BRIVARACETAM
BRIVARACETAM is indicated for the treatment of Partial-Onset Seizures.
How BRIVARACETAM Works
The precise mechanism by which brivaracetam exerts its anticonvulsant activity is not fully known. The drug functions by displaying a high and selective affinity for synaptic vesicle protein 2A (SV2A) within the brain. This interaction with the SV2A protein is believed to contribute to the medication's therapeutic anticonvulsant effect.
Details
- Status
- Prescription
- First Approved
- 2022-06-09
- Routes
- INTRAVENOUS, ORAL
- Dosage Forms
- SOLUTION, TABLET
Companies
BRIVARACETAM Approval History
What BRIVARACETAM Treats
1 indicationsBRIVARACETAM is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
BRIVARACETAM 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.
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 BRIVARACETAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07563634 | QF-Brivaracetam-POS-302 | Ph 3 | completed | Long-term Safety and Efficacy of Adjunctive Brivaracetam in Chinese Patients With Uncontrolled Focal Epilepsy |
| NCT05639946 results posted | PMR-2022-30886 | Ph 3 | completed | Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
| NCT04666610 EXPAND | N01269 2020-002750-24, 2023-510428-55-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy |
| NCT05899764 EHAD | 22-001000 | Ph 1, Ph 2 | not yet recruiting | Epileptic Hippocampus in Alzheimer's Disease |
| NCT03083665 results posted | EP0083 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy |
| NCT04379011 results posted | Morse | Ph 1, Ph 2 | completed | Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury |
| NCT03250377 results posted | EP0085 | Ph 3 | completed | A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization |
| NCT04715646 | EP0156 2020-003664-29 | Ph 3 | recruiting | A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures |
| NCT05315947 results posted | EP0110 | Ph 1 | completed | A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants |
| NCT04882540 results posted | EP0101 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects |
| NCT01261325 BRITE results posted | N01358 2010-019361-28 | Ph 3 | completed | Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures |
| NCT03405714 results posted | EP0065 2016-002452-25 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy |
| NCT01339559 BRITE™ results posted | N01379 2010-020345-27 | Ph 3 | completed | Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy |
| NCT03685630 | EP0118 | Ph 3 | completed | A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization |
| NCT03021018 results posted | EP0087 | Ph 2 | completed | A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting |
| NCT03695094 results posted | UP0070 2018-001941-16 | Ph 1 | completed | A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil |
| NCT01710670 | EP0041 2012-002591-14 | Ph 1 | completed | A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects |
| NCT01728077 results posted | N01372 2012-000827-42 | Ph 3 | completed | Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy |
| NCT00761774 results posted | N01315 2008-001433-98 | Ph 3 | completed | An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam |
| NCT01653262 results posted | N01395 2011-005177-23 | Ph 3 | completed | Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV) |
| NCT00698581 results posted | N01276 2008-000144-14 | Ph 3 | terminated | A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures |
| NCT00699283 results posted | N01306 RPCE07F1216, 2008-000145-58 | Ph 3 | terminated | A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures |
| NCT00422422 results posted | N01263 2006-006536-22 | Ph 2 | completed | Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy. |
| NCT02602860 | EP0074 | Ph 1 | completed | A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers |
| NCT00736931 | N01297 | Ph 1 | completed | Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam |
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.
BRIVARACETAM FDA Label Details
Indications & Usage
BRIVARACETAM is indicated for the treatment of Partial-Onset Seizures.
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BRIVIACT
Full clinical data, patents, trials, and competitive landscape for brivaracetam.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.