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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/01/26 | Phase 4 | Recruiting | Dr Cipto Mangunkusumo General Hospital | ||
2018/09/19 | Not Applicable | Recruiting | |||
2017/12/13 | Phase 4 | Completed | |||
2017/06/22 | N/A | Recruiting | |||
2016/04/04 | Phase 4 | UNKNOWN | Pavel Klein | ||
2015/10/01 | Phase 2 | Completed | |||
2015/10/01 | Phase 2 | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/07/11 | Phase 3 | Terminated | |||
2014/06/25 | Phase 3 | Withdrawn |
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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PHARMACOR CLOBAZAM clobazam 10 mg tablet blister pack | 316680 | Medicine | A | 6/22/2020 | |
FRISIUM clobazam 10mg tablet blister pack | 12400 | Medicine | A | 8/1/1991 | |
Frisium | 364330 | Medicine | A | 5/4/2021 | |
CLOBIUM clobazam 10 mg tablet bottle | 316683 | Medicine | A | 6/22/2020 | |
PHARMACOR CLOBAZAM clobazam 10 mg tablet bottle | 316682 | Medicine | A | 6/22/2020 | |
CLOBIUM clobazam 10 mg tablet blister pack | 316681 | Medicine | A | 6/22/2020 |