ONFI (clobazam)
ONFI (clobazam) is a benzodiazepine indicated for the adjunctive treatment of seizures in patients with Lennox-Gastaut syndrome (LGS). It is approved for use in pediatric and adult populations aged 2 years and older. As an adjunctive therapy, it is used in combination with other medications to manage the specific seizure types associated with this condition.
How ONFI Works
Clobazam is a 1,5-benzodiazepine that is thought to work by modulating neurotransmission in the central nervous system. The drug binds to the benzodiazepine site of the GABA A receptor, which potentiates GABAergic neurotransmission. This action enhances the inhibitory effects of GABA, which is believed to be the mechanism by which the drug produces its anticonvulsant effects.
Details
- Status
- Prescription
- First Approved
- 2011-10-21
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
ONFI Approval History
What ONFI Treats
2 indicationsONFI is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Seizures
- Lennox-Gastaut Syndrome
ONFI Boxed Warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Prec...
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . The use of benzodiazepines, including ONFI, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing ONFI and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )] . The continued use of benzodiazepines, including ONFI, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of ONFI after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue ONFI or reduce the dosage [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )] . WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are
ONFI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02565108 results posted | GWEP1428 Blinded Phase 2014-002942-33 | Ph 2 | completed | A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol |
| NCT02564952 results posted | GWEP1428 Open-Label Extension 2014-002942-33 | Ph 2 | completed | An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol |
| NCT03371836 results posted | onfi90037 | Ph 4 | completed | Use of Clobazam for Epilepsy and Anxiety |
| NCT02134366 | EPC-1 | Ph 3 | terminated | Clobazam Use in Epilepsia Partialis Continua - Pilot Study |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02187809 results posted | 14362B | Ph 3 | terminated | Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome |
| NCT01179828 Predictio | KEK 213/09 grant: SPUM no. 33CM30_124117 | Ph 3 | completed | Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio) |
| NCT02174094 | 14362A | Ph 3 | withdrawn | Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome |
| NCT01291316 | GABA-SPUM | Ph 1, Ph 2 | completed | GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation |
| NCT01011036 | 152/09 SNF SPUM no.33CM30_124117 | Ph 3 | completed | Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ONFI FDA Label Details
Indications & Usage
FDA Label (PDF)ONFI is indicated for the treatment of Seizures; Lennox-Gastaut Syndrome.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.