MedPath

Clobazam

Generic Name
Clobazam
Brand Names
Onfi, Sympazan
Drug Type
Small Molecule
Chemical Formula
C16H13ClN2O2
CAS Number
22316-47-8
Unique Ingredient Identifier
2MRO291B4U

Overview

Clobazam belongs to the 1,5-benzodiazepine class of drugs and is marketed under different names, Onfi, Frisium, Urbanyl, and others.. Clobazam was first synthesized in 1966 and first published in 1969, following the incidental synthesis and discovery of the first benzodiazepine chlordiazepoxide in the 1950s. Unlike older 1,4-benzodiazepines, clobazam has a better side-effects profile, particularly less sedative and amnesic effects. This is likely because of clobazam's higher affinity to the α subunit of the GABA receptor, which mediates anxiolytic effects, than the α subunit, which mediates sedative effect. Additionally, clobazam is believed to be a partial agonist to the GABA receptor rather than non-selective full receptor agonists like 1,4-benzodiazepines, thus potentially explaining the decreased incidence of sedative effects. Clobazam has been marketed as an anxiolytic since 1975 and an anticonvulsant since 1984. In October 21, 2011, the FDA approved clobazam as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children aged two years and older. In 2005, clobazam also received approval from Health Canada as an add-on therapy for generalized tonic-clonic, myoclonic, and focal impaired awareness seizures.

Background

Clobazam belongs to the 1,5-benzodiazepine class of drugs and is marketed under different names, Onfi, Frisium, Urbanyl, and others.. Clobazam was first synthesized in 1966 and first published in 1969, following the incidental synthesis and discovery of the first benzodiazepine chlordiazepoxide in the 1950s. Unlike older 1,4-benzodiazepines, clobazam has a better side-effects profile, particularly less sedative and amnesic effects. This is likely because of clobazam's higher affinity to the α subunit of the GABA receptor, which mediates anxiolytic effects, than the α subunit, which mediates sedative effect. Additionally, clobazam is believed to be a partial agonist to the GABA receptor rather than non-selective full receptor agonists like 1,4-benzodiazepines, thus potentially explaining the decreased incidence of sedative effects. Clobazam has been marketed as an anxiolytic since 1975 and an anticonvulsant since 1984. In October 21, 2011, the FDA approved clobazam as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome in adults and children aged two years and older. In 2005, clobazam also received approval from Health Canada as an add-on therapy for generalized tonic-clonic, myoclonic, and focal impaired awareness seizures.

Indication

Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Associated Conditions

  • Anxiety
  • Catamenial Epilepsy
  • Refractory Status Epilepticus
  • Seizures
  • Status Epilepticus

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Amneal Pharmaceuticals NY LLC
69238-1306
ORAL
20 mg in 1 1
3/27/2023
Zydus Pharmaceuticals USA Inc.
70710-1326
ORAL
20 mg in 1 1
11/8/2022
Breckenridge Pharmaceutical, Inc.
51991-901
ORAL
20 mg in 1 1
1/1/2023
Bionpharma Inc.
69452-116
ORAL
2.5 mg in 1 mL
12/26/2023
Aurobindo Pharma Limited
59651-401
ORAL
2.5 mg in 1 mL
5/26/2023
Micro Labs Limited
42571-315
ORAL
10 mg in 1 1
3/20/2024
Ascend Laboratories, LLC
67877-665
ORAL
10 mg in 1 1
9/28/2023
Breckenridge Pharmaceutical, Inc.
51991-958
ORAL
5 mg in 1 1
1/1/2023
Sandoz Inc.
0781-8014
ORAL
20 mg in 1 1
2/22/2021
VistaPharm, LLC
66689-058
ORAL
2.5 mg in 1 mL
3/13/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
FRISIUM 10 TABLET 10 mg
SIN01591P
TABLET
10 mg
6/1/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Clobazam Tablets
国药准字HJ20250003
化学药品
片剂
1/2/2025
Clobazam Tablets
国药准字HJ20250002
化学药品
片剂
1/2/2025
Clobazam Tablets
国药准字H20223677
化学药品
片剂
9/14/2022
Clobazam Tablets
国药准字H20223678
化学药品
片剂
9/14/2022

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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