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
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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
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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 | — | 3 | 2 | 7 | 3 | 15 |
| Drug resistant epilepsy | D000069279 | — | — | — | — | — | 3 | 1 | 4 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | — | 2 | — | 2 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | 1 | — | 2 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | — | — | 1 | — | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | 3 | — | 1 | 4 |
| Seizures | D012640 | — | G40.4 | — | 1 | 2 | — | — | 3 |
| Lennox gastaut syndrome | D065768 | — | G40.81 | — | 1 | 2 | — | — | 3 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | 1 | 2 |
| Myoclonic epilepsies | D004831 | EFO_1001900 | G40.4 | — | — | 2 | — | — | 2 |
| Generalized epilepsy | D004829 | — | — | — | 1 | 1 | — | — | 2 |
| Tuberous sclerosis | D014402 | — | Q85.1 | — | — | 1 | — | — | 1 |
| Sclerosis | D012598 | — | — | — | — | 1 | — | — | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuralgia | D009437 | EFO_0009430 | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
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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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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,375 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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