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brivaracetam (BRV) tablet
brivaracetam (BRV) tablet is a SV2A receptor agonist Small molecule drug developed by UCB Biopharma SRL. It is currently in Phase 3 development for Partial-onset seizures, Primary generalized tonic-clonic seizures. Also known as: BRV, Briviact.
Brivaracetam is a selective, high-affinity SV2A receptor agonist.
Brivaracetam is a small molecule that modulates synaptic vesicle glycoprotein 2A, a protein involved in neurotransmitter release. It is used to treat conditions such as epilepsy and has been studied in clinical trials for its potential effects on Unverricht-Lundborg Disease.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | brivaracetam (BRV) tablet |
|---|---|
| Also known as | BRV, Briviact |
| Sponsor | UCB Biopharma SRL |
| Drug class | SV2A receptor agonist |
| Target | SV2A |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
It modulates neurotransmitter release by binding to the synaptic vesicle protein SV2A, which is involved in the regulation of neurotransmitter release. This action is thought to contribute to its antiepileptic effects.
Approved indications
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
Common side effects
- Somnolence
- Fatigue
- Dizziness
- Nausea
- Headache
Key clinical trials
- Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy (PHASE3)
- 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 (PHASE3)
- A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures (PHASE3)
- A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants (PHASE1)
- A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants (PHASE1)
- Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults (PHASE3)
- A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- brivaracetam (BRV) tablet CI brief — competitive landscape report
- brivaracetam (BRV) tablet updates RSS · CI watch RSS
- UCB Biopharma SRL portfolio CI
Frequently asked questions about brivaracetam (BRV) tablet
What is brivaracetam (BRV) tablet?
How does brivaracetam (BRV) tablet work?
What is brivaracetam (BRV) tablet used for?
Who makes brivaracetam (BRV) tablet?
Is brivaracetam (BRV) tablet also known as anything else?
What drug class is brivaracetam (BRV) tablet in?
What development phase is brivaracetam (BRV) tablet in?
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What does brivaracetam (BRV) tablet target?
Related
- Drug class: All SV2A receptor agonist drugs
- Target: All drugs targeting SV2A
- Manufacturer: UCB Biopharma SRL — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Partial-onset seizures
- Indication: Drugs for Primary generalized tonic-clonic seizures
- Also known as: BRV, Briviact
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing