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| Stem definition | Drug id | CAS RN |
|---|---|---|
| humanized origin | 5281 | 1326244-10-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.
|
| Dose | Unit | Route |
|---|---|---|
| 1.11 | mg | P |
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 29, 2020 | PMDA | Sun Pharma Japan Ltd. | |
| March 20, 2018 | FDA | SUN PHARMA GLOBAL | |
| Sept. 17, 2018 | EMA | ALMIRALL SA |
| 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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 165.65 | 40.26 | 64 | 533 | 291623 | 90336227 |
| Death | 84.07 | 40.26 | 46 | 551 | 456505 | 90171345 |
| Self-medication | 57.89 | 40.26 | 11 | 586 | 3209 | 90624641 |
| Drug ineffective | 54.79 | 40.26 | 55 | 542 | 1384243 | 89243607 |
| Therapy cessation | 43.35 | 40.26 | 14 | 583 | 36347 | 90591503 |
| 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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 148.10 | 46.20 | 63 | 600 | 154302 | 42466370 |
| Death | 80.06 | 46.20 | 62 | 601 | 471123 | 42149549 |
| Drug ineffective | 60.48 | 46.20 | 60 | 603 | 630137 | 41990535 |
| 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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 77.83 | 39.36 | 39 | 686 | 321743 | 110266831 |
| Death | 63.55 | 39.36 | 45 | 680 | 698824 | 109889750 |
| Psoriasis | 39.72 | 39.36 | 19 | 706 | 139974 | 110448600 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AC17 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors |
| FDA MoA | N0000192798 | Interleukin-23 Antagonists |
| FDA EPC | N0000192799 | Interleukin-23 Antagonist |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Plaque psoriasis | indication | 200965009 |
None
None
None
None
None
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interleukin-23 | Cytokine | ANTIBODY BINDING | Kd | 9.50 | IUPHAR | DRUG LABEL |
| ID | Source |
|---|---|
| DEW6X41BEK | UNII |
| 4037782 | VANDF |
| 4037783 | VANDF |
| C4043954 | UMLSCUI |
| CHEBI:753629 | CHEBI |
| CHEMBL2108681 | ChEMBL_ID |
| DB14004 | DRUGBANK_ID |
| D10400 | KEGG_DRUG |
| 9672 | INN_ID |
| C000598434 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8093 | IUPHAR_LIGAND_ID |
| 771591006 | SNOMEDCT_US |
| 771665003 | SNOMEDCT_US |
| 277523 | MMSL |
| 34167 | MMSL |
| d08783 | MMSL |
| 017483 | NDDF |
| 2053436 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ILUMYA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47335-177 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 25 sections |