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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
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 |
|---|---|---|---|---|
| XCOPRI | SK Life Science | N-212839 RX | 2020-03-10 | 6 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xcopri | New Drug Application | 2025-09-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| partial epilepsies | EFO_0004263 | D004828 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CENOBAMATE, XCOPRI, SK LIFE | |||
| 2025-03-10 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | 2 | 2 | — | 7 | 12 |
| Partial epilepsies | D004828 | EFO_0004263 | — | 1 | 3 | 2 | — | 2 | 8 |
| Generalized epilepsy | D004829 | — | — | — | — | 3 | — | — | 3 |
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 | — | — | — | 4 | — | — | — | — | 4 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | — | — | — | 1 | 2 |
| Drug misuse | D000076064 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Partial epilepsy motor | D020938 | EFO_1001089 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cenobamate |
| INN | cenobamate |
| 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 class | tranquilizers/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-ID | 913088-80-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989949 |
| ChEBI ID | — |
| PubChem CID | 11962412 |
| DrugBank | DB06119 |
| UNII ID | P85X70RZWS (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
GABRA4
GABRA4
GABRA6
GABRA6
Organism
Homo sapiens
Gene name
GABRA4
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
Gabra4 (14397)
gamma-aminobutyric acid receptor subunit alpha-4 (Q9D6F4)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 541 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,965 adverse events reported
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