clobazam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
diazepam derivatives	682	22316-47-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: clobazam clobazepam frisium frizium urbadan	A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY. Molecular weight: 300.74 Formula: C16H13ClN2O2 CLOGP: 2.44 LIPINSKI: 0 HAC: 4 HDO: 0 TPSA: 40.62 ALOGS: -3.26 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

clobazam
clobazepam
frisium
frizium
urbadan

A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.

Molecular weight: 300.74
Formula: C16H13ClN2O2
CLOGP: 2.44
LIPINSKI: 0
HAC: 4
HDO: 0
TPSA: 40.62
ALOGS: -3.26
ROTB: 1

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
20	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.08 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Oct. 21, 2011	FDA	LUNDBECK LLC

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Seizure	1494.10	19.19	735	17448	131899	63338940
Status epilepticus	601.31	19.19	208	17975	15025	63455814
Multiple-drug resistance	568.03	19.19	155	18028	5015	63465824
Epilepsy	491.72	19.19	210	17973	26855	63443984
Drug withdrawal convulsions	407.10	19.19	92	18091	1333	63469506
Psychogenic seizure	349.72	19.19	84	18099	1608	63469231
Drug resistance	277.11	19.19	134	18049	22799	63448040
Somnolence	274.58	19.19	295	17888	178390	63292449
Drug interaction	232.36	19.19	306	17877	228825	63242014
Partial seizures	231.23	19.19	80	18103	5762	63465077

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Seizure	1185.74	19.29	700	16595	104157	34835479
Status epilepticus	574.90	19.29	221	17074	12393	34927243
Multiple-drug resistance	366.40	19.29	126	17169	5113	34934523
Somnolence	335.01	19.29	339	16956	110777	34828859
Drug ineffective	310.27	19.29	688	16607	456063	34483573
Drug withdrawal convulsions	280.41	19.29	73	17222	1104	34938532
Epilepsy	263.50	19.29	152	17143	21343	34918293
Generalised tonic-clonic seizure	257.61	19.29	149	17146	21025	34918611
Aggression	196.33	19.29	159	17136	38805	34900831
Petit mal epilepsy	191.98	19.29	68	17227	3010	34936626

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Seizure	1676.29	17.43	962	27523	187872	79528031
Status epilepticus	999.90	17.43	365	28120	24676	79691227
Multiple-drug resistance	787.06	17.43	236	28249	8572	79707331
Epilepsy	644.27	17.43	307	28178	40553	79675350
Somnolence	528.46	17.43	531	27954	238450	79477453
Drug withdrawal convulsions	503.54	17.43	124	28361	2096	79713807
Psychogenic seizure	418.52	17.43	104	28381	1827	79714076
Drug ineffective	401.66	17.43	1057	27428	1079856	78636047
Generalised tonic-clonic seizure	385.39	17.43	223	28262	43687	79672216
Partial seizures	343.69	17.43	127	28358	8851	79707052

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Weight gain poor	27.56	27.02	10	257	72	89453

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Pharmacologic Action:

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Source	Code	Description
ATC	N05BA09	NERVOUS SYSTEM PSYCHOLEPTICS ANXIOLYTICS Benzodiazepine derivatives
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:50268	GABA modulators
FDA CS	M0002356	Benzodiazepines
FDA EPC	N0000175694	Benzodiazepine
FDA MoA	N0000182137	Cytochrome P450 2D6 Inhibitors
FDA MoA	N0000185506	Cytochrome P450 3A4 Inducers
MeSH PA	D014151	Anti-Anxiety Agents
MeSH PA	D000927	Anticonvulsants

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Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Lennox-Gastaut syndrome	indication	230418006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.14	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	SYMPAZAN	OTTER PHARMS	N210833	Nov. 1, 2018	RX	FILM	ORAL	11541002	Jan. 31, 2040	METHOD OF TREATING SEIZURES
20MG	SYMPAZAN	OTTER PHARMS	N210833	Nov. 1, 2018	RX	FILM	ORAL	11541002	Jan. 31, 2040	METHOD OF TREATING SEIZURES
5MG	SYMPAZAN	OTTER PHARMS	N210833	Nov. 1, 2018	RX	FILM	ORAL	11541002	Jan. 31, 2040	METHOD OF TREATING SEIZURES

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN	POSITIVE ALLOSTERIC MODULATOR				WOMBAT-PK	CHEMBL

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External reference:

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ID	Source
003693	NDDF
14923	MMSL
151794	RXNORM
2789	PUBCHEM_CID
2MRO291B4U	UNII
3055	INN_ID
387572002	SNOMEDCT_US
4025788	VUID
4025788	VANDF
66309	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0526	TABLET	10 mg	ORAL	ANDA	31 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0527	TABLET	20 mg	ORAL	ANDA	31 sections
clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0561	SOLUTION	2.50 mg	ORAL	ANDA	32 sections
clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0561	SOLUTION	2.50 mg	ORAL	ANDA	32 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8043	SUSPENSION	2.50 mg	ORAL	ANDA	35 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0378-8043	SUSPENSION	2.50 mg	ORAL	ANDA	35 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1681	TABLET	10 mg	ORAL	ANDA	32 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0527-1682	TABLET	20 mg	ORAL	ANDA	32 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5301	SUSPENSION	2.50 mg	ORAL	ANDA	33 sections
Clobazam	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5301	SUSPENSION	2.50 mg	ORAL	ANDA	33 sections

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