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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
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Onfi, Sympazan (generic drugs available since 2018-10-22)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clobazam
Tradename
Company
Number
Date
Products
ONFILundbeckN-202067 RX2011-10-21
2 products, RLD, RS
ONFILundbeckN-203993 RX2012-12-14
1 products, RLD, RS
SYMPAZANOtter PharmaceuticalsN-210833 RX2018-11-01
3 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
clobazamANDA2023-04-17
onfiNew Drug Application2021-02-18
sympazanNew Drug Application2020-08-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lennox gastaut syndromeD065768G40.81
seizuresHP_0007359D012640G40.4
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Clobazam, Sympazan, Otter Pharms
115410022040-01-31DPU-724
86035142024-04-03DP
87651672024-02-20DP
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05B: Anxiolytics
N05BA: Benzodiazepine derivative anxiolytics
N05BA09: Clobazam
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10294116
Subarachnoid hemorrhageD013345EFO_0000713I60213
Aortic aneurysmD001014EFO_0001666I71.9112
Cerebral hemorrhageD00254311
Pulmonary hypertensionD006976EFO_0001361I27.2011
Intracranial hemorrhagesD020300EFO_0000551I6211
Aortic diseasesD00101811
Brain neoplasmsD001932EFO_0003833C7111
EpilepsyD004827EFO_0000474G40.911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart failureD006333EFO_0003144I5022
DyspneaD004417HP_0002094R06.011
HemorrhageD006470MP_0001914R5811
StrokeD020521EFO_0000712I63.911
Blood pressureD001794EFO_000432511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Critical illnessD01663811
Intracranial aneurysmD002532EFO_0003870I67.111
Intracranial vasospasmD020301EFO_1000994G45.911
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Vascular diseasesD014652EFO_0004264I7711
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCLOBAZAM
INNclobazam
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 classBenzodiazepine
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21
Identifiers
PDB
CAS-ID22316-47-8
RxCUI21241
ChEMBL IDCHEMBL70418
ChEBI ID31413
PubChem CID2789
DrugBankDB00349
UNII ID2MRO291B4U (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Sympazan - Assertio Therapeutics
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,123 documents
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Safety
Black-box Warning
Black-box warning for: Clobazam, Onfi, Sympazan
Adverse Events
Top Adverse Reactions
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278 adverse events reported
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