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Drug ReportsNemolizumab
Nemolizumab
Nemluvio (nemolizumab) is an antibody pharmaceutical. Nemolizumab was first approved as Nemluvio on 2024-08-12. It is used to treat prurigo in the USA. The pharmaceutical is active against interleukin-31 receptor subunit alpha.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Nemluvio
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Nemolizumab
Tradename
Proper name
Company
Number
Date
Products
Nemluvionemolizumab-iltoGaldermaN-761390 RX2024-08-12
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
nemluvioBiologic Licensing Application2024-08-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prurigo—D011536L28.2
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L20—64——10
DermatitisD003872HP_0011123L30.9—64——10
EczemaD004485HP_0000964L30.9—54——9
PrurigoD011536—L28.2—14——5
NeurodermatitisD009450—L28.0——4——4
Chronic renal insufficiencyD051436—N18—11——1
Kidney diseasesD007674EFO_0003086N08—11——1
PruritusD011537HP_0000989L29—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Systemic sclerodermaD012595EFO_0000717M34.0—1———1
Diffuse sclerodermaD045743EFO_0000404——1———1
SclerosisD012598———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNemolizumab
INNnemolizumab
Description
Nemolizumab is an experimental drug for the treatment of itching in people with atopic dermatitis. It is a monoclonal antibody that blocks the interleukin-31 receptor A. Results of a Phase II clinical trial were published in March 2017.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297794
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDGN465U8B72 (ChemIDplus, GSRS)
Target
Agency Approved
IL31RA
IL31RA
Organism
Homo sapiens
Gene name
IL31RA
Gene synonyms
CRL3, GPL
NCBI Gene ID
Protein name
interleukin-31 receptor subunit alpha
Protein synonyms
class I cytokine receptor, Cytokine receptor-like 3, GLM-R, Gp130-like monocyte receptor, Gp130-like receptor, hGLM-R, IL-31 receptor subunit alpha, IL-31R subunit alpha, soluble type I cytokine receptor CRL3, ZcytoR17
Uniprot ID
Mouse ortholog
Il31ra (218624)
interleukin-31 receptor subunit alpha (Q8R501)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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