.78 | 19 | 488 | 35031 | 90592909 |
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| 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 |
|---|---|---|---|---|---|---|
| Rash | 102.26 | 55.51 | 70 | 846 | 820894 | 109767489 |
| Lymphocyte count decreased | 83.00 | 55.51 | 27 | 889 | 57216 | 110531167 |
| Nausea | 80.85 | 55.51 | 72 | 844 | 1235618 | 109352765 |
| Pyrexia | 59.66 | 55.51 | 53 | 863 | 898212 | 109690171 |
| Rash pruritic | 58.37 | 55.51 | 24 | 892 | 98045 | 110490338 |
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| Source | Code | Description |
|---|---|---|
| ATC | A10XX01 | ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES OTHER DRUGS USED IN DIABETES Other drugs used in diabetes |
| MeSH PA | D007004 | Hypoglycemic Agents |
| FDA MoA | N0000175617 | CD3-directed Antibody Interactions |
| FDA EPC | N0000194084 | CD3-directed Antibody |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Diabetes mellitus type 1 | indication | 46635009 | DOID:9744 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| T-cell surface glycoprotein CD3 | Surface antigen | BINDING AGENT | Kd | 5.64 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:750155 | CHEBI |
| CHEMBL1743078 | ChEMBL_ID |
| C502540 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12252 | IUPHAR_LIGAND_ID |
| DB06606 | DRUGBANK_ID |
| 4041858 | VANDF |
| 4041859 | VANDF |
| C2743673 | UMLSCUI |
| 8869 | INN_ID |
| D09013 | KEGG_DRUG |
| 363273 | MMSL |
| 41083 | MMSL |
| d09948 | MMSL |
| 019232 | NDDF |
| S4M959U2IJ | UNII |
| 2621880 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TZIELD | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73650-316 | INJECTION | 1 mg | INTRAVENOUS | BLA | 29 sections |