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Emgality(galcanezumab)
Emgality (galcanezumab) is an antibody pharmaceutical. Galcanezumab was first approved as Emgality on 2018-09-27. It is used to treat cluster headache in the USA. It has been approved in Europe to treat migraine disorders. The pharmaceutical is active against calcitonin; calcitonin gene-related peptide 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Emgality
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)
Galcanezumab
Tradename
Proper name
Company
Number
Date
Products
Emgalitygalcanezumab-gnlmEli LillyN-761063 RX2018-09-27
3 products
Labels
FDA
EMA
Brand Name
Status
Last Update
emgalityBiologic Licensing Application2020-09-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cluster headacheHP_0012199D003027G44.00
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02C: Antimigraine preparations
— N02CD: Calcitonin gene-related peptide (cgrp) antagonists
— N02CD02: Galcanezumab
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G433374320
Trigeminal neuralgiaD014277EFO_1001219G50.0———1—1
Glossopharyngeal nerve diseasesD020435G52.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cluster headacheD003027HP_0012199G44.00——3——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Knee osteoarthritisD020370EFO_0004616M17—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine without auraD020326EFO_0005296G43.0————11
Migraine with auraD020325EFO_0005295G43.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGALCANEZUMAB
INNgalcanezumab
Description
Galcanezumab, sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine. It is also used for cluster headaches.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1578199-75-3
RxCUI2058846
ChEMBL IDCHEMBL3707328
ChEBI ID—
PubChem CID—
DrugBankDB14042
UNII ID55KHL3P693 (ChemIDplus, GSRS)
Target
Agency Approved
CALCA
CALCA
Organism
Homo sapiens
Gene name
CALCA
Gene synonyms
CALC1
NCBI Gene ID
796
Protein name
calcitonin; calcitonin gene-related peptide 1
Protein synonyms
Alpha-type CGRP, calcitonin 1, Calcitonin gene-related peptide I, calcitonin/calcitonin-related polypeptide, alpha, CGRP-I, katacalcin
Uniprot ID
Q52LX7
Mouse ortholog
Calca (12310)
calcitonin gene-related peptide 1 (Q99JA0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Emgality - Eli Lilly
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 724 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,250 adverse events reported
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