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Xcopri, Ontozry(cenobamate)
Ontozry, Xcopri (cenobamate) is a small molecule pharmaceutical. Cenobamate was first approved as Xcopri on 2020-03-10. It is used to treat partial epilepsies in the USA. It has been approved in Europe to treat epilepsy. It is known to target gamma-aminobutyric acid receptor subunit alpha-4 and gamma-aminobutyric acid receptor subunit alpha-6.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Xcopri
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cenobamate
Tradename
Company
Number
Date
Products
XCOPRISK Life ScienceN-212839 RX2020-03-10
6 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
xcopriNew Drug Application2020-10-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
partial epilepsiesEFO_0004263D004828—
Agency Specific
FDA
EMA
Expiration
Code
CENOBAMATE, XCOPRI, SK LIFE
2025-03-10NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Cenobamate, Xcopri, Sk Life
116541332039-06-16U-3610
75982792027-10-30DP
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX25: Cenobamate
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Partial epilepsiesD004828EFO_0004263122—16
SeizuresD012640G40.4——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—4————4
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCENOBAMATE
INNcenobamate
Description
Cenobamate, sold under the brand names Xcopri (US) and Ontozry (EU), is a medication used for the treatment of partial-onset seizures, a kind of epilepsy, in adults. It is taken by mouth.
Classification
Small molecule
Drug classtranquilizers/antiepileptics (propanediol and pentanediol groups)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NC(=O)O[C@@H](Cn1ncnn1)c1ccccc1Cl
Identifiers
PDB—
CAS-ID913088-80-9
RxCUI—
ChEMBL IDCHEMBL3989949
ChEBI ID—
PubChem CID11962412
DrugBankDB06119
UNII IDP85X70RZWS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GABRA4
GABRA4
GABRA6
GABRA6
Organism
Homo sapiens
Gene name
GABRA4
Gene synonyms
NCBI Gene ID
2557
Protein name
gamma-aminobutyric acid receptor subunit alpha-4
Protein synonyms
GABA(A) receptor subunit alpha-4, GABA(A) receptor, alpha 4, gamma-aminobutyric acid (GABA) A receptor, alpha 4, gamma-aminobutyric acid A receptor alpha 4, gamma-aminobutyric acid type A receptor alpha4 subunit
Uniprot ID
Q8IYR7
Mouse ortholog
Gabra4 (14397)
gamma-aminobutyric acid receptor subunit alpha-4 (Q9D6F4)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 168 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6 adverse events reported
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