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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (humanized origin); lymphocyte | 5689 | 1476039-58-3 |
| Molecule | Description |
|---|---|
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Synonyms:
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Nemolizumab is a subcutaneously administered humanized anti-interleukin-31 (IL-31) receptor A (IL-31RA) monoclonal antibody to treat skin diseases, including atopic dermatitis, AD associated pruritus, prurigo nodularis, chronic kidney disease associated pruritus and systemic sclerosis.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 28, 2022 | PMDA | Maruho Co., Ltd. |
| 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 |
|---|---|---|---|---|---|---|
| Pruritus | 139.68 | 55.51 | 72 | 636 | 541453 | 90086286 |
| Dermatitis atopic | 128.90 | 55.51 | 31 | 677 | 23441 | 90604298 |
| Neurodermatitis | 108.30 | 55.51 | 19 | 689 | 3019 | 90624720 |
| Eczema | 86.78 | 55.51 | 27 | 681 | 52843 | 90574896 |
| Rash | 57.58 | 55.51 | 48 | 660 | 796052 | 89831687 |
| 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 |
|---|---|---|---|---|---|---|
| Pruritus | 96.69 | 78.54 | 38 | 236 | 188733 | 42432328 |
| Dermatitis atopic | 85.74 | 78.54 | 19 | 255 | 12385 | 42608676 |
| 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 |
|---|---|---|---|---|---|---|
| Dermatitis atopic | 182.58 | 62.02 | 41 | 743 | 25500 | 110563015 |
| Pruritus | 156.04 | 62.02 | 77 | 707 | 581483 | 110007032 |
| Neurodermatitis | 124.58 | 62.02 | 21 | 763 | 2911 | 110585604 |
| Eczema | 93.16 | 62.02 | 30 | 754 | 72263 | 110516252 |
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| Source | Code | Description |
|---|---|---|
| ATC | D11AH12 | DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Agents for dermatitis, excluding corticosteroids |
| MeSH PA | D003879 | Dermatologic Agents |
| FDA EPC | N0000194121 | Interleukin-31 Receptor alpha Antagonist |
| FDA MoA | N0000194122 | Interleukin-31 Receptor alpha Antagonists |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pruritus associated with atopic dermatitis | indication | 24079001 | DOID:3310 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Interleukin-31 receptor subunit alpha | Cytokine | INHIBITOR | Kd | 9.43 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE |
| ID | Source |
|---|---|
| CHEBI:757240 | CHEBI |
| CHEMBL4297794 | ChEMBL_ID |
| C000612881 | MESH_SUPPLEMENTAL_RECORD_UI |
| 8720 | IUPHAR_LIGAND_ID |
| DB15252 | DRUGBANK_ID |
| 933506281000036107 | SNOMEDCT_US |
| 4043334 | VANDF |
| C4505530 | UMLSCUI |
| 10064 | INN_ID |
| D11080 | KEGG_DRUG |
| 43049 | MMSL |
| d10210 | MMSL |
| GN465U8B72 | UNII |
| 2691310 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| NEMLUVIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0299-6220 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 30 mg | SUBCUTANEOUS | BLA | 28 sections |