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AboutPricing
Drug ReportsMepolizumab
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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Clinical
Drug
Target
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Financial
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Safety
Events Timeline
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1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
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
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 Application2023-03-08
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
132 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_0000270J45151551339
Pulmonary eosinophiliaD011657EFO_0007257J82.8133511
EosinophiliaD004802HP_0001880D72.1112115
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD01357712518
Churg-strauss syndromeD015267EFO_0007208M30.112338
Hypereosinophilic syndromeD017681EFO_1001467D72.11516
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.92416
Granulomatosis with polyangiitisD014890EFO_0005297M31.3325
Systemic vasculitisD056647314
Nasal polypsD009298HP_0100582J331124
Eosinophilic granulomaD004803C96.6213
Lung diseasesD008171HP_0002088J98.4213
PolypsD011127EFO_000066222
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Eosinophilic esophagitisD057765EFO_0004232K20.033
EsophagitisD004941HP_0100633K2033
Atopic dermatitisD003876EFO_0000274L2011
EczemaD004485HP_0000964L30.911
DermatitisD003872HP_0011123L30.911
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FasciitisD005208HP_0100537M72.911
Chronic urticariaD000080223L50.811
UrticariaD014581EFO_0005531L5011
SinusitisD012852EFO_0007486J3211
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Airway remodelingD05615111
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)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
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
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
Top Adverse Reactions
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36,817 adverse events reported
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