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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies | 5776 | None |
| Molecule | Description |
|---|---|
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Synonyms:
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Garadacimab is a fully human IgG4/lambda recombinant monoclonal antibody which binds to the catalytic domain of activated Factor XII (FXIIa and βFXIIa) and inhibits its catalytic activity. The inhibition of FXIIa, the first factor activated in the contact system, prevents HAE attacks by blocking the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in HAE attacks.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 10, 2025 | EMA | CSL Behring GmbH | |
| June 16, 2025 | FDA | CSL Behring | |
| Feb. 20, 2025 | PMDA | CSL Behring K.K. |
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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 |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 35.53 | 25.54 | 4 | 4 | 1477 | 42619850 |
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| Source | Code | Description |
|---|---|---|
| ATC | B06AC07 | BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Drugs used in hereditary angioedema |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hereditary angioneurotic edema | indication | 82966003 | DOID:14735 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Coagulation factor XII | Enzyme | INHIBITOR | Kd | 7.26 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 2162134-62-3 | SECONDARY_CAS_RN |
| C000731822 | MESH_SUPPLEMENTAL_RECORD_UI |
| 13402 | IUPHAR_LIGAND_ID |
| DB15629 | DRUGBANK_ID |
| 4044062 | VANDF |
| 4044063 | VANDF |
| C5238067 | UMLSCUI |
| 10996 | INN_ID |
| D12613 | KEGG_DRUG |
| 44182 | MMSL |
| d10289 | MMSL |
| 020146 | NDDF |
| 32W6AJL0DY | UNII |
| 2717168 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ANDEMBRY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63833-925 | INJECTION, SOLUTION | 200 mg | SUBCUTANEOUS | BLA | 28 sections |