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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (humanized origin); interleukin and interleukin receptors | 5722 | 1884201-71-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Mirikizumab is a humanised IgG4 monoclonal, anti-interleukin-23 (anti-IL-23) antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. In humans, selective blockade of IL-23 was shown to normalise production of these cytokines.
|
| Dose | Unit | Route |
|---|---|---|
| 7.10 | mg | P |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 26, 2023 | EMA | ELI LILLY NEDERLAND B.V. | |
| March 27, 2023 | PMDA | Eli Lilly Japan 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 |
|---|---|---|---|---|---|---|
| Haematochezia | 70.28 | 59.78 | 20 | 202 | 115504 | 110473573 |
None
| Source | Code | Description |
|---|---|---|
| ATC | L04AC24 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Interleukin inhibitors |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D000897 | Anti-Ulcer Agents |
| MeSH PA | D005765 | Gastrointestinal Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D018689 | Sensory System Agents |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| FDA MoA | N0000192798 | Interleukin-23 Antagonists |
| FDA EPC | N0000192799 | Interleukin-23 Antagonist |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Moderately to severely active ulcerative colitis | indication | 64766004 | DOID:8577 |
| Active tuberculosis | contraindication | 427099000 |
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None
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interleukin-23 subunit alpha | Cytokine | BINDING AGENT | Kd | 10.68 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:756496 | CHEBI |
| CHEMBL3990014 | ChEMBL_ID |
| C000708407 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9846 | IUPHAR_LIGAND_ID |
| DB14910 | DRUGBANK_ID |
| 2054111000122105 | SNOMEDCT_US |
| 4042727 | VANDF |
| C5139904 | UMLSCUI |
| 10657 | INN_ID |
| 372963 | MMSL |
| 42125 | MMSL |
| d10126 | MMSL |
| D11123 | KEGG_DRUG |
| Z7HVY03PHP | UNII |
| 2668384 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-1442 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-3116 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-3116 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-7575 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-7575 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-8011 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-8011 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-8870 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |
| Omvoh | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-8870 | INJECTION, SOLUTION | 100 mg | SUBCUTANEOUS | BLA | 30 sections |