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Nucala(mepolizumab)
Nucala (mepolizumab) is an antibody pharmaceutical. Mepolizumab was first approved as Nucala on 2015-11-04. It is used to treat asthma in the USA. It has been approved in Europe to treat asthma. The pharmaceutical is active against interleukin-5.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
immune system diseasesD007154
Trade Name
FDA
EMA
Nucala
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)
Mepolizumab
Tradename
Proper name
Company
Number
Date
Products
NucalamepolizumabGSKN-125526 RX2015-11-04
4 products
NucalamepolizumabGSKN-761122 RX2019-06-06
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
nucalaBiologic Licensing Application2020-09-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
asthmaEFO_0000270D001249J45
Agency Specific
FDA
EMA
Expiration
Code
mepolizumab, Nucala, GlaxoSmithKline LLC
2027-09-25Orphan excl.
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
R03: Drugs for obstructive airway diseases
R03D: Other systemic drugs for obstructive airway diseases in atc
R03DX: Other systemic drugs for obstructive airway diseases in atc
R03DX09: Mepolizumab
HCPCS
Code
Description
J2182
Injection, mepolizumab, 1 mg
Clinical
Clinical Trials
91 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J452514101344
Nasal polypsD009298HP_0100582J3312249
EosinophiliaD004802HP_0001880D72.121226
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Churg-strauss syndromeD015267EFO_0007208M30.123317
Hypereosinophilic syndromeD017681EFO_1001467D72.1111517
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.9267
Eosinophilic granulomaD004803C96.622
Virus diseasesD014777B3411
BronchitisD001991J4011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Eosinophilic esophagitisD057765EFO_0004232K20.0144
AngioedemaD000799EFO_0005532T78.311
Atopic dermatitisD003876EFO_0000274L2011
Bullous pemphigoidD010391EFO_0007187L1211
GastroenteritisD005759EFO_1001463K52.9111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059911
Healthy volunteers/patients11
Chronic urticariaD000080223L50.811
Hemophagocytic lymphohistiocytosisD051359D76.111
Granulomatosis with polyangiitisD014890EFO_0005297M31.311
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Aspirin-induced asthmaD055963HP_001204211
SinusitisD012852EFO_0007486J3211
BronchiectasisD001987HP_0002110J4711
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMEPOLIZUMAB
INNmepolizumab
Description
Mepolizumab, sold under the brand name Nucala, is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis, and hypereosinophilic syndrome (HES). It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID196078-29-2
RxCUI1720597
ChEMBL IDCHEMBL2108429
ChEBI ID
PubChem CID
DrugBankDB06612
UNII ID90Z2UF0E52 (ChemIDplus, GSRS)
Target
Agency Approved
IL5
IL5
Organism
Homo sapiens
Gene name
IL5
Gene synonyms
NCBI Gene ID
Protein name
interleukin-5
Protein synonyms
B-cell differentiation factor I, colony-stimulating factor, eosinophil, Eosinophil differentiation factor, T-cell replacing factor, TRF
Uniprot ID
Mouse ortholog
Il5 (16191)
interleukin-5 (P04401)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,869 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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5,743 adverse events reported
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