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Drug ReportsEptinezumab
Vyepti(eptinezumab)
Vyepti (eptinezumab) is an antibody pharmaceutical. Eptinezumab was first approved as Vyepti on 2020-02-21. 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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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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FDA approval date
EMA approval date
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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
nervous system diseasesD009422
Trade Name
FDA
EMA
Vyepti
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)
Eptinezumab
Tradename
Proper name
Company
Number
Date
Products
Vyeptieptinezumab-jjmrLundbeckN-761119 RX2020-02-21
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
vyeptiBiologic Licensing Application2024-08-30
Indications
FDA
EMA
No data
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
— N02CD05: Eptinezumab
HCPCS
Code
Description
J3032
Injection, eptinezumab-jjmr, 1 mg
Clinical
Clinical Trials
33 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_0003821G431—93—13
HeadacheD006261—R51——31—4
Secondary headache disordersD051271————11—2
Prescription drug overuseD000067490————11—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cluster headacheD003027—G44.00——2——2
EmergenciesD004630————1——1
Indications Phases 2
No data
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
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEptinezumab
INNeptinezumab
Description
Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. It is administered by intravenous infusion.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3833320
ChEBI ID—
PubChem CID—
DrugBankDB14040
UNII ID8202AY8I7H (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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 721 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,423 adverse events reported
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