Clobazam
Clobazam, Onfi, Sympazan (clobazam) is a small molecule pharmaceutical. Clobazam was first approved as Onfi on 2011-10-21. It is used to treat lennox gastaut syndrome and seizures in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Clobazam, Onfi, Sympazan (discontinued: Clobazam, Onfi)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| clobazam | ANDA | 2025-03-21 |
| clobazam clobazam | ANDA | 2022-12-14 |
| onfi | New Drug Application | 2024-03-25 |
| sympazan | New Drug Application | 2024-03-12 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | 2 | 2 | — | 5 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | — | 1 | — | 1 |
| Drug resistant epilepsy | D000069279 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lennox gastaut syndrome | D065768 | — | G40.81 | — | 1 | 2 | — | — | 3 |
| Syndrome | D013577 | — | — | — | — | 3 | — | — | 3 |
| Myoclonic epilepsies | D004831 | EFO_1001900 | G40.4 | — | — | 2 | — | — | 2 |
| Seizures | D012640 | — | G40.4 | — | 1 | 1 | — | — | 2 |
| Generalized epilepsy | D004829 | — | — | — | 1 | 1 | — | — | 2 |
| Epilepsia partialis continua | D017036 | EFO_1000924 | G40.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Clobazam |
| INN | clobazam |
| Description | Clobazam is 7-Chloro-1H-1,5-benzodiazepine-2,4(3H,5H)-dione in which the hydrogen attached to the nitrogen at position 1 is substituted by a methyl group, whilst that attached to the other nitrogen is substituted by a phenyl group. It is used for the short-term management of acute anxiety and as an adjunct in the treatment of epilepsy in association with other antiepileptics. It has a role as an anticonvulsant, an anxiolytic drug and a GABA modulator. It is a 1,4-benzodiazepinone and an organochlorine compound. |
| Classification | Small molecule |
| Drug class | Benzodiazepine |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21 |
Identifiers
| PDB | — |
| CAS-ID | 22316-47-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL70418 |
| ChEBI ID | 31413 |
| PubChem CID | 2789 |
| DrugBank | DB00349 |
| UNII ID | 2MRO291B4U (ChemIDplus, GSRS) |
Target
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Sympazan – Assertio Therapeutics
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Trends
PubMed Central
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Additional graphs summarizing 6,430 documents
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Safety
Black-box Warning
Black-box warning for: Clobazam, Clobazam clobazam, Onfi, Sympazan
Adverse Events
Top Adverse Reactions
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12,860 adverse events reported
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