SYMPAZAN (clobazam)
SYMPAZAN (clobazam) is a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). The medication is approved for use in both pediatric and adult patients 2 years of age or older. It is utilized as a supplemental therapy to help manage the seizure activity characteristic of this condition.
How SYMPAZAN Works
SYMPAZAN is a 1,5-benzodiazepine that targets the GABA A receptor within the central nervous system. While the exact mechanism is not fully understood, the drug is thought to bind to the benzodiazepine site of the receptor to potentiate GABAergic neurotransmission. This process enhances inhibitory signaling, which is believed to be responsible for its therapeutic effect.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-01
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- FILM
SYMPAZAN Approval History
What SYMPAZAN Treats
2 indicationsSYMPAZAN is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Seizures
- Lennox-Gastaut Syndrome
SYMPAZAN 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 in 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 in 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) , and Drug Interactions (7.1) ]. The use of benzodiazepines, including SYMPAZAN, 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 SYMPAZAN 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 SYMPAZAN, 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 SYMPAZAN 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 SYMPAZAN 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 in patients for whom alternative treatmen
SYMPAZAN 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.
Drugs Similar to SYMPAZAN
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.
SYMPAZAN FDA Label Details
Indications & Usage
FDA Label (PDF)SYMPAZAN 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 in patients...
Pro Intelligence Preview
Deep insights for SYMPAZAN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 21 active patents
Trial Analysis
- • 10 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment