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 diseases | D009422 |
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 |
|---|---|---|---|---|---|
| Emgality | galcanezumab-gnlm | Eli Lilly | N-761063 RX | 2018-09-27 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| emgality | Biologic Licensing Application | 2020-09-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cluster headache | HP_0012199 | D003027 | G44.00 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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 disorders | D008881 | EFO_0003821 | G43 | 3 | 3 | 7 | 4 | 3 | 20 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | — | — | 1 | — | 1 |
| Glossopharyngeal nerve diseases | D020435 | G52.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | 3 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 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 aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 1 | 1 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GALCANEZUMAB |
| INN | galcanezumab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1578199-75-3 |
| RxCUI | 2058846 |
| ChEMBL ID | CHEMBL3707328 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14042 |
| UNII ID | 55KHL3P693 (ChemIDplus, GSRS) |
Target
Agency Approved
CALCA
CALCA
Organism
Homo sapiens
Gene name
CALCA
Gene synonyms
CALC1
NCBI Gene ID
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
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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€
£
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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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